WorldWideScience

Sample records for current regulatory environment

  1. Current Regulations and Regulatory Actions

    Science.gov (United States)

    This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

  2. 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.

  3. Current status of developmental neurotoxicity: regulatory view

    DEFF Research Database (Denmark)

    Hass, Ulla

    2003-01-01

    . 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...... 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...

  4. 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.

  5. Current european regulatory perspectives on insulin analogues

    Directory of Open Access Journals (Sweden)

    Enzmann Harald G

    2011-07-01

    Full Text Available Abstract Insulin analogues are increasingly considered as an alternative to human insulin in the therapy of diabetes mellitus. Insulin analogues (IAs are chemically different from human insulin and may have different pharmacokinetic or pharmacodynamic properties. The significance of the modifications of the insulin molecule for the safety profile of IAs must be considered. This review describes the regulatory procedure and the expectations for the scientific content of European marketing authorization applications for innovative IAs submitted to the European Medicines Agency. Particular consideration is given to a potential cancer hazard. Specific regulatory guidance on how to address a possible carcinogenic or tumor promoting effect of innovative IAs in non-clinical studies is available. After marketing authorization, the factual access of patients to the new product will be determined to great extent by health technology assessment bodies, reimbursement decisions and the price. Whereas the marketing authorization is a European decision, pricing and reimbursement are national or regional responsibilities. The assessment of benefit and risk by the European Medicines Agency is expected to influence future decisions on price and reimbursement on a national or regional level. Collaborations between regulatory agencies and health technology assessment bodies have been initiated on European and national level to facilitate the use of the European Medicines Agency's benefit risk assessment as basis on which to build the subsequent health technology assessment. The option for combined or joint scientific advice procedures with regulators and health technology assessment bodies on European level or on a national level in several European Member States may help applicants to optimize their development program and dossier preparation in regard of both European marketing authorization application and reimbursement decisions.

  6. 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...... for a network of regulatory actors with different regulatory purposes....

  7. 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.

  8. Regulatory environment and claims - limits and opportunities.

    Science.gov (United States)

    Martin, Ambroise

    2010-01-01

    During the past decade, the use of claims became more and more important in many countries in relation to the increased awareness of consumer about the link between foods and health, offering to industry a valuable opportunity to differentiate and valorize their products and to promote innovation. However, more and more stringent regulations are developed, all based on the general principles adopted by the Codex Alimentarius Commission. In addition to the different regulatory processes and administrative requirements according to the country, the high level (and cost) of scientific substantiation of claims, the constraints introduced by nutrient profiles and the poor knowledge of the impact on consumer depending on the cultural contexts may limit these opportunities or, at least complicate their use. All these issues are briefly analyzed, highlighting some striking convergences and differences between countries.

  9. 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

  10. Regulatory environment for clinical research: Recent past and expected future

    Science.gov (United States)

    Bhave, Amita; Menon, Suresh

    2017-01-01

    In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest.

  11. Favorable genomic environments for cis-regulatory evolution: A novel theoretical framework.

    Science.gov (United States)

    Maeso, Ignacio; Tena, Juan J

    2016-09-01

    Cis-regulatory changes are arguably the primary evolutionary source of animal morphological diversity. With the recent explosion of genome-wide comparisons of the cis-regulatory content in different animal species is now possible to infer general principles underlying enhancer evolution. However, these studies have also revealed numerous discrepancies and paradoxes, suggesting that the mechanistic causes and modes of cis-regulatory evolution are still not well understood and are probably much more complex than generally appreciated. Here, we argue that the mutational mechanisms and genomic regions generating new regulatory activities must comply with the constraints imposed by the molecular properties of cis-regulatory elements (CREs) and the organizational features of long-range chromatin interactions. Accordingly, we propose a new integrative evolutionary framework for cis-regulatory evolution based on two major premises for the origin of novel enhancer activity: (i) an accessible chromatin environment and (ii) compatibility with the 3D structure and interactions of pre-existing CREs. Mechanisms and DNA sequences not fulfilling these premises, will be less likely to have a measurable impact on gene expression and as such, will have a minor contribution to the evolution of gene regulation. Finally, we discuss current comparative cis-regulatory data under the light of this new evolutionary model, and propose that the two most prominent mechanisms for the evolution of cis-regulatory changes are the overprinting of ancestral CREs and the exaptation of transposable elements.

  12. Liquid Biopsies in Oncology and the Current Regulatory Landscape.

    Science.gov (United States)

    Strotman, Lindsay N; Millner, Lori M; Valdes, Roland; Linder, Mark W

    2016-10-01

    There is a profound need in oncology to detect cancer earlier, guide individualized therapies, and better monitor progress during treatment. Currently, some of this information can be achieved through solid tissue biopsy and imaging. However, these techniques are limited because of the invasiveness of the procedure and the size of the tumor. A liquid biopsy can overcome these barriers as its non-invasive nature allows samples to be collected over time. Liquid biopsies may also allow earlier detection than traditional imaging. Liquid biopsies include the analysis of circulating tumor cells (CTCs), cell-free nucleic acid (cfNA), or extracellular vesicles obtained from a variety of biofluids, such as peripheral blood. In this review, we discuss different liquid biopsy types and how they fit into the current regulatory landscape.

  13. 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

  14. 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

  15. 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

  16. 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 regulat......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...

  17. 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

  18. Prebiotics and the health benefits of fiber: current regulatory status, future research, and goals.

    Science.gov (United States)

    Brownawell, Amy M; Caers, Wim; Gibson, Glenn R; Kendall, Cyril W C; Lewis, Kara D; Ringel, Yehuda; Slavin, Joanne L

    2012-05-01

    First defined in the mid-1990s, prebiotics, which alter the composition and activity of gastrointestinal (GI) microbiota to improve health and well-being, have generated scientific and consumer interest and regulatory debate. The Life Sciences Research Organization, Inc. (LSRO) held a workshop, Prebiotics and the Health Benefits of Fiber: Future Research and Goals, in February 2011 to assess the current state of the science and the international regulatory environment for prebiotics, identify research gaps, and create a strategy for future research. A developing body of evidence supports a role for prebiotics in reducing the risk and severity of GI infection and inflammation, including diarrhea, inflammatory bowel disease, and ulcerative colitis as well as bowel function disorders, including irritable bowel syndrome. Prebiotics also increase the bioavailability and uptake of minerals and data suggest that they reduce the risk of obesity by promoting satiety and weight loss. Additional research is needed to define the relationship between the consumption of different prebiotics and improvement of human health. New information derived from the characterization of the composition and function of different prebiotics as well as the interactions among and between gut microbiota and the human host would improve our understanding of the effects of prebiotics on health and disease and could assist in surmounting regulatory issues related to prebiotic use.

  19. 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.

  20. 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

  1. 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.

  2. 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.

  3. Environment protection: The current challenge in radioecology

    Directory of Open Access Journals (Sweden)

    Bréchignac F.

    2012-04-01

    Full Text Available 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.

  4. 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.

  5. 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.

  6. Cloud based spectrum manager for future wireless regulatory environment

    CSIR Research Space (South Africa)

    Masonta, MT

    2015-12-01

    Full Text Available and economic manifestation and, thus, a versatile tool would be desirable to deal with technical, economic and socio-economic objectives in various bands. While approaches based on geolocation spectrum databases and radio environment map architecture have...

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

    Science.gov (United States)

    Tsai, Wen-Tien

    2010-01-01

    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. PMID:21139852

  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. 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...

  10. Risk assessment of GM trees in the EU: current regulatory framework and guidance

    Directory of Open Access Journals (Sweden)

    Aguilera J

    2013-04-01

    Full Text Available The use of genetically modified organisms - their release into the environment, import, and utilisation as food/feed or food/feed ingredients - is regulated in the European Union (EU. For placing onto the market, current legislations require a comprehensive and science-based risk assessment. This risk assessment (RA is performed by applicants and then evaluated by national authorities in close cooperation with the European Food Safety Authority (EFSA. The EFSA Panel on Genetically Modified Organisms (GMO has published a comprehensive set of guidance documents for applicants and risk assessors for the RA of GM plants (GMP, their products for food and/or feed use, and their cultivation. In those documents, the strategy and the criteria to conduct the assessment are explained, as well as the scientific data to be provided by the applicant. The assessment starts with the molecular characterisation of the GMP. If the GMP or products derived from it are to be consumed, the evaluation of its composition, potential toxicity and/or allergenicity, and nutritional value constitute further cornerstones of the process. The environmental risk assessment (ERA considers biotic and abiotic interactions and the impacts of the management of the GM plant when it is intended for cultivation. In the case of GM trees special emphasis would be placed on assessing their characteristic features such as their longevity, ability to disperse and their ecological significance in a range of environments. The outcome of the assessment is reflected in a published opinion from the EFSA GMO panel that indicates whether the GMP and its products raise any safety issues. This scientific opinion constitutes one of the elements taken into account by the different European regulatory authorities prior to a decision regarding authorisation to commercialise the product.

  11. Data Integrity-A Study of Current Regulatory Thinking and Action.

    Science.gov (United States)

    Shafiei, Nader; De Montardy, Regis; Rivera-Martinez, Edwin

    2015-01-01

    In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls. These case studies largely represent position of the U.S. Food and Drug Administration and the regulatory agencies affiliated with the European Medicines Agency. Also discussed is the role of human factors as a potential source of data integrity problems. The article concludes by recommending some remedial controls that could be established to avoid or reduce occurrences of data integrity problems.Lay Abstract: In fulfilling their mission to protect public health, regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency) must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. The level of confidence they build is directly proportional to the scientific validity and integrity of data presented to them by the sponsors of medical products. In this article we present analysis of 65 case studies that document regulatory action taken by various regulatory agencies on breach of data integrity between 2002 and 2014. The ensuing discussion on current trends largely represents position of the U.S. Food and Drug Administration and European Medicines Agency. The article concludes by proposing some remedial controls that could be established by pharmaceutical companies to avoid or reduce

  12. PDA PAC iAM 2017 Survey on Post Approval Change Is the regulatory environment hindering much needed innovation in the Pharma Industry?

    Science.gov (United States)

    Seymour, Melissa

    2017-08-17

    As part of the effort to identify, assess and address current barriers to PACs, the PDA administered a global, blinded, cross-functional survey to document industry experience with PACs in the current global regulatory environment, and to better understand the regulatory complexity and burden on the industry. The survey interrogated on specific points related to annual volume of PACs, reasons, time commitments/cycle time, impact of regional differences on change implementation, current use of tools (e.g. PACMPs), impact on supply chain complexity (e.g. inventory, variants to manage, non-compliance to filings, drug shortages), manufacturing innovation, and resources needed. Copyright © 2017, Parenteral Drug Association.

  13. Cognitive radio: aligning the regulatory environment with the technology, a business case perspective

    NARCIS (Netherlands)

    Anker, P.D.C.; Lemstra, W.

    2012-01-01

    This paper proposes to use the perspective of the business case to deal with the alignment between the introduction of new technology and the regulatory environment. Although this perspective can be used more generally this paper deals with this perspective in the context of the alignment between

  14. 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.

  15. 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.

  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. Current and emergent strategies for disinfection of hospital environments.

    Science.gov (United States)

    Abreu, Ana C; Tavares, Rafaela R; Borges, Anabela; Mergulhão, Filipe; Simões, Manuel

    2013-12-01

    A significant number of hospital-acquired infections occur due to inefficient disinfection of hospital surfaces, instruments and rooms. The emergence and wide spread of multiresistant forms of several microorganisms has led to a situation where few compounds are able to inhibit or kill the infectious agents. Several strategies to disinfect both clinical equipment and the environment are available, often involving the use of antimicrobial chemicals. More recently, investigations into gas plasma, antimicrobial surfaces and vapour systems have gained interest as promising alternatives to conventional disinfectants. This review provides updated information on the current and emergent disinfection strategies for clinical environments.

  18. 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.

  19. 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).

  20. 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)

  1. Current status and regulatory perspective of chimeric antigen receptor-modified T cell therapeutics.

    Science.gov (United States)

    Kim, Mi-Gyeong; Kim, Dongyoon; Suh, Soo-Kyung; Park, Zewon; Choi, Min Joung; Oh, Yu-Kyoung

    2016-04-01

    Chimeric antigen receptor-modified T cells (CAR-T) have emerged as a new modality for cancer immunotherapy due to their potent efficacy against terminal cancers. CAR-Ts are reported to exert higher efficacy than monoclonal antibodies and antibody-drug conjugates, and act via mechanisms distinct from T cell receptor-engineered T cells. These cells are constructed by transducing genes encoding fusion proteins of cancer antigen-recognizing single-chain Fv linked to intracellular signaling domains of T cell receptors. CAR-Ts are classified as first-, second- and third-generation, depending on the intracellular signaling domain number of T cell receptors. This review covers the current status of CAR-T research, including basic proof-of-concept investigations at the cell and animal levels. Currently ongoing clinical trials of CAR-T worldwide are additionally discussed. Owing to the lack of existing approved products, several unresolved concerns remain with regard to safety, efficacy and manufacturing of CAR-T, as well as quality control issues. In particular, the cytokine release syndrome is the major side-effect impeding the successful development of CAR-T in clinical trials. Here, we have addressed the challenges and regulatory perspectives of CAR-T therapy.

  2. 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.

  3. Future improvements and implementation of animal care practices within the animal testing regulatory environment.

    Science.gov (United States)

    Guittin, Pierre; Decelle, Thierry

    2002-01-01

    Animal welfare is an increasingly important concern when considering biomedical experimentation. Many of the emerging regulations and guidelines specifically address animal welfare in laboratory animal care and use. The current revision of the appendix of the European Convention, ETS123 (Council of Europe), updates and improves on the current animal care standardization in Europe. New guidelines from the Organisation for Economic Co-operation and Development and the European Federation of Pharmaceutical Industries Association focus specifically on safety testing. These guidelines will affect the way toxicity studies are conducted and therefore the global drug development process. With the 3Rs principles taken into account, consideration regarding animal welfare will demand changes in animal care practices in regulatory safety testing. The most significant future improvements in animal care and use practices are likely to be environmental enrichment, management of animal pain and distress, and improved application of the humane endpoints. Our challenge is to implement respective guidelines based on scientific data and animal welfare, through a complex interplay of regulatory objective and public opinion. The current goal is to work toward solutions that continue to provide relevant animal models for risk assessment in drug development and that are science based. In this way, future improvements in animal care and use practices can be founded on facts, scientific results, and analysis. Some of these improvements become common practice in some countries. International harmonization can facilitate the development and practical application of "best scientific practices" by the consensus development process that harmonization requires. Since the implementation of good laboratory practices (GLP) standards in safety testing, these new regulations and recommendations represent a new way forward for animal safety studies.

  4. The roles of regulatory focus and medical recommendation avatars' trustworthiness in virtual environment-based e-health.

    Science.gov (United States)

    Jin, Seung-A Annie

    2010-08-01

    This study examined the influence of regulatory focus and medical recommendation avatars' trustworthiness in avatar-based e-health within 3D virtual environments (VEs). Drawing on Higgins's regulatory focus theory and the existing literature on self-construal, a 2 x 2 (regulatory focus: promotion vs. prevention by interdependent self-construal: low vs. high) between-participants factorial design experiment tested the moderating role of health consumers' interdependent self-construal in determining the effects of regulatory focus in VE-based e-health. Results showed an interaction effect of regulatory focus and interdependent self-construal such that VE users with a dominant interdependent self-construal indicated greater issue familiarity and involvement when exposed to a prevention-focused e-health intervention than when exposed to a promotion-focused e-health intervention, whereas the effects of regulatory focus on issue familiarity and involvement among users low in interdependent self-construal demonstrated the opposite pattern. A path analysis further revealed that VE users' evaluation of a medical recommendation avatar's trustworthiness mediated the effects regulatory focus had on their perceived informational and educational values of the health messages. Theoretical contributions and practical implications for VE-based e-health applications are discussed.

  5. Complex Unsaturated Zone Flow and Thermohydrologic Processes in a Regulatory Environment: A Perspective on Uncertainty

    Science.gov (United States)

    Fedors, R. W.; Manepally, C.; Justus, P. S.; Basagaoglu, H.; Pensado, O.; Dubreuilh, P.

    2007-12-01

    An important part of a risk-informed, performance-based regulatory review of a potential license application for disposal of high-level radioactive waste at Yucca Mountain, Nevada, is the consideration of alternative interpretations and models of risk significant physical processes. The Nuclear Regulatory Commission (NRC) expects that simplified models will be abstracted from complex process-level models to conduct total-system performance assessments. There are several phases or steps to developing an abstracted model and its supporting basis from more detailed and complicated models for each area of the total system. For complex ambient and thermally perturbed flow in fractured tuffs of the unsaturated zone at Yucca Mountain, these steps c,an be summarized as (i) site characterization and observation, (ii) field and laboratory tests, (iii) conceptual model development, (iv) process-level numerical modeling, and (v) abstraction development. Each step is affected by uncertainty in (i) assessing parameters for models and (ii) conceptualization and understanding of governing processes. Because of the complexity and uncertainty, alternative interpretations and models become important aspects in the regulatory environment. NRC staff gain confidence in performance assessment model results through understanding the uncertainty in the various models. An example of a complex process in the unsaturated zone is seepage into drifts, which leads to liquid water potentially contacting waste packages. Seepage is a risk-important process for the unsaturated zone at Yucca Mountain because of its potential effect on waste package integrity and trainsport of potentially released radionuclides. Complexities for seepage include (i) characterization of fractures that carry flow, (ii) effect of small to intermediate scale structural features on flow, (iii) consideration of the diverse flow regimes (rivulets, film flow, capillarity) in fractures, (iv) effect of vapor transport associated

  6. Drug interaction studies on new drug applications: current situations and regulatory views in Japan.

    Science.gov (United States)

    Nagai, Naomi

    2010-01-01

    Drug interaction studies on new drug applications (NDAs) for new molecular entities (NMEs) approved in Japan between 1997 and 2008 are examined in the Pharmaceuticals and Medical Devices Agency (PMDA). The situations of drug interaction studies in NDAs have changed over the past 12 years, especially in metabolizing enzyme and transporter-based drug interactions. Materials and approaches to study drug-metabolizing enzyme-based drug interactions have improved, and become more rational based on mechanistic theory and new technologies. On the basis of incremental evidence of transporter roles in human pharmacokinetics, transporter-based drug interactions have been increasingly studied during drug development and submitted in recent NDAs. Some recently approved NMEs include transporter-based drug interaction information in their package inserts (PIs). The regulatory document "Methods of Drug Interaction Studies," in addition to recent advances in science and technology, has also contributed to plan and evaluation of drug interaction studies in recent new drug development. This review summarizes current situations and further discussion points on drug interaction studies in NDAs in Japan.

  7. Uncertainty and innovation: Understanding the role of cell-based manufacturing facilities in shaping regulatory and commercialization environments.

    Science.gov (United States)

    Isasi, Rosario; Rahimzadeh, Vasiliki; Charlebois, Kathleen

    2016-12-01

    The purpose of this qualitative study is to elucidate stakeholder perceptions of, and institutional practices related to cell-based therapies and products (CTP) regulation and commercialization in Canada. The development of reproducible, safe and effective CTPs is predicated on regulatory and commercialization environments that enable innovation. Manufacturing processes constitute a critical step for CTP development in this regard. The road from CTP manufacturing to translation in the clinic, however, has yet to be paved. This study aims to fill an empirical gap in the literature by exploring how CTP manufacturing facilities navigate Canadian regulatory and commercialization environments, which together drive the translation of novel CTPs from bench to bedside. Using the multi-level model of practice-driven institutional change proposed by Smets et al., we demonstrate how CTP manufacturing practices are governed by established standards, yet meaningfully shape higher-order regulatory and commercial norms in CTP research and development. We identify four key themes that undergird such processes of innovation: 1) managing regulatory uncertainty, which stems from an inability to classify CTPs within existing regulatory categories for approval and commercialization purposes; 2) building a 'business case' whereby a CTP's market potential is determined in large part by proving its safety and effectiveness; 3) standardizing manufacturing procedures that mobilize CTPs from a research and development phase to a commercialization one; and 4) networking between researchers and regulators to develop responsible commercialization processes that reflect the uniqueness of CTPs as distinct from other biologics and medical devices.

  8. DOES AN EFFICIENT BUSINESS REGULATORY ENVIRONMENT MATTER AT URBAN LEVEL? SOME EVIDENCE FROM CHINESE CITIES

    Directory of Open Access Journals (Sweden)

    Alessandro MARRA,

    2011-06-01

    Full Text Available It is widely acknowledged that firms require an efficient regulatory environment: if transaction costs generated by business regulations are not onerous, firms grow more and develop more quickly, attract more foreign direct investment, and employ more workers. But what does it induce alterations in the basic institutional framework? In this paper we intend to test North’s thesis by which as trade expands and the size of the market grows, transaction costs increase requiring that more and more resources should be devoted to improving existing regulations and, then, reducing such costs. The paper is structured as follows. Section 1 introduces. Section 2 provides the theoretical background. Section 3, based on World Bank data on 30 Chinese cities, investigates whether there is a correlation at urban and provincial levels between efficient business regulations on one side and economic outcomes (gross domestic product, foreign direct investment, employment, etc. on the other. Section 4 addresses the pilot question mentioned above and tests whether simpler and less costly ways of meeting legal requirements for starting and running a business are associated with long-run trade. Section 5 discusses results in the light of theoretically assumed causal links and proposes a 2SLS regression model, whereby a geographical instrumental variable is used to investigate the causal relationship between business regulations and exports.

  9. 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.

  10. 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.

  11. [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.

  12. 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

  13. Microplastics in the marine environment: Current trends and future perspectives.

    Science.gov (United States)

    Barboza, Luís Gabriel Antão; Gimenez, Barbara Carolina Garcia

    2015-08-15

    Over the last decade, the presence of microplastics on marine environments has become an important environmental concern and focus of interest of many researches. Thus, to provide a more integrated view of the research trends regarding this topic, we use a scientometric approach to systematically assess and quantify advances in knowledge related to microplastics in the marine environment. The papers that we used for our assessment were obtained from the database Thomson Reuters (ISI Web of Science), between 2004 and 2014. Our results reveal the overall research performance in the study area of microplastics present in the marine environment over the past decade as a newly developed research field. It has been recognized that there are several important issues that should be investigated. Toward that end, based on the suggested directions on all papers reviewed, we point out areas/topics of interest that may guide future work in the coming years.

  14. Regulatory Impact Assessment: Its Current Status and Development Prospects in Russia

    Directory of Open Access Journals (Sweden)

    A V Minaev

    2011-12-01

    Full Text Available The article examines the procedure of Regulatory Impact Assessment (RIA, which is widely used in developed countries for elaborating and making state-level decisions and is new to Russia. The paper analyzes the origins and essential features of the RIA model applied abroad, reviews major methodological approaches to the preparation of statements on regulatory impact assessment. The study focuses on the Russian RIA model, describing its differences from the foreign analogues; the paper also analyzes the shortcomings of this model. A forecast for the development of RIA in Russia is made by the author.

  15. Gene-environment interactions and alcohol use and dependence: current status and future challenges

    NARCIS (Netherlands)

    Zwaluw, C.S. van der; Engels, R.C.M.E.

    2009-01-01

    To discuss the current status of gene-environment interaction research with regard to alcohol use and dependence. Further, we highlight the difficulties concerning gene-environment studies. Overview of the current evidence for gene-environment interactions in alcohol outcomes, and of the associated

  16. 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 a suppr...

  17. 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

  18. 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

  19. Non-human primate regulatory T cells: Current biology and implications for transplantation

    NARCIS (Netherlands)

    E.M. Dons (Eefje); G. Raimondi (Giorgio); D.K.C. Cooper (David); A.W. Thomson (Angus)

    2010-01-01

    textabstractRegulatory T cells (Treg) offer potential for improving long-term outcomes in cell and organ transplantation. The non-human primate model is a valuable resource for addressing issues concerning the transfer of Treg therapy to the clinic. Herein, we discuss the properties of non-human pri

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

    Directory of Open Access Journals (Sweden)

    Helen Larkin

    2015-07-01

    Full Text Available 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.

  1. 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 ...

  2. 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 ...

  3. Current automation environment of PETROBRAS offshore production units

    Energy Technology Data Exchange (ETDEWEB)

    Moura, C.H.W.; Mendes, F.M.R.; Silva Filho, J.A.P.; Loureiro, P. [PETROBRAS, Rio de Janeiro, RJ (Brazil)

    1996-12-31

    This paper aims to show the evolution of automation in PETROBRAS` off-shore production units during the last decade. It also displays the currently used standard architecture, describing the main aspects of each sub-system which is part of the entire automation system. The changes in PETROBRAS` purchasing policy, and their consequences, are also discussed. 2 figs.

  4. Limitations of eddy current testing in a fast reactor environment

    Science.gov (United States)

    Wu, Tao; Bowler, John R.

    2016-02-01

    The feasibility of using eddy current probes for detecting flaws in fast nuclear reactor structures has been investigated with the aim of detecting defects immersed in electrically conductive coolant including under liquid sodium during standby. For the inspections to be viable, there is a need to use an encapsulated sensor system that can be move into position with the aid of visualization tools. The initial objective being to locate the surface to be investigated using, for example, a combination of electromagnetic sensors and sonar. Here we focus on one feature of the task in which eddy current probe impedance variations due to interaction with the external surface of a tube are evaluated in order to monitor the probe location and orientation during inspection.

  5. 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.

  6. 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

  7. CURRENT ENVIRONMENT STATE OF COASTAL MARINE WATER OF DAGESTAN

    Directory of Open Access Journals (Sweden)

    S. A. Guseinova

    2014-01-01

    Full Text Available Aim. We analysed current environmental state of the Dagestan coast of the Caspian Sea. Data on the spatial variability of contaminants in the coastal areas of the Dagestan segment of the Caspian Sea from the northern districts (Lopatin to the central (Sulak coastal land and, further, to the southern district (within Russian subsoil management confirm that it is caused by irregular contamination of the sea by above-ground sources. Location. Dagestan coastal area of the Caspian SeaMethods. Concentration analysis of background contamination of chemical agents in the Dagestan coastal water from northern districts (Lopatin to southern (Sulak coastal land during the period between 2004 and 2007.Results. Data on the spatial variability of contaminants in the coastal areas of the Dagestan segment of the Caspian Sea from the northern districts (Lopatin to the central (Sulak coastal land and, further, to the southern district (within Russian subsoil management confirm that it is caused by irregular contamination of the sea by above-ground sources.Main conclusions. The envisaged large-scale hydrocarbon resource development requires regular monitoring of sea currents on Makhachkala, Izberbash and Derbent roads.

  8. 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.

  9. Clinical Potential of Regulatory T Cell Therapy in Liver Diseases: An Overview and Current Perspectives

    Science.gov (United States)

    Jeffery, Hannah C.; Braitch, Manjit Kaur; Brown, Solomon; Oo, Ye Htun

    2016-01-01

    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 facilities have paved the way to apply Treg cells as a potential therapy to restore peripheral self-tolerance in autoimmune liver diseases (AILD), chronic rejection, and posttransplantation. Past and on-going studies have applied Treg in type-1 diabetes mellitus, systemic lupus erythematosus, graft versus host diseases, and solid organ transplantations. There have not been any new therapies for the AILD 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. PMID:27656181

  10. 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.

  11. Multi-target trapping in constrained environments using gene regulatory network-based pattern formation

    Directory of Open Access Journals (Sweden)

    Xingguang Peng

    2016-10-01

    Full Text Available Inspired by the morphogenesis of biological organisms, gene regulatory network-based methods have been used in complex pattern formation of swarm robotic systems. In this article, obstacle information was embedded into the gene regulatory network model to make the robots trap targets with an expected pattern while avoiding obstacles in a distributed manner. Based on the modified gene regulatory network model, an implicit function method was adopted to represent the expected pattern which is easily adjusted by adding extra feature points. Considering environmental constraints (e.g. tunnels or gaps in which robots must adjust their pattern to conduct trapping task, a pattern adaptation strategy was proposed for the pattern modeler to adaptively adjust the expected pattern. Also to trap multiple targets, a splitting pattern adaptation strategy was proposed for diffusively moving targets so that the robots can trap each target separately with split sub-patterns. The proposed model and strategies were verified through a set of simulation with complex environmental constraints and non-consensus movements of targets.

  12. Managing Carbon Regulatory Risk in Utility Resource Planning:Current Practices in the Western United States

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-05-16

    Concerns about global climate change have substantially increased the likelihood that future policy will seek to minimize carbon dioxide emissions. Assuch, 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 fifteen 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 U.S., 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 U.S. 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

  13. Managing Carbon Regulatory Risk in Utility Resource Planning: Current Practices in the Western United States

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-07-11

    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 fifteen 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 U.S., 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 U.S. 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.

  14. Development of neuroleptic agents: pharmacogenetics and current safety issues of regulatory concern.

    Science.gov (United States)

    Shah, Rashmi

    2002-12-01

    The development of safe and effective new drug treatments for schizophrenia poses a challenging task. This class of drugs is known to be associated with a wide range of serious and troublesome safety problems that include neurological, cardiac, endocrine, and metabolic side effects. Many of these drugs have a narrow therapeutic index and generate metabolites that often have their own unique pharmacological profile different from the parent compound. These features make it imperative that the optimal dose schedules for neuroleptic drugs are carefully characterized. Many of these drugs are metabolized by cytochrome P450 enzymes, which show genetic polymorphism and a bi modal distribution within the population, A significant subset of the population cannot eliminate these drugs as effectively as the majority. This brings an added dimension of complexity in characterizing the dose and individualizing therapy. Many neuroleptic agents are proarrhythmic with an adverse effect on cardiac repolarization. They are prone to prolonging the QT interval and inducing torsade de pointes. Given the potentially fatal outcome of this ventricular tachyarrhythmia, drug development programs need to ensure that the proarrhythmic potential of any new neuroleptic agent is thoroughly explored and its proarrhythmic risk characterized. The clinical use of many of these drugs is further troubled by their high potential for drug-drug interactions. These too need to be adequately investigated during development The approval and the labeling of a new neuroleptic agent require a careful regulatory assessment of its risk/benefit ratio in comparison with the available alternatives. Their safe and effective use in routine clinical practice depends on careful attention to prescribing information, especially the contraindications, precautions, and patient-monitoring requirements.

  15. Relevance of animal studies in regulatory toxicology : current approaches and future opportunities

    NARCIS (Netherlands)

    Sandt, J.J.M. van de; Feron, V.J.

    1996-01-01

    With rapidly increasing knowledge of toxicological processes, the scientific value and relevance of toxicity studies for risk assessment must be re-evaluated. In this paper, it is proposed that the rigid risk evaluation currently required should be replaced by a more flexible, case-by-case approach,

  16. 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.

  17. Preserving the Environment of Outer Space - Legal, Regulatory and Institutional Aspects of Active Orbital Debris Removal

    Science.gov (United States)

    Mankata Nyampong, Y. O.

    2012-01-01

    In view of the massive quantities of space debris already deposited in outer space, any effort aimed at guaranteeing the sustainability of mankind's access to outer space and the continued safety of space operations must not be limited exclusively to mitigating the creation of new debris, but must also focus on the active removal of existing pieces of debris from space (remediation) as a matter of necessity. Presently, technologies that will enable active debris removal (ADR) are only just emerging. As the technology develops, however, several legal, regulatory and institutional issues that may hinder the conduct of ADR activities must also be addressed. This paper highlights and explores some of the foregoing issues in an effort to draw international attention to these matters and ultimately to pave the way for the smooth conduct of ADR activities once the technology matures.

  18. Training in clinical forensic medicine in the UK--perceptions of current regulatory standards.

    Science.gov (United States)

    Stark, Margaret M; Norfolk, Guy A

    2011-08-01

    As clinical forensic medicine (CFM) is not currently recognised as a speciality in the UK there are no nationally agreed mandatory standards for training forensic physicians in either general forensic (GFM) or sexual offence medicine (SOM). The General Medical Council (GMC), the medical regulator in the UK, has issued clear standards for training in all specialities recommending that "trainees must be supported to acquire the necessary skills and experience through induction, effective educational supervision, an appropriate workload and time to learn". In order to evaluate the current situation in the field of clinical forensic medicine, doctors who have recently (within the last two years) started working in the field "trainees" (n = 38), and trainers (n = 61) with responsibility for clinical and educational supervision of new trainees, were surveyed by questionnaire to gather their perceptions of how the relevant GMC standards are being met in initial on-the-job training. Telephone interviews were performed with eleven doctors working as clinical or medical directors to determine their views. It is clear that currently the quality of training in CFM is sub-standard and inconsistent and that the published standards, as to the minimum requirement for training that must be met by post-graduate medical and training providers at all levels, are not being met. The Faculty of Forensic and Legal Medicine (FFLM) needs to set explicit minimum standards which will comply with the regulator and work to pilot credentialing for forensic physicians. A number of recommendations are made for urgent FFLM development.

  19. 76 FR 38399 - Assessing the Current Research, Policy, and Practice Environment in Public Health Genomics

    Science.gov (United States)

    2011-06-30

    ... HUMAN SERVICES Centers for Disease Control and Prevention Assessing the Current Research, Policy, and..., and other information helpful to assess the current research, policy, and practice environment in... Control and Prevention (CDC) has worked to integrate genomics into public health research, policy,...

  20. 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.

  1. The current situation of impact of coal mine developing on environment in China and government proposal

    Energy Technology Data Exchange (ETDEWEB)

    Lu Yang [China University of Mining and Technology, Beijing (China). Ministry of Land and Resources

    2005-07-01

    Current environmental problems caused by coal mining in China, the importance of management of the environment, impact of coal mining on land and water resources, and upcoming coal development are discussed. It is suggested that the government should act in two ways: take responsibility for management of reclamation of mines existing before 1986, and set up mechanisms to protect the environment, starting with the publishing of relevant laws and regulations. Methods for solving environmental issues include: prepare a practical plan, establish an environmental control fund, establish a special fund to protect the environment, and develop new ways to combine protection of the biological environment and land reclamation. 5 refs., 3 tabs.

  2. 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 andshortcoming

  3. 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)

  4. 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.

  5. Offshore produced water management: A review of current practice and challenges in harsh/Arctic environments.

    Science.gov (United States)

    Zheng, Jisi; Chen, Bing; Thanyamanta, Worakanok; Hawboldt, Kelly; Zhang, Baiyu; Liu, Bo

    2016-03-15

    Increasing offshore oil and gas exploration and development in harsh/Arctic environments require more effective offshore produced water management, as these environments are much more sensitive to changes in water quality than more temperate climates. However, the number and scope of studies of offshore produced water management in harsh/Arctic environments are limited. This paper reviews the current state of offshore produced water management, impacts, and policies, as well as the vulnerability, implications and operational challenges in harsh/Arctic environments. The findings show that the primary contaminant(s) of concern are contained in both the dissolved oil and the dispersed oil. The application of emerging technologies that can tackle this issue is significantly limited by the challenges of offshore operations in harsh/Arctic environments. Therefore, there is a need to develop more efficient and suitable management systems since more stringent policies are being implemented due to the increased vulnerability of harsh/Arctic environments.

  6. 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 and shor...... is the best available technology for chemical monitoring of nonpolar organic compounds. Key issues to be addressed by scientists and environmental managers are outlined.......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...... 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...

  7. Clinical compliance of viewing conditions in radiology reporting environments against current guidelines and standards

    Science.gov (United States)

    Daly, S.; Rainford, L.; Butler, M. L.

    2014-03-01

    Several studies have demonstrated the importance of environmental conditions in the radiology reporting environment, with many indicating that incorrect parameters could lead to error and misinterpretation. Literature is available with recommendations as to the levels that should be achieved in clinical practice, but evidence of adherence to these guidelines in radiology reporting environments is absent. This study audited the reporting environments of four teleradiologist and eight hospital based radiology reporting areas. This audit aimed to quantify adherence to guidelines and identify differences in the locations with respect to layout and design, monitor distance and angle as well as the ambient factors of the reporting environments. In line with international recommendations, an audit tool was designed to enquire in relation to the layout and design of reporting environments, monitor angle and distances used by radiologists when reporting, as well as the ambient factors such as noise, light and temperature. The review of conditions were carried out by the same independent auditor for consistency. The results obtained were compared against international standards and current research. Each radiology environment was given an overall compliance score to establish whether or not their environments were in line with recommended guidelines. Poor compliance to international recommendations and standards among radiology reporting environments was identified. Teleradiology reporting environments demonstrated greater compliance than hospital environments. The findings of this study identified a need for greater awareness of environmental and perceptual issues in the clinical setting. Further work involving a larger number of clinical centres is recommended.

  8. The Role of Learning Environment on High School Chemistry Students' Motivation and Self-Regulatory Processes

    Science.gov (United States)

    Judd, Jeffrey S.

    2009-01-01

    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…

  9. The regulatory environment past and future--incentive or impediment to developments in food science and technology: a perspective from FDA.

    Science.gov (United States)

    Shank, F R; Carson, K

    1994-01-01

    The best system for protecting public health is one that involves two layers of control before food reaches the consumer. The first layer of control is the industry's clear responsibility to prepare food that is safe. The second layer of control is the monitoring that is provided by government to ensure that the industry is doing its job and is in fact producing safe food. While some may view this "second layer" as an impediment in the development and marketing of new technologies, there is another way to look at the "regulatory environment". The regulatory environment itself, is not an impediment to the development of food science and technology. The regulatory environment, with all its components--scientists, consumers, industry, and Congress--defines "safety" within the context of today's technology, scientific capability, and tolerance level of the lay public. The entire regulatory environment serves to guide the development of food science and technology by providing signposts, in the form of scientifically sound regulatory decisions. The scientific basis of these decisions becomes building blocks on which to rest further refinement of the technology, product, ingredient, or packaging material or on which research in related technologies or research in innovative directions can build. This scientific groundwork becomes very important as more and more companies move away from having self-contained research laboratories toward using commercial laboratories and academic institutions, as well as participating in cooperative research endeavors to meet food safety and product development research needs.(ABSTRACT TRUNCATED AT 250 WORDS)

  10. Effect of the electromagnetic environment on current fluctuations in driven tunnel junctions

    Science.gov (United States)

    Frey, Moritz; Grabert, Hermann

    2016-07-01

    We examine current fluctuations in tunnel junctions driven by a superposition of a constant and a sinusoidal voltage source. In standard setups, the external voltage is applied to the tunneling element via an impedance providing an electromagnetic environment of the junction. The modes of this environment are excited by the time-dependent voltage and are the source of Johnson-Nyquist noise. We determine the autocorrelation function of the current flowing in the leads of the junction in the weak tunneling limit up to terms of second order in the tunneling Hamiltonian. The driven modes of the electromagnetic environment are treated exactly by means of a unitary transformation introduced recently. Particular emphasis is placed on the spectral function of the current fluctuations. The spectrum is found to comprise three contributions: a term arising from the Johnson-Nyquist noise of the environmental impedance, a part due to the shot noise of the tunneling element, and a third contribution which comes from the cross correlation between fluctuations caused by the electromagnetic environment and fluctuations of the tunneling current. All three parts of the spectral function occur already for devices under dc bias. The spectral function of ac driven tunneling elements can be determined from the result for a dc bias by means of a photoassisted tunneling relation of the Tien-Gordon type. Specific results are given for an Ohmic environment and for a junction driven through a resonator.

  11. Do biological medicinal products pose a risk to the environment?: a current view on ecopharmacovigilance.

    Science.gov (United States)

    Kühler, Thomas C; Andersson, Mikael; Carlin, Gunnar; Johnsson, Ann; Akerblom, Lennart

    2009-01-01

    The occurrence of active pharmaceutical substances in the environment is of growing concern. The vast majority of the compounds in question are of low molecular weight, intended for oral use and designed to tolerate, for example, the digestive enzymes in the upper alimentary tract, the harsh milieus found in the acidic stomach, or the microbe rich intestine. Accordingly, these xenobiotic compounds may, due to their inherent biological activity, constitute a risk to the environment. Biological medicinal products, for example recombinant human insulin or monoclonal antibodies, however, are different. They are primarily made up of oligomers or polymers of amino acids, sugars or nucleotides and are thus readily metabolized. They are therefore generally not considered to pose any risk to the environment. Certain classes of biological medicinal products, however, are associated with specific safety issues. Genetically modified organisms as vectors in vaccines or in gene therapy products have attracted much attention in this regard. Issues include the degree of attenuation of the live recombinant vaccine, replication restrictions of the vaccine vector, alteration of the host and tissue tropism of the vector, the possibility of reversion to virulence, and risk to the ecosystem. In this review we discuss the fate and the potential environmental impact of biological medicinal products following clinical use from an ecopharmacovigilance point of view, and review relevant policy documents and regulatory statements.

  12. 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.

  13. STRATEGIC MANAGEMENT OF COSTS - THE MAIN TOOL OF COMPETITIVE ADVANTAGE IN THE CURRENT ECONOMIC ENVIRONMENT

    Directory of Open Access Journals (Sweden)

    CORINA MICULESCU

    2012-05-01

    Full Text Available Both global and national hipercompetiţia and globalization are two phenomena that generate complexity and instability in the business. Therefore, the economic context in which organizations operate has changed a lot, the current environment characterized by globalization, increased competition, rapidly changing, market segmentation, changes in technology, demand volatility, the importance of information. These phenomena not only create a state of turmoil and turbulence in the competitive environment and generate changes in market conditions, but require changes and development in organizations. In these circumstances organizations worldwide are forced to adapt constantly, products and services to market needs to turn its attention to customer satisfaction, they need sophisticated production processes, internal processes flexible to respond quickly to changes environment.Therefore to achieve any competitive advantage, organizations must take the current economic environment strategies that integrate environmental opportunities, market and technology advantages in the most efficient way. In this context the question of modernization, the transformation cost information system, an adaptation to the realities and requirements of this, to change tools, processes and methods to meet current scientific and technical progress.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  15. The average direct current offset values for small digital audio recorders in an acoustically consistent environment.

    Science.gov (United States)

    Koenig, Bruce E; Lacey, Douglas S

    2014-07-01

    In this research project, nine small digital audio recorders were tested using five sets of 30-min recordings at all available recording modes, with consistent audio material, identical source and microphone locations, and identical acoustic environments. The averaged direct current (DC) offset values and standard deviations were measured for 30-sec and 1-, 2-, 3-, 6-, 10-, 15-, and 30-min segments. The research found an inverse association between segment lengths and the standard deviation values and that lengths beyond 30 min may not meaningfully reduce the standard deviation values. This research supports previous studies indicating that measured averaged DC offsets should only be used for exclusionary purposes in authenticity analyses and exhibit consistent values when the general acoustic environment and microphone/recorder configurations were held constant. Measured average DC offset values from exemplar recorders may not be directly comparable to those of submitted digital audio recordings without exactly duplicating the acoustic environment and microphone/recorder configurations.

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

    OpenAIRE

    Richard C. Thompson; Moore, Charles J.; Frederick S Vom Saal; 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...

  17. 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...

  18. 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)

  19. North Atlantic Current and European environments during the declining stage of the last interglacial

    Science.gov (United States)

    Müller, Ulrich C.; Kukla, George J.

    2004-12-01

    This paper provides a tentative reconstruction of environmental shifts in Europe associated with changes of the North Atlantic Current and related meridional sea-surface temperature (SST) gradients. During most of the Eemian interglacial (ca. 126 115 ka), the North Atlantic Current extended far north into the Nordic Seas and European environments were comparable to those of the Holocene. However, ca. 115 ka an SST drop in the Nordic Seas marked a southward displacement of the North Atlantic Current. This hydrographic shift was associated with substantial cooling in northern Europe and drier conditions in the Mediterranean region. The polar timberline retreated southward from 69°N in northernmost Scandinavia to 52°N in central Europe, and thermophilous deciduous trees became extinct north of the 48th parallel. Woodlands persisted in southern Europe for another 5 k.y. well into marine isotope substage 5d. These conditions indicate steep vegetation and climate gradients at the inception of the last glacial.

  20. Acoustic Doppler current profiler measurements in coastal and estuarine environments: examples from the Tay Estuary, Scotland

    Science.gov (United States)

    Wewetzer, Silke F. K.; Duck, Robert W.; Anderson, James M.

    1999-08-01

    Acoustic Doppler current profilers (ADCPs) provide a means to measure the components of water current velocities in three dimensions. Such instruments have been used widely by the oil industry in deep offshore waters but their application to nearshore coastal and estuarine environments has been principally confined to the USA. Using examples of ADCP datasets acquired from the macrotidal Tay Estuary, eastern Scotland, the principles of field deployment, data acquisition and forms of output are critically summarised. It is shown, for the first time in the Tay Estuary, that vertical current velocities are significant and are particularly so in downwelling zones associated with the development and passage of axially convergent tidal fronts. The improved understanding of three-dimensional water and suspended sediment dynamics in coastal and estuarine waters is crucial to, inter alia, the sustainable management of effluent discharges and, in more general terms, it is predicted on the basis of the Tay case study, that ADCP measurements afford significant opportunities to refine understanding of geomorphological processes in a variety of aquatic environments worldwide.

  1. Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014.

    Science.gov (United States)

    Ho, Mei Mei; Baca-Estrada, Maria; Conrad, Christoph; Karikari-Boateng, Eric; Kang, Hye-Na

    2015-08-26

    The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme.

  2. 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.

  3. HIGH-RESOLUTION MONITORING OF CURRENT RAPID TRANSFORMATIONS ON GLACIAL AND PERIGLACIAL ENVIRONMENTS

    Directory of Open Access Journals (Sweden)

    L. Carturan

    2014-01-01

    Full Text Available Glacial and periglacial environments are highly sensitive to climatic changes. Processes of cryosphere degradation may strongly impact human activities and infrastructures, and need to be monitored for improved understanding and for mitigation/adaptation. Studying glacial and periglacial environments using traditional techniques may be difficult or not feasible, but new remote sensing techniques like terrestrial and aerial laser scanner opened new possibilities for cryospheric studies. This work presents an application of the terrestrial laser scanner (TLS for monitoring the current rapid changes occurring on the Montasio Occidentale glacier (Eastern Italian alps, which is representative of low-altitude, avalanche-fed and debris-cover glaciers. These glaciers are quite common in the Alps but their reaction to climate changes is still poorly known. The mass balance, surface velocity fields, debris cover dynamics and effects of meteorological extremes were investigated by repeat high-resolution TLS scanning from September 2010 to October 2012. The results were encouraging and shed light on the peculiar response of this glacier to climatic changes, on its current dynamics and on the feedback played by the debris cover, which is critical for its preservation. The rapid transformations in act, combined with the unstable ice mass, large amount of loose debris and channeled runoff during intense rainfalls, constitute a potential area for the formation of large debris flows, as shown by field evidences and documented by the recent literature.

  4. The significance of personal learning environments (PLEs) in nursing education: Extending current conceptualizations.

    Science.gov (United States)

    Patterson, Christopher; Stephens, Moira; Chiang, Vico; Price, Ann M; Work, Fiona; Snelgrove-Clarke, Erna

    2017-01-01

    Personal learning environments (PLEs) have been shown to be a critical part of how students negotiate and manage their own learning. Understandings of PLEs appear to be constrained by narrow definitions that focus primarily on technological engagement with a range of web tools and associated applications. This paper addresses a gap in the literature around PLEs for students currently enrolled in undergraduate nursing degrees. To provide in-depth insights into how undergraduate students of nursing manage and experience their learning. This was an international multi-site qualitative study, utilizing focus groups. A schedule of 10 questions and nominal group techniques were used. Whilst the focus groups took place in very different geographical locations, there were strong similarities in student understandings of effective PLEs. These went well beyond current technological definitions. Findings were organized into three major themes; technologies, learning modalities and influencing factors. We propose a broader understanding of PLEs that acknowledges individual personal and cultural contexts which we call the personally significant learning environment (PSLE). There is a need for greater investigation of how students understand and systematize their PSLE. This paper and our findings will be of interest to educators, researchers and institutions for developing appropriate frameworks that may maximize learning outcomes, encourage cultural sensitivities and facilitate greater understandings of how to support students to create appropriate PSLEs. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. 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.

  6. How the American, Degree-Granting For-Profit Higher Education Sector Manages the Regulatory Environment: An Intrinsic Case Study

    Science.gov (United States)

    Barron, Caulyne Nichole

    2013-01-01

    This intrinsic case study examined the context of the American, degree-granting for-profit higher education sector between 2009 and 2012, applying institutional theory and resource dependency theory to develop an understanding of how the degree-granting for-profit sector of American higher education manages regulatory pressures. The study examines…

  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. 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

  9. The Long Reach of Nurturing Family Environments: Links With Midlife Emotion-Regulatory Styles and Late-Life Security in Intimate Relationships.

    Science.gov (United States)

    Waldinger, Robert J; Schulz, Marc S

    2016-11-01

    Does the warmth of children's family environments predict the quality of their intimate relationships at the other end of the life span? Using data collected prospectively on 81 men from adolescence through the eighth and ninth decades of life, this study tested the hypotheses that warmer relationships with parents in childhood predict greater security of attachment to intimate partners in late life, and that this link is mediated in part by the degree to which individuals in midlife rely on emotion-regulatory styles that facilitate or inhibit close relationship connections. Findings supported this mediational model, showing a positive link between more nurturing family environments in childhood and greater security of attachment to spouses more than 60 years later. This link was partially mediated by reliance on more engaging and less distorting styles of emotion regulation in midlife. The findings underscore the far-reaching influence of childhood environment on well-being in adulthood. © The Author(s) 2016.

  10. Extreme Environment Simulation - Current and New Capabilities to Simulate Venus and Other Planetary Bodies

    Science.gov (United States)

    Kremic, Tibor; Vento, Dan; Lalli, Nick; Palinski, Timothy

    2014-01-01

    Science, technology, and planetary mission communities have a growing interest in components and systems that are capable of working in extreme (high) temperature and pressure conditions. Terrestrial applications range from scientific research, aerospace, defense, automotive systems, energy storage and power distribution, deep mining and others. As the target environments get increasingly extreme, capabilities to develop and test the sensors and systems designed to operate in such environments will be required. An application of particular importance to the planetary science community is the ability for a robotic lander to survive on the Venus surface where pressures are nearly 100 times that of Earth and temperatures approach 500C. The scientific importance and relevance of Venus missions are stated in the current Planetary Decadal Survey. Further, several missions to Venus were proposed in the most recent Discovery call. Despite this interest, the ability to accurately simulate Venus conditions at a scale that can test and validate instruments and spacecraft systems and accurately simulate the Venus atmosphere has been lacking. This paper discusses and compares the capabilities that are known to exist within and outside the United States to simulate the extreme environmental conditions found in terrestrial or planetary surfaces including the Venus atmosphere and surface. The paper then focuses on discussing the recent additional capability found in the NASA Glenn Extreme Environment Rig (GEER). The GEER, located at the NASA Glenn Research Center in Cleveland, Ohio, is designed to simulate not only the temperature and pressure extremes described, but can also accurately reproduce the atmospheric compositions of bodies in the solar system including those with acidic and hazardous elements. GEER capabilities and characteristics are described along with operational considerations relevant to potential users. The paper presents initial operating results and concludes

  11. 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.

  12. 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.

  13. Evolutionary Psychology: How Psychological Mechanisms Shaped by Natural Selection for Ancestral Environments Produce Current Behaviours

    Institute of Scientific and Technical Information of China (English)

    Charles Crawford

    2009-01-01

    The central purpose of this paper is to explain how Darwin's theory of evolution by natural selection can be used in understanding current human behaviour. First, Darwin's logic is briefly described. Development is an important issue when applying evolutionary theory to human behaviour. The notion of innate developmental orga-nization of psychological mechanisms is introduced. The possible social and political outcomes produced when differ-ent levels of innate developmental organization are paired with different beliefs about it are considered. The notion of psychological mechanisms as evolved adaptations is considered in some detail. Then I discuss different ways evo-htionists think about how genes are involved in the development of adaptations. The paper concludes with a frame-work for considering how ancestral adaptations function in current environments and outlines some ways of studying them. In China and many other parts of the world people desire a more harmonious society. Ⅰ hope that this paper will be of some small help in achieving this great task.

  14. Regulatory T cells as a therapeutic tool to induce solid-organ transplant tolerance: current clinical experiences.

    Science.gov (United States)

    Nikoueinejad, Hassan; Sharif, Mohammad Reza; Amirzargar, Aliakbar; Mirshafiey, Abbas; Einollahi, Behzad

    2013-10-01

    Long-term tolerance is potentially an ideal in organ transplant. Achieving this leads us to eliminate immunosuppressive therapies and their associated side effects. Although most succession in this field belongs to mixed chimerism methods of tolerance induction, regulatory T cells and (T-reg)-based methods also have been demonstrated to prevent organ rejection and lead to transplant tolerance through different mechanisms. In contrast to chimeric protocols (which require bone marrow transplant), T-reg-mediated protocols do not aggressively manipulate blood and the immune system. Most treatment has been done for graft-versus-host disease after hematopoietic stem cell transplant. This review describes different types and mechanisms of action and clinical strategies using T-regs to induce transplant tolerance.

  15. 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

  16. 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

  17. Analysis of currently available data for characterising the risk of engineered nanomaterials to the environment and human health--lessons learned from four case studies.

    Science.gov (United States)

    Aschberger, Karin; Micheletti, Christian; Sokull-Klüttgen, Birgit; Christensen, Frans M

    2011-08-01

    Production volumes and the use of engineered nanomaterials in many innovative products are continuously increasing, however little is known about their potential risk for the environment and human health. We have reviewed publicly available hazard and exposure data for both, the environment and human health and attempted to carry out a basic risk assessment appraisal for four types of nanomaterials: fullerenes, carbon nanotubes, metals, and metal oxides (ENRHES project 2009(1)). This paper presents a summary of the results of the basic environmental and human health risk assessments of these case studies, highlighting the cross cutting issues and conclusions about fate and behaviour, exposure, hazard and methodological considerations. The risk assessment methodology being the basis for our case studies was that of a regulatory risk assessment under REACH (ECHA, 2008(2)), with modifications to adapt to the limited available data. If possible, environmental no-effect concentrations and human no-effect levels were established from relevant studies by applying assessment factors in line with the REACH guidance and compared to available exposure data to discuss possible risks. When the data did not allow a quantitative assessment, the risk was assessed qualitatively, e.g. for the environment by evaluating the information in the literature to describe the potential to enter the environment and to reach the potential ecological targets. Results indicate that the main risk for the environment is expected from metals and metal oxides, especially for algae and Daphnia, due to exposure to both, particles and ions. The main risks for human health may arise from chronic occupational inhalation exposure, especially during the activities of high particle release and uncontrolled exposure. The information on consumer and environmental exposure of humans is too scarce to attempt a quantitative risk characterisation. It is recognised that the currently available database for both

  18. 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.

  19. 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

    2017-06-07

    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."

  20. 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.

  1. 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

  2. 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

  3. 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....

  4. 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

    2017-06-01

    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.

  5. 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.

  6. 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.

  7. Variability in delivered dose and respirable delivered dose from nebulizers: are current regulatory testing guidelines sufficient to produce meaningful information?

    Science.gov (United States)

    Hatley, Ross HM; Byrne, Sarah M

    2017-01-01

    Background To improve convenience to patients, there have been advances in the operation of nebulizers, resulting in fast treatment times and less drug lost to the environment. However, limited attention has been paid to the effects of these developments on the delivered dose (DD) and respirable delivered dose (RDD). Published pharmacopoeia and ISO testing guidelines for adult-use testing utilize a single breathing pattern, which may not be sufficient to enable effective comparisons between the devices. Materials and methods The DD of 5 mg of salbutamol sulfate into adult breathing patterns with inhalation:exhalation (I:E) ratios between 1:1 and 1:4 was determined. Droplet size was determined by laser diffraction and RDD calculated. Nine different nebulizer brands with different modes of operation (conventional, venturi, breath-enhanced, mesh, and breath-activated) were tested. Results Between the non-breath-activated nebulizers, a 2.5-fold difference in DD (~750–1,900 µg salbutamol) was found; with RDD, there was a more than fourfold difference (~210–980 µg). With increasing time spent on exhalation, there were progressive reductions in DD and RDD, with the RDD at an I:E ratio of 1:4 being as little as 40% of the dose with the 1:1 I:E ratio. The DD and RDD from the breath-activated mesh nebulizer were independent of the I:E ratio, and for the breath-activated jet nebulizer, there was less than 20% change in RDD between the I:E ratios of 1:1 and 1:4. Conclusion Comparing nebulizers using the I:E ratio recommended in the guidelines does not predict relative performance between the devices at other ratios. There was significant variance in DD or RDD between different brands of non-breath-activated nebulizer. In future, consideration should be given to revision of the test protocols included in the guidelines, to reflect more accurately the potential therapeutic dose that is delivered to a realistic spectrum of breathing patterns. PMID:28203110

  8. Geologic uncertainty in a regulatory environment: An example from the potential Yucca Mountain nuclear waste repository site

    Science.gov (United States)

    Rautman, C. A.; Treadway, A. H.

    1991-11-01

    Regulatory geologists are concerned with predicting the performance of sites proposed for waste disposal or for remediation of existing pollution problems. Geologic modeling of these sites requires large-scale expansion of knowledge obtained from very limited sampling. This expansion induces considerable uncertainty into the geologic models of rock properties that are required for modeling the predicted performance of the site. One method for assessing this uncertainty is through nonparametric geostatistical simulation. Simulation can produce a series of equiprobable models of a rock property of interest. Each model honors measured values at sampled locations, and each can be constructed to emulate both the univariate histogram and the spatial covariance structure of the measured data. Computing a performance model for a number of geologic simulations allows evaluation of the effects of geologic uncertainty. A site may be judged acceptable if the number of failures to meet a particular performance criterion produced by these computations is sufficiently low. A site that produces too many failures may be either unacceptable or simply inadequately described. The simulation approach to addressing geologic uncertainty is being applied to the potential high-level nuclear waste repository site at Yucca Mountain, Nevada, U.S.A. Preliminary geologic models of unsaturated permeability have been created that reproduce observed statistical properties reasonably well. A spread of unsaturated groundwater travel times has been computed that reflects the variability of those geologic models. Regions within the simulated models exhibiting the greatest variability among multiple runs are candidates for obtaining the greatest reduction in uncertainty through additional site characterization.

  9. Survival in extreme environments – on the current knowledge of adaptations in tardigrades

    DEFF Research Database (Denmark)

    Møbjerg, Nadja; Halberg, Kenneth Agerlin; Jørgensen, Aslak

    2011-01-01

    of the tardigrades and highlight species that are currently used as models for physiological and molecular investigations. Tardigrades are uniquely adapted to a range of environmental extremes. Cryptobiosis, currently referred to as a reversible ametabolic state induced by e.g. desiccation, is common especially...... to below )20 C, presumably relying on efficient DNA repair mechanisms and osmoregulation. This review summarizes the current knowledge on adaptations found among tardigrades, and presents new data on tardigrade cell numbers and osmoregulation....

  10. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2007-01-01

    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...

  11. 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.

  12. An Assessment of the Current LEO Debris Environment and the Need for Active Debris Removal

    Science.gov (United States)

    Liou, Jer-Chyi

    2010-01-01

    The anti-satellite test on the Fengun-1 C weather satellite in early 2007 and the collision between Iridium 33 and Cosmos 2251 in 2009 dramatically altered the landscape of the human-made orbital debris environment in the low Earth orbit (LEO). The two events generated approximately 5500 fragments large enough to be tracked by the U.S. Space Surveillance Network. Those fragments account for more than 60% increase to the debris population in LEO. However, even before the ASAT test, model analyses already indicated that the debris population (for those larger than 10 cm) in LEO had reached a point where the population would continue to increase, due to collisions among existing objects, even without any future launches. The conclusion implies that as satellites continue to be launched and unexpected breakup events continue to occur, commonly-adopted mitigation measures will not be able to stop the collision-driven population growth. To remediate the debris environment in LEO, active debris removal must be considered. This presentation will provide an updated assessment of the debris environment after the Iridium 33/Cosmos 2251 collision, an analysis of several future environment projections based on different scenarios, and a projection of collision activities in LEO in the near future. The need to use active debris removal to stabilize future debris environment will be demonstrated and the effectiveness of various active debris removal strategies will be quantified.

  13. Microplastics in freshwater and terrestrial environments: Evaluating the current understanding to identify the knowledge gaps and future research priorities.

    Science.gov (United States)

    Horton, Alice A; Walton, Alexander; Spurgeon, David J; Lahive, Elma; Svendsen, Claus

    2017-05-15

    Plastic debris is an environmentally persistent and complex contaminant of increasing concern. Understanding the sources, abundance and composition of microplastics present in the environment is a huge challenge due to the fact that hundreds of millions of tonnes of plastic material is manufactured for societal use annually, some of which is released to the environment. The majority of microplastics research to date has focussed on the marine environment. Although freshwater and terrestrial environments are recognised as origins and transport pathways of plastics to the oceans, there is still a comparative lack of knowledge about these environmental compartments. It is highly likely that microplastics will accumulate within continental environments, especially in areas of high anthropogenic influence such as agricultural or urban areas. This review critically evaluates the current literature on the presence, behaviour and fate of microplastics in freshwater and terrestrial environments and, where appropriate, also draws on relevant studies from other fields including nanotechnology, agriculture and waste management. Furthermore, we evaluate the relevant biological and chemical information from the substantial body of marine microplastic literature, determining the applicability and comparability of this data to freshwater and terrestrial systems. With the evidence presented, the authors have set out the current state of the knowledge, and identified the key gaps. These include the volume and composition of microplastics entering the environment, behaviour and fate of microplastics under a variety of environmental conditions and how characteristics of microplastics influence their toxicity. Given the technical challenges surrounding microplastics research, it is especially important that future studies develop standardised techniques to allow for comparability of data. The identification of these research needs will help inform the design of future studies, to

  14. 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

  15. Vulnerability of the Barents Sea environment to climate changes: a review of the current assessments

    Energy Technology Data Exchange (ETDEWEB)

    Gelfan, A.; Danilov-Danilyan, V.

    2009-07-15

    Authors' conclusion: Climate change is not considered to be just 'one more stress' on the ecosystem, but rather it will create complex and dynamic changes in the environment that may alter the level of its vulnerability. Cumulative effects can be defined as changes to the environment that are caused by an action in combination with other past, present and future human actions (Environment Canada 2003). The magnitude and effects of multiple stresses can be equal to the sum of the individual effects (additive effects) or they may strengthen or weaken each other (positive or negative feedbacks). To understand complex interactions within the system atmosphere-land surface-ocean at regional scales and to assess influence of the environmental changes on the ecological conditions, sophisticated models should be developed allowing to account for regional peculiarities of these systems. Development of such models is considered as one of the main challenge of the Earth system science. (author)

  16. Current views of health care design and construction: practical implications for safer, cleaner environments.

    Science.gov (United States)

    Bartley, Judene M; Olmsted, Russell N; Haas, Janet

    2010-06-01

    Infection preventionists (IP) play an increasingly important role in preventing health care-associated infection in the physical environment associated with new construction or renovation of health care facilities. The Guidelines for Design and Construction of Hospital and Healthcare Facilities, 2010, formerly known as "AIA Guidelines" was the origin of the "infection control risk assessment" now required by multiple agencies. These Guidelines represent minimum US health care standards and provide guidance on best practices. They recognize that the built environment has a profound affect on health and the natural environment and require that health care facilities be designed to "first, do no harm." This review uses the Guidelines as a blueprint for IPs' role in design and construction, updating familiar concepts to the 2010 edition with special emphasis on IP input into design given its longer range impact on health care-associated infection prevention while linking to safety and sustainability. Section I provides an overview of disease transmission risks from the built environment and related costs, section II presents a broad view of design and master planning, and section III addresses the detailed design strategies for infection prevention specifically addressed in the 2010 Facility Guidelines Institute edition.

  17. Implications of Current Reference Structures for Authority Work in Online Environments.

    Science.gov (United States)

    Watson, Mark R.; Taylor, Arlene G.

    1987-01-01

    Describes a study which examined (1) the percentage of personal and corporate name authority records in the Library of Congress authority file that do not contain any references, and (2) the percentage of references present on existing authority records that are not needed in an automatic right hand truncation, keyword searching environment. (CLB)

  18. 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…

  19. An Atlas of Human Regulatory T Helper-like Cells Reveals Features of Th2-like Tregs that Support a Tumorigenic Environment.

    Science.gov (United States)

    Halim, Leena; Romano, Marco; McGregor, Reuben; Correa, Isabel; Pavlidis, Polychronis; Grageda, Nathali; Hoong, Sec-Julie; Yuksel, Muhammed; Jassem, Wayel; Hannen, Rosalind F; Ong, Mark; Mckinney, Olivia; Hayee, Bu'Hussain; Karagiannis, Sophia N; Powell, Nicholas; Lechler, Robert I; Nova-Lamperti, Estefania; Lombardi, Giovanna

    2017-07-18

    Regulatory T cells (Tregs) play a pivotal role in maintaining immunological tolerance, but they can also play a detrimental role by preventing antitumor responses. Here, we characterized T helper (Th)-like Treg subsets to further delineate their biological function and tissue distribution, focusing on their possible contribution to disease states. RNA sequencing and functional assays revealed that Th2-like Tregs displayed higher viability and autocrine interleukin-2 (IL-2)-mediated activation than other subsets. Th2-like Tregs were preferentially found in tissues rather than circulation and exhibited the highest migratory capacity toward chemokines enriched at tumor sites. These cellular responses led us to hypothesize that this subset could play a role in maintaining a tumorigenic environment. Concurrently, Th2-like Tregs were enriched specifically in malignant tissues from patients with melanoma and colorectal cancer compared to healthy tissue. Overall, our results suggest that Th2-like Tregs may contribute to a tumorigenic environment due to their increased cell survival, higher migratory capacity, and selective T-effector suppressive ability. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  20. An Atlas of Human Regulatory T Helper-like Cells Reveals Features of Th2-like Tregs that Support a Tumorigenic Environment

    Directory of Open Access Journals (Sweden)

    Leena Halim

    2017-07-01

    Full Text Available Regulatory T cells (Tregs play a pivotal role in maintaining immunological tolerance, but they can also play a detrimental role by preventing antitumor responses. Here, we characterized T helper (Th-like Treg subsets to further delineate their biological function and tissue distribution, focusing on their possible contribution to disease states. RNA sequencing and functional assays revealed that Th2-like Tregs displayed higher viability and autocrine interleukin-2 (IL-2-mediated activation than other subsets. Th2-like Tregs were preferentially found in tissues rather than circulation and exhibited the highest migratory capacity toward chemokines enriched at tumor sites. These cellular responses led us to hypothesize that this subset could play a role in maintaining a tumorigenic environment. Concurrently, Th2-like Tregs were enriched specifically in malignant tissues from patients with melanoma and colorectal cancer compared to healthy tissue. Overall, our results suggest that Th2-like Tregs may contribute to a tumorigenic environment due to their increased cell survival, higher migratory capacity, and selective T-effector suppressive ability.

  1. Plasma environment during hot cathode direct current discharge plasma chemical vapor deposition of diamond films

    Institute of Scientific and Technical Information of China (English)

    朱晓东; 詹如娟; 周海洋; 胡敏; 温晓辉; 周贵恩; 李凡庆

    1999-01-01

    The plasma characteristics have been investigated in situ by using optical emission spectroscopy (OES) and the Langmuir probe during hot cathode direct current discharge plasma chemical vapor deposition of diamond films. The changes of atomic H and CH radical in the ground state have been calculated quantitatively according to the results of OES and the Langmuir probe measurement as discharge current density varied. It is shown that atomic H and CH radicals both in the ground state and in the excited state increase with the enhancement of the discharge current density in the plasma. The electron density and CH emission intensity increase linearly with the enhancement of discharge current densities. The generation of different carbon-containing radicals is related to the elevation of electron temperature. Combining the growth process of diamond films and the diagnostic results, it is shown that atomic H in the excited state may improve the diamond growth efficiently, and the increase of electron temperat

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

    Science.gov (United States)

    2008-06-01

    Complicated/ expensive systems - Business practices Legal - USA Patriot Act - Military prison scandals - CIA leak probe (Plume Affair) - Enron , Tyco...54 such as Enron , Tyco and WorldCom were prosecuted and received prison sentences for the roles they played in these scandals .114 These...of the author aided in shaping the environment. DoD Political -Vietnam War -Kennedy Assassination -Great Society Initiatives -Watergate Scandal

  3. 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

    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 increased if design rework is reduced. Set-bas...

  4. Responding to biological incidents--what are the current issues in remediation of the contaminated environment?

    Science.gov (United States)

    Pottage, T; Goode, E; Wyke, S; Bennett, A M

    2014-11-01

    Since 2000 there have been a number of biological incidents resulting in environmental contamination with Bacillus anthracis, the causative agent of anthrax. These incidents include the US anthrax attacks in 2001, the US and UK drumming incidents in 2006-2008 and more recently, anthrax contamination of heroin in 2009/2010 and 2012/2013. Remediation techniques used to return environments to normal have varied between incidents, with different decontamination technologies being employed. Many factors need to be considered before a remediation strategy or recovery option can be implemented, including; cost, time (length of application), public perception of risk, and sampling strategies (and results) to name a few. These incidents have demonstrated that consolidated guidance for remediating biologically contaminated environments in the aftermath of a biological incident was required. The UK Recovery Handbook for Biological Incidents (UKRHBI) is a project led by Public Health England (PHE), formerly the Health Protection Agency (HPA) to provide guidance and advice on how to remediate the environment following a biological incident or outbreak of infection, and is expected to be published in 2015. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  5. Leakage Current Phenomenon on Ceramics and Epoxy Resin as 20 kV Outdoor Insulator at Tropical Environment

    Directory of Open Access Journals (Sweden)

    Valdi Rizki Yandri

    2011-01-01

    Full Text Available This paper explains the research results of  leakage current, hydrophobicity and flashover voltage comparison on ceramics and epoxy  resin 20 kV outdoor insulator in a  chamber at tropical climate conditions. The waveform of leakage current (LC was measured using a digital oscilloscope. The digital data was transferred to a personal computer using a RS-232 cable. The digital data was analyzed using Fast Fourier Transform. The result showed that LC was affected by various environment conditions like temperature, humidity and pollution. LC of ceramics insulator was higher than epoxy resin insulator in low temperature, high humidity and high pollution condition.

  6. 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

  7. Evaluation of current state of agricultural land using problem-oriented fuzzy indicators in GIS environment

    Science.gov (United States)

    Current state of agricultural lands is defined under influence of processes in soil, plants and atmosphere and is described by observation data, complicated models and subjective opinion of experts. Problem-oriented indicators summarize this information in useful form for decision of the same specif...

  8. 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 advan

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

    OpenAIRE

    2013-01-01

    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 aft...

  10. Biotemplated materials for sustainable energy and environment: current status and challenges.

    Science.gov (United States)

    Zhou, Han; Fan, Tongxiang; Zhang, Di

    2011-10-17

    Materials science will play a key role in the further development of emerging solutions for the increasing problems of energy and environment. Materials found in nature have many inspiring structures, such as hierarchical organizations, periodic architectures, or nanostructures, that endow them with amazing functions, such as energy harvesting and conversion, antireflection, structural coloration, superhydrophobicity, and biological self-assembly. Biotemplating is an effective strategy to obtain morphology-controllable materials with structural specificity, complexity, and related unique functions. Herein, we highlight the synthesis and application of biotemplated materials for six key areas of energy and environment technologies, namely, photocatalytic hydrogen evolution, CO(2) reduction, solar cells, lithium-ion batteries, photocatalytic degradation, and gas/vapor sensing. Although the applications differ from each other, a common fundamental challenge is to realize optimum structures for improved performances. We highlight the role of four typical structures derived from biological systems exploited to optimize properties: hierarchical (porous) structures, periodic (porous) structures, hollow structures, and nanostructures. We also provide examples of using biogenic elements (e.g., C, Si, N, I, P, S) for the creation of active materials. Finally, we disscuss the challenges of achieving the desired performance for large-scale commercial applications and provide some useful prototypes from nature for the biomimetic design of new materials or systems. The emphasis is mainly focused on the structural effects and compositional utilization of biotemplated materials. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. 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.

  12. Geared induction motor fault diagnosis by current, noise and vibration considering measurement environment

    Directory of Open Access Journals (Sweden)

    Ki-Seok Kim

    2017-01-01

    Full Text Available Lots of motors have been being used in industry. Therefore many studies have been carried out about the failure diagnosis of motors. In this paper, a diagnosis of gear fault connected to a motor shaft is studied. The fault diagnosis is executed through the comparison of normal gear and abnormal gear. In the abnormal gearbox, a tooth of the intermediate gear is damaged. The measured FFT data are compared with the normal data and analyzed for q-axis current, noise and vibration. Fault gear was found by comparing the FFT with normal FFT. From these, the difference between the normal and abnormal states can be seen by the frequency characteristic analysis for the current as well as noise and vibration.

  13. Survival in extreme environments - on the current knowledge of adaptations in tardigrades.

    Science.gov (United States)

    Møbjerg, N; Halberg, K A; Jørgensen, A; Persson, D; Bjørn, M; Ramløv, H; Kristensen, R M

    2011-07-01

    Tardigrades are microscopic animals found worldwide in aquatic as well as terrestrial ecosystems. They belong to the invertebrate superclade Ecdysozoa, as do the two major invertebrate model organisms: Caenorhabditis elegans and Drosophila melanogaster. We present a brief description of the tardigrades and highlight species that are currently used as models for physiological and molecular investigations. Tardigrades are uniquely adapted to a range of environmental extremes. Cryptobiosis, currently referred to as a reversible ametabolic state induced by e.g. desiccation, is common especially among limno-terrestrial species. It has been shown that the entry and exit of cryptobiosis may involve synthesis of bioprotectants in the form of selective carbohydrates and proteins as well as high levels of antioxidant enzymes and other free radical scavengers. However, at present a general scheme of mechanisms explaining this phenomenon is lacking. Importantly, recent research has shown that tardigrades even in their active states may be extremely tolerant to environmental stress, handling extreme levels of ionizing radiation, large fluctuation in external salinity and avoiding freezing by supercooling to below -20 °C, presumably relying on efficient DNA repair mechanisms and osmoregulation. This review summarizes the current knowledge on adaptations found among tardigrades, and presents new data on tardigrade cell numbers and osmoregulation.

  14. Gravity Currents: In the Environment and the Laboratory, Ellis Horwood Series in Environmental Sciences

    Science.gov (United States)

    Csanady, G. T.

    There are books and courses on experimental physics, thorough and rigorous, which contain only simple formulae and use only elementary algebra. The subject is explained in lucid and precise language, with the help of many sketches, photos, and diagrams. The book under review belongs to this genre and is in fact one of its most successful members.About half of the book is devoted to the description of a variety of natural phenomena in which gravity currents play an important role. The class of gravity currents is taken to be quite broad, to include almost any kind of quasi-horizontal motion caused by density differences. The range of natural phenomena surveyed is correspondingly great, from tidal bores through thunderstorms to the eruption of Mount St. Helens. The atmospheric examples are especially thorough and interesting. The broad panorama certainly brings home to the reader the many ways in which fluids (including fluidized rock) can move under the influence of gravity. However, not all of the examples show typical gravity behavior, nor are they all treated with equal thoroughness. The Gulf Stream is mentioned, and the variability of its position is shown in an illustration, but this is not connected with anything typical of gravity currents, nor is the important interplay between Earth rotation and such large-scale “gravity currents” (if one insists on calling them that) at all adequately explained.

  15. Staying Relevant and Current with Online Learning in an Increasingly Global and Competitive Environment

    Directory of Open Access Journals (Sweden)

    Grace Lynch

    2012-08-01

    Full Text Available This paper outlines the success of online learning in the workplace with corporate partners through Open Universities Australia (OUA. OUA is recognized as the national leader in online higher education in Australia with over 200,000 students studying with OUA since 1993. The corporate program helps employees formalize or extend their current skills, reach the next level in their organization or pursue relevant interests through tertiary studies. The business sector sees OUA as a highly attractive solution to fostering a culture of professional development, engagement and inclusiveness.

  16. 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.

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

    Science.gov (United States)

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

    2013-08-01

    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.

  18. Method for transferring data between at least one lagrangian buoy for measuring currents for ocean and costal environments and a base station, and lagrangian buoy for measuring currents for ocean and costal environments

    OpenAIRE

    Martínez-Ledesma, Miquel; Álvarez, Alberto; Vizoso, Guillermo; Tintoré, Joaquín

    2011-01-01

    [EN] Method for transferring data between at least one lagrangian buoy for measuring currents for ocean and coastal environments and a base station, which comprises capturing data by the buoy by means of the parameter-measuring sensors and the GPS receiver and storing said data in a first file which is segmented into packets of a maximum length defined by the SBD Iridium protocol for the subsequent sending thereof to the base station. The invention also relates to the lagrangian buoy for meas...

  19. The Impact of Neighborhood Social and Built Environment Factors across the Cancer Continuum: Current Research, Methodologic Considerations, and Future Directions

    Science.gov (United States)

    Gomez, Scarlett Lin; Shariff-Marco, Salma; De Rouen, Mindy; Keegan, Theresa H. M.; Yen, Irene H.; Mujahid, Mahasin; Satariano, William A.; Glaser, Sally L.

    2015-01-01

    Neighborhood social and built environments have been recognized as important contexts in which health is shaped. We review the extent to which these neighborhood factors have been addressed in population-level cancer research, with a scan of the literature for research that focuses on specific social and/or built environment characteristics and association with outcomes across the cancer continuum, including incidence, diagnosis, treatment, survivorship, and survival. We discuss commonalities and differences in methodologies across studies, current challenges in research methodology, and future directions in this research area. The assessment of social and built environment factors in relation to cancer is a relatively new field, with 82% of 34 reviewed papers published since 2010. Across the wide range of social and built environment exposures and cancer outcomes considered by the studies, numerous associations were reported. However, the directions and magnitudes of association varied, due in large part to the variation in cancer sites and outcomes being studied, but also likely due to differences in study populations, geographical region, and, importantly, choice of neighborhood measure and geographic scale. We recommend that future studies consider the life course implications of cancer incidence and survival, integrate secondary and self-report data, consider work neighborhood environments, and further develop analytical and statistical approaches appropriate to the geospatial and multilevel nature of the data. Incorporating social and built environment factors into research on cancer etiology and outcomes can provide insights into disease processes, identify vulnerable populations, and generate results with translational impact of relevance for interventionists and policy makers. PMID:25847484

  20. The current state of workers' pneumoconiosis in relationship to dusty working environments in Okayama Prefecture, Japan.

    Directory of Open Access Journals (Sweden)

    Takigawa T

    2002-12-01

    Full Text Available This study involved the examination of 1,006 chest x-ray films of workers from the industries devoted to shipyard welding, stone grinding, and refractory crushing in southern Okayama prefecture. Of the reviewed films, analysis was focused on subjects with a profusion rate of 0/1 as well as pneumoconiotic subjects (exhibiting profusion rates of 1/0 or greater in order to discover cases in the beginning stages. One-hundred-and-seventy-four films illustrated a profusion rate of 0/1 or greater, and the proportion of this profusion rate was revealed to be highest in shipyard welders. Even some workers under 40 years of age were found to have already developed pneumoconiosis. Of these 1,006 subjects, 30 volunteers permitted us to measure their personal dust exposure concentrations. The measured concentration of the shipyard welders' dust exposure (respirable dust; 3.3 86.3 mg/m3, total dust; 7.5-117.0 mg/m3 was higher than those of the other 2 industries. Statistical differences among the industries were observed in the respirable dust concentrations. A statistically significant positive correlation was demonstrated between the working duration in dusty environments and the rate of profusion. The present findings suggest the need for taking adequate measures in Okayama in order to prevent workers from developing, or to help retard the progression of, pneumoconiosis.

  1. 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.

  2. High Temperature Corrosion studies on Pulsed Current Gas Tungsten Arc Welded Alloy C-276 in Molten Salt Environment

    Science.gov (United States)

    Manikandan, M.; Arivarasu, M.; Arivazhagan, N.; Puneeth, T.; Sivakumar, N.; Murugan, B. Arul; Sathishkumar, M.; Sivalingam, S.

    2016-09-01

    Alloy C-276 is widely used in the power plant environment due to high strength and corrosion in highly aggressive environment. The investigation on high- temperature corrosion resistance of the alloy C-276 PCGTA weldment is necessary for prolonged service lifetime of the components used in corrosive environments. Investigation has been carried out on Pulsed Current Gas Tungsten Arc Welding by autogenous and different filler wires (ERNiCrMo-3 and ERNiCrMo-4) under molten state of K2SO4-60% NaCl environment at 675oC under cyclic condition. Thermogravimetric technique was used to establish the kinetics of corrosion. Weight gained in the molten salt reveals a steady-state parabolic rate law while the kinetics with salt deposits displays multi-stage growth rates. PCGTA ERNiCrMo-3 shows the higher parabolic constant compared to others. The scale formed on the weldment samples upon hot corrosion was characterized by using X-ray diffraction, SEM and EDAX analysis to understand the degradation mechanisms. From the results of the experiment the major phases are identified as Cr2O3, Fe2O3, and NiCr2O4. The result showed that weld fabricated by ERNiCrMo-3 found to be more prone to degradation than base metal and ERNiCrMo-4 filler wire due to higher segregation of alloying element of Mo and W in the weldment

  3. Using probabilistic terrorism risk modeling for regulatory benefit-cost analysis: application to the Western hemisphere travel initiative in the land environment.

    Science.gov (United States)

    Willis, Henry H; LaTourrette, Tom

    2008-04-01

    This article presents a framework for using probabilistic terrorism risk modeling in regulatory analysis. We demonstrate the framework with an example application involving a regulation under consideration, the Western Hemisphere Travel Initiative for the Land Environment, (WHTI-L). First, we estimate annualized loss from terrorist attacks with the Risk Management Solutions (RMS) Probabilistic Terrorism Model. We then estimate the critical risk reduction, which is the risk-reducing effectiveness of WHTI-L needed for its benefit, in terms of reduced terrorism loss in the United States, to exceed its cost. Our analysis indicates that the critical risk reduction depends strongly not only on uncertainties in the terrorism risk level, but also on uncertainty in the cost of regulation and how casualties are monetized. For a terrorism risk level based on the RMS standard risk estimate, the baseline regulatory cost estimate for WHTI-L, and a range of casualty cost estimates based on the willingness-to-pay approach, our estimate for the expected annualized loss from terrorism ranges from $2.7 billion to $5.2 billion. For this range in annualized loss, the critical risk reduction for WHTI-L ranges from 7% to 13%. Basing results on a lower risk level that results in halving the annualized terrorism loss would double the critical risk reduction (14-26%), and basing the results on a higher risk level that results in a doubling of the annualized terrorism loss would cut the critical risk reduction in half (3.5-6.6%). Ideally, decisions about terrorism security regulations and policies would be informed by true benefit-cost analyses in which the estimated benefits are compared to costs. Such analyses for terrorism security efforts face substantial impediments stemming from the great uncertainty in the terrorist threat and the very low recurrence interval for large attacks. Several approaches can be used to estimate how a terrorism security program or regulation reduces the

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

    Science.gov (United States)

    Xue, C; Wood, A W; Dovan, T

    2004-12-01

    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 & 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.

  5. 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…

  6. Legacy and currently used pesticides in the atmospheric environment of Lake Victoria, East Africa.

    Science.gov (United States)

    Arinaitwe, Kenneth; Kiremire, Bernard T; Muir, Derek C G; Fellin, Phil; Li, Henrik; Teixeira, Camilla; Mubiru, Drake N

    2016-02-01

    The Lake Victoria watershed has extensive agricultural activity with a long history of pesticide use but there is limited information on historical use or on environmental levels. To address this data gap, high volume air samples were collected from two sites close to the northern shore of Lake Victoria; Kakira (KAK) and Entebbe (EBB). The samples, to be analyzed for pesticides, were collected over various periods between 1999 and 2004 inclusive (KAK 1999-2000, KAK 2003-2004, EBB 2003 and EBB 2004 sample sets) and from 2008 to 2010 inclusive (EBB 2008, EBB 2009 and EBB 2010 sample sets). The latter sample sets (which also included precipitation samples) were also analyzed for currently used pesticides (CUPs) including chlorpyrifos, chlorthalonil, metribuzin, trifluralin, malathion and dacthal. Chlorpyrifos was the predominant CUP in air samples with average concentrations of 93.5, 26.1 and 3.54 ng m(-3) for the EBB 2008, 2009, 2010 sample sets, respectively. Average concentrations of total endosulfan (ΣEndo), total DDT related compounds (ΣDDTs) and hexachlorocyclohexanes (ΣHCHs) ranged from 12.3-282, 22.8-130 and 3.72-81.8 pg m(-3), respectively, for all the sample sets. Atmospheric prevalence of residues of persistent organic pollutants (POPs) increased with fresh emissions of endosulfan, DDT and lindane. Hexachlorobenzene (HCB), pentachlorobenzene (PeCB) and dieldrin were also detected in air samples. Transformation products, pentachloroanisole, 3,4,5-trichloroveratrole and 3,4,5,6-tetrachloroveratrole, were also detected. The five most prevalent compounds in the precipitation samples were in the order chlorpyrifos>chlorothalonil>ΣEndo>ΣDDTs>ΣHCHs with average fluxes of 1123, 396, 130, 41.7 and 41.3 ng m(-2)sample(-1), respectively. PeCB exceeded HCB in precipitation samples. The reverse was true for air samples. Backward air trajectories suggested transboundary and local emission sources of the analytes. The results underscore the need for a concerted

  7. NRC regulatory initiatives

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, T.C. [Nuclear Regulatory Commission (United States)

    1989-11-01

    The US Nuclear Regulatory Commission (NRC) is addressing several low-level waste disposal issues that will be important to waste generators and to States and Compacts developing new disposal capacity. These issues include Greater-Than-Class C (GTCC) waste, mixed waste, below regulatory concern (BRC) waste, and the low-level waste data base. This paper discusses these issues and their current status.

  8. A review on emerging contaminants in wastewaters and the environment: current knowledge, understudied areas and recommendations for future monitoring.

    Science.gov (United States)

    Petrie, Bruce; Barden, Ruth; Kasprzyk-Hordern, Barbara

    2015-04-01

    of using an integrated analytical approach which compliments targeted and non-targeted screening with biological assays to measure ecological impact. With respect to current toxicity testing protocols, failure to consider the enantiomeric distribution of chiral compounds found in the environment, and the possible toxicological differences between enantiomers is concerning. Such information is essential for the development of more accurate environmental risk assessment.

  9. 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

  10. 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

    2017-01-01

    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. PMID:28773078

  11. Current asthma, respiratory symptoms and airway infections among students in relation to the school and home environment in Japan.

    Science.gov (United States)

    Takaoka, Motoko; Suzuki, Kyoko; Norbäck, Dan

    2017-08-01

    To study associations between the school and home environment and current asthma, respiratory symptoms and airway infections among Japanese students. Japanese students (12-15 y) (N = 1048) in four schools responded to a questionnaire on respiratory health, allergy and the home environment. Temperature, relative air humidity (RH) and student density (students/m(2) floor area) was measured in the classrooms: dust was collected from floors and in classroom air and analysed for cat (Fel d 1) and dog (Can f 1) allergens. Health associations were analysed by multi-level logistic regression. Doctor's diagnosed asthma was common (13.4%), 8.8% reported cat allergy and 6.1% dog allergy. The median level in floor dust was 41 ng/g (IQR 23-92) for Fel d 1 and 101 ng/g (IQR 54-101) for Can f 1. The median level in air was 18.6 ng/ m(2)/ day (IQR5.9-25.1) for Fel d 1 and 18.6 ng/ m(2)/ day (IQR 6.0-13.3) for Can f 1. High RH, high student density and airborne cat allergen was associated with airway infections. In the home environment, recent indoor painting, new floor materials, odour, having cats as pets, window pane condensation in winter, and dampness in floor construction were associated with respiratory illness. High relative air humidity, high student density and airborne cat allergens at school may increase the risk of airway infections. Having cats as pets, chemical emissions from paint and new floor materials, odour and dampness can constitute domestic risk factors for respiratory symptoms while having dogs as pets could be protective.

  12. [Current status of operations in community general support centers and the correlation of personal traits, work environment and occupational stress].

    Science.gov (United States)

    Yamaguchi, Yoshie

    2010-01-01

    The purpose of this study was to identify the current status of operations at community general support centers which provide coordination for elderly care and the correlation of personal traits, work environment and the occupational stress of the staff. Subjects of the study were 251 staff members of community general support centers. The current status of operations at the community general support centers and the personal traits, work environment, effort-remuneration imbalance model (ERI) and general health questionnaire (GHQ) were surveyed. The initial analysis involved a comparison by a chi-square test on: The effort-remuneration ratio (E/R ratio) of personal traits and work environment, risk of over-commitment (OC), and GHQ score. To explore the correlation between the E/R ratio of the three GHQ groups (low, middle and high score groups) and the OC value, one-way analysis of variance was performed. Out of the four basic functions of the community general support centers, 22.0% of the respondents noted that "establishment of a regional, comprehensive/multi-tiered service network" was functioning, and 50.4% of respondents noted that "comprehensive and continuous care management" was functioning. The average effort score was 15.5 +/- 5.3, approximately double the average value of preceding studies. Significant differences found in GHQ scores were related to working hours (pworking hours of 50 h or more" (OR: 10.38, 95% CI: 2.52-42.70), "Unstable employment" (OR: 2.75, 95% CI: 1.22-6.21) and "Anxiety related to task content" (OR: 17.04, 95% CI: 3.57-81.24). Items observed to have significant correlation with OC value risk factors were: "Weekly working hours of 50 h or more" (OR: 8.04, 95% CI: 1.99-32.41) and "Anxiety related to task content" (OR: 4.60, 95% CI: 2.04-10.37). We conclude that the basic functions of the community general support centers are not presently very functional. The stress levels of the community general support center staff are high and

  13. Modeling the fate of Escherichia coli O157:H7 and Salmonella enterica in the agricultural environment: current perspective.

    Science.gov (United States)

    Ongeng, Duncan; Haberbeck, Leticia U; Mauriello, Gianluigi; Ryckeboer, Jaak; Springael, Dirk; Geeraerd, Annemie H

    2014-04-01

    The significance of fresh vegetable consumption on human nutrition and health is well recognized. Human infections with Escherichia coli O157:H7 and Salmonella enterica linked to fresh vegetable consumption have become a serious public health problem inflicting a heavy economic burden. The use of contaminated livestock wastes such as manure and manure slurry in crop production is believed to be one of the principal routes of fresh vegetable contamination with E. coli O157:H7 and S. enterica at preharvest stage because both ruminant and nonruminant livestock are known carriers of E. coli O157:H7 and S. enterica in the environment. A number of challenge-testing studies have examined the fate of E. coli O157:H7 and S. enterica in the agricultural environment with the view of designing strategies for controlling vegetable contamination preharvest. In this review, we examined the mathematical modeling approaches that have been used to study the behavior of E. coli O157:H7 and S. enterica in the manure, manure-amended soil, and in manure-amended soil-plant ecosystem during cultivation of fresh vegetable crops. We focused on how the models have been applied to fit survivor curves, predict survival, and assess the risk of vegetable contamination preharvest. The inadequacies of the current modeling approaches are discussed and suggestions for improvements to enhance the applicability of the models as decision tools to control E. coli O157:H7 and S. enterica contamination of fresh vegetables during primary production are presented.

  14. 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

  15. Parental Involvement and Home Environment in Music: Current and Former Students from Selected Community Music Programs in Brazil and the United States

    Science.gov (United States)

    Barnes, Gail V.; DeFreitas, Aureo; Grego, John

    2016-01-01

    The purpose of this study was to determine whether individuals' perceptions of parental involvement and home environment in music vary with nationality (Brazil/United States) and time frame (past/current). Past and current students from selected community music programs in the United States and Brazil completed the PI-HEM (Parental Involvement and…

  16. Internal structure and current evolution of very small debris-covered glacier systems located in alpine permafrost environments

    Directory of Open Access Journals (Sweden)

    Jean-Baptiste eBosson

    2016-04-01

    Full Text Available This contribution explores the internal structure of very small debris-covered glacier systems located in permafrost environments and their current dynamical responses to short-term climatic variations. Three systems were investigated with electrical resistivity tomography and dGPS monitoring over a 3-year period. Five distinct sectors are highlighted in each system: firn and bare-ice glacier, debris-covered glacier, heavily debris-covered glacier of low activity, rock glacier and ice-free debris. Decimetric to metric movements, related to ice ablation, internal deformation and basal sliding affect the glacial zones, which are mainly active in summer. Conversely, surface lowering is close to zero (-0.04 m yr-1 in the rock glaciers. Here, a constant and slow internal deformation was observed (c. 0.2 m yr-1. Thus, these systems are affected by both direct and high magnitude responses and delayed and attenuated responses to climatic variations. This differential evolution appears mainly controlled by (1 the proportion of ice, debris and the presence of water in the ground, and (2 the thickness of the superficial debris layer.

  17. Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference.

    Science.gov (United States)

    Hochhaus, Guenther; Davis-Cutting, Craig; Oliver, Martin; Lee, Sau L; Lyapustina, Svetlana

    2015-09-01

    This article summarizes discussions at the March 2014 conference organized by the University of Florida (UF) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), entitled "Orlando Inhalation Conference: Approaches in International Regulation." The special focus of the conference was on global scientific and regulatory issues associated with the testing and demonstration of equivalence for the registration of orally inhaled drug products (OIDPs) in the United States, Europe, Brazil, China, and India. The scope included all types of OIDPs throughout their lifecycle, e.g., innovator/brand-name products, generics, modifications due to lifecycle management, device changes, etc. Details were presented for the U.S. "weight of evidence approach" for registration of generic products (which includes demonstration of in vitro and in vivo equivalence, as well as quantitative and qualitative sameness, and device similarity). The European "stepwise" approach was elucidated, and the thinking of regulatory agencies in the major emerging markets was clarified. The conference also highlighted a number of areas that would benefit from further research and discussion, especially around patient/device interface and human factor studies, statistical methods and criteria for demonstrating equivalence, the relative roles of in vivo and in vitro tests, and appropriate designs and metrics for in vivo studies of inhaled drugs.

  18. 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...

  19. 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...

  20. 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....

  1. Shipping and the Environment: The View from the Shoreline.

    Science.gov (United States)

    Dixon, Trevor R.

    1991-01-01

    Discussed are the effectiveness of the current international regulatory framework to protect the marine environment, the need for more stringent maritime regulations fostered by an increased popular awareness that this current framework is outdated, and the strategies deemed appropriate to assimilate the "total environmental view" within…

  2. Evolution of the Synthetic Environment in the FFSE Section: Survey of Current Usage of Synthetic Environment within FFSE and Recommendations for the Future

    Science.gov (United States)

    2005-11-01

    d’outils de modélisation et de simulation pour créer des expériences et des exercices virtuels pour DND, dans le but d’aider au développement de...différents outils, exercices et expériences, onze instances de simulations ont été identifiées et caractérisées. Ces instances sont décrites brièvement...Mission Rehearsal in a Synthetic Environment: Summary and Preliminary Analyses . (DRDC Ottawa TM 2004-200). Defence R&D Canada - Ottawa 5. B. Kim

  3. The wider use of fixed-dose combinations emphasizes the need for a global approach to regulatory guideline development

    DEFF Research Database (Denmark)

    Gautam, Yvonne; Bjerrum, Ole Jannik; Schmiegelow, Merete

    2015-01-01

    face the regulatory world: how to improve the role of regulatory science and provide clear quantification in assessment decisions; the role of guidelines and their impact on innovation; and, most important, the question of globalization and how to move toward a more harmonized regulatory system....... in the EU and US. A review of the FDC guidelines set forth by the EMA, FDA, and ICH, followed by interviews of key informants in industry, identified 5 main industry concerns related to development of FDCs. These concerns were presented to key informants from both the EU and US regulatory authorities....... It was clear from the results that the current regulatory environment for FDCs lacks consistency. This may create a barrier to innovation moving from the laboratory to the clinic, as companies cannot clearly see the development path requirements. This project also highlighted certain challenges that currently...

  4. 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.

  5. REGULATORY AGENCIES, CONSUMER AND ENVIROMENT

    Directory of Open Access Journals (Sweden)

    Giseli Valezi Raymundo

    2011-03-01

    Full Text Available The aim of this paper is to present the analysis on the insertion of the consumer in the current model of State in Brazil, considering the nowaday legal system. It is wished to be shown, moreover, the already existing reality on the theme, even if modest, so to in a way to question the responsibility of the consumer, according to its consuming habits and its inertia, takes in today’s technological society. To such proposal, the most effective research method, and, for this reason had been used in this paper, is the extensive bibliography research and legislation consultation. Through it, it had been found that the State model has changed over the past decades in order to delegate the execution of various activities of State ownership to private enterprise, in view of the existence of a minimal State and governor. In this sense, there were created the Regulatory Agencies, which are indirect public administration entities, with the ultimate objective of regulating and supervising the execution of those legal activities, performed by the private sector. The consumer, inserted in this reality, is the direct recipient of the action of the mentioned entities, questioning the legislative and sanction legitimacy of the regulatory entities as well as the possibility of judicial review on the merits of administrative actions of these entities and the applicability of the Brazilian Code of Defense of the Consumer (CDC to the execution of public services, a discipline that affects the administrative law rights. Notwithstanding the above analysis in context, all these social workers, consumers and regulatory agencies are immersed in changing habits, due to the optimization of actions, aimed at preserving the environment, the prospect of achieving sustainable development. Based on this perspective, the results brought by the survey showed that the application of the Brazilian Code of Defense of the Consumer in relations between consumers does not preclude

  6. 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...

  7. Study for the electric arc of alternative current at the single phase welding machine using the Matlab/Simulink environment

    Science.gov (United States)

    Baciu, I.; Ghiormez, L.; Vasar, C.

    2017-01-01

    In this paper is presented a mathematical model of the electric arc for an alternative current welding machine of low power. The electric arc model is based on dividing the voltage-current characteristic of the electric arc in many functioning zones. For the model of the entire welding machine are used real parameters as the ones of the proper welding machine. The voltage and current harmonics spectrum that is obtained during the welding process is presented. Also, the waveforms for the current and voltage of the electric arc plotted against time and the voltage-current characteristic of the electric arc are illustrated. The electric arc is considered as being supplied by alternative voltage from the electrical power network using a single phase transformer which has the output voltage of 80 volts. The model of the welding machine is developed in Simulink and the variations of some parameters of the electric arc are obtained by modifying of them in a Matlab function. Also, in this paper is presented the total harmonic distortion for the voltage and current of the electric arc obtained during simulation of the welding machine.

  8. Análise comparativa do desenho normativo de instituições reguladoras do presente e do passado Comparative analysis of the normative design of former and current regulatory institutions

    Directory of Open Access Journals (Sweden)

    Antonio Gelis Filho

    2006-08-01

    Full Text Available Este artigo desenvolve um modelo matricial para avaliação do desenho normativo de instituições reguladoras do presente e do passado (autarquias econômicas da república "populista". Desenho normativo é definido como o conjunto de possibilidades de estruturação e de atuação de uma instituição que é delimitado pelas normas jurídicas que a criaram. O modelo é estruturado a partir de dois parâmetros principais: independência em relação ao poder central e transparência em relação à sociedade. Foram testadas cinco hipóteses, concluindo-se que as instituições reguladoras do presente apresentam desenhos normativos heterogêneos e que se distinguem de instituições do passado tanto por maior independência quanto por maior transparência, sendo a diferença mais acentuada em relação ao segundo parâmetro.This article develops a matrix model to assess the normative design of past and current regulatory institutions (economic autarchies of the 'populist' republic. Normative design is defined as a set of possibilities for an institution's structure and actions which is limited by the legal norms that created it. The model is structured based on two main parameters: independence in relation to the central power and transparency in relation to society. Five hypothesis were tested, and the conclusion was that current regulatory institutions have heterogeneous designs and they differ from the former ones for being both more independent and more transparent, and the largest difference is in the second parameter.

  9. Healthcare regulatory concepts in Brazil.

    Science.gov (United States)

    Oliveira, Robson Rocha de; Elias, Paulo Eduardo Mangeon

    2012-06-01

    The healthcare regulatory concepts used in Brazilian scientific publications on healthcare management were reviewed. A typo-logical classification for regulatory concepts was developed from the most current ideas in five disciplines: life sciences, law, economics, sociology and political science. Four ideas stood out: control, balance, adaptation and direction, with greatest emphasis on the technical nature of regulation. The political nature of regulation was secondary. It was considered that dis-cussion of healthcare regulatory concepts was connected with comprehension of the role that the state plays in this sector. De-finition of the forms of state intervention is the key convergence point between the different ways of conceptualizing healthcare regulation.

  10. A Practical approach for fault component network for Current and Voltage Phasor Diagram in Power Electronic Environment

    Directory of Open Access Journals (Sweden)

    Mr. Ashish Choubey

    2011-09-01

    Full Text Available In many large-scale power plants, the structure of its auxiliary power system is complex, and the coordination of its relay protections is difficult. To enhance power supply reliability for the user terminals in the case of the distribution system to avoid interference by the fault again, rapidly complete the automatic identification, positioning, automatic fault isolation, network reconfiguration until the resumption of supply of non-fault section, a microprocessor-based relay protection device has developed. As the fault component theory is widely used in microcomputer protection, and fault component exists in the network of fault component, it is necessary to build up the fault component network when short circuit fault emerging and to draw the current and voltage component phasor diagram at fault point. We proposed a special phase sequence component based on the boundary condition. We analysis the velocity according to the relationship between analysis formula and phasor diagram and current in fault component boundary conditions and sequence voltage and current in boundary conditions. The negative and zero sequence component current and voltage at fault point are the same as fault component. The positive sequence component current and voltage at fault point are different from the fault component. So we consider the positive sequences according to that sequences we analyze the fault point

  11. A Practical approach for fault component network for Current and Voltage Phasor Diagram in Power Electronic Environment

    Directory of Open Access Journals (Sweden)

    Ashish Choubey

    2011-12-01

    Full Text Available In many large-scale power plants, the structure of its auxiliary power system is complex, and the coordination of its relay protections is difficult. To enhance power supply reliability for the user terminals in the case of the distribution system to avoid interference by the fault again, rapidly complete the automatic identification, positioning, automatic fault isolation, network reconfiguration until the resumption of supply of non-fault section, a microprocessor-based relay protection device has developed. As the fault component theory is widely used in microcomputer protection, and fault component exists in the network of fault component, it is necessary to build up the fault component network when short circuit fault emerging and to draw the current and voltage component phasor diagram at fault point. We proposed a special phase sequence component based on the boundary condition. We analysis the velocity according to the relationship between analysis formula and phasor diagram and current in fault component boundary conditions and sequence voltage and current in boundary conditions. The negative and zero sequence component current and voltage at fault point are the same as fault component. The positive sequence component current and voltage at fault point are different from the fault component. So we consider the positive sequences according to that sequences we analyze the fault point.

  12. 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.

  13. Small regulatory RNA and Legionella pneumophila

    Directory of Open Access Journals (Sweden)

    Sebastien P Faucher

    2011-05-01

    Full Text Available Legionella pneumophila is a gram-negative bacterial species that is ubiquitous in almost any aqueous environment. It is the agent of Legionnaires’ disease, an acute and often under-reported form of pneumonia. In mammals, L. pneumophila replicates inside macrophages within a modified vacuole. Many protein regulators have been identified that control virulence-related properties, including RpoS, LetA/LetS and PmrA/PmrB. In the past few years, the importance of regulation of virulence factors by small regulatory RNA has been increasingly appreciated. This is also the case in L. pneumophila where three sRNAs (RsmY, RsmZ and 6S RNA were recently shown to be important determinants of virulence regulation and 79 actively transcribed sRNAs were identified. In this review we describe current knowledge about sRNAs and their regulatory properties and how this relates to the known regulatory systems of L. pneumophila. We also provide a model for sRNA-mediated control of gene expression that serves as a framework for understanding the regulation of virulence-related properties of L. pneumophila.

  14. Risk assessment of chlortetracycline, oxytetracycline, sulfamethazine, sulfathiazole, and erythromycin in aquatic environment: are the current environmental concentrations safe?

    Science.gov (United States)

    Ji, Kyunghee; Kim, Sunmi; Han, Sunyoung; Seo, Jihyun; Lee, Sangwoo; Park, Yoonsuk; Choi, Kyunghee; Kho, Young-Lim; Kim, Pan-Gyi; Park, Jeongim; Choi, Kyungho

    2012-10-01

    To understand potential risks of major pharmaceutical residues in waters, we evaluated ecotoxicities of five major veterinary pharmaceuticals, i.e., chlortetracycline, oxytetracycline, sulfamethazine, sulfathiazole, and erythromycin, which have been frequently detected in freshwater environment worldwide. We conducted acute and chronic toxicity tests using two freshwater invertebrates (Daphnia magna and Moina macrocopa) and a fish (Oryzias latipes). In general, D. magna exhibited greater sensitivity than M. macrocopa, and chronic reproduction was the most sensitive endpoints for both organisms. The population growth rate was adversely influenced by exposure to chlortetracycline, sulfamethazine, or sulfathiazole in water fleas, but reduction in population size was not expected. In O. latipes, the tested pharmaceuticals affected several reproduction related endpoints including time to hatch and growth. Based on the toxicity values from the present study and literature, algae appeared to be the most sensitive organism, followed by Daphnia and fish. Hazard quotients derived from measured environmental concentrations (MECs) and predicted no effect concentrations (PNECs) for erythromycin and oxytetracycline exceeded unity, suggesting that potential ecological effects at highly contaminated sites cannot be ruled out. Long-term consequences of veterinary pharmaceutical contamination in the environment deserve further investigation.

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

    DEFF Research Database (Denmark)

    Primdahl, Jorgen; 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...... 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...

  16. 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.

  17. Magnetic Reconnection in the Heliospheric Current Sheet: The Implications of the Different Environments Seen by the VoyagerSpacecraft

    Science.gov (United States)

    Swisdak, M. M.; Drake, J. F.; Opher, M.

    2014-12-01

    The magnetic field abutting the heliospheric current sheet (HCS) is primarily in the azimuthal direction, either east-to-west or west-to-east. Mis-alignment of the solar rotational and magnetic axesleads to the characteristic ballerina-skirt shape of the HCS and during the solar cycle there can be large excursions in the sheet's latitudinal extent. Voyager 2's observations of energetic electrondropouts are related to its crossing of this boundary. Magnetic reconnection is also thought to occur as the HCS compresses and narrows between the termination shock and the heliopause. Near theequator the two HCS field alignments are present in roughly equal amounts, while near the edges the distribution can be considerably skewed. This will lead to substantial differences in the environmentsof the two Voyager spacecraft since Voyager 1 is north of the equator, but firmly in the sector region, while Voyager 2 is south of the equator and skirting the edges of the sector region. We presentparticle-in-cell simulations demonstrating the consequences of the reconnection of asymmetric amounts of flux. In particular, we will discuss Voyager 2's remaining time in the heliosphere -- including theimplications for the solar wind velocity, energetic particle transport, and the expected structure of Voyager 2's heliopause crossing -- and compare it with the data collected from Voyager 1.

  18. Global Security Rule Sets An Analysis of the Current Global Security Environment and Rule Sets Governing Nuclear Weapons Release

    Energy Technology Data Exchange (ETDEWEB)

    Mollahan, K; Nattrass, L

    2004-09-30

    America is in a unique position in its history. In maintaining its position as the world's only superpower, the US consistently finds itself taking on the role of a global cop, chief exporter of hard and soft power, and primary impetus for globalization. A view of the current global situation shows an America that can benefit greatly from the effects of globalization and soft power. Similarly, America's power can be reduced significantly if globalization and its soft power are not handled properly. At the same time, America has slowly come to realize that its next major adversary is not a near peer competitor but terrorism and disconnected nations that seek nuclear capabilities. In dealing with this new threat, America needs to come to terms with its own nuclear arsenal and build a security rule set that will establish for the world explicitly what actions will cause the US to consider nuclear weapons release. This rule set; however, needs to be established with sensitivity to the US's international interests in globalization and soft power. The US must find a way to establish its doctrine governing nuclear weapons release without threatening other peaceful nations in the process.

  19. 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.

  20. Risk factors for stereotypic behavior and self-biting in rhesus macaques (Macaca mulatta): animal's history, current environment, and personality.

    Science.gov (United States)

    Gottlieb, Daniel H; Capitanio, John P; McCowan, Brenda

    2013-10-01

    Captive rhesus macaques sometimes exhibit undesirable abnormal behaviors, such as motor stereotypic behavior (MSB) and self-abuse. Many risk factors for these behaviors have been identified but the list is far from comprehensive, and large individual differences in rate of behavior expression remain. The goal of the current study was to determine which experiences predict expression of MSB and self-biting, and if individual differences in personality can account for additional variation in MSB expression. A risk factor analysis was performed utilizing data from over 4,000 rhesus monkeys at the California National Primate Research Center. Data were analyzed using model selection, with the best fitting models evaluated using Akaike Information Criterion. Results confirmed previous research that males exhibit more MSB and self-biting than females, MSB decreases with age, and indoor reared animals exhibit more MSB and self-biting than outdoor reared animals. Additionally, results indicated that animals exhibited less MSB and self-biting for each year spent outdoors; frequency of room moves and number of projects positively predicted MSB; pair separations positively predicted MSB and self-biting; pair housed animals expressed less MSB than single housed and grate paired animals; and that animals expressed more MSB and self-biting when in bottom rack cages, or cages near the room entrance. Based on these results we recommend limiting exposure to these risk factors when possible. Our results also demonstrated a relationship between personality and MSB expression, with animals low on gentle temperament, active in response to a human intruder, and high on novel object contact expressing more MSB. From these results we propose that an animal's MSB is related to its predisposition for an active personality, with active animals expressing higher rates of MSB.

  1. Regulatory Snapshots: integrative mining of regulatory modules from expression time series and regulatory networks.

    Directory of Open Access Journals (Sweden)

    Joana P Gonçalves

    Full Text Available Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1 apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2 ignore local patterns, abundant in most interesting cases of transcriptional activity; (3 neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4 limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots. Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in

  2. 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

  3. 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

  4. 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.

  5. Current studies on nursing work environment and strategies for improvement of nursing work environment%护理工作环境的研究探讨与改革策略

    Institute of Scientific and Technical Information of China (English)

    尤黎明; 刘佳丽; 郑晶; 刘可

    2016-01-01

    The important role of nursing work environment has received much attention in the management of nursing workforce and the quality of health care services. This paper analyzed current studies on nursing work environment, and suggested that the government and hospital administrators pay more attention to the development of nursing workforce, adequate clinical nurse staffing levels and promoting healthy work environment for nurses.%护理工作环境在护士队伍建设和护理服务质量管理中的重要地位在近年来受到广泛关注。本文分析了国内外护理工作环境的研究结果及国外护理工作环境的改革策略,建议我国各级卫生行政部门和医疗卫生机构重视护理人才队伍建设,切实保障临床护理人力配置,共同努力构建健康的护理工作环境。

  6. 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

  7. Mapping the Tidewater Submarine and Ice-Marginal Environment Using Interferometric Bathymetry, Ground-Based LiDAR and Current Velocities; Hubbard Glacier, Alaska

    Science.gov (United States)

    Finnegan, D. C.; Lawson, D. E.; Butler, W.; Waller, T.; Pratt, T.

    2009-12-01

    The seasonal advance and retreat of tidewater glaciers is a relatively well-documented phenomenon. But our understanding of the processes and conditions within the ice-marginal submarine environment that drive or result from this activity is limited. Capturing holistic information within this environment such as bathymetric topography, hydrographic measurements and geospatial information about the terminus itself is often limited to discrete measurements far from the terminus grounding line or lack the detail and scale necessary to identify features that may be indicative of process. To understand these processes, it is essential to accurately obtain data at resolutions that are sufficient to understand the geologic and marine environment. This paper describes the results of a first-of-its-kind survey of the submarine and ice-marginal terrestrial environment of the Hubbard Glacier tidewater terminus. Hubbard Glacier is the largest non-polar tidewater glacier in the world. It encompasses an area of 3500 sq km and flows 120 km from the flanks of Mt Logan (5959 m) in the Wrangell St. Elias Mountains (Canada) to sea level where its terminus widens to ~13 km. In contrast to most glaciers in Southeast Alaska, Hubbard Glacier continues to advance and thicken and is predicted to continue for the foreseeable future. We utilize a multi-sensor fusion approach that integrates high-resolution interferometric (swath-based) multibeam bathymetry with high-resolution ground-based LiDAR topography and current velocity profiles to provide a detailed look at the section of the glacier where significant ice advance and potential ice-damming occurs. Through simultaneous collection of these data we are able to precisely map the topography of the sea floor adjacent to and at the grounding line of the ice terminus while simultaneously mapping the ice terminus and surrounding terrain to create a complete 3D topographic model of the aerial and submarine environment. These data allow for

  8. The Contributing Role of the Regulatory Environment

    Science.gov (United States)

    1991-04-09

    Sources: Carriers and KJH Comnunicationa (Atlanta) Reproduced in part from " Commuiaions January 1991, p. 102.8 FI THE com ymrnNG ROLE oF HE...were awaiting government approval at the time of publication. - Sources: Carrieo and KJH comnmticatiom (Atlanta) Reproduced in part from " " January 1991. p. 103-4. A’ 4

  9. Toxicogenomics in regulatory ecotoxicology

    Science.gov (United States)

    Ankley, Gerald T.; Daston, George P.; Degitz, Sigmund J.; Denslow, Nancy D.; Hoke, Robert A.; Kennedy, Sean W.; Miracle, Ann L.; Perkins, Edward J.; Snape, Jason; Tillitt, Donald E.; Tyler, Charles R.; Versteeg, Donald

    2006-01-01

    Recently, we have witnessed an explosion of different genomic approaches that, through a combination of advanced biological, instrumental, and bioinformatic techniques, can yield a previously unparalleled amount of data concerning the molecular and biochemical status of organisms. Fueled partially by large, well-publicized efforts such as the Human Genome Project, genomic research has become a rapidly growing topical area in multiple biological disciplines. Since 1999, when the term “toxicogenomics” was coined to describe the application of genomics to toxicology (1), a rapid increase in publications on the topic has occurred (Figure 1). The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions and, as with any new technology, has evoked a wide range of opinion (2–6). VIEWPOINT © 2006 american chemical Society july 1, 2006 / EnvironmEntal SciEncE & tEchnology n 4055 The purpose of this feature article is to consider the roles of toxicogenomics in the field of regulatory ecotoxicology, explore current limitations in the science and practice of genomics, and propose possible avenues to approach and resolve some of the major challenges. A significant amount of input to our analysis came from a workshop sponsored by the Society of Environmental Toxicology and Chemistry (SETAC) in Pellston, Mich., in September 2005. A complete list of names and affiliations of the experts participating in that workshop is provided online in Table 1 of the Supporting Information for this paper.

  10. 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....

  11. 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

  12. LightForce photon-pressure collision avoidance: Efficiency analysis in the current debris environment and long-term simulation perspective

    Science.gov (United States)

    Yang Yang, Fan; Nelson, Bron; Aziz, Jonathan; Carlino, Roberto; Dono Perez, Andres; Faber, Nicolas; Foster, Cyrus; Frost, Chad; Henze, Chris; Karacalıoğlu, Arif Göktuğ; Levit, Creon; Marshall, William; Mason, James; O'Toole, Conor; Swenson, Jason; Worden, Simon P.; Stupl, Jan

    2016-09-01

    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 20 kW 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 % 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 planned simulation approach for that effort. For the efficiency analysis of collision avoidance in the current debris environment, we utilize a simulation approach that uses the entire Two Line Element (TLE) catalog in LEO for a given day as initial input. These objects are propagated for one year and an all-on-all conjunction analysis is performed. For conjunctions that fall below a range threshold, we calculate the probability of collision and record those values. To assess efficiency, we compare a baseline

  13. Adaptive Dynamics of Regulatory Networks: Size Matters

    Directory of Open Access Journals (Sweden)

    2009-03-01

    Full Text Available To accomplish adaptability, all living organisms are constructed of regulatory networks on different levels which are capable to differentially respond to a variety of environmental inputs. Structure of regulatory networks determines their phenotypical plasticity, that is, the degree of detail and appropriateness of regulatory replies to environmental or developmental challenges. This regulatory network structure is encoded within the genotype. Our conceptual simulation study investigates how network structure constrains the evolution of networks and their adaptive abilities. The focus is on the structural parameter network size. We show that small regulatory networks adapt fast, but not as good as larger networks in the longer perspective. Selection leads to an optimal network size dependent on heterogeneity of the environment and time pressure of adaptation. Optimal mutation rates are higher for smaller networks. We put special emphasis on discussing our simulation results on the background of functional observations from experimental and evolutionary biology.

  14. Adaptive Dynamics of Regulatory Networks: Size Matters

    Directory of Open Access Journals (Sweden)

    Martinetz Thomas

    2009-01-01

    Full Text Available To accomplish adaptability, all living organisms are constructed of regulatory networks on different levels which are capable to differentially respond to a variety of environmental inputs. Structure of regulatory networks determines their phenotypical plasticity, that is, the degree of detail and appropriateness of regulatory replies to environmental or developmental challenges. This regulatory network structure is encoded within the genotype. Our conceptual simulation study investigates how network structure constrains the evolution of networks and their adaptive abilities. The focus is on the structural parameter network size. We show that small regulatory networks adapt fast, but not as good as larger networks in the longer perspective. Selection leads to an optimal network size dependent on heterogeneity of the environment and time pressure of adaptation. Optimal mutation rates are higher for smaller networks. We put special emphasis on discussing our simulation results on the background of functional observations from experimental and evolutionary biology.

  15. Regulatory considerations for biosimilars

    Directory of Open Access Journals (Sweden)

    Ranjani Nellore

    2010-01-01

    Full Text Available Currently there is considerable interest in the legislative debate around generic biological drugs or "biosimilars" in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved "similar" biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products.

  16. 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.

  17. 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.

  18. Regulatory network operations in the Pathway Tools software

    Directory of Open Access Journals (Sweden)

    Paley Suzanne M

    2012-09-01

    Full Text Available Abstract Background Biologists are elucidating complex collections of genetic regulatory data for multiple organisms. Software is needed for such regulatory network data. Results The Pathway Tools software supports storage and manipulation of regulatory information through a variety of strategies. The Pathway Tools regulation ontology captures transcriptional and translational regulation, substrate-level regulation of enzyme activity, post-translational modifications, and regulatory pathways. Regulatory visualizations include a novel diagram that summarizes all regulatory influences on a gene; a transcription-unit diagram, and an interactive visualization of a full transcriptional regulatory network that can be painted with gene expression data to probe correlations between gene expression and regulatory mechanisms. We introduce a novel type of enrichment analysis that asks whether a gene-expression dataset is over-represented for known regulators. We present algorithms for ranking the degree of regulatory influence of genes, and for computing the net positive and negative regulatory influences on a gene. Conclusions Pathway Tools provides a comprehensive environment for manipulating molecular regulatory interactions that integrates regulatory data with an organism’s genome and metabolic network. Curated collections of regulatory data authored using Pathway Tools are available for Escherichia coli, Bacillus subtilis, and Shewanella oneidensis.

  19. Genomics in the land of regulatory science.

    Science.gov (United States)

    Tong, Weida; Ostroff, Stephen; Blais, Burton; Silva, Primal; Dubuc, Martine; Healy, Marion; Slikker, William

    2015-06-01

    Genomics science has played a major role in the generation of new knowledge in the basic research arena, and currently question arises as to its potential to support regulatory processes. However, the integration of genomics in the regulatory decision-making process requires rigorous assessment and would benefit from consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) hosted the fourth Global Summit on Regulatory Science (GSRS2014) to discuss the role of genomics in regulatory decision making, with a specific emphasis on applications in food safety and medical product development. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the analysis, interpretation and reporting of genomics data with an emphasis on transparency, traceability and "fitness for purpose" for the intended application. It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent, reliable, reproducible and auditable processes in the management of food and medical product safety risks. It was also recognized that training is an important mechanism in achieving internationally consistent outcomes. GSRS2014 provided an effective venue for regulators andresearchers to meet, discuss common issues, and develop collaborations to address the challenges posed by the application of genomics to regulatory science, with the ultimate goal of wisely integrating novel technical innovations into regulatory decision-making.

  20. 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

  1. 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.

  2. 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...

  3. 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.

  4. 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.

  5. Regulating regulatory T cells.

    Science.gov (United States)

    Le, N T; Chao, N

    2007-01-01

    Regulatory T cells (Tregs) are a specialized subpopulation of T cells that act to suppress activation of other immune cells and thereby maintain immune system homeostasis, self-tolerance as well as control excessive response to foreign antigens. The mere concept of Tregs was the subject of significant controversy among immunologists for many years owing to the paucity of reliable markers for defining these cells and the ambiguity of the nature and molecular basis of suppressive phenomena. However, recent advances in the molecular characterization of this cell population have firmly established their existence and their vital role in the vertebrate immune system. Of interest, accumulating evidence from both humans and experimental animal models has implicated the involvement of Tregs in the development of graft-versus-host disease (GVHD). The demonstration that Tregs could separate GVHD from graft-versus-tumor (GVT) activity suggests that their immunosuppressive potential could be manipulated to reduce GVHD without detrimental consequence on GVT effect. Although a variety of T lymphocytes with suppressive capabilities have been reported, the two best-characterized subsets are the naturally arising, intrathymic-generated Tregs (natural Tregs) and the peripherally generated, inducible Tregs (inducible Tregs). This review summarizes our current knowledge of the generation, function and regulation of these two populations of Tregs during an immune response. Their role in the development of GVHD and their therapeutic potential for the prevention and treatment of GVHD will also be described.

  6. 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

  7. 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.

  8. Non-transcriptional regulatory processes shape transcriptional network dynamics

    OpenAIRE

    Ray, J. Christian J; Tabor, Jeffrey J.; Igoshin, Oleg A.

    2011-01-01

    Information about the extra- or intracellular environment is often captured as biochemical signals propagating through regulatory networks. These signals eventually drive phenotypic changes, typically by altering gene expression programs in the cell. Reconstruction of transcriptional regulatory networks has given a compelling picture of bacterial physiology, but transcriptional network maps alone often fail to describe phenotypes. In many cases, the dynamical performance of transcriptional re...

  9. 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.

  10. Regulatory guidance document

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    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.

  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. 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.

  13. Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report.

    Science.gov (United States)

    Solomon, Howard M; Makris, Susan L; Alsaid, Hasan; Bermudez, Oscar; Beyer, Bruce K; Chen, Antong; Chen, Connie L; Chen, Zhou; Chmielewski, Gary; DeLise, Anthony M; de Schaepdrijver, Luc; Dogdas, Belma; French, Julian; Harrouk, Wafa; Helfgott, Jonathan; Henkelman, R Mark; Hesterman, Jacob; Hew, Kok-Wah; Hoberman, Alan; Lo, Cecilia W; McDougal, Andrew; Minck, Daniel R; Scott, Lelia; Stewart, Jane; Sutherland, Vicki; Tatiparthi, Arun K; Winkelmann, Christopher T; Wise, L David; Wood, Sandra L; Ying, Xiaoyou

    2016-06-01

    During the past two decades the use and refinements of imaging modalities have markedly increased making it possible to image embryos and fetuses used in pivotal nonclinical studies submitted to regulatory agencies. Implementing these technologies into the Good Laboratory Practice environment requires rigorous testing, validation, and documentation to ensure the reproducibility of data. A workshop on current practices and regulatory requirements was held with the goal of defining minimal criteria for the proper implementation of these technologies and subsequent submission to regulatory agencies. Micro-computed tomography (micro-CT) is especially well suited for high-throughput evaluations, and is gaining popularity to evaluate fetal skeletons to assess the potential developmental toxicity of test agents. This workshop was convened to help scientists in the developmental toxicology field understand and apply micro-CT technology to nonclinical toxicology studies and facilitate the regulatory acceptance of imaging data. Presentations and workshop discussions covered: (1) principles of micro-CT fetal imaging; (2) concordance of findings with conventional skeletal evaluations; and (3) regulatory requirements for validating the system. Establishing these requirements for micro-CT examination can provide a path forward for laboratories considering implementing this technology and provide regulatory agencies with a basis to consider the acceptability of data generated via this technology. Published by Elsevier Inc.

  14. 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.

  15. Regulatory T cell memory

    Science.gov (United States)

    Rosenblum, Michael D.; Way, Sing Sing; Abbas, Abul K.

    2016-01-01

    Memory for antigen is a defining feature of adaptive immunity. Antigen-specific lymphocyte populations show an increase in number and function after antigen encounter and more rapidly re-expand upon subsequent antigen exposure. Studies of immune memory have primarily focused on effector B cells and T cells with microbial specificity, using prime challenge models of infection. However, recent work has also identified persistently expanded populations of antigen-specific regulatory T cells that protect against aberrant immune responses. In this Review, we consider the parallels between memory effector T cells and memory regulatory T cells, along with the functional implications of regulatory memory in autoimmunity, antimicrobial host defence and maternal fetal tolerance. In addition, we discuss emerging evidence for regulatory T cell memory in humans and key unanswered questions in this rapidly evolving field. PMID:26688349

  16. 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.

  17. Recommendations on legislative and regulatory framework and regulatory body of nuclear security in China

    Institute of Scientific and Technical Information of China (English)

    PU Jilong; LI Xiaoyan

    2007-01-01

    This paper describes the definition of nuclear security that has been changing from the cold war age to the post-911 period, and clarifies the close relationship and yet a clear distinction between nuclear security, nuclear safety and nuclear safeguard. Based on analyses of the current state of nuclear security activities in China as well as the requirements and the law infrastructure, a legislative and regulatory framework of nuclear security and the mandate of a regulatory body in China are recommended.

  18. Chemistry, toxicity, and bioavailability of copper and its relationship to regulation in the marine environment. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Seligman, P.E.; Zirino, A.

    1998-11-01

    This document details issues addressed at a June 1997 workshop attended by Navy and regulatory representatives and scientific experts. Objectives discussed were: (1) define the current status and future direction of copper (Cu) regulations, (2) define problems and issues associated with the introduction of copper into the estuarine environment, and (3) discuss and evaluate the relationship between copper speciation, bio-availability, and toxicity.

  19. Drilling in Current-Controlled Sedimentary Environments on the Southeast African Margin - The SAFARI Pre-Site Survey Challenges on the Madagascar, Mozambique and the South African Margin

    Science.gov (United States)

    Spiess, V.; Preu, B.; Schwenk, T.; Palamenghi, L.; Schneider, R.; Zahn, R.; Hall, I.

    2009-04-01

    As part of the global conveyer belt circulation, the Agulhas, Mozambique and Madagascar Currents are guided southward along the Southeast African margin as strong contour currents, affecting local sediment mobilization, redistribution and deposition. To gain a better understanding of their evolution through time, a transect of drill sites ranging from the southern tip of Africa to Madagascar was proposed by Zahn et al. (SAFARI, IODP proposal 702). As contour currents become erosive in their vicinity, deposition may be inhibited and incoming sediment will be redistributed. To find suitable drill sites, they must be positioned strategically to provide continuous depositional records on the one hand by not not being located in the core of the current, and to record variations in current activity and strength, which requires a certain proximity to the mean current position. Furthermore, sources of sediment and their spatial and temporal variability play a role for the interpretation of accumulation rates, provenance of particles, reconstruction of current velocities and terrestrial input, which can be compared as climate indicators with marine geochemical tracers. Six different working areas, West of Capetown, Natal Valley, Limpopo Cone, Zambezi margin, Davie Ridge and N-Madagascar margin, were visited during R/V Meteor Cruises M63/1 (2005) and M75/3 (2008) to gain an understanding of sediment deposition and to select sites for the drilling proposal. Main observations of both cruises were, in contrast to the expectation of margins being predominantly shaped by fan deposition and mass wasting processes, the widespread occurrences of large scales contourite bodies, which were situated between 100 and 1500 m water depth. They appear to be independent of the mechanisms and volume of sediment input, revealing a close relationship to the acting contour currents. Accordingly, the drift bodies appear to be suitable deposits which record the activity of the currents by

  20. Department of Agriculture Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... members of the public have advocated for amending the regulations for sourcing dairy replacement animals. They have asserted that the current regulatory language on sourcing dairy replacement animals lacks... Order for dairy product promotion, research, and nutrition education as part of a comprehensive strategy...

  1. Current developments of research on permafrost engineering and cold region environment:a report of the 8th International Symposium on Permafrost Engineering

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    The Eighth International Symposium on Permafrost Engineering was held in Xi’an,China,October 2009.The major topics discussed in the symposium included:permafrost engineering (involving design,construction and evaluation);mitigation of frost hazards in the regions affected by seasonally frozen ground;properties of frozen soils,model development and their applications;frost hazards and periglacial environments in mountain and plateau regions;climatic,environmental and cryospheric changes;and permafrost hydrology,cold regions water resources and land uses.The papers submitted to the symposium and lectures during the meeting represented some new developments of research on cold region engineering and environment.Here we summarized the works of the symposium in topics including:Permafrost engineering;General geocryology;Properties of frozen soils:model development and their applications;And climatic,environmental and cryospheric changes.During the symposium,the attendees pointed out that future studies should pay more attention to theoretical study and engineering mechanism study,and also on interaction between climate change and cold region environments and their engineering affects.

  2. Cancer therapy using nanoformulated substances: scientific, regulatory and financial aspects.

    Science.gov (United States)

    Alphandéry, Edouard; Grand-Dewyse, Pierre; Lefèvre, Raphael; Mandawala, Chalani; Durand-Dubief, Mickael

    2015-01-01

    Several nanoformulated anti-cancer substances are currently commercialized or under development. Pre-clinical and clinical results have revealed better properties, that is, larger efficacy and lower toxicity for these substances than for conventional anti-cancer treatments. Here, we review the development of several of these substances such as Marqibo, Myocet, Doxil, DaunoXome, MM398, MM302, Mepact, Versamune, Thermodox, Depocyt, Livatag, Abraxane, Eligard, Opaxio, Zinostatin Stimalamer (SMANCS), Pegasys and PegIntron, BIND-014, CRLX-101, Oncaspar, Neulasta, Aurimmune, Auroshell, AuNPs, Nanotherm, NanoXray, Magnetosome chains, Kadcyla (T-DM1), Ontak (DAB/IL2), Gendicine and Curcumin. We describe their specific properties, such as their stability, solubility, mean of administration or targeting, distribution, metabolism and toxicity. We discuss their categorization as medical devices or drugs, their fabrication process within a regulatory environment as well as intellectual property and financial aspects that are all essential to enable their industrial development.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

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

    Science.gov (United States)

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

    2017-07-01

    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.

  8. 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.

  9. Current Status of Agriculture and Plant Protection in Malaysia (Original papers in Kobe Symposium on Agriculture, Food and Environment in Asia : Towards the 21st Century)

    OpenAIRE

    Khew, K. l.

    1997-01-01

    Malaysia with the warm (21-32℃) and humid (200-250cm annual rainfall) climate, is a tropical wonderland for plants, conducive to the growth of a number of agricultural crops. The major agricultural commodities include oil palm (Elaeis guineensis), rubber (Hevea brasiliensis), cocoa (Theobroma cacao), pepper (Piper nigrum) rice (Oryza sativus) and together with fruits, vegetables and floriculture which play a less dominant role. Malaysia is currently the world's largest producer and exporter o...

  10. Evaluation of JSAF EM Propagation Prediction Methods for Navy Continuous Training Environment/Fleet Synthetic Training Results and Recommendations: Part 1 - Evaluation of Current JSAF EM Propagation Modeling

    Science.gov (United States)

    2012-12-01

    FFACTR” which is a part of the Engineers Refractive Index Prediction System (EREPS) Tactical Decision Aid ( TDA ) developed by what is now SPAWARS SSC San...currently used in JSAF is “FFACTR” which is a part of the Engineers Refractive Index Prediction System (EREPS) Tactical Decision Aid ( TDA ) developed by what...Decision Aid ( TDA ) developed by what is now SPAWARS SSC San Diego in 1988. This model is no longer supported by SPAWARS or any other group and has been

  11. Ethical and regulatory challenges posed by synthetic biology.

    Science.gov (United States)

    Rager-Zisman, Bracha

    2012-01-01

    Synthetic biology is a relatively new science with tremendous potential to change how we view and know the life sciences, but like many developing technologies, it has provoked ethical concerns from the scientific community and the public and confronts demands for new regulatory measures. The concerns raised involve the danger of "dual use," in which results for improving human well-being and the environment may be misappropriated for bioterror. To counteract these dangers, many governments, but the United States and Israel in particular, have introduced new laws and redoubled measures for biosafety and biosecurity. In the United States, the recent H5N1 results achieved by two groups of NIH-funded investigators highlighted the dilemma of balancing the risk of dual-use research and the freedom of science. In Israel, concern for unconventional terrorism is long-standing, and the country is constantly engaged in improving biosecurity and biodefense measures. In 2008, the Israeli parliament passed the Regulation of Research into Biological Disease Agents Law, a legislative framework for safeguarding research into biological disease agents. This article summarizes and analyzes the current state of affairs in the United States and Israel, ethical attitudes, and regulatory responses to synthetic biology.

  12. 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.

  13. 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.

  14. 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...

  15. Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part I: medical devices.

    Science.gov (United States)

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

    2012-05-01

    Radiofrequency identification (RFID) technology has acheived significant success and has penetrated into various areas of healthcare. Several RFID-based applications are used in various modalities with the ultimate aim of improving patient care. When a wireless technology is used in a healthcare environment, attention must be paid to the potential risks deriving from its use; one of the most important being electromagnetic interference with medical devices. In this paper, the regulatory framework concerning the electromagnetic compatibility between RFID and medical devices is analyzed to understand whether and how the application of the current standards allows for the effective control of the risks of electromagnetic interference.

  16. Evolution of evolvability in gene regulatory networks.

    Directory of Open Access Journals (Sweden)

    Anton Crombach

    Full Text Available Gene regulatory networks are perhaps the most important organizational level in the cell where signals from the cell state and the outside environment are integrated in terms of activation and inhibition of genes. For the last decade, the study of such networks has been fueled by large-scale experiments and renewed attention from the theoretical field. Different models have been proposed to, for instance, investigate expression dynamics, explain the network topology we observe in bacteria and yeast, and for the analysis of evolvability and robustness of such networks. Yet how these gene regulatory networks evolve and become evolvable remains an open question. An individual-oriented evolutionary model is used to shed light on this matter. Each individual has a genome from which its gene regulatory network is derived. Mutations, such as gene duplications and deletions, alter the genome, while the resulting network determines the gene expression pattern and hence fitness. With this protocol we let a population of individuals evolve under Darwinian selection in an environment that changes through time. Our work demonstrates that long-term evolution of complex gene regulatory networks in a changing environment can lead to a striking increase in the efficiency of generating beneficial mutations. We show that the population evolves towards genotype-phenotype mappings that allow for an orchestrated network-wide change in the gene expression pattern, requiring only a few specific gene indels. The genes involved are hubs of the networks, or directly influencing the hubs. Moreover, throughout the evolutionary trajectory the networks maintain their mutational robustness. In other words, evolution in an alternating environment leads to a network that is sensitive to a small class of beneficial mutations, while the majority of mutations remain neutral: an example of evolution of evolvability.

  17. 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

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

    NARCIS (Netherlands)

    Noort, van Guda; Kerkhof, Peter; Fennis, Bob 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 preventio

  19. 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 preventio

  20. 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.

  1. 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.

  2. Bitcoin: a regulatory nightmare to a libertarian dream

    Directory of Open Access Journals (Sweden)

    Primavera De Filippi

    2014-05-01

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

  3. 接地线缆HEMP电流响应规律研究%Study on Current Response of Grounding Cable in HEMP Environment

    Institute of Scientific and Technical Information of China (English)

    柴焱杰; 张春光; 许凯; 赵煜

    2014-01-01

    The cable connecting the information systems may be coupled by the electromagnetic pulse energy to the internal cir-cuit,resulting in system performance degradation,damage and even burned,and bringing great harm. Therefore,the work to research cables’ effects under electromagnetic pulse is the precondition to take electromagnetic protective measures. The finite-difference time-domain ( FDTD) method and Noda thin models are used to establish the space and computational model with high-altitude nuclear elec-tromagnetic pulse (HEMP) as the incident source,the grounding cable HEMP current response in the different states is analyzed and calculated. The results show that the response current of grounding cable attenuates rapidly in the oscillation process with a large peak at a position higher;the incident direction changes of the wave source can produce different results in response,and the response current mainly appears from the cable laid in the same direction with the electric field excitation component. The conclusions can provide useful guidance for the cable electromagnetic protection.%连接电子系统的线缆能够将电磁脉冲能量耦合至系统的内部电路,造成系统性能降级、损伤甚至烧毁,带来极大的危害,因此开展线缆的电磁脉冲效应研究工作是采取针对性电磁防护措施的必要前提。以高空核爆电磁脉冲(HEMP)为入射源,基于时域有限差分(FDTD)方法和Noda细线模型建立仿真空间和计算模型,分析计算了不同状态下接地线缆的HEMP电流响应。结果表明,接地线缆的响应电流在振荡过程中迅速衰减,且在较高位置处峰值较大;波源入射方向的改变会产生不同的响应结果,线缆响应电流主要来自与其布设方向一致的电场分量的激励。所得结论能够为线缆的电磁防护提供有益指导。

  4. [Considering the current state of fire safety in Taiwan's care environment from the perspective of the nation's worst recent hospital fire].

    Science.gov (United States)

    Tseng, Wei-Wen; Shih, Chung-Liang; Chien, Shen-Wen

    2013-04-01

    Taiwan's worst hospital fire in history on October 23rd, 2012 at Sinying Hospital's Bei-Men Branch resulted in 13 elderly patient deaths and over 70 injuries. The heavy casualties were due in part to the serious condition of patients. Some patients on life-support machines were unable to move or be moved. This disaster highlights the issue of fire safety in small-scale hospitals that have transformed existing hospital space into special care environments for elderly patients. Compared with medical centers and general hospitals, these small-scale health facilities are ill equipped to deal properly with fire safety management and emergency response issues due to inadequate fire protection facilities, fire safety equipment, and human resources. Small-scale facilities that offer health care and medical services to mostly immobile patients face fire risks that differ significantly from general health care facilities. This paper focuses on fire risks in small-scale facilities and suggests a strategy for fire prevention and emergency response procedures, including countermeasures for fire risk assessment, management, and emergency response, in order to improve fire safety at these institutions in Taiwan.

  5. 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)

    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. PMID:27513336

  6. Regulatory Science in Professional Education.

    Science.gov (United States)

    Akiyama, Hiroshi

    2017-01-01

     In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.

  7. Like or dislike : Intrapersonal regulatory fit affects the intensity of interpersonal evaluation

    NARCIS (Netherlands)

    Hamstra, Melvyn R. W.; Van Yperen, Nico W.; Wisse, Barbara; Sassenberg, Kai

    2013-01-01

    Regulatory fit is an experience of motivational force that makes individuals feel 'right'. Prior work has almost exclusively focused on how regulatory fit affects individuals' experience of tasks, activities, and products and has primarily focused on the bright side of regulatory fit. The current re

  8. Like or dislike : Intrapersonal regulatory fit affects the intensity of interpersonal evaluation

    NARCIS (Netherlands)

    Hamstra, Melvyn R. W.; Van Yperen, Nico W.; Wisse, Barbara; Sassenberg, Kai

    Regulatory fit is an experience of motivational force that makes individuals feel 'right'. Prior work has almost exclusively focused on how regulatory fit affects individuals' experience of tasks, activities, and products and has primarily focused on the bright side of regulatory fit. The current

  9. Like or dislike : Intrapersonal regulatory fit affects the intensity of interpersonal evaluation

    NARCIS (Netherlands)

    Hamstra, Melvyn R. W.; Van Yperen, Nico W.; Wisse, Barbara; Sassenberg, Kai

    2013-01-01

    Regulatory fit is an experience of motivational force that makes individuals feel 'right'. Prior work has almost exclusively focused on how regulatory fit affects individuals' experience of tasks, activities, and products and has primarily focused on the bright side of regulatory fit. The current re

  10. Nuclear Regulatory Commission information digest

    Energy Technology Data Exchange (ETDEWEB)

    None,

    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.

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

    Energy Technology Data Exchange (ETDEWEB)

    Garcia-Talavera, M., E-mail: mgtm@csn.e [Consejo de Seguridad Nuclear (CSN), Justo Dorado, 11, E-28040 Madrid (Spain); Matarranz, J.L.M.; Salas, R.; Ramos, L. [Consejo de Seguridad Nuclear (CSN), Justo Dorado, 11, E-28040 Madrid (Spain)

    2011-01-15

    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: {yields} The radiological impact of the Spanish phosphate industry has substantially decreased as a side result of environmental regulations on chemical pollution.{yields} A more efficient control of NORM industries could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks.{yields} 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.{yields} On shorter-term, administrative measures that require active cooperation among the regulatory bodies involved can be taken.

  12. Emplacement of pyroclastic density currents (PDCs) in a deep-sea environment: The Val d'Aveto Formation case (Northern Apennines, Italy)

    Science.gov (United States)

    Di Capua, Andrea; Groppelli, Gianluca

    2016-12-01

    The occurrence of PDC deposits in a foredeep basin sequence, named Val d'Aveto Formation (32-29 Ma, Northern Apennines, Italy), provides new information on the behavior of pyroclastic density currents entering the water. In this work, stratigraphic, petrographic and mineralogical features that characterize three pyroclastic deposits have been described and analyzed in the field (facies and lithological analysis on the blocky-size fraction) and in the laboratory (image analyses on the blocky-size detritus, optical analyses of the microtextures, mineralogical analyses through X-ray powder diffraction (XRPD) and scanning electron microscope with energy dispersive X-ray spectometry (SEM-EDS). The deposits are lapilli- to blocky-size, with a blocky-size fraction constituted of accidental detritus. In thin sections, their groundmass texture varies from porphyritic to eutaxitic where coarser particles become close each others. Growth rims have been also detected around plagioclase crystals. Pyrite habits and oxidation, and plagioclase albitization are consistent with hydrothermal temperature conditions of 200 °C. All these results have been compared with the information provided by modern examples of PDC deposits and laboratory experiments on the behavior of water/hot particles mixing. Grain-to-grain collision has been considered as the main flow mechanism that sustained and avoided the disaggregation of the PDCs entering the water.

  13. Hastening the regulatory process

    Energy Technology Data Exchange (ETDEWEB)

    Stringham, G. [Canadian Association of Petroleum Producers, Calgary, AB (Canada)

    2001-07-01

    The state of the Canadian oil industry was discussed during this power point presentation with particular emphasis on its production, exports, drilling, industry revenues and capital investment levels. The proposed projects in each of northern Alberta's oil sands deposits, the Athabasca, Peace River and Cold Lake were were announced, along with the inventory of major Alberta projects and the projection of oil sands capital investment. Since 1998, $9 billion has been invested and a further $33 billion has been announced for new or expanded oil sands projects. The year 2000 estimates for Canadian crude oil and natural gas production are 2.3 million barrels per day and 6.3 trillion cubic feet per year respectively. This represented a record year for production of both crude oil and natural gas. In 2000, more than 15,500 wells were drilled in Canada. A graph depicting Canadian crude oil supply forecasted a steady increase in supply from year 2000 to 2010. The Canadian Association of Petroleum Producers (CAPP) completed a review of the Alberta Energy and Utilities Board regulatory and enforcement processes. Both industry and government efforts are focusing on eliminating regulatory overlap and duplication. Some of the main areas of interest for exploration, drilling, production and pipeline facilities include the examination of regulatory processes for environmentally sensitive areas, rural municipalities with planning bylaws, aboriginal lands and additional fees. 8 figs.

  14. Research Issues and Current Progress in Underwater Sensor Networks for Intelligent Environment Monitoring%水下传感器网络研究挑战与探索

    Institute of Scientific and Technical Information of China (English)

    杜秀娟

    2015-01-01

    水下传感器网络采用声波进行通信,具有长时延、低带宽、高错误率、低能耗要求和稀疏部署等技术挑战,使现有通信协议无法满足性能要求,节点的有限资源决定了其上运行的协议栈不能太复杂.文章阐述了水下传感网络的应用、通信特点,分析了传统协议架构在水下传感网络的局限性,指出:水下传感器网络需要研究一种新型的、绿色网络体系架构模型,基于该架构模型实现各层协议的优化设计,在满足QoS性能要求和系统有限资源的约束下,提高能量效率、延长网络生存期,实现绿色网络.%Underwater sensor network (UWSN) adopts acoustic communication,characterized by high delay,low bandwidth,high error rate,low energy-consumption requirement and sparse deployment which lead to great challenges for UWSN communication.Conventional communication protocols are unable to satisfy the performance of UWSN while the limited resources of nodes determine the protocol stack run-ning on it shouldn't be much complicated.Through analyzing the characteristics of application and commu-nication in UWSN and the limitations of traditional protocol architecture for UWSN,we indicate that re-search of UWSN for intelligent environment monitoring require to develop a new,green network protocol architecture model,and realize protocol optimization design for each layer in the new protocol architecture model so as to improve energy efficiency,prolong the network lifetime and achieve green network while meeting the requirement of QoS with the constraints of limited resource.

  15. Non-transcriptional regulatory processes shape transcriptional network dynamics.

    Science.gov (United States)

    Ray, J Christian J; Tabor, Jeffrey J; Igoshin, Oleg A

    2011-10-11

    Information about the extra- or intracellular environment is often captured as biochemical signals that propagate through regulatory networks. These signals eventually drive phenotypic changes, typically by altering gene expression programmes in the cell. Reconstruction of transcriptional regulatory networks has given a compelling picture of bacterial physiology, but transcriptional network maps alone often fail to describe phenotypes. Cellular response dynamics are ultimately determined by interactions between transcriptional and non-transcriptional networks, with dramatic implications for physiology and evolution. Here, we provide an overview of non-transcriptional interactions that can affect the performance of natural and synthetic bacterial regulatory networks.

  16. 移动医疗APP运行现状及其法律监管问题初探%Discussion on the Current Running Status of Mobile Medical APP and Relevant Legal Regulatory Issues

    Institute of Scientific and Technical Information of China (English)

    邓勇; 刘威; 李桐萱

    2015-01-01

    In recent years, the mobile medical market is increasingly becoming a trans-boundary focus. The operation of "medical + IT" mode has constructed a complete mobile medical industry chain. However, the development of emerging health industry represented by mobile medical APP (Application) is facing a lot of trouble. What's more, its benign operation also needs legal regulation. This paper ifrstly interpreted the formation, development and function of mobile medical APP, and then analyzed the current dilemma that mobile medical APP suffered from, ifnally put forward the concrete measures to solve the problems in running of the mobile medical APP.%近年来,移动医疗市场正日益成为跨界焦点,"医疗+IT"模式的运行,构建了一条完整的移动医疗产业链.然而,以移动医疗APP为代表的新兴医疗产业正面临诸多发展困境,其良性运行亦亟待法律监管.本文首先解读了移动医疗APP的产生、发展及功能,然后剖析了当前移动医疗APP遇到的种种困境,最后针对性地提出了破解移动医疗APP运行困境的具体对策.

  17. Regulatory overview of digital I and C system in Taiwan Lungmen Project

    Energy Technology Data Exchange (ETDEWEB)

    Chuang, C.F. [Department of Engineering and System Science, National Tsing Hua University, Taipei, Taiwan (China); Nuclear Regulatory Division, Atomic Energy Council, Taiwan (China)], E-mail: chuang@aec.gov.tw; Chou, H.P. [Department of Engineering and System Science, National Tsing Hua University, Taipei, Taiwan (China)], E-mail: hpc@mx.nthu.edu.tw; Chen, Y.B. [Nuclear Regulatory Division, Atomic Energy Council, Taiwan (China)], E-mail: ybchen@aec.gov.tw; Shiao, H. [Nuclear Regulatory Division, Atomic Energy Council, Taiwan (China)], E-mail: shiao@aec.gov.tw

    2008-05-15

    The Lungmen Nuclear Power Plant (LMNPP) is currently under construction in Taiwan, which consists of two Advanced Boiling Water Reactor (ABWR) units. The instrumentation and control (I and C) systems of the Lungmen NPS are based on the state-of-the-art modernized fully integrated digital design. The design and architecture of digital systems are inherently different from those of analog systems. We face challenges in areas where there is limited technical guidance and regulatory precedent. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital I and C systems in the Lungmen Project.

  18. Regulatory Impact Analysis: a new tool for better regulation at ANVISA.

    Science.gov (United States)

    Alves, Flávia Neves Rocha; Peci, Alketa

    2011-08-01

    Regulatory Impact Analysis, which is recommended to regulatory departments, aims to improve regulatory quality by providing information about the costs and benefits of regulation as well as solutions to current issues to enhance the decision-making process. This article discusses the importance of Regulatory Impact Analysis in the context of the National Agency for Sanitary Surveillance performance as well as the agency's current phase of regulation improvement and strengthening. Also, the main definitions related to the regulatory field as well as some international case experiences are presented.

  19. 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

  20. 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.

  1. 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).

  2. A feasibility study on regulatory analysis in the nuclear regulatory decision making process in Korea

    Energy Technology Data Exchange (ETDEWEB)

    Lee, K. J.; Lee, B. W.; Lee, D. K.; Lim, C. Y.; Choi, Y. S.; Kim, K. K. [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    1996-12-15

    Nuclear safety regulation has different implications from economic regulation. In recent survey, it was found that Korea people want more regulatory effort than current one. This indicates that scientific method is necessary to improve the efficiency of regulation with limited resources of regulators. The main reason to conduct the regulatory analysis like cost-benefit analysis is obtaining the rationality of regulation to be implemented and persuading the licensees to comply under the quantified condition. That is, the ultimate goal is to verify the necessity and justice of regulation and to achieve the safety goal with minimum impacts. Guidelines and procedures developed in this study should help regulators to reach that goal.

  3. Regulating environments to reduce obesity.

    Science.gov (United States)

    Hayne, Cheryl L; Moran, Patricia A; Ford, Mary M

    2004-01-01

    The marked increase in the prevalence of obesity appears to be attributable to environmental conditions that implicitly discourage physical activity while explicitly encouraging the consumption of greater quantities of energy-dense, low-nutrient foods. In the United States food environment, consumers are bombarded with advertising for unhealthy food, and receive inadequate nutritional information, especially at restaurants. In the US school environment children have access to sugary sodas and unhealthy a la carte foods in their cafeterias, at the same time getting inadequate physical activity and nutrition education. In the built environment, sprawl has reduced active living. We describe these environments and explore the potential effects of regulatory measures on these environments. In the United States, regulatory opportunities exist at the national, state and local levels to mandate action and to allocate funds for promising health-promoting strategies. Regulatory approaches, much like litigation, can transform the entire environment in which corporations operate. Even with incomplete enforcement of rules, they send a public message about what is acceptable behavior for corporations and individuals. Additionally, because the United States is party to many multilateral and bilateral trade agreements and is an active participant in the GATT/WTO framework, US regulatory actions promise to have a beneficial impact both domestically and globally.

  4. 以热环境优化为目标的控制性详细规划编制技术%The exploitation of technology of regulatory detailed planning aiming at optimization of thermal environment

    Institute of Scientific and Technical Information of China (English)

    王频; 罗瑜斌

    2016-01-01

    The relationship of existing indicators and thermal environmental impact factors was analyzed,and the assessment indicators were pro-posed,which were,building density,floor area ratio,greening rate,sky view factor,impervious rate and greenery coverage rate. Control stand-ard classification of thermal environment and quantification of indicators were also described. In addition,the feasibility of floor area ratio incen-tive mechanism was confirmed by using computer numerical simulating method DUIE and Fluent,and the applicable conditions were put forward.%通过分析控制性详细规划传统指标与热环境影响因子的关系,在建筑密度、容积率和绿地率等指标的基础上,提出天空角系数、不透水率、绿化覆盖率等热环境评估补充指标,并运用计算机数值模拟方法DUTE和Fluent,模拟限定条件下的容积率奖励案例对近地面风场、温度场的影响,直观地展示容积率奖励机制在热环境控制方面的价值,为控规编制技术提供新的思路。

  5. 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...

  6. 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.

  7. 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.

  8. Adaptation by Plasticity of Genetic Regulatory Networks

    Science.gov (United States)

    Brenner, Naama

    2007-03-01

    Genetic regulatory networks have an essential role in adaptation and evolution of cell populations. This role is strongly related to their dynamic properties over intermediate-to-long time scales. We have used the budding yeast as a model Eukaryote to study the long-term dynamics of the genetic regulatory system and its significance in evolution. A continuous cell growth technique (chemostat) allows us to monitor these systems over long times under controlled condition, enabling a quantitative characterization of dynamics: steady states and their stability, transients and relaxation. First, we have demonstrated adaptive dynamics in the GAL system, a classic model for a Eukaryotic genetic switch, induced and repressed by different carbon sources in the environment. We found that both induction and repression are only transient responses; over several generations, the system converges to a single robust steady state, independent of external conditions. Second, we explored the functional significance of such plasticity of the genetic regulatory network in evolution. We used genetic engineering to mimic the natural process of gene recruitment, placing the gene HIS3 under the regulation of the GAL system. Such genetic rewiring events are important in the evolution of gene regulation, but little is known about the physiological processes supporting them and the dynamics of their assimilation in a cell population. We have shown that cells carrying the rewired genome adapted to a demanding change of environment and stabilized a population, maintaining the adaptive state for hundreds of generations. Using genome-wide expression arrays we showed that underlying the observed adaptation is a global transcriptional programming that allowed tuning expression of the recruited gene to demands. Our results suggest that non-specific properties reflecting the natural plasticity of the regulatory network support adaptation of cells to novel challenges and enhance their evolvability.

  9. Clinical research: regulatory issues.

    Science.gov (United States)

    Wermeling, D P

    1999-02-01

    The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.

  10. 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).

  11. Challenges in orphan drug development and regulatory policy in China

    OpenAIRE

    Cheng, Alice; Xie, Zhi

    2017-01-01

    While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements ...

  12. Beyond the Crisis: Financial Regulatory Reform in Emerging Asia

    OpenAIRE

    Lee, Chee Sung; Park, Cyn-Young

    2009-01-01

    The main objective of this paper is to suggest reform measures to address the gaps and weaknesses in emerging Asia's financial regulatory and supervisory systems, on the basis of lessons drawn from the global crisis. For emerging Asia, the direct impact of the global financial crisis has been limited, thus generating substantially less pressure for financial restructuring and regulatory reform than is the case in developed economies. However, the underlying causes of the current turmoil—such ...

  13. (Q)SAR modeling and safety assessment in regulatory review.

    Science.gov (United States)

    Kruhlak, N L; Benz, R D; Zhou, H; Colatsky, T J

    2012-03-01

    The ability to predict clinical safety based on chemical structures is becoming an increasingly important part of regulatory decision making. (Quantitative) structure-activity relationship ((Q)SAR) models are currently used to evaluate late-arising safety concerns and possible nonclinical effects of a drug and its related compounds when adequate safety data are absent or equivocal. Regulatory use will likely increase with the standardization of analytical approaches, more complete and reliable data collection methods, and a better understanding of toxicity mechanisms.

  14. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1997-02-01

    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.

  16. 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.

  17. 75 FR 54210 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2010-09-03

    ...-2010-032] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... Transactions August 30, 2010. On June 17, 2010, the Financial Industry Regulatory Authority, Inc....

  18. Investigation for Current Situation of College Students’ Environmental Awareness and Strategies for Environment Education%高校学生环境意识现状调查与环境教育对策

    Institute of Scientific and Technical Information of China (English)

    杜卫红; 王振龙

    2015-01-01

    The environment education is an effective method to achieve strategy of sustainable development and build the socialist cultural power.Colleges and universities take on the historical responsibility of training high-quality talents for our country, offering environ-mental education curriculum is good for college students to understand the relation of resources, development and environment, establish environmental values, improve environmental literacy effectively, strengthen social responsibility of environmental protection, and create a beautiful China collectively.This paper takes Hulunbuir College as an example, investigates the environmental awareness of college students, analyzes the current situation and deficiency of environmental education, puts forward the corresponding measures and provides a reference for the environmental education in Colleges and universities.%环境教育是实现可持续发展战略和建设社会主义文化强国的有效手段。高等院校担负着为国家培养高素质人才的重任,开设环境教育课程有利于大学生正确认识资源、发展与环境的关系,树立环境价值观,增强环境保护的社会责任感,共创美丽中国。本文以呼伦贝尔学院为例,调查大学生的环境意识状况,分析环境教育的现状与不足,并提出相应的措施,为高校环境教育提供参考。

  19. Emerging regulatory paradigms in glutathione metabolism

    Science.gov (United States)

    Liu, Yilin; Hyde, Annastasia S.; Simpson, Melanie A.; Barycki, Joseph J.

    2015-01-01

    One of the hallmarks of cancer is the ability to generate and withstand unusual levels of oxidative stress. In part, this property of tumor cells is conferred by elevation of the cellular redox buffer glutathione. Though enzymes of the glutathione synthesis and salvage pathways have been characterized for several decades, we still lack a comprehensive understanding of their independent and coordinate regulatory mechanisms. Recent studies have further revealed that overall central metabolic pathways are frequently altered in various tumor types, resulting in significant increases in biosynthetic capacity, and feeding into glutathione synthesis. In this review, we will discuss the enzymes and pathways affecting glutathione flux in cancer, and summarize current models for regulating cellular glutathione through both de novo synthesis and efficient salvage. In addition, we examine the integration of glutathione metabolism with other altered fates of intermediary metabolites, and highlight remaining questions about molecular details of the accepted regulatory modes. PMID:24974179

  20. Regulatory mechanisms link phenotypic plasticity to evolvability.

    Science.gov (United States)

    van Gestel, Jordi; Weissing, Franz J

    2016-04-18

    Organisms have a remarkable capacity to respond to environmental change. They can either respond directly, by means of phenotypic plasticity, or they can slowly adapt through evolution. Yet, how phenotypic plasticity links to evolutionary adaptability is largely unknown. Current studies of plasticity tend to adopt a phenomenological reaction norm (RN) approach, which neglects the mechanisms underlying plasticity. Focusing on a concrete question - the optimal timing of bacterial sporulation - we here also consider a mechanistic approach, the evolution of a gene regulatory network (GRN) underlying plasticity. Using individual-based simulations, we compare the RN and GRN approach and find a number of striking differences. Most importantly, the GRN model results in a much higher diversity of responsive strategies than the RN model. We show that each of the evolved strategies is pre-adapted to a unique set of unseen environmental conditions. The regulatory mechanisms that control plasticity therefore critically link phenotypic plasticity to the adaptive potential of biological populations.

  1. Metabolic constraint-based refinement of transcriptional regulatory networks.

    Science.gov (United States)

    Chandrasekaran, Sriram; Price, Nathan D

    2013-01-01

    There is a strong need for computational frameworks that integrate different biological processes and data-types to unravel cellular regulation. Current efforts to reconstruct transcriptional regulatory networks (TRNs) focus primarily on proximal data such as gene co-expression and transcription factor (TF) binding. While such approaches enable rapid reconstruction of TRNs, the overwhelming combinatorics of possible networks limits identification of mechanistic regulatory interactions. Utilizing growth phenotypes and systems-level constraints to inform regulatory network reconstruction is an unmet challenge. We present our approach Gene Expression and Metabolism Integrated for Network Inference (GEMINI) that links a compendium of candidate regulatory interactions with the metabolic network to predict their systems-level effect on growth phenotypes. We then compare predictions with experimental phenotype data to select phenotype-consistent regulatory interactions. GEMINI makes use of the observation that only a small fraction of regulatory network states are compatible with a viable metabolic network, and outputs a regulatory network that is simultaneously consistent with the input genome-scale metabolic network model, gene expression data, and TF knockout phenotypes. GEMINI preferentially recalls gold-standard interactions (p-value = 10(-172)), significantly better than using gene expression alone. We applied GEMINI to create an integrated metabolic-regulatory network model for Saccharomyces cerevisiae involving 25,000 regulatory interactions controlling 1597 metabolic reactions. The model quantitatively predicts TF knockout phenotypes in new conditions (p-value = 10(-14)) and revealed potential condition-specific regulatory mechanisms. Our results suggest that a metabolic constraint-based approach can be successfully used to help reconstruct TRNs from high-throughput data, and highlights the potential of using a biochemically-detailed mechanistic framework to

  2. Regulatory approaches to worker protection in nanotechnology industry in the USA and European union.

    Science.gov (United States)

    Murashov, Vladimir; Schulte, Paul; Geraci, Charles; Howard, John

    2011-01-01

    A number of reports have been published regarding the applicability of existing regulatory frameworks to protect consumers and the environment from potentially adverse effects related to introduction of nanomaterials into commerce in the United States and the European Union. However, a detailed comparison of the regulatory approaches to worker safety and health in the USA and in the EU is lacking. This report aims to fill this gap by reviewing regulatory frameworks designed to protect workers and their possible application to nanotechnology.

  3. Regulatory practices for nuclear power plants in India

    Indian Academy of Sciences (India)

    S S Bajaj

    2013-10-01

    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.

  4. 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 g

  5. Reconsidering Styles of Regulatory Enforcement

    DEFF Research Database (Denmark)

    May, Peter J.; Winter, Søren

    2000-01-01

    This study addresses enforcement styles of regulatory inspectors, based on an examination of the municipal enforcement of agro-environmental policies in Denmark. Our findings make three contributions to the regulatory literature. One contribution is to add empirical support for theorizing about i...

  6. Reconsidering Styles of Regulatory Enforcement

    DEFF Research Database (Denmark)

    J. May, Peter; Winter, Søren

    2007-01-01

    This study addresses enforcement styles of regulatory inspectors based on an examination of the municipal enforcement of agro-environmental policies in Denmark. Our findings make three contributions to the regulatory literature. One contribution is to add empirical support for theorizing about in...

  7. Regulatory Foci and Organizational Commitment

    Science.gov (United States)

    Markovits, Yannis; Ullrich, Johannes; van Dick, Rolf; Davis, Ann J.

    2008-01-01

    We use regulatory focus theory to derive specific predictions regarding the differential relationships between regulatory focus and commitment. We estimated a structural equation model using a sample of 520 private and public sector employees and found in line with our hypotheses that (a) promotion focus related more strongly to affective…

  8. Disclosure as a regulatory tool

    DEFF Research Database (Denmark)

    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....

  9. Anti-regulatory T cells

    DEFF Research Database (Denmark)

    Andersen, Mads Hald

    2017-01-01

    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...... 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...

  10. 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.

  11. Regulatory Streamlining and Improvement

    Energy Technology Data Exchange (ETDEWEB)

    Mark A. Carl

    2006-07-11

    The Interstate Oil and Gas Compact Commission (IOGCC) engaged in numerous projects outlined under the scope of work discussed in the United States Department of Energy (DOE) grant number DE-FC26-04NT15456 awarded to the IOGCC. Numerous projects were completed that were extremely valuable to state oil and gas agencies as a result of work performed utilizing resources provided by the grant. There are numerous areas in which state agencies still need assistance. This additional assistance will need to be addressed under future scopes of work submitted annually to DOE's Project Officer for this grant. This report discusses the progress of the projects outlined under the grant scope of work for the 2005-2006 areas of interest, which are as follows: Area of Interest No. 1--Regulatory Streamlining and Improvement: This area of interest continues to support IOGCC's regulatory streamlining efforts that include the identification and elimination of unnecessary duplications of efforts between and among state and federal programs dealing with exploration and production on public lands. Area of Interest No. 2--Technology: This area of interest seeks to improve efficiency in states through the identification of technologies that can reduce costs. Area of Interest No. 3--Training and Education: This area of interest is vital to upgrading the skills of regulators and industry alike. Within the National Energy Policy, there are many appropriate training and education opportunities. Education was strongly endorsed by the President's National Energy Policy Development group. Acting through the governors offices, states are very effective conduits for the dissemination of energy education information. While the IOGCC favors the development of a comprehensive, long-term energy education plan, states are also supportive of immediate action on important concerns, such as energy prices, availability and conservation. Area of Interest No. 4--Resource Assessment and

  12. Impact of regulatory science on global public health.

    Science.gov (United States)

    Patel, Meghal; Miller, Margaret Ann

    2012-07-01

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

  13. 75 FR 30453 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-06-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  14. 75 FR 40000 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change Relating to the Restated Certificate of Incorporation of Financial Industry Regulatory Authority, Inc. July 2, 2010. On May 21, 2010, Financial Industry Regulatory Authority, Inc....

  15. 气象探测环境现状及保护措施的探讨%Discussion on current situation of meteorological observational environment and its protection measurements

    Institute of Scientific and Technical Information of China (English)

    张国华; 关彦华; 郭艳岭

    2012-01-01

    environment were reviewed, and the current situation was analyzed by using a case study. According to the statistical data, the height of buildings around the meteorological observational sites exceeds the standard height from the law of "protection method of meteorological observational environment and equipment", which was the main reason destroying the meteorological observational environment. The sources of reasons could be attributed to two parts, i. e. inside one and outside one. The real estate construction was rapidly expanding because of the rapid development of economy and society and the interests of the local government,and these were the outside reason. On the other hand, the construction standard of office building and the new station selection model in the meteorological depart- ments made the selection of the new station location difficult and also made weather station moved frequently, and these were the inside reason. Some specific measurements protecting meteorological observational environment were proposed as follows: scientificity and preciseness of meteorological observational environment protection standard should be established in the meteorological department, and the protection mechanism based on classification of meteorological observational environment should be set up;protecting the meteorological observational environment by the corresponding law and adequate administrative intervention should be used;go with the trend of national socio-economic development and handle comprehensively problems of the meteorological observational environment protection ;For the station that must be moved, the meteorological observational environment protection should be the first as selecting new station locations. At the same time, the various patterns may be used to the construction layout of a new station.

  16. 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 whi

  17. 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.

  18. Internationalization of regulatory requirements.

    Science.gov (United States)

    Juillet, Y

    2003-02-01

    The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

  19. Cellular immune responses towards regulatory cells.

    Science.gov (United States)

    Larsen, Stine Kiær

    2016-01-01

    This thesis describes the results from two published papers identifying spontaneous cellular immune responses against the transcription factors Foxp3 and Foxo3. The tumor microenvironment is infiltrated by cells that hinder effective tumor immunity from developing. Two of these cell types, which have been linked to a bad prognosis for patients, are regulatory T cells (Treg) and tolerogenic dendritic cells (DC). Tregs inhibit effector T cells from attacking the tumor through various mechanisms, including secreted factors and cell-to-cell contact. Tregs express the transcription factor Foxp3, which is necessary for their development and suppressive activities. Tolerogenic DCs participate in creating an environment in the tumor where effector T cells become tolerant towards the tumor instead of attacking it. The transcription factor Foxo3 was recently described to be highly expressed by tolerogenic DCs and to programme their tolerogenic influence. This thesis describes for the first time the existence of spontaneous cellular immune responses against peptides derived from Foxp3 and Foxo3. We have detected the presence of cytotoxic T cells that recognise these peptides in an HLA-A2 restricted manner in cancer patients and for Foxp3 in healthy donors as well. In addition, we have demonstrated that the Foxp3- and Foxo3-specific CTLs recognize Foxp3- and Foxo3-expressing cancer cell lines and importantly, suppressive immune cells, namely Tregs and in vitro generated DCs. Cancer immunotherapy is recently emerging as an important treatment modality improving the survival of selected patients. The current progress is largely owing to targeting of the immune suppressive milieu that is dominating the tumor microenvironment. This is being done through immune checkpoint blockade with CTLA-4 and PD-1/PD-L1 antibodies and through lymphodepleting conditioning of patients and ex vivo activation of TILs in adoptive cell transfer. Several strategies are being explored for depletion of

  20. NGNP Project Regulatory Gap Analysis for Modular HTGRs

    Energy Technology Data Exchange (ETDEWEB)

    Wayne Moe

    2011-09-01

    The Next Generation Nuclear Plant (NGNP) Project Regulatory Gap Analysis (RGA) for High Temperature Gas-Cooled Reactors (HTGR) was conducted to evaluate existing regulatory requirements and guidance against the design characteristics specific to a generic modular HTGR. This final report presents results and identifies regulatory gaps concerning current Nuclear Regulatory Commission (NRC) licensing requirements that apply to the modular HTGR design concept. This report contains appendices that highlight important HTGR licensing issues that were found during the RGA study. The information contained in this report will be used to further efforts in reconciling HTGR-related gaps in the NRC licensing structure, which has to date largely focused on light water reactor technology.

  1. Experience in implementing regulatory requirements to protect against industrial sabotage

    Energy Technology Data Exchange (ETDEWEB)

    Knuth, D.F.

    1978-01-01

    Some of the problems and concerns in implementing the current regulatory requirements in physical protection of nuclear power plants are discussed. Until 1973, the Nuclear Regulatory Commission (NRC) was of the opinion that a determined group of professional saboteurs was beyond the scope of protection required. Since then regulatory changes have altered that concept; each successive regulatory change envisions a higher level of threat, and, hence, requires more provisions to protect the facilities. The author contends that, in some areas, NRC's decisions were hastily conceived with unrealistic implementation schedules. These decisions and regulations, if fully implemented, could be counterproductive to maintaining good security in a nuclear power plant, and are counterproductive to safety and operability of the plants.

  2. The national and international regulatory environment in tobacco control.

    Science.gov (United States)

    Warner, Kenneth E

    2015-07-09

    Despite their lethality, cigarettes are subject to little regulation that directly restricts their contents or their legality. This may change in the near future with the Framework Convention on Tobacco Control (FCTC), the world's first global health treaty, now in force, as well as developments in a few individual countries. Cigarettes are subject to a substantial number of country-specific regulations regarding their conditions of sale: their price (mostly through taxation), the places where they can be consumed (clean indoor air laws), who can smoke them (prohibitions on their use by or sales to minors), how they can be advertised or promoted (if at all), and how they must be packaged (minimum pack sizes, warning labels, plain packaging). Such policies constitute the core of successful tobacco control. The FCTC has been ratified by 180 countries representing 90% of the world's population. The FCTC requires compliance with numerous provisions relating to the kinds of regulations noted above. The treaty also mandates explicit attention to direct product regulation. Several countries have such authority, at least in limited forms. In the US, for example, the Food and Drug Administration (FDA) now has the legal authority to regulate tobacco products, including their contents. The possibility exists that, in the foreseeable future, a country will mandate product standards that will substantially reduce the appeal of cigarettes and other combusted tobacco products, which are by far the leading sources of the death and disease associated with tobacco.

  3. 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 studi...

  4. 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...

  5. 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)

  6. Technical efficiency under alternative environmental regulatory regimes : The case of Dutch horticulture

    NARCIS (Netherlands)

    van der Vlist, Arno J.; Withagen, Cees; Folmer, Henk

    2007-01-01

    We consider the performance of small and medium sized enterprises in Dutch horticulture under different environmental policy regimes across time. We address the question whether technical performance differs under these alternative regulatory regimes to test Porter's hypothesis that stricter environ

  7. Technical efficiency under alternative environmental regulatory regimes: The case of Dutch horticulture

    NARCIS (Netherlands)

    Vlist, van der A.J.; Withagen, C.; Folmer, H.

    2007-01-01

    We consider the performance of small and medium sized enterprises in Dutch horticulture under different environmental policy regimes across time. We address the question whether technical performance differs under these alternative regulatory regimes to test Porter's hypothesis that stricter environ

  8. Cytokine release assays: current practices and future directions.

    Science.gov (United States)

    Finco, D; Grimaldi, C; Fort, M; Walker, M; Kiessling, A; Wolf, B; Salcedo, T; Faggioni, R; Schneider, A; Ibraghimov, A; Scesney, S; Serna, D; Prell, R; Stebbings, R; Narayanan, P K

    2014-04-01

    As a result of the CD28 superagonist biotherapeutic monoclonal antibody (TGN 1412) "cytokine storm" incident, cytokine release assays (CRA) have become hazard identification and prospective risk assessment tools for screening novel biotherapeutics directed against targets having a potential risk for eliciting adverse pro-inflammatory clinical infusion reactions. Different laboratories may have different strategies, assay formats, and approaches to the reporting, interpretation, and use of data for either decision making or risk assessment. Additionally, many independent contract research organizations (CROs), academic and government laboratories are involved in some aspect of CRA work. As a result, while some pharmaceutical companies are providing CRA data as part of the regulatory submissions when necessary, technical and regulatory practices are still evolving to provide data predictive of cytokine release in humans and that are relevant to safety. This manuscript provides an overview of different approaches employed by the pharmaceutical industry and CROs, for the use and application of CRA based upon a survey and post survey follow up conducted by ILSI-Health and Environmental Sciences Institute (HESI) Immunotoxicology Committee CRA Working Group. Also discussed is ongoing research in the academic sector, the regulatory environment, current limitations of the assays, and future directions and recommendations for cytokine release assays.

  9. Current directions in screening-level ecological risk assessments

    Energy Technology Data Exchange (ETDEWEB)

    Carlsen, T M; Efroymson, R A

    2000-12-11

    Ecological risk assessment (ERA) is a tool used by many regulatory agencies to evaluate the impact to ecological receptors from changes in environmental conditions. Widespread use of ERAs began with the United States Environmental Protection Agency's Superfund program to assess the ecological impact from hazardous chemicals released to the environment. Many state hazardous chemical regulatory agencies have adopted the use of ERAs, and several state regulatory agencies are evaluating the use of ERAs to assess ecological impacts from releases of petroleum and gas-related products. Typical ERAs are toxicologically-based, use conservative assumptions with respect to ecological receptor exposure duration and frequency, often require complex modeling of transport and exposure and are very labor intensive. In an effort to streamline the ERA process, efforts are currently underway to develop default soil screening levels, to identify ecological screening criteria for excluding sites from formal risk assessment, and to create risk-based corrective action worksheets. This should help reduce the time spent on ERAs, at least for some sites. Work is also underway to incorporate bioavailability and spatial considerations into ERAs. By evaluating the spatial nature of contaminant releases with respect to the spatial context of the ecosystem under consideration, more realistic ERAs with respect to the actual impact to ecological receptors at the population, community or ecosystem scale should be possible. In addition, by considering the spatial context, it should be possible to develop mitigation and monitoring efforts to more appropriately address such sites within the context of an ecological framework.

  10. 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.

  11. 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...

  12. 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/.

  13. 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.)

  14. Taking Stock of Regulatory Variation.

    Science.gov (United States)

    Maurano, Matthew T; Stamatoyannopoulos, John A

    2015-07-29

    Three recent studies measure individual variation in regulatory DNA accessibility. What do they tell us about the prospects of assessing variation in single cells and across populations? Copyright © 2015 Elsevier Inc. All rights reserved.

  15. 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

  16. Regulatory facility guide for Ohio

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, S.S.; Bock, R.E.; Francis, M.W.; Gove, R.M.; Johnson, P.E.; Kovac, F.M.; Mynatt, J.O. [Oak Ridge National Lab., TN (United States); Rymer, A.C. [Transportation Consulting Services, Knoxville, TN (United States)

    1994-02-28

    The Regulatory Facility Guide (RFG) has been developed for the DOE and contractor facilities located in the state of Ohio. It provides detailed compilations of international, federal, and state transportation-related regulations applicable to shipments originating at destined to Ohio facilities. This RFG was developed as an additional resource tool for use both by traffic managers who must ensure that transportation operations are in full compliance with all applicable regulatory requirements and by oversight personnel who must verify compliance activities.

  17. Electronic Commerce Removing Regulatory Impediments

    Science.gov (United States)

    1992-05-01

    AD-A252 691 ELECTRONIC COMMERCE Removing Regulatory Impediments ~DuiG A% ELECTE I JUL1 8 1992 0 C D Daniel J. Drake John A. Ciucci ... - ""N ST AT KE...Management Institute 6400 Goldsboro Road Bethesda, Maryland 20817-5886 92 LMI Executive Summary ELECTRONIC COMMERCE : REMOVING REGULATORY IMPEDIMENTS... Electronic Commerce techniques, such as electronic mail and electronic data interchange (EDI), enable Government agencies to conduct business without the

  18. Modeling for regulatory purposes (risk and safety assessment).

    Science.gov (United States)

    El-Masri, Hisham

    2013-01-01

    Chemicals provide many key building blocks that are converted into end-use products or used in industrial processes to make products that benefit society. Ensuring the safety of chemicals and their associated products is a key regulatory mission. Current processes and procedures for evaluating and assessing the impact of chemicals on human health, wildlife, and the environment were, in general, designed decades ago. These procedures depend on generation of relevant scientific knowledge in the laboratory and interpretation of this knowledge to refine our understanding of the related potential health risks. In practice, this often means that estimates of dose-response and time-course behaviors for apical toxic effects are needed as a function of relevant levels of exposure. In many situations, these experimentally determined functions are constructed using relatively high doses in experimental animals. In absence of experimental data, the application of computational modeling is necessary to extrapolate risk or safety guidance values for human exposures at low but environmentally relevant levels.

  19. Structural imprints in vivo decode RNA regulatory mechanisms

    Science.gov (United States)

    Spitale, Robert C.; Flynn, Ryan A.; Zhang, Qiangfeng Cliff; Crisalli, Pete; Lee, Byron; Jung, Jong-Wha; Kuchelmeister, Hannes Y.; Batista, Pedro J.; Torre, Eduardo A.; Kool, Eric T.; Chang, Howard Y.

    2015-03-01

    Visualizing the physical basis for molecular behaviour inside living cells is a great challenge for biology. RNAs are central to biological regulation, and the ability of RNA to adopt specific structures intimately controls every step of the gene expression program. However, our understanding of physiological RNA structures is limited; current in vivo RNA structure profiles include only two of the four nucleotides that make up RNA. Here we present a novel biochemical approach, in vivo click selective 2'-hydroxyl acylation and profiling experiment (icSHAPE), which enables the first global view, to our knowledge, of RNA secondary structures in living cells for all four bases. icSHAPE of the mouse embryonic stem cell transcriptome versus purified RNA folded in vitro shows that the structural dynamics of RNA in the cellular environment distinguish different classes of RNAs and regulatory elements. Structural signatures at translational start sites and ribosome pause sites are conserved from in vitro conditions, suggesting that these RNA elements are programmed by sequence. In contrast, focal structural rearrangements in vivo reveal precise interfaces of RNA with RNA-binding proteins or RNA-modification sites that are consistent with atomic-resolution structural data. Such dynamic structural footprints enable accurate prediction of RNA-protein interactions and N6-methyladenosine (m6A) modification genome wide. These results open the door for structural genomics of RNA in living cells and reveal key physiological structures controlling gene expression.

  20. [Future Regulatory Science through a Global Product Development Strategy to Overcome the Device Lag].

    Science.gov (United States)

    Tsuchii, Isao

    2016-01-01

    Environment that created "medical device lag (MDL)" has changed dramatically, and currently that term is not heard often. This was mainly achieved through the leadership of three groups: government, which determined to overcome MDL and took steps to do so; medical societies, which exhibited accountability in trial participation; and MD companies, which underwent a change in mindset that allowed comprehensive tripartite cooperation to reach the current stage. In particular, the global product development strategy (GPDS) of companies in a changing social environment has taken a new-turn with international harmonization trends, like Global Harmonization Task Force and International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. As a result, this evolution has created opportunities for treatment with cutting-edge MDs in Japanese society. Simultaneously, it has had a major impact on the planning process of GPDS of companies. At the same time, the interest of global companies has shifted to emerging economies for future potential profit since Japan no longer faces MDL issue. This economic trend makes MDLs a greater problem for manufacturers. From the regulatory science viewpoint, this new environment has not made it easy to plan a global strategy that will be adaptable to local societies. Without taking hasty action, flexible thinking from the global point of view is necessary to enable the adjustment of local strategies to fit the situation on the ground so that the innovative Japanese medical technology can be exported to a broad range of societies.

  1. The current situation and trend of environment control technology in greenhouse%温室环境控制技术的研究现状与发展趋势

    Institute of Scientific and Technical Information of China (English)

    2013-01-01

      随着数字化农业技术的发展,智能温室在我国得到了更广泛的应用,为保证蔬菜供应、增加农民收入做出了重要贡献。准确掌握温室环境控制技术的发展成就与研究现状,并对未来的发展方向进行展望,对于促进我国温室环境控制技术的发展具有重要意义。%Along with the development of digital agriculture technology, intelligent greenhouse in our country has got more extensive applica-tion, and been contributing a lot to solving the problem of vegetables supply and increasing peasants' income. To understand the current sit-uation and prospect the trend, the paper had important directive significance for the development environment control technology in green-house in China.

  2. Online versus conventional shopping: consumers' risk perception and regulatory focus.

    Science.gov (United States)

    van Noort, Guda; Kerkhof, Peter; Fennis, Bob M

    2007-10-01

    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 prevention focus. The findings in Study 1 demonstrate these effects by using self-report measures for risk perception and prevention focus. In Study 2, we replicated these findings and demonstrated that the effect of an online shopping environment carries over to behavior in a domain unrelated to shopping.

  3. Regulatory research / Pesquisa regulatória

    Directory of Open Access Journals (Sweden)

    Altair Souza de Assis

    2013-05-01

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

  4. 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.

  5. Regulatory and Permitting Issues

    Energy Technology Data Exchange (ETDEWEB)

    Larry Myer

    2005-12-01

    As part of the West Coast Regional Carbon Sequestration Partnership (WESTCARB), Terralog Technologies USA, Inc., reviewed current state and federal regulations related to carbon dioxide capture and storage within geologic formations and enhanced carbon uptake in terrestrial ecosystems. We have evaluated and summarized the current and possible future permitting requirements for the six states that comprise the West Coast Regional Partnership. Four options exist for CO{sub 2} injection into appropriate geologic formations, including storage in: (1) oil and gas reservoirs, (2) saline formations, (3) unmineable coal beds, and (4) salt caverns. Terrestrial CO{sub 2} sequestration involves improved carbon conservation management (e.g. reduction of deforestation), carbon substitution (e.g., substitution for fossil fuel-based products, energy conservation through urban forestry, biomass for energy generation), and improved carbon storage management (e.g., expanding the storage of carbon in forest ecosystems). The primary terrestrial options for the West Coast Region include: (1) reforestation of under-producing lands (including streamside forest restoration), (2) improved forest management, (3) forest protection and conservation, and (4) fuel treatments for the reduction of risk of uncharacteristically severe fires (potentially with associated biomass energy generation). The permits and/or contracts required for any land-use changes/disturbances and biomass energy generation that may occur as part of WESTCARB's activities have been summarized for each state.

  6. Modeling genomic regulatory networks with big data.

    Science.gov (United States)

    Bolouri, Hamid

    2014-05-01

    High-throughput sequencing, large-scale data generation projects, and web-based cloud computing are changing how computational biology is performed, who performs it, and what biological insights it can deliver. I review here the latest developments in available data, methods, and software, focusing on the modeling and analysis of the gene regulatory interactions in cells. Three key findings are: (i) although sophisticated computational resources are increasingly available to bench biologists, tailored ongoing education is necessary to avoid the erroneous use of these resources. (ii) Current models of the regulation of gene expression are far too simplistic and need updating. (iii) Integrative computational analysis of large-scale datasets is becoming a fundamental component of molecular biology. I discuss current and near-term opportunities and challenges related to these three points.

  7. 77 FR 46339 - Chrysanthemum White Rust Regulatory Status and Restrictions

    Science.gov (United States)

    2012-08-03

    ..., destruction, treatment, or other sanitation measures called for in our National Management Plan. The... reevaluating our current regulatory strategy in order to improve the effectiveness and economic efficiency of...-Goldner, National Program Manager, Emergency and Domestic Programs, PPQ, APHIS, 4700 River Road Unit 160...

  8. Perspectives on an alternative career path in regulatory science

    OpenAIRE

    Fields, F. Owen

    2013-01-01

    Perspectives are provided on an alternative career path in regulatory science for those currently involved in basic biology research. This path is compared and contrasted with basic research, and factors to be examined if one is considering such a path are discussed.

  9. Perspectives on an alternative career path in regulatory science.

    Science.gov (United States)

    Fields, F Owen

    2013-07-01

    Perspectives are provided on an alternative career path in regulatory science for those currently involved in basic biology research. This path is compared and contrasted with basic research, and factors to be examined if one is considering such a path are discussed.

  10. Powerplant productivity improvements and regulatory incentives

    Energy Technology Data Exchange (ETDEWEB)

    Hardy, D; Brown, D

    1980-10-27

    The purpose of this study was to examine the benefits to be gained from increased powerplant productivity and to validate and demonstrate the use of incentives within the regulatory process to promote the improvement of powerplant productivity. The system-wide costs savings to be gained from given productivity improvement scenarios are estimated in both the short and long term. Numerous reports and studies exist which indicate that productivity improvements at the powerplant level are feasible and cost effective. The efforts of this study widen this focus and relate system-wide productivity improvements with system-wide cost savings. The initial thrust of the regulatory section of this study is to validate the existence of reasonable incentive procedures which would enable regulatory agencies to better motivate electric utilities to improve productivity on both the powerplant and system levels. The voluntary incentive format developed in this study was designed to facilitate the link between profit and efficiency which is typically not clear in most regulated market environments. It is concluded that at the present time, many electric utilities in this country could significantly increase the productivity of their base load units, and the adoption of an incentive program of the general type recommended in this study would add to rate of return regulation the needed financial incentives to enable utilities to make such improvements without losing long-run profit. In light of the upcoming oil import target levels and mandatory cutbacks of oil and gas as boiler fuels for electric utilities, the use of incentive programs to encourage more efficient utilization of coal and nuclear base load capacity will become far more inviting over the next two decades.

  11. The Regulatory Stage of pharmaceutical patents: Compulsory Licensing as a RD&I-based Regulatory Tool

    Directory of Open Access Journals (Sweden)

    Márcio Iorio Aranha

    2016-09-01

    Full Text Available Access to strategic medicines as a guarantee of the right to health was submitted to a decisive test in the first half of 2000s, when the US and Europe positioned themselves in frontal collision with several developing nations, particularly South Africa and Brazil, on the topic of extension of the legal construct of compulsory license inaugurated by the TRIPS Agreement. This paper puts side-by-side the legal construct of compulsory license and RD&I investment in the pharmaceutical sector as regulatory tools prone to interact in the law sociological stage, as they present themselves as acts of an encompassing regulatory scheme. The regulatory stage makes use of off-stage characteristics of the socioeconomic environment to set up those tools in different ways. Compulsory license has been used as a threat that blocks arbitrary price increase of drugs, while RD&I investment has been applied to counteract the big pharma expectations of state inability to produce drugs following specific threats to break patented pharmaceutical inventions. This paper addresses the role of RD&I investments towards drug development to modulate the efficacy of compulsory licenses.

  12. Adolescent threat-related interpretive bias and its modification: the moderating role of regulatory control

    NARCIS (Netherlands)

    Salemink, E.; Wiers, R.W.

    2012-01-01

    Dual process models describe psychopathology as the consequence of an imbalance between a fast, impulsive system and a regulatory control system and have recently been applied to anxiety disorders. The aim of the current study was to specifically examine the role of a regulatory control system in re

  13. 78 FR 62728 - Self Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-10-22

    ... responsibilities. Therefore, the Series 14 measures the knowledge and skills related to the position of a... provide direction to Participant Firms designing their supervisory systems and reinforce the importance of... regulatory, compliance and sales practice matters in the industry. Currently, there are two Regulatory...

  14. Impact of Safety-Related Regulatory Action on Clinical Practice A Systematic Review

    NARCIS (Netherlands)

    Piening, Sigrid; Haaijer-Ruskamp, Flora M.; de Vries, Jonie T. N.; van der Elst, Menno E.; de Graeff, Pieter A.; Straus, Sabine M. J. M.; Mol, Peter G. M.

    2012-01-01

    Background: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of th

  15. Why some groups just feel better : The regulatory fit of group power

    NARCIS (Netherlands)

    Sassenberg, K.; Jonas, K.J; Shah, J.Y; Brazy, P.C

    2007-01-01

    The current research applied the regulatory fit hypothesis (E. T. Higgins, 2000) to the evaluation of groups, suggesting that individuals' group appraisal depends on how well the groups fit their regulatory needs. Specifically, it was predicted that higher power groups would fit and be more valued b

  16. 77 FR 13258 - Biotechnology Regulatory Services; Changes Regarding the Solicitation of Public Comment for...

    Science.gov (United States)

    2012-03-06

    ... Animal and Plant Health Inspection Service Biotechnology Regulatory Services; Changes Regarding the.... FOR FURTHER INFORMATION CONTACT: Dr. T. Clint Nesbitt, Chief of Staff, Biotechnology Regulatory...://www.aphis.usda.gov/biotechnology/pet_proc_imp.shtml . Current Comment Process for Petitions for...

  17. Regulatory Expectations for Safety Culture

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Su Jin; Oh, Jang Jin; Choi, Young Sung [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-05-15

    The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety.

  18. Genomic research in Zambia: confronting the ethics, policy and regulatory frontiers in the 21st Century.

    Science.gov (United States)

    Chanda-Kapata, Pascalina; Kapata, Nathan; Moraes, Albertina Ngomah; Chongwe, Gershom; Munthali, James

    2015-10-29

    Genomic research has the potential to increase knowledge in health sciences, but the process has to ensure the safety, integrity and well-being of research participants. A legal framework for the conduct of health research in Zambia is available. However, the ethical, policy and regulatory framework to operationalise genomic research requires a paradigm shift. This paper outlines the current legal and policy framework as well as the ethics environment, and suggests recommendations for Zambia to fully benefit from the opportunity that genomic research presents. This will entail creating national research interest, improving knowledge levels, and building community trust among researchers, policymakers, donors, regulators and, most importantly, patients and research participants. A real balancing act of the risk and benefits will need to be objectively undertaken.

  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.

  20. Bioattractors: dynamical systems theory and the evolution of regulatory processes.

    Science.gov (United States)

    Jaeger, Johannes; Monk, Nick

    2014-06-01

    In this paper, we illustrate how dynamical systems theory can provide a unifying conceptual framework for evolution of biological regulatory systems. Our argument is that the genotype-phenotype map can be characterized by the phase portrait of the underlying regulatory process. The features of this portrait--such as attractors with associated basins and their bifurcations--define the regulatory and evolutionary potential of a system. We show how the geometric analysis of phase space connects Waddington's epigenetic landscape to recent computational approaches for the study of robustness and evolvability in network evolution. We discuss how the geometry of phase space determines the probability of possible phenotypic transitions. Finally, we demonstrate how the active, self-organizing role of the environment in phenotypic evolution can be understood in terms of dynamical systems concepts. This approach yields mechanistic explanations that go beyond insights based on the simulation of evolving regulatory networks alone. Its predictions can now be tested by studying specific, experimentally tractable regulatory systems using the tools of modern systems biology. A systematic exploration of such systems will enable us to understand better the nature and origin of the phenotypic variability, which provides the substrate for evolution by natural selection.

  1. White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.

    Science.gov (United States)

    Wilks, M F; Roth, N; Aicher, L; Faust, M; Papadaki, P; Marchis, A; Calliera, M; Ginebreda, A; Andres, S; Kühne, R; Schüürmann, G

    2015-07-15

    The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more

  2. Regulatory processes in Aspergillus niger

    DEFF Research Database (Denmark)

    Poulsen, Lars

    some disadvantages as well, those are byproduct formation, secretion of proteolytic enzymes and formation of mycotoxins. The aim of this project was to reduce these disadvantages, though investigating the regulatory processes. The first objective was to study the regulatory events leading to A. niger......T. The physiological batch characterization showed that the ΔprtT strain had the lowest protease activity (fivefold reduced), but also featured excessive CO2 yield, reduced growth rate and lower biomass yields. The ΔprtB strain had a close to twofold reduced levels of secreted proteases but with additional beneficial...

  3. The Existing Regulatory Conditions for 'Energy Smart Water Utilities'

    DEFF Research Database (Denmark)

    Basse, Ellen Margrethe

    2014-01-01

    conditions. Based on these facts, the resource efficiency and low–carbon policy of the EU as well as the EU’s rules of relevance for the utilities are highlighted in section 4. It is concluded that the current EU legislation makes it possible for the Member States to promote energy–smart water utilities...... of the national regulatory design and the problems related to legal barriers are illustrated in section 5 with examples from Danish legislation. The Danish regulatory style is more inflexible than necessary. The benchmarking model and price-cap systems – established as mandatory legal conditions together...

  4. A regulatory theory of cortical organization and its applications to robotics

    Science.gov (United States)

    Thangavelautham, Jekanthan

    2009-11-01

    Fundamental aspects of biologically-inspired regulatory mechanisms are considered in a robotics context, using artificial neural-network control systems. Regulatory mechanisms are used to control expression of genes, adaptation of form and behavior in organisms. Traditional neural network control architectures assume networks of neurons are fixed and are interconnected by wires. However, these architectures tend to be specified by a designer and are faced with several limitations that reduce scalability and tractability for tasks with larger search spaces. Traditional methods used to overcome these limitations with fixed network topologies are to provide more supervision by a designer. More supervision as shown does not guarantee improvement during training particularly when making incorrect assumptions for little known task domains. Biological organisms often do not require such external intervention (more supervision) and have self-organized through adaptation. Artificial neural tissues (ANT) addresses limitations with current neural-network architectures by modeling both wired interactions between neurons and wireless interactions through use of chemical diffusion fields. An evolutionary (Darwinian) selection process is used to 'breed' ANT controllers for a task at hand and the framework facilitates emergence of creative solutions since only a system goal function and a generic set of basis behaviours need be defined. Regulatory mechanisms are formed dynamically within ANT through superpositioning of chemical diffusion fields from multiple sources and are used to select neuronal groups. Regulation drives competition and cooperation among neuronal groups and results in areas of specialization forming within the tissue. These regulatory mechanisms are also shown to increase tractability without requiring more supervision using a new statistical theory developed to predict performance characteristics of fixed network topologies. Simulations also confirm the

  5. 75 FR 70757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-11-18

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a... 12, 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc... Kimmel, Executive Director, Financial Information Forum, to Elizabeth M. Murphy, Secretary,...

  6. 77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2012-08-08

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal... FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority,...

  7. 77 FR 55517 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-09-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a.... Introduction On May 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... General Counsel, Securities Industry and Financial Markets Association, dated June 26, 2012...

  8. 75 FR 62439 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-10-08

    ...-2010-043] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA..., 2010 (``Wiesenberg Letter''); Letter from Manisha Kimmel, Executive Director, Financial...

  9. 77 FR 12340 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-02-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... Accounting Support Fee February 23, 2012. I. Introduction On December 20, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  10. 76 FR 20757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-13

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... February 4, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the...

  11. 75 FR 61793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-10-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... Encrypted September 29, 2010. I. Introduction On June 2, 2010, the Financial Industry Regulatory Authority... Taunt, Chief Executive Officer, Regal Financial Group, to Elizabeth M. Murphy, Secretary,...

  12. Subordinate regulatory mode and leader power: Interpersonal regulatory complementarity predicts task performance

    NARCIS (Netherlands)

    Hamstra, M.R.W.; Orehek, E.; Holleman, M.

    2014-01-01

    This research examines the implications of locomotion regulatory mode (orientation toward making progress on goals) and assessment regulatory mode (orientation toward critically evaluating alternatives) for employees' performance. Regulatory mode theory suggests that, although these are both integra

  13. Legal and regulatory concerns about transgenic plants in Brazil.

    Science.gov (United States)

    Fontes, Eliana M G

    2003-06-01

    Brazil has a biosafety law that was approved in 1995. This law provides for a horizontal type of regulation that coordinates other existing regulatory frameworks in the areas of agriculture, health and environment. Various federal government departments are responsible for implementing the law. The National Technical Biosafety Commission is the national competent authority on biosafety with overall responsibility. In the case of Bt plants or any insecticidal organism, the Agrochemical Law also applies and authorization for laboratory, greenhouse and field studies must be obtained from the Plant Protection Secretariat, the Brazilian Institute of Environment and the National Agency of Health. Furthermore, the National Environmental Council must issue a license for commercialization of any GMO. There is pressure needed for capacity building and to harmonize the regulatory and administrative frameworks among the different federal departments involved. Some perspectives and challenges for the commercial registration of transgenic crops are discussed.

  14. Scientific and Regulatory Policy Committee (SRPC) Review: Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment.

    Science.gov (United States)

    Wood, Charles E; Hukkanen, Renee R; Sura, Radhakrishna; Jacobson-Kram, David; Nolte, Thomas; Odin, Marielle; Cohen, Samuel M

    2015-08-01

    Increased cell proliferation is a central key event in the mode of action for many non-genotoxic carcinogens, and quantitative cell proliferation data play an important role in the cancer risk assessment of many pharmaceutical and environmental compounds. Currently, there is limited unified information on assay standards, reference values, targeted applications, study design issues, and quality control considerations for proliferation data. Here, we review issues in measuring cell proliferation indices, considerations for targeted studies, and applications within current risk assessment frameworks. As the regulatory environment moves toward more prospective evaluations based on quantitative pathway-based models, standardization of proliferation assays will become an increasingly important part of cancer risk assessment. To help address this development, we also discuss the potential role for proliferation data as a component of alternative carcinogenicity testing models. This information should improve consistency of cell proliferation methods and increase efficiency of targeted testing strategies.

  15. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

    Science.gov (United States)

    Sabata, Roger; Verges, Josep; Zugaza, José L.; Ruiz, Adolfina; Clares, Beatriz

    2016-01-01

    Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs. PMID:27999600

  16. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

    Directory of Open Access Journals (Sweden)

    Patricia Galvez-Martin

    2016-01-01

    Full Text Available Mesenchymal stem cells (MSCs are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs. The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP. Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs.

  17. 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.

  18. Dose response relationship in anti-stress gene regulatory networks.

    OpenAIRE

    Qiang Zhang; Andersen, Melvin E.

    2007-01-01

    To maintain a stable intracellular environment, cells utilize complex and specialized defense systems against a variety of external perturbations, such as electrophilic stress, heat shock, and hypoxia, etc. Irrespective of the type of stress, many adaptive mechanisms contributing to cellular homeostasis appear to operate through gene regulatory networks that are organized into negative feedback loops. In general, the degree of deviation of the controlled variables, such as electrophiles, misf...

  19. Lymph node trafficking of regulatory T cells is prerequisite for immune suppression.

    Science.gov (United States)

    Huang, Miao-Tzu; Lin, Been-Ren; Liu, Wei-Liang; Lu, Chun-Wei; Chiang, Bor-Luen

    2016-04-01

    Regulatory T cells have a crucial role in health and disease because of their immune regulation function. However, the anatomic sites where regulatory T cells exert optimal immune regulation are open to debate. In our current study with the use of a shear-stress flow assay, we found that regulatory T cells exhibited significantly decreased adhesion to either activated endothelial monolayer or intercellular adhesion molecule 1 or E-selectin-coated surfaces compared with activated effector T cells. The less transmigration capacity of the regulatory T cells prompted our speculation of preferential lymph node localization for the regulatory T cells that endowed these cells with immune regulation function in the most efficient manner. To test this hypothesis, the role of lymph node localization in regulatory T cell-mediated immune suppression was evaluated with a footpad inflammation model. We found that adoptively transferred regulatory T cells inhibited the development of footpad inflammation. In addition, although blockage of CCR7 or CD62L had no effect on the immune suppressive function of the regulatory T cells per se, pretreatment of the regulatory T cells with either CCR7 or CD62L blocking antibodies prevented their recruitment into draining lymph nodes and concomitantly abrogated the immune suppressive effects of adoptively transferred regulatory T cells during footpad inflammation. Our data demonstrate the crucial role of lymph node localization in regulatory T cell-mediated immune suppression and suggest a probable hierarchy in the anatomic sites for optimal immune regulation. Elucidating the relationships between the transmigration characteristics of the regulatory T cells and their immune regulation function will provide insightful information for regulatory T cell-based cell therapy.

  20. Current Status of JRR-3

    Energy Technology Data Exchange (ETDEWEB)

    Kinase, Masami; Arai, Masaji; Maruo, Takeshi [Japan Atomic Energy Agency, Ibaraki (Japan)

    2013-07-01

    JRR-3 at the Tokai-Shirakata site of JAEA was in its regular maintenance period, when the Great East Japan Earthquake took place on 11th March 2011. The reactor building with the solid foundations and the equipment important to safety survived the earthquake without serious damage, and no radioactive leakage has been occurred. Recovery works, check and test to confirm the integrity of all components and structures, and seismic assessment necessary for proving that the seismic loads which worked on a structure or component by the earthquake accommodated within its allowable stress have been carried out. After our recovery works and verification of the integrity of JRR-3, we confirmed that the integrity is ensured, and then reported the fact to the regulatory body. As another topic, the regulatory body will introduce new regulatory requirements for research reactors. Now, JRR-3 considers applying the new requirements for restart. This paper presents the current status of JRR-3 including the recovery works, seismic assessment and new regulatory requirements.

  1. 75 FR 36445 - Draft Regulatory Guide, DG-4018, “Constraint on Releases of Airborne Radioactive Materials To the...

    Science.gov (United States)

    2010-06-25

    ... COMMISSION Draft Regulatory Guide, DG-4018, ``Constraint on Releases of Airborne Radioactive Materials To the... of Airborne Radioactive Materials to the Environment for Licensees Other than Power Reactors.'' This....resource@nrc.gov . The Draft Regulatory Guide, DG-4018, ``Constraint on Releases of Airborne...

  2. Current issues with research support

    Energy Technology Data Exchange (ETDEWEB)

    Russell, W.T.

    1996-03-01

    It would be difficult to condense current issues in nuclear reactor regulation to just a few minutes. So, let me start off by saying that I have not tried to give a comprehensive listing of issues that are currently facing the reactor program, but rather to select those that I thought were relevant as they relate to research activities. Use of probabilistic risk assessment in regulatory decisions; materials aging issues concerning steam generators and reactor vessels; high burnup fuels; accident management; and digital instrumentation and control, are just a sampling of the important issues that I want to talk about.

  3. Uterus transplantation: ethical and regulatory challenges.

    Science.gov (United States)

    Arora, Kavita Shah; Blake, Valarie

    2014-06-01

    Moving forward rapidly in the clinical research phase, uterus transplantation may be a future treatment option for women with uterine factor infertility, which accounts for three per cent of all infertility in women. This new method of treatment would allow women, who currently rely on gestational surrogacy or adoption, to gestate and birth their own genetic offspring. Since uterus transplantation carries significant risk when compared with surrogacy and adoption as well as when compared with other organ transplants, it requires greater justification because its goals are quality of life, not life-saving, in their scope. It is important to address questions regarding the physical, psychosocial and ethical risks and benefits of uterus transplantation for all three parties involved--the patient, the donor and the potential child--as well as discuss the regulatory implications as research on uterus transplantations moves forward.

  4. Vaccines in Argentina: a regulatory view.

    Science.gov (United States)

    Pérez, A C; Diez, R A

    2003-07-28

    In Argentina, vaccines for immuno-preventable diseases are regulated by the national regulatory agency, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (the National Administration of Drugs, Food and Medical Devices, or ANMAT) created in 1992 to ensure efficacy and safety of drugs, food and medical devices available in the country, according to Law 16,463 and Decree 150/92. ANMAT has licensed 84 out of 157 vaccines registered in Argentina. Since 1994, ANMAT evaluated, approved and inspected 20 clinical trials with vaccines (1.8% of the 1062 trials approved by the agency since that time). The National System of Pharmaco-vigilance has received 318 communications of eventual adverse post-vaccination events (0.3% of the total). In addition, ANMAT provides support to the National Immunisation Programme. The current procedure is to follow international guidelines in the field, to be prepared for new, rapidly changing scenarios.

  5. Mechanisms of T regulatory cell function.

    Science.gov (United States)

    Askenasy, Nadir; Kaminitz, Ayelet; Yarkoni, Shai

    2008-05-01

    Regulatory T cells (Treg) play a pivotal role in tolerance to self-antigens and tissue grafts, and suppression of autoimmune reactions. These cells modulate the intensity and quality of immune reactions through attenuation of the cytolytic activities of reactive immune cells. Treg cells operate primarily at the site of inflammation where they modulate the immune reaction through three major mechanisms: a) direct killing of cytotoxic cells through cell-to-cell contact, b) inhibition of cytokine production by cytotoxic cells, in particular interleukin-2, c) direct secretion of immunomodulatory cytokines, in particular TGF-beta and interleukin-10. In addition to differential contributions of these mechanisms under variable inflammatory conditions, mechanistic complexity and diversity evolves from the diverse tasks performed by various Treg cell subsets in different stages of the immune reaction. Here we attempt to integrate the current experimental evidence to delineate the major suppressive pathways of Treg cells.

  6. EOP Current Magnitude and Direction

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — These data contain shipboard current magnitudes and directions collected in the Pacific, both pelagic and near shore environments. Data is collected using an RD...

  7. The Political Economy of Regulatory Risk

    OpenAIRE

    Roland Strausz

    2009-01-01

    I investigate the argument that, in a two–party system with different regulatory objectives, political uncertainty generates regulatory risk. I show that this risk has a fluctuation effect that hurts both parties and an output–expansion effect that benefits one party. Consequently, at least one party dislikes regulatory risk. Moreover, both political parties gain from eliminating regulatory risk when political divergence is small or the winning probability of the regulatory–risk–averse party ...

  8. The political economy of regulatory risk

    OpenAIRE

    Strausz, Roland

    2009-01-01

    I investigate the argument that, in a twoparty system with different regulatory objectives, political uncertainty generates regulatory risk. I show that this risk has a fluctuation effect that hurts both parties and an outputexpansion effect that benefits one party. Consequently, at least one party dislikes regulatory risk. Moreover, both political parties gain from eliminating regulatory risk when political divergence is small or the winning probability of the regulatoryriskaverse party is n...

  9. Nuclear Regulatory Commission 1989 Information Digest

    Energy Technology Data Exchange (ETDEWEB)

    None,

    1989-03-01

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

  10. PROACTIVE REGULATORY INTERVENTION IN EU COMMUNICATIONS SECTOR AND ITS FORESEEABLE FUTURE

    Directory of Open Access Journals (Sweden)

    Mantas Barčys

    2013-06-01

    Full Text Available Purpose – to review and provide insights on the issues concerning ex ante regulatory approach in EU telecommunications (hereinafter – electronic communications industry, identify and emphasise benefits, main challenges and further regulatory prospective. Design/methodology/approach – based on current regulatory framework and analysis of academic literature, author discusses problematic issues related to the needs and further perspectives of proactive regulatory regime in EU electronic communications sector. Findings – the author reviews special qualities for different regulatory regimes (ex ante, ex post and examines them in the context of sharp developments of the industry and EU regulatory policy. Research limitations/implications –the analysis aims to convey the main understanding on the regulatory specifics of the communications industry, the main features, distinguishing communications industry from the others and foreseeable regulatory perspectives Practical implications – the core aspect of the paper is to evaluate current regulatory approach of the EU electronic communications sector and assess potential regulatory approaches in the context of making self-sustaining pro-competitive market structure, technological development. Originality/Value – the paper highlights some significant changes between two regulatory approaches in the light of specific features in EU electronic communications. Author provides his insights on the status and perspectives on application for both regulatory methods. Apparently, these issues have so far been subjected too little academic analysis. As shown in this paper, regulatory policy can have the essential impact on the activities taken by other players. The decision to give an even bigger role to competition rules, do not mean to eliminate sector specifics itself. With this in mind, EU legislators are not able to eliminate proactive regulatory control, thus reducing ex ante rules progressively

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

    Science.gov (United States)

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

    2007-04-11

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

  12. Ubiquitous Working Environments

    Science.gov (United States)

    Jansson, Carl Gustaf

    This chapter presents the Ubiquitous Working Environments, a vision for the work environments of the future and how this vision is manifested in current experimental environments and projects at KTH. Building upon the Ubiquitous Computing paradigm, our research targets environments, which support collaborating mobile workers in a seamless way, providing work support anywhere and anytime. In our design work so far, we have been particularly interested in the following three design aspects: First, context aware, proactive, and adaptive services; second, ad hoc configuration and synchronization of available resources, including both devices and services; third, new ways of sharing and using resources in a work environment. The systems we design comprise both devices, services, and their interfaces.

  13. Preservation of Built Environments

    DEFF Research Database (Denmark)

    Pilegaard, Marie Kirstine

    When built environments and recently also cultural environments are to be preserved, the historic and architectural values are identified as the key motivations. In Denmark the SAVE system is used as a tool to identify architectural values, but in recent years it has been criticized for having...... a too narrow aesthetic goal, especially when it comes to the evaluation of built environments as a whole. Architectural value has therefore been perceived as a different concept than aesthetic value, primarily related to a static and unchanging expression. This fact creates problems in relation...... to current conservation tasks, which today include more and more untraditionally built environments, including cultural environments. Architectural value must in this case rather be associated with development, ongoing processes, and allow room for future change. The Danish architect Johannes Exner, defines...

  14. 21 CFR 500.88 - Regulatory method.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b)...

  15. 77 FR 10351 - Regulatory Review Plan

    Science.gov (United States)

    2012-02-22

    ... XII Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION: Notice of final regulatory review plan. SUMMARY: The Federal Housing Finance Agency (FHFA) is issuing a notice of the final FHFA regulatory review plan for review of existing regulations under Executive Order 13579, ``Regulation...

  16. Regulatory Status of Dissimilar Metal Weld (DMW)

    Energy Technology Data Exchange (ETDEWEB)

    Kim, K. C.; Hong, J. K.; Shin, H. S.; Kang, S. S.; Song, M. H.; Chung, H. D. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2009-05-15

    In this technical article, the regulatory status for Dissimilar Metal Water (DMW) was discussed. In order to decide the regulatory direction of DMW, the USA's accidents of PWSCC and their regulatory directions were reviewed. By reviewing their experiences, the Korean DMW regulation approach was decided.

  17. Regulatory institutions in liberalised electricity markets

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

    The reform of the electricity supply industry is gathering pace in many countries. Independent regulatory agencies and other regulatory bodies have been created, and regulatory responsibilities redefined. This book reviews the evolving institutional structures to regulate the electricity supply industry in IEA member countries. It is the latest in a series of IEA publications on energy market reform.

  18. Genetic flexibility of regulatory networks.

    Science.gov (United States)

    Hunziker, Alexander; Tuboly, Csaba; Horváth, Péter; Krishna, Sandeep; Semsey, Szabolcs

    2010-07-20

    Gene regulatory networks are based on simple building blocks such as promoters, transcription factors (TFs) and their binding sites on DNA. But how diverse are the functions that can be obtained by different arrangements of promoters and TF binding sites? In this work we constructed synthetic regulatory regions using promoter elements and binding sites of two noninteracting TFs, each sensing a single environmental input signal. We show that simply by combining these three kinds of elements, we can obtain 11 of the 16 Boolean logic gates that integrate two environmental signals in vivo. Further, we demonstrate how combination of logic gates can result in new logic functions. Our results suggest that simple elements of transcription regulation form a highly flexible toolbox that can generate diverse functions under natural selection.

  19. Regulatory T Cells and Parasites

    Directory of Open Access Journals (Sweden)

    TP. Velavan

    2011-01-01

    Full Text Available Human host encounters a wide array of parasites; however, the crucial aspect is the failure of the host immune system to clear these parasites despite antigen recognition. In the recent past, a new immunological concept has emerged, which provides a framework to better understand several aspects of host susceptibility to parasitic infection. It is widely believed that parasites are able to modulate the magnitude of effector responses by inducing regulatory T cell (Tregs population and several studies have investigated whether this cell population plays a role in balancing protective immunity and pathogenesis during parasite infection. This review discusses the several mechanism of Treg-mediated immunosuppression in the human host and focuses on the functional role of Tregs and regulatory gene polymorphisms in infectious diseases.

  20. Reconsidering Styles of Regulatory Enforcement

    DEFF Research Database (Denmark)

    May, Peter J.; Winter, Søren

    2000-01-01

    This study addresses enforcement styles of regulatory inspectors, based on an examination of the municipal enforcement of agro-environmental policies in Denmark. Our findings make three contributions to the regulatory literature. One contribution is to add empirical support for theorizing about...... inspectors’ enforcement styles as consisting of multiple components, rather than a single continuum. We show that inspectors’ enforcement styles comprise the degree of formalism and the degree of coercion that they exercise when carrying out inspections. A second contribution is in showing the relationship...... of different types of enforcement styles to the two underlying dimensions of the concept. A third contribution is an examination of the ways in which inspectors’ enforcement styles relate to their enforcement actions. The consistency of our findings with those of other studies suggests that the dimensions...

  1. Regulatory Changes in Depository Institutions

    OpenAIRE

    Yang, Brian Sejoon

    2016-01-01

    In this dissertation we investigate the effect of monetary policy and regulatory changes on asset pricing and investor behavior. In the first chapter, using unique data on over-the-counter bank stock prices and balance sheet information from 1940 to 1968, we find that the largest commercial bank stocks, ranked by market value or gross deposits, have significant lower risk-adjusted annual returns than do small sized bank stocks even after controlling for standard risk factors including size. ...

  2. Escherichia coli transcriptional regulatory network

    Directory of Open Access Journals (Sweden)

    Agustino Martinez-Antonio

    2011-06-01

    Full Text Available Escherichia coli is the most well-know bacterial model about the function of its molecular components. In this review are presented several structural and functional aspects of their transcriptional regulatory network constituted by transcription factors and target genes. The network discussed here represent to 1531 genes and 3421 regulatory interactions. This network shows a power-law distribution with a few global regulators and most of genes poorly connected. 176 of genes in the network correspond to transcription factors, which form a sub-network of seven hierarchical layers where global regulators tend to be set in superior layers while local regulators are located in the lower ones. There is a small set of proteins know as nucleoid-associated proteins, which are in a high cellular concentrations and reshape the nucleoid structure to influence the running of global transcriptional programs, to this mode of regulation is named analog regulation. Specific signal effectors assist the activity of most of transcription factors in E. coli. These effectors switch and tune the activity of transcription factors. To this type of regulation, depending of environmental signals is named the digital-precise-regulation. The integration of regulatory programs have place in the promoter region of transcription units where it is common to observe co-regulation among global and local TFs as well as of TFs sensing exogenous and endogenous conditions. The mechanistic logic to understand the harmonious operation of regulatory programs in the network should consider the globalism of TFs, their signal perceived, coregulation, genome position, and cellular concentration. Finally, duplicated TFs and their horizontal transfer influence the evolvability of members of the network. The most duplicated and transferred TFs are located in the network periphery.

  3. Mitochondrial Plasticity With Exercise Training and Extreme Environments

    DEFF Research Database (Denmark)

    Boushel, Robert; Lundby, Carsten; Qvortrup, Klaus

    2014-01-01

    Mitochondria form a reticulum in skeletal muscle. Exercise training stimulates mitochondrial biogenesis, yet an emerging hypothesis is that training also induces qualitative regulatory changes. Substrate oxidation, oxygen affinity and biochemical coupling efficiency may be differentially regulated...... with training and exposure to extreme environments. Threshold training doses inducing mitochondrial up-regulation remain to be elucidated considering fitness level. SUMMARY: Muscle mitochondrial are responsive to training and environment, yet thresholds for volume vs. regulatory changes and their physiological...

  4. 18 CFR 367.2420 - Account 242, Miscellaneous current and accrued liabilities.

    Science.gov (United States)

    2010-04-01

    ..., FEDERAL POWER ACT AND NATURAL GAS ACT Balance Sheet Chart of Accounts Current and Accrued Liabilities... Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE PUBLIC...

  5. Food irradiation--US regulatory considerations

    Energy Technology Data Exchange (ETDEWEB)

    Morehouse, Kim M. E-mail: kim.morehouse@cfsan.fda.gov

    2002-03-01

    The use of ionizing radiation in food processing has received increased interest as a means of reducing the level of foodborne pathogens. This overview discusses the regulatory issues connected with the use of this technology in the United States. Several recent changes in the FDA's review process are discussed. These include the current policy that utilizes an expedited review process for petitions seeking approval of additives and technologies intended to reduce pathogen levels in food, and the recent USDA rule that eliminates the need for a separate rulemaking process by USDA for irradiation of meat and poultry. Recently promulgated rules and pending petitions before the FDA associated with the use of ionizing radiation for the treatment of foods are also discussed along with the current FDA labeling requirements for irradiated foods and the 1999 advanced notice of proposed rule on labeling. Another issue that is presented is the current status of the approval of packaging materials intended for food contact during irradiation treatment of foods.

  6. Current Titles

    Energy Technology Data Exchange (ETDEWEB)

    Various

    2006-06-01

    This booklet is published for those interested in current research being conducted at the National Center for Electron Microscopy. The NCEM is a DOE-designated national user facility and is available at no charge to qualified researchers. Access is controlled by an external steering committee. Interested researchers may contact Jane Cavlina, Administrator, at 510/486-6036.

  7. Critical dynamics in genetic regulatory networks: examples from four kingdoms.

    Science.gov (United States)

    Balleza, Enrique; Alvarez-Buylla, Elena R; Chaos, Alvaro; Kauffman, Stuart; Shmulevich, Ilya; Aldana, Maximino

    2008-06-18

    The coordinated expression of the different genes in an organism is essential to sustain functionality under the random external perturbations to which the organism might be subjected. To cope with such external variability, the global dynamics of the genetic network must possess two central properties. (a) It must be robust enough as to guarantee stability under a broad range of external conditions, and (b) it must be flexible enough to recognize and integrate specific external signals that may help the organism to change and adapt to different environments. This compromise between robustness and adaptability has been observed in dynamical systems operating at the brink of a phase transition between order and chaos. Such systems are termed critical. Thus, criticality, a precise, measurable, and well characterized property of dynamical systems, makes it possible for robustness and adaptability to coexist in living organisms. In this work we investigate the dynamical properties of the gene transcription networks reported for S. cerevisiae, E. coli, and B. subtilis, as well as the network of segment polarity genes of D. melanogaster, and the network of flower development of A. thaliana. We use hundreds of microarray experiments to infer the nature of the regulatory interactions among genes, and implement these data into the Boolean models of the genetic networks. Our results show that, to the best of the current experimental data available, the five networks under study indeed operate close to criticality. The generality of this result suggests that criticality at the genetic level might constitute a fundamental evolutionary mechanism that generates the great diversity of dynamically robust living forms that we observe around us.

  8. The politics of surveillance policy: UK regulatory dynamics after Snowden

    Directory of Open Access Journals (Sweden)

    Arne Hintz

    2016-09-01

    Full Text Available The revelations by NSA whistleblower Edward Snowden have illustrated the scale and extent of digital surveillance carried out by different security and intelligence agencies. The publications have led to a variety of concerns, public debate, and some diplomatic fallout regarding the legality of the surveillance, the extent of state interference in civic life, and the protection of civil rights in the context of security. Debates about the policy environment of surveillance emerged quickly after the leaks began, but actual policy change is only starting. In the UK, a draft law (Investigatory Powers Bill has been proposed and is currently discussed. In this paper, we will trace the forces and dynamics that have shaped this particular policy response. Addressing surveillance policy as a site of struggle between different social forces and drawing on different fields across communication policy research, we suggest eight dynamics that, often in conflicting ways, have shaped the regulatory framework of surveillance policy in the UK since the Snowden leaks. These include the governmental context; national and international norms; court rulings; civil society advocacy; technical standards; private sector interventions; media coverage; and public opinion. We investigate how state surveillance has been met with criticism by parts of the technology industry and civil society, and that policy change was required as a result of legal challenges, review commissions and normative interventions. However a combination of specific government compositions, the strong role of security agendas and discourses, media justification and a muted reaction by the public have hindered a more fundamental review of surveillance practices so far and have moved policy debate towards the expansion, rather than the restriction, of surveillance in the aftermath of Snowden.

  9. 77 FR 1524 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2012-01-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and... effective date of the proposed rule change in a Regulatory Notice to be published no later than 60...

  10. 78 FR 54359 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-09-03

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 20, 2103, Financial Industry Regulatory.... \\3\\ 15 U.S.C. 78s(b)(3)(A)(i). \\4\\ 17 CFR 240.19b-4(f)(1). ] I. Self-Regulatory...

  11. 78 FR 10655 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2013-02-14

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...) February 8, 2013. I. Introduction On December 20, 2012, Financial Industry Regulatory Authority, Inc... Equity Securities.\\5\\ FINRA may impose a ``Foreign Regulatory Halt'' when a foreign securities...

  12. 77 FR 33527 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-06-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... hereby given that on May 23, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  13. 77 FR 12092 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-02-28

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...\\ notice is hereby given that February 9, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  14. 75 FR 28841 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-05-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on May 18, 2010, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  15. 76 FR 2739 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-01-14

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... is hereby given that on January 5, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is...

  16. 76 FR 20065 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-04-11

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on March 30, 2011, Financial Industry Regulatory... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  17. 75 FR 49542 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-08-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... 19b-4 thereunder,\\2\\ notice is hereby given that on July 27, 2010, Financial Industry Regulatory... from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

  18. 76 FR 70195 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-11-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...,\\2\\ notice is hereby given that on October 28, 2011, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  19. 78 FR 42581 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-07-16

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... thereunder,\\2\\ notice is hereby given that on June 27, 2013, Financial Industry Regulatory Authority, Inc.... 78s(b)(3)(A)(i). \\4\\ 17 CFR 240.19b-4(f)(1). I. Self-Regulatory Organization's Statement of the...

  20. 77 FR 12098 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-02-28

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... February 9, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of...

  1. 76 FR 72463 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-11-23

    ...-FINRA-2011-044] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... is hereby given that on November 8, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA...\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the...

  2. 76 FR 9840 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-02-22

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... that on February 4, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  3. 78 FR 78451 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-12-26

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on December 9, 2013, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  4. 78 FR 25331 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2013-04-30

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal.... On January 7, 2013, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... Regulatory Policy, Wells Fargo Advisors, LLC, dated Feb. 15, 2013; Letter from Tamara K. Salmon,...

  5. 76 FR 67787 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-11-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on October 13, 2011, Financial Industry Regulatory Authority, Inc.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  6. 78 FR 76341 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-12-17

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that, on December 2, 2013, Financial Industry Regulatory Authority, Inc... considers the subscriber's financial condition and its regulatory history. FINRA believes that the...

  7. 75 FR 2899 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-01-19

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... January 12, 2010. On November 24, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k...- regulatory organizations.\\6\\ \\6\\ See, e.g., Nasdaq Rule 4761 and NYSE-Arca Rule 7.39. It is therefore...

  8. 78 FR 24261 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-04-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 15, 2013, Financial Industry Regulatory...\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of...

  9. 75 FR 7532 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-02-19

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...,\\2\\ notice is hereby given that on February 4, 2010, Financial Industry Regulatory Authority, Inc... in Regulatory Notice 09-71 that the new financial responsibility rules will be implemented...

  10. 77 FR 58880 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-09-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and...,\\2\\ notice is hereby given that on September 17, 2012, Financial Industry Regulatory Authority, Inc...\\ 15 U.S.C. 78s(b)(3)(A). \\4\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement...

  11. 75 FR 58004 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-09-23

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... is hereby given that on September 7, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA... Securities Exchange, LLC, Financial Industry Regulatory Authority, Inc., The New York Stock Exchange,...

  12. 76 FR 78706 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2011-12-19

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a... On October 20, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... advised that it would announce the implementation date of the proposed rule change in a Regulatory...

  13. 75 FR 9459 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-03-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... hereby given that Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  14. 75 FR 39069 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-07-07

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on June 30, 2010, Financial Industry Regulatory.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  15. 77 FR 33537 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2012-06-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... is hereby given that on May 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  16. 78 FR 75954 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-12-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on November 25, 2013, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  17. 75 FR 69503 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-11-12

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...\\ notice is hereby given that on October 29, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  18. 75 FR 15470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-03-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... thereunder,\\2\\ notice is hereby given that, on March 9, 2010, Financial Industry Regulatory Authority, Inc...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is...

  19. 75 FR 53998 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-09-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 16, 2010, Financial Industry Regulatory.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  20. 77 FR 5611 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-02-03

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a..., 2012. I. Introduction On October 13, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA... change in a Regulatory Notice to be published no later than 90 days following Commission approval,...

  1. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-10-26

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving.... Introduction On August 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National... Regulatory Notice to be published no later than 90 days following this Commission approval. The...

  2. 75 FR 62901 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-10-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... thereunder,\\2\\ notice is hereby given that on September 27, 2010, the Financial Industry Regulatory Authority....19b-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the...

  3. 76 FR 50515 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-08-15

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 5, 2011, Financial Industry Regulatory...-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed...

  4. 76 FR 65758 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-24

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on October 5, 2011, Financial Industry Regulatory Authority, Inc.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  5. 75 FR 18245 - Public Federal Regulatory Enforcement Fairness Hearing Region IX Regulatory Fairness Board

    Science.gov (United States)

    2010-04-09

    ... ADMINISTRATION Public Federal Regulatory Enforcement Fairness Hearing Region IX Regulatory Fairness Board.... Small Business Administration (SBA) Region IX Regulatory Fairness Board and the SBA Office of the National Ombudsman will hold a National Regulatory Fairness Hearing on Monday, April 26, 2010, at 1:30 p.m...

  6. 78 FR 30384 - Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board

    Science.gov (United States)

    2013-05-22

    ... ADMINISTRATION Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board AGENCY: U.S... Business Regulatory Fairness Board. SUMMARY: The (SBA) Office of the National Ombudsman is issuing this notice to announce the location, date and time of the Regional Small Business Regulatory Fairness hearing...

  7. 75 FR 17793 - Public Federal Regulatory Enforcement Fairness Hearing; Region III Regulatory Fairness Board

    Science.gov (United States)

    2010-04-07

    ... ADMINISTRATION Public Federal Regulatory Enforcement Fairness Hearing; Region III Regulatory Fairness Board.... Small Business Administration (SBA) Region III Regulatory Fairness Board and the SBA Office of the National Ombudsman will hold a National Regulatory Fairness Hearing on Tuesday, May 18, 2010, at 10 a.m...

  8. 78 FR 36011 - Region VII Regulatory Fairness Board; Federal Regulatory Enforcement Fairness Hearing

    Science.gov (United States)

    2013-06-14

    ... ADMINISTRATION Region VII Regulatory Fairness Board; Federal Regulatory Enforcement Fairness Hearing AGENCY: U.S... Business Regulatory Fairness Board. SUMMARY: The (SBA) Office of the National Ombudsman is issuing this notice to announce the location, date and time of the Regional Small Business Regulatory Fairness hearing...

  9. Followers feel valued : When leaders' regulatory focus makes leaders exhibit behavior that fits followers' regulatory focus

    NARCIS (Netherlands)

    Hamstra, Melvyn; Sassenberg, K.; Van Yperen, Nico W.; Wisse, Barbara

    2014-01-01

    When do followers feel valued by their leader? We propose that leaders' regulatory focus can make followers feel valued when leaders' regulatory focus is the same as followers' regulatory focus, that is, when there is regulatory fit between leaders and followers. We further propose that the reason w

  10. 75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

    Science.gov (United States)

    2010-03-10

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the...

  11. Shaping adult phenotypes through early life environments.

    Science.gov (United States)

    Weaver, Ian C G

    2009-12-01

    A major question in the biology of stress and environmental adaptation concerns the neurobiological basis of how neuroendocrine systems governing physiological regulatory mechanisms essential for life (metabolism, immune response, organ function) become harmful. The current view is that a switch from protection to damage occurs when vulnerable phenotypes are exposed to adverse environmental conditions. In accordance with this theory, sequelae of early life social and environmental stressors, such as childhood abuse, neglect, poverty, and poor nutrition, have been associated with the emergence of mental and physical illness (i.e., anxiety, mood disorders, poor impulse control, psychosis, and drug abuse) and an increased risk of common metabolic and cardiovascular diseases later in life. Evidence from animal and human studies investigating the associations between early life experiences (including parent-infant bonding), hypothalamus-pituitary-adrenal axis activity, brain development, and health outcome provide important clues into the neurobiological mechanisms that mediate the contribution of stressful experiences to personality development and the manifestation of illness. This review summarizes our current molecular understanding of how early environment influences brain development in a manner that persists through life and highlights recent evidence from rodent studies suggesting that maternal care in the first week of postnatal life establishes diverse and stable phenotypes in the offspring through epigenetic modification of genes expressed in the brain that shape neuroendocrine and behavioral stress responsivity throughout life.

  12. Regulatory criteria: Legal or ecological thresholds?

    Energy Technology Data Exchange (ETDEWEB)

    Cook, J.M.; Skorupa, J.P.; Schwarzbach, S.E. [Fish and Wildlife Service, Sacramento, CA (United States)

    1994-12-31

    Selenium-laden irrigation drainwater has been identified as a significant threat to breeding waterfowl and shorebirds in terminal sink environments throughout the western United States. Due to historic wetland habitat losses, irrigation drainwater disposal ponds represent virtually all the available breeding habitat for waterbirds in the southern San Joaquin Valley of California. Egg selenium residues from birds breeding at these ponds have been monitored by the US Fish and Wildlife Service since 1987, and physiological risk thresholds for individual and population-level hatchability and teratogenesis have been determined from these studies. For Blacknecked stilt populations, egg selenium below 3 ppm may be considered a safe level, hatchability is significantly depressed at mean egg selenium concentrations above 8 ppm, and induction of teratogenesis is virtually certain at egg selenium levels above 18 ppm (p < 0.05). Egg samples collected in 1993 from these ponds showed concentrations as high as 160 ppm. Despite the high degree of statistical confidence in these effects thresholds, and the incidence of selenium-induced bird death and deformity at these ponds, regulation of evaporation ponds has been problematic. Existing civil statutes regarding water quality are dependent on risk-based criteria, but irrigation drainwater is exempted from these regulations. The only applicable law is the Migratory Bird Treaty Act, a criminal statute with no risk-based guidelines, and consequently no wildlife safety factors. The authors present data from the San Joaquin Valley in the context of these regulatory and legal limitations. Evaluation of acute and chronic models for ambient water quality indicate that this approach may not provide adequate protection for breeding birds. Based on the inadequacy of these models, the authors consider the development of regulatory criteria for egg selenium, a standard which is ecologically relevant.

  13. Regulatory issues related to functional foods and natural health products in Canada: possible implications for manufacturers of conjugated linoleic acid.

    Science.gov (United States)

    Fitzpatrick, Kelley C

    2004-06-01

    The Canadian Food and Drugs Act and Regulations, through its definitions of food and drug, currently restricts health-related claims for foods, food ingredients, and natural health products (NHPs). Over the past few decades, scientific research has led to a large body of information that demonstrates the benefits for health of many food and NHP ingredients. Health Canada recognized the constraints of the current regulatory environment and started to develop regulations related to the allowance of health claims for functional foods and NHPs, including those foods and NHPs that would contain conjugated linoleic acid isomers. Health Canada has 3 initiatives under way in the area of health claims for foods: 1) to adopt the generic health claims of the United States within a Canadian context, 2) to develop scientific standards of evidence and a guidance document for supporting the validity of product-specific claims, and 3) to develop an overall regulatory framework for functional foods. In 2000, Health Canada announced approval for the use of 5 generic diet-related health claims: sodium and hypertension, calcium and osteoporosis, saturated and trans fat and cholesterol and coronary artery disease, fruits and vegetables and cancer, and sugar alcohols and dental caries. Under a separate initiative, Natural Health Products Regulations were published in the Canada Gazette Part II on June 18, 2003. The NHP Regulations came into force on January 1, 2004, with a transition period ranging from 2 y (for site licensing) to 6 y (for product licensing, for products already issued a drug identification number).

  14. Observing environments

    DEFF Research Database (Denmark)

    Alrøe, Hugo Fjelsted; Noe, Egon

    2012-01-01

    , and analyse how their conceptions of environment are connected to differences of perspective and observation. Results: We show the need to distinguish between inside and outside perspectives on the environment, and identify two very different and complementary logics of observation, the logic of distinction......, and that it is based fully on the conception of observation as indication by means of distinction....

  15. Encapsulated Environment

    NARCIS (Netherlands)

    McLellan, T.M.; Daanen, H.A.M.; Cheung, S.S.

    2013-01-01

    In many occupational settings, clothing must be worn to protect individuals from hazards in their work environment. However, personal protective clothing (PPC) restricts heat exchange with the environment due to high thermal resistance and low water vapor permeability. As a consequence, individuals

  16. Regulatory interaction in electricity retail theory and evidence from the United States and the European Union

    OpenAIRE

    2010-01-01

    In this research I have used a sample that was to cover market - regulatory environment - firm performance permutations capturing the changes in competitive dynamics and the co-evolutionary paths the firms and their respective business environment have taken when the markets were opened for competition. The research process builds on Event Structure Analysis (ESA) as a means to create causal patterns in the interaction between the firm and the environment. Data was collected from primary and ...

  17. 75 FR 28073 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-05-19

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-3039, ``Standard Format and Content...

  18. 75 FR 48382 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-08-10

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1228, ``Standard Format and Content...

  19. Current State of Digital Reference in Primary and Secondary Education; The Technological Challenges of digital Reference; Question Negotiation and the Technological Environment; Evaluation of Chat Reference Service Quality; Visual Resource Reference: Collaboration between Digital Museums and Digital Libraries.

    Science.gov (United States)

    Lankes, R. David; Penka, Jeffrey T.; Janes, Joseph; Silverstein, Joanne; White, Marilyn Domas; Abels, Eileen G.; Kaske, Neal; Goodrum, Abby A.

    2003-01-01

    Includes five articles that discuss digital reference in elementary and secondary education; the need to understand the technological environment of digital reference; question negotiation in digital reference; a pilot study that evaluated chat reference service quality; and collaborative digital museum and digital library reference services. (LRW)

  20. Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, January 1--June 30, 1988

    Energy Technology Data Exchange (ETDEWEB)

    Baum, J W; Boccio, J L; Diamond, D; Fitzpatrick, R; Ginsberg, T; Greene, G A; Guppy, J G; Hall, R E; Higgins, J C; Weiss, A J [comp.

    1988-12-01

    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 December 31, 1987.

  1. Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, October 1--December 31, 1988

    Energy Technology Data Exchange (ETDEWEB)

    Weiss, A J; Azarm, A; Baum, J W; Boccio, J L; Carew, J; Diamond, D J; Fitzpatrick, R; Ginsberg, T; Greene, G A; Guppy, J G; Haber, S B

    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. Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, July 1--September 30, 1988

    Energy Technology Data Exchange (ETDEWEB)

    Weiss, A J [comp.

    1989-02-01

    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 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 June 30, 1988. 71 figs., 24 tabs.

  3. Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, January 1--March 31, 1989

    Energy Technology Data Exchange (ETDEWEB)

    Weiss, A.J. (comp.)

    1989-08-01

    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 December 31, 1988.

  4. Safety research programs sponsored by Office of Nuclear Regulatory Research: Progress report, October 1--December 31, 1988

    Energy Technology Data Exchange (ETDEWEB)

    Weiss, A J; Azarm, A; Baum, J W; Boccio, J L; Carew, J; Diamond, D J; Fitzpatrick, R; Ginsberg, T; Greene, G A; Guppy, J G; Haber, S B

    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.

  5. The core regulatory network in human cells.

    Science.gov (United States)

    Kim, Man-Sun; Kim, Dongsan; Kang, Nam Sook; Kim, Jeong-Rae

    2017-03-04

    In order to discover the common characteristics of various cell types in the human body, many researches have been conducted to find the set of genes commonly expressed in various cell types and tissues. However, the functional characteristics of a cell is determined by the complex regulatory relationships among the genes rather than by expressed genes themselves. Therefore, it is more important to identify and analyze a core regulatory network where all regulatory relationship between genes are active across all cell types to uncover the common features of various cell types. Here, based on hundreds of tissue-specific gene regulatory networks constructed by recent genome-wide experimental data, we constructed the core regulatory network. Interestingly, we found that the core regulatory network is organized by simple cascade and has few complex regulations such as feedback or feed-forward loops. Moreover, we discovered that the regulatory links from genes in the core regulatory network to genes in the peripheral regulatory network are much more abundant than the reverse direction links. These results suggest that the core regulatory network locates at the top of regulatory network and plays a role as a 'hub' in terms of information flow, and the information that is common to all cells can be modified to achieve the tissue-specific characteristics through various types of feedback and feed-forward loops in the peripheral regulatory networks. We also found that the genes in the core regulatory network are evolutionary conserved, essential and non-disease, non-druggable genes compared to the peripheral genes. Overall, our study provides an insight into how all human cells share a common function and generate tissue-specific functional traits by transmitting and processing information through regulatory network.

  6. Management of Excess Reactive Nitrogen in the Environment

    Science.gov (United States)

    Galloway, J. N.; Theis, T.; Doering, O.

    2011-12-01

    problem. Such silos have to be broken down if the excess Nr problem is to be dealt with holistically. (3) Essential Monitoring and Research. The Committee recommends improved monitoring and research to enhance our understanding of Nr in the environment. In some cases our knowledge has such wide margins of error that we cannot identify or quantify important concentrations or flows sufficiently for necessary decisions. In other cases there is incomplete knowledge about the indirect impacts of Nr, while in still others there is a need for much better understanding of the efficacy of actions that might be taken to control Nr. (4) Setting Goals for Action. In spite of knowledge gaps identified by the Committee, there is sufficient understanding of the Nr problem to enable the responsible regulatory agencies to begin to decrease excess Nr entering the environment. The Committee suggests actions that might be taken by EPA or other management authorities using current technologies and regulatory authority to decrease Nr in the environment by 25% over the near (10-20 year) term, without negatively impacting dietary needs or economic trends.

  7. Should the scope of human mixture risk assessment span legislative/regulatory silos for chemicals?

    Science.gov (United States)

    Evans, Richard M; Martin, Olwenn V; Faust, Michael; Kortenkamp, Andreas

    2016-02-01

    Current chemicals regulation operates almost exclusively on a chemical-by-chemical basis, however there is concern that this approach may not be sufficiently protective if two or more chemicals have the same toxic effect. Humans are indisputably exposed to more than one chemical at a time, for example to the multiple chemicals found in food, air and drinking water, and in household and consumer products, and in cosmetics. Assessment of cumulative risk to human health and/or the environment from multiple chemicals and routes can be done in a mixture risk assessment (MRA). Whilst there is a broad consensus on the basic science of mixture toxicology, the path to regulatory implementation of MRA within chemical risk assessment is less clear. In this discussion piece we pose an open question: should the scope of human MRA cross legislative remits or 'silos'? We define silos as, for instance, legislation that defines risk assessment practice for a subset of chemicals, usually on the basis of substance/product, media or process orientation. Currently any form of legal mandate for human MRA in the EU is limited to only a few pieces of legislation. We describe two lines of evidence, illustrated with selected examples, that are particularly pertinent to this question: 1) evidence that mixture effects have been shown for chemicals regulated in different silos and 2) evidence that humans are co-exposed to chemicals from different silos. We substantiate the position that, because there is no reason why chemicals allocated to specific regulatory silos would have non-overlapping risk profiles, then there is also no reason to expect that MRA limited only to chemicals within one silo can fully capture the risk that may be present to human consumers. Finally, we discuss possible options for implementation of MRA and we hope to prompt wider discussion of this issue.

  8. The role of research in NRC regulatory programs

    Energy Technology Data Exchange (ETDEWEB)

    Jackson, S.A.

    1996-03-01

    This article is the text of the opening remarks by NRC Chairwoman Shirley Jackson to the Reactor Safety Meeting. In her remarks, Dr. Jackson discusses the role of research in NRC regulatory programs and points out by way of example that many of the research programs provide considerable benefit to the industry as well as to the Commission. She then outlines current activities as well as future plans.

  9. Codes and standards and other guidance cited in regulatory documents. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R. [Pacific Northwest Lab., Richland, WA (United States)

    1994-08-01

    As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. 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, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800).

  10. Current titles

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-07-01

    This booklet is published for those interested in current research being conducted at the National Center for Electron Microscopy. The NCEM is a DOE-designated national user facility and is available at no charge to qualified researchers. Access is controlled by an external steering committee. Interested researchers may contact Gretchen Hermes at (510) 486-5006 or address below for a User`s Guide. Copies of available papers can be ordered from: Theda Crawford National Center for Electron Microscopy, Lawrence Berkeley Laboratory, One Cyclotron Rd., MS72, Berkeley, California, USA 94720.

  11. Dynamic simulation of regulatory networks using SQUAD

    Directory of Open Access Journals (Sweden)

    Xenarios Ioannis

    2007-11-01

    Full Text Available Abstract Background The ambition of most molecular biologists is the understanding of the intricate network of molecular interactions that control biological systems. As scientists uncover the components and the connectivity of these networks, it becomes possible to study their dynamical behavior as a whole and discover what is the specific role of each of their components. Since the behavior of a network is by no means intuitive, it becomes necessary to use computational models to understand its behavior and to be able to make predictions about it. Unfortunately, most current computational models describe small networks due to the scarcity of kinetic data available. To overcome this problem, we previously published a methodology to convert a signaling network into a dynamical system, even in the total absence of kinetic information. In this paper we present a software implementation of such methodology. Results We developed SQUAD, a software for the dynamic simulation of signaling networks using the standardized qualitative dynamical systems approach. SQUAD converts the network into a discrete dynamical system, and it uses a binary decision diagram algorithm to identify all the steady states of the system. Then, the software creates a continuous dynamical system and localizes its steady states which are located near the steady states of the discrete system. The software permits to make simulations on the continuous system, allowing for the modification of several parameters. Importantly, SQUAD includes a framework for perturbing networks in a manner similar to what is performed in experimental laboratory protocols, for example by activating receptors or knocking out molecular components. Using this software we have been able to successfully reproduce the behavior of the regulatory network implicated in T-helper cell differentiation. Conclusion The simulation of regulatory networks aims at predicting the behavior of a whole system when subject

  12. Defining Tobacco Regulatory Science Competencies.

    Science.gov (United States)

    Wipfli, Heather L; Berman, Micah; Hanson, Kacey; Kelder, Steven; Solis, Amy; Villanti, Andrea C; Ribeiro, Carla M P; Meissner, Helen I; Anderson, Roger

    2017-02-01

    In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational programs. The purpose of this paper is to describe the Panel's work to develop core TRS domains and competencies. The Panel developed the list of domains and competencies using a semistructured Delphi method divided into four phases occurring between November 2013 and August 2015. The final proposed list included a total of 51 competencies across six core domains and 28 competencies across five specialized domains. There is a need for continued discussion to establish the utility of the proposed set of competencies for emerging TRS curricula and to identify the best strategies for incorporating these competencies into TRS training programs. Given the field's broad multidisciplinary nature, further experience is needed to refine the core domains that should be covered in TRS training programs versus knowledge obtained in more specialized programs. Regulatory science to inform the regulation of tobacco products is an emerging field. The paper provides an initial list of core and specialized domains and competencies to be used in developing curricula for new and emerging training programs aimed at preparing a new cohort of scientists to conduct critical TRS research. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  13. Getting it right the first time: developing nanotechnology while protecting workers, public health, and the environment.

    Science.gov (United States)

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

    2006-09-01

    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. Innovative nanotechnology products 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, two distinct kinds of initiatives are urgently needed: first, a major increase in the federal investment nanomaterial risk research, and second, rapid development and implementation of voluntary standards of care pending development of adequate regulatory safeguards. The U.S. government should increase federal funding for nanomaterial risk research under the National Nanotechnology Initiative to at least $100 million annually for the next several years. 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, harmonized globally, are necessary to provide a level playing field for industry while adequately protecting human health and the environment.

  14. Current ornithology

    CERN Document Server

    1983-01-01

    The appearance of the first volume of a projected series is the occasion for comment on scope, aims, and genesis of the work. The scope of Current Ornithology is all of the biology of birds. Ornithology, as a whole-organism science, is concerned with birds at every level of bi­ ological organization, from the molecular to the community, at least from the Jurassic to the present time, and over every scholarly discipline in which bird biology is done; to say this is merely to expand a dic­ tionary definition of "ornithology. " The aim of the work, to be realized over several volumes, is to present reviews or position statements con­ cerning the active fields of ornithological research. The reviews will be relatively short, and often will be done from the viewpoint of a readily­ identified group or school. Such a work could have come into being at any time within the past fifty years, but that Current Ornithology appears now is a result of events that are only seven to eight years old. One important event wa...

  15. Innovative farmers and regulatory gatekeepers: Genetically modified crops regulation and adoption in developing countries.

    Science.gov (United States)

    Sinebo, Woldeyesus; Maredia, Karim

    2016-01-02

    The regulation of genetically modified (GM) crops is a topical issue in agriculture and environment over the past 2 decades. The objective of this paper is to recount regulatory and adoption practices in some developing countries that have successfully adopted GM crops so that aspiring countries may draw useful lessons and best practices for their biosafatey regulatory regimes. The first 11 mega-GM crops growing countries each with an area of more than one million hectares in 2014 were examined. Only five out of the 11 countries had smooth and orderly adoption of these crops as per the regulatory requirement of each country. In the remaining 6 countries (all developing countries), GM crops were either introduced across borders without official authorization, released prior to regulatory approval or unapproved seeds were sold along with the approved ones in violation to the existing regulations. Rapid expansion of transgenic crops over the past 2 decades in the developing world was a result of an intense desire by farmers to adopt these crops irrespective of regulatory roadblocks. Lack of workable biosafety regulatory system and political will to support GM crops encouraged unauthorized access to GM crop varieties. In certain cases, unregulated access in turn appeared to result in the adoption of substandard or spurious technology which undermined performance and productivity. An optimal interaction among the national agricultural innovation systems, biosafety regulatory bodies, biotech companies and high level policy makers is vital in making a workable regulated progress in the adoption of GM crops. Factoring forgone opportunities to farmers to benefit from GM crops arising from overregulation into biosafety risk analysis and decision making is suggested. Building functional biosafety regulatory systems that balances the needs of farmers to access and utilize the GM technology with the regulatory imperatives to ensure adequate safety to the environment and human

  16. Creative responses needed in controlled environment.

    Science.gov (United States)

    Rogatz, P

    1978-08-01

    Faced with an increasingly regulatory environment, hospitals must find innovative ways by which, first, to survive and, then, to respond constructively to externally applied constraints. Decertification of beds and a move to ambulatory care programs are only two of many possible responses. The key to success will be the measure of cooperation between health care providers, insurers, and government.

  17. Computational Genetic Regulatory Networks Evolvable, Self-organizing Systems

    CERN Document Server

    Knabe, Johannes F

    2013-01-01

    Genetic Regulatory Networks (GRNs) in biological organisms are primary engines for cells to enact their engagements with environments, via incessant, continually active coupling. In differentiated multicellular organisms, tremendous complexity has arisen in the course of evolution of life on earth. Engineering and science have so far achieved no working system that can compare with this complexity, depth and scope of organization. Abstracting the dynamics of genetic regulatory control to a computational framework in which artificial GRNs in artificial simulated cells differentiate while connected in a changing topology, it is possible to apply Darwinian evolution in silico to study the capacity of such developmental/differentiated GRNs to evolve. In this volume an evolutionary GRN paradigm is investigated for its evolvability and robustness in models of biological clocks, in simple differentiated multicellularity, and in evolving artificial developing 'organisms' which grow and express an ontogeny starting fr...

  18. Evaluation of Current Computer Models Applied in the DOE Complex for SAR Analysis of Radiological Dispersion & Consequences

    Energy Technology Data Exchange (ETDEWEB)

    O' Kula, K. R. [Savannah River Site (SRS), Aiken, SC (United States); East, J. M. [Savannah River Site (SRS), Aiken, SC (United States); Weber, A. H. [Savannah River Site (SRS), Aiken, SC (United States); Savino, A. V. [Savannah River Site (SRS), Aiken, SC (United States); Mazzola, C. A. [Savannah River Site (SRS), Aiken, SC (United States)

    2003-01-01

    The evaluation of atmospheric dispersion/ radiological dose analysis codes included fifteen models identified in authorization basis safety analysis at DOE facilities, or from regulatory and research agencies where past or current work warranted inclusion of a computer model. All computer codes examined were reviewed using general and specific evaluation criteria developed by the Working Group. The criteria were based on DOE Orders and other regulatory standards and guidance for performing bounding and conservative dose calculations. Included were three categories of criteria: (1) Software Quality/User Interface; (2) Technical Model Adequacy; and (3) Application/Source Term Environment. A consensus-based limited quantitative ranking process was used to base an order of model preference as both an overall conclusion, and under specific conditions.

  19. Selective constraints in experimentally defined primate regulatory regions.

    Directory of Open Access Journals (Sweden)

    Daniel J Gaffney

    2008-08-01

    Full Text Available Changes in gene regulation may be important in evolution. However, the evolutionary properties of regulatory mutations are currently poorly understood. This is partly the result of an incomplete annotation of functional regulatory DNA in many species. For example, transcription factor binding sites (TFBSs, a major component of eukaryotic regulatory architecture, are typically short, degenerate, and therefore difficult to differentiate from randomly occurring, nonfunctional sequences. Furthermore, although sites such as TFBSs can be computationally predicted using evolutionary conservation as a criterion, estimates of the true level of selective constraint (defined as the fraction of strongly deleterious mutations occurring at a locus in regulatory regions will, by definition, be upwardly biased in datasets that are a priori evolutionarily conserved. Here we investigate the fitness effects of regulatory mutations using two complementary datasets of human TFBSs that are likely to be relatively free of ascertainment bias with respect to evolutionary conservation but, importantly, are supported by experimental data. The first is a collection of almost >2,100 human TFBSs drawn from the literature in the TRANSFAC database, and the second is derived from several recent high-throughput chromatin immunoprecipitation coupled with genomic microarray (ChIP-chip analyses. We also define a set of putative cis-regulatory modules (pCRMs by spatially clustering multiple TFBSs that regulate the same gene. We find that a relatively high proportion ( approximately 37% of mutations at TFBSs are strongly deleterious, similar to that at a 2-fold degenerate protein-coding site. However, constraint is significantly reduced in human and chimpanzee pCRMS and ChIP-chip sequences, relative to macaques. We estimate that the fraction of regulatory mutations that have been driven to fixation by positive selection in humans is not significantly different from zero. We also find

  20. Regulatory focus and work-related outcomes: a review and meta-analysis.

    Science.gov (United States)

    Lanaj, Klodiana; Chang, Chu-Hsiang Daisy; Johnson, Russell E

    2012-09-01

    Regulatory focus theory (Higgins, 1997) has received growing attention in organizational psychology, necessitating a quantitative review that synthesizes its effects on important criteria. In addition, there is need for theoretical integration of regulatory focus theory with personality research. Theoretical integration is particularly relevant, since personality traits and dispositions are distal factors that are unlikely to have direct effects on work behaviors, yet they may have indirect effects via regulatory focus. The current meta-analysis introduces an integrative framework in which the effects of personality on work behaviors are best understood when considered in conjunction with more proximal motivational processes such as regulatory focus. Using a distal-proximal approach, we identify personality antecedents and work-related consequences of regulatory foci in a framework that considers both general and work-specific regulatory foci as proximal motivational processes. We present meta-analytic results for relations of regulatory focus with its antecedents (approach and avoid temperaments, conscientiousness, openness to experience, agreeableness, self-esteem, and self-efficacy) and its consequences (work behaviors and attitudes). In addition to estimates of bivariate relationships, we support a meta-analytic path model in which distal personality traits relate to work behaviors via the mediating effects of general and work-specific regulatory focus. Results from tests of incremental and relative validity indicated that regulatory foci predict unique variance in work behaviors after controlling for established personality, motivation, and attitudinal predictors. Consistent with regulatory focus theory and our integrative theoretical framework, regulatory focus has meaningful relations with work outcomes and is not redundant with other individual difference variables.

  1. The governance of hydro power in Norway and Sweden: How to manage the European current?

    Energy Technology Data Exchange (ETDEWEB)

    Ruud, Audun; Jacobsen, Gerd; Knudsen, Joergen; Nilsson, Maans; Rudberg, Peter

    2010-07-01

    Objectives of the paper: The proposed paper will be based on studies of renewable electricity production within two different national contexts. Experiences clearly demonstrate that variations in political settings provide energy companies with disparate opportunities, constraints and motivations (Lafferty et Ruud, 2008). This is also the case with two countries as similar as Norway and Sweden. Both countries are, however, committed by EU-based legislation, not least former and current Directives on renewable electricity and energy as well as the Water Framework Management Directive. By comparing current governance of hydropower and how environmental concerns are taken into account, the paper aims at discussing differences in regulatory practice, and thereby assess to what extent EU legislation modify and/or reinforce the existing regulatory framework in Norway and Sweden. Organisation and methodology: The paper is related to the ongoing research project Governance for Renewable Electricity Production (GOVREP), which is part of the Centre for Environmental Design of Renewable Energy (CEDREN) one of the eight newly established Centres for Environment-friendly Energy research. GOVREP aims at contributing to a better integration of environmental- and energy policy concerns in renewable electricity production. The authors of the proposed paper are working within the project. The proposed paper will present a comparative case study of specific hydro power projects. The research method is based on document analysis as well as interviews with relevant stakeholders. The primary data to be presented in the paper will thus represent original findings. The research will employ analytical approaches related to policy analysis and europeanization of national policies. Outline of results: The paper will assess the importance of national differences in regulatory practice vis-a-vis specific hydropower projects. Furthermore, the paper will provide an assessment as to what extent

  2. Expanding antigen-specific regulatory networks to treat autoimmunity.

    Science.gov (United States)

    Clemente-Casares, Xavier; Blanco, Jesus; Ambalavanan, Poornima; Yamanouchi, Jun; Singha, Santiswarup; Fandos, Cesar; Tsai, Sue; Wang, Jinguo; Garabatos, Nahir; Izquierdo, Cristina; Agrawal, Smriti; Keough, Michael B; Yong, V Wee; James, Eddie; Moore, Anna; Yang, Yang; Stratmann, Thomas; Serra, Pau; Santamaria, Pere

    2016-02-25

    Regulatory T cells hold promise as targets for therapeutic intervention in autoimmunity, but approaches capable of expanding antigen-specific regulatory T cells in vivo are currently not available. Here we show that systemic delivery of nanoparticles coated with autoimmune-disease-relevant peptides bound to major histocompatibility complex class II (pMHCII) molecules triggers the generation and expansion of antigen-specific regulatory CD4(+) T cell type 1 (TR1)-like cells in different mouse models, including mice humanized with lymphocytes from patients, leading to resolution of established autoimmune phenomena. Ten pMHCII-based nanomedicines show similar biological effects, regardless of genetic background, prevalence of the cognate T-cell population or MHC restriction. These nanomedicines promote the differentiation of disease-primed autoreactive T cells into TR1-like cells, which in turn suppress autoantigen-loaded antigen-presenting cells and drive the differentiation of cognate B cells into disease-suppressing regulatory B cells, without compromising systemic immunity. pMHCII-based nanomedicines thus represent a new class of drugs, potentially useful for treating a broad spectrum of autoimmune conditions in a disease-specific manner.

  3. Lineage stability and phenotypic plasticity of Foxp3⁺ regulatory T cells.

    Science.gov (United States)

    Hori, Shohei

    2014-05-01

    Regulatory T (Treg) cells expressing the transcription factor forkhead box protein 3 (Foxp3) constitute a unique T-cell lineage committed to suppressive functions. While their differentiation state is remarkably stable in the face of various perturbations from the extracellular environment, they are able to adapt to diverse and fluctuating tissue environments by changing their phenotype. The lineage stability and phenotypic plasticity of Treg cells thus ensure the robustness of self-tolerance and tissue homeostasis. Recent studies have suggested, however, that Treg cells may retain lineage plasticity, the ability to switch their cell fate to various effector T-cell types under certain circumstances such as inflammation, a notion that remains highly contentious. While accumulating evidence indicates that some Treg cells can downregulate Foxp3 expression and/or acquire effector T-helper cell-like phenotypes, results from my laboratory have shown that Treg cells retain epigenetic memory of, and thus remain committed to, Foxp3 expression and suppressive functions despite such phenotypic plasticity. It has also become evident that Foxp3 can be promiscuously and transiently expressed in activated T cells. Here, I argue that the current controversy stems partly from the lack of the lineage specificity of Foxp3 expression and also from the confusion between phenotypic plasticity and lineage plasticity, and discuss implications of our findings in Treg cell fate determination and maintenance.

  4. Design of a 10-bit segmented current-steering digital-to-analog converter in CMOS 65 nm technology for the bias of new generation readout chips in high radiation environment

    Science.gov (United States)

    De Robertis, G.; Loddo, F.; Mattiazzo, S.; Pacher, L.; Pantano, D.; Tamma, C.

    2016-01-01

    A new pixel front end chip for HL-LHC experiments in CMOS 65nm technology is under development by the CERN RD53 collaboration together with the Chipix65 INFN project. This work describes the design of a 10-bit segmented current-steering Digital-to-Analog Converter (DAC) to provide a programmable bias current to the analog blocks of the circuit. The main requirements are monotonicity, good linearity, limited area consumption and radiation hardness up to 10 MGy. The DAC was prototyped and electrically tested, while irradiation tests will be performed in Autumn 2015.

  5. Regulatory Issues Surrounding Merchant Interconnection

    Energy Technology Data Exchange (ETDEWEB)

    Kuijlaars, Kees-Jan; Zwart, Gijsbert [Office for Energy Regulation (DTe), The Hague (Netherlands)

    2003-11-01

    We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections.

  6. Endocrine cells producing regulatory peptides.

    Science.gov (United States)

    Solcia, E; Usellini, L; Buffa, R; Rindi, G; Villani, L; Zampatti, C; Silini, E

    1987-07-15

    Recent data on the immunolocalization of regulatory peptides and related propeptide sequences in endocrine cells and tumors of the gastrointestinal tract, pancreas, lung, thyroid, pituitary (ACTH and opioids), adrenals and paraganglia have been revised and discussed. Gastrin, xenopsin, cholecystokinin (CCK), somatostatin, motilin, secretin, GIP (gastric inhibitory polypeptide), neurotensin, glicentin/glucagon-37 and PYY (peptide tyrosine tyrosine) are the main products of gastrointestinal endocrine cells; glucagon, CRF (corticotropin releasing factor), somatostatin, PP (pancreatic polypeptide) and GRF (growth hormone releasing factor), in addition to insulin, are produced in pancreatic islet cells; bombesin-related peptides are the main markers of pulmonary endocrine cells; calcitonin and CGRP (calcitonin gene-related peptide) occur in thyroid and extrathyroid C cells; ACTH and endorphins in anterior and intermediate lobe pituitary cells, alpha-MSH and CLIP (corticotropin-like intermediate lobe peptide) in intermediate lobe cells; met- and leu-enkephalins and related peptides in adrenal medullary and paraganglionic cells as well as in some gut (enterochromaffin) cells; NPY (neuropeptide Y) in adrenaline-type adrenal medullary cells, etc.. Both tissue-appropriate and tissue-inappropriate regulatory peptides are produced by endocrine tumours, with inappropriate peptides mostly produced by malignant tumours.

  7. Reforming Financial Regulatory System in China after the Stock Market Turbulence:Problems and the Responses

    Institute of Scientific and Technical Information of China (English)

    Chen Zhenyun

    2016-01-01

    In an age when modern financial companies have become more and more complex,and if not adequately supervised,they can cause lethal harm to the stability of one’ s financial system. In post-financial crisis era,major developed economies have apparently rein-forced the function of the central bank in a country’ s financial regulatory system. Over the past several years,China has witnessed the huge changes in the financial sector but the financial regulatory framework remains the same as before. The Chinese stock market crash that began on June 12 2015 has urged the domestic regulators to restructure its financial regulatory sys-tem. The issue that which modal China should follow has perplexed Chinese policymakers. The governor of People’ s Bank of China,Zhou Xiaochuan,clearly responded to the problem concerning the current financial regulatory system, and indicated that Chinese regulators and policymakers had still studied the regulatory approach China would adopt during the press of People’s Congress of 2016. This paper reviews the development of China’s banking regulato-ry system,points out the deficiencies in its original system and analyzes the recent trends of fi-nancial regulatory reform in UK to learn the international experience for further reform re-garding financial regulatory system in China.

  8. Low-income, minority fathers' control strategies and their children's regulatory skills.

    Science.gov (United States)

    Malin, Jenessa L; Cabrera, Natasha J; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith L

    2014-01-01

    The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24 months, and children's regulatory skills at prekindergarten (pre-K). Using a sample of low-income, minority families with 2-year-olds from the Early Head Start Research and Evaluation Project (n = 71), we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24 months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at prekindergarten. There were three main findings. First, fathers overwhelmingly used commands (e.g., "Do that.") to promote compliance in their 24-month-old children. Second, children's vocabulary skills predicted fathers' regulatory behaviors during a father-child interaction whereas children's gender predicted fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24 months predicted children's sustained attention at pre-K whereas fathers' regulatory language at 24 months predicted children's emotion regulation at pre-K. Our findings highlight the importance of examining paternal contributions to children's regulatory skills.

  9. 76 FR 65255 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing of Proposed Rule Change...

    Science.gov (United States)

    2011-10-20

    ... herein, the current corporate structure, governance and self-regulatory independence and separation of... Relating to a Corporate Transaction in Which Its Indirect Parent, Deutsche B rse AG, Will Become a Wholly... 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed...

  10. 76 FR 65264 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing of Proposed Rule Change...

    Science.gov (United States)

    2011-10-20

    ... modifications described herein, the current corporate structure, governance and self-regulatory independence and... Relating to a Corporate Transaction in Which Its Indirect Parent, Deutsche B rse AG, Will Become a Wholly... 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed...

  11. Adolescent threat-related interpretive bias and its modification: the moderating role of regulatory control.

    Science.gov (United States)

    Salemink, Elske; Wiers, Reinout W

    2012-01-01

    Dual process models describe psychopathology as the consequence of an imbalance between a fast, impulsive system and a regulatory control system and have recently been applied to anxiety disorders. The aim of the current study was to specifically examine the role of a regulatory control system in regulating 1) threat-related interpretive bias and 2) the effectiveness of interpretive bias training in adolescents. In total, 67 adolescents participated and followed either a positive Cognitive Bias Modification of Interpretation (CBM-I) training or a placebo-control condition. Results revealed that interpretive bias and the effectiveness of its modification depended on individual differences in regulatory control. That is, low levels of regulatory control in combination with high levels of state anxiety were associated with the strongest threat-related interpretive bias and those individuals benefited the most of the positive interpretation training. The current study provided empirical support for the role of dual processes in adolescent threat-related interpretive bias.

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

    Science.gov (United States)

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

    2015-09-01

    The Association of Southeast Asian Nations aims to act as a single market and allow free movement of goods, services, and manpower. The purpose of this article is to present an overview of the current regulatory framework for health claims in Southeast Asia and to highlight the current barriers and opportunities in the regulatory frameworks in the Association of Southeast Asian Nations. To date, 5 countries in Southeast Asia, i.e., Indonesia, Malaysia, the Philippines, Singapore, and Thailand, have regulations and guidelines to permit the use of health claims on food products. There are inconsistencies in the regulations and the types of evidence required for health claim applications in these countries. A clear understanding of the regulatory frameworks in these countries may help to increase trade in this fast-growing region and to provide direction for the food industry and the regulatory community to develop and market food products with better nutritional quality tailored to the needs of Southeast Asian consumers.

  13. Regulatory issues of digital instrumentation and control system in Lungmen project

    Energy Technology Data Exchange (ETDEWEB)

    Chuang, C.F. [Nuclear Regulation Division, Atomic Energy Council, Taipei (China); Chou, H.P. [Department of Engineering and System Science National Tsing Hua University, (China)

    2004-07-01

    The Lungmen Nuclear Power Station (LNPS) is currently under construction in Taiwan, which consists of 2 advanced boiling water reactor (ABWR) units. The instrumentation and control (IC) systems of the LNPS are based on the state-of-the-art modernized fully integrated digital design. These IC systems possess many advantages and distinguished features comparing to traditional analog IC systems, they enjoy set-point stability, self-diagnostic and automatic testing ability, fault tolerance and avoidance, low power requirements, data handling and storage capability, as well as enhanced human-machine interfaces. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital IC systems in the Lungmen Project.

  14. Recent regulatory experience of low-Btu coal gasification. Volume III. Supporting case studies

    Energy Technology Data Exchange (ETDEWEB)

    Ackerman, E.; Hart, D.; Lethi, M.; Park, W.; Rifkin, S.

    1980-02-01

    The MITRE Corporation conducted a five-month study for the Office of Resource Applications in the Department of Energy on the regulatory requirements of low-Btu coal gasification. During this study, MITRE interviewed representatives of five current low-Btu coal gasification projects and regulatory agencies in five states. From these interviews, MITRE has sought the experience of current low-Btu coal gasification users in order to recommend actions to improve the regulatory process. This report is the third of three volumes. It contains the results of interviews conducted for each of the case studies. Volume 1 of the report contains the analysis of the case studies and recommendations to potential industrial users of low-Btu coal gasification. Volume 2 contains recommendations to regulatory agencies.

  15. B-type suppression: a role played by "regulatory B cells" or "regulatory plasma cells"?

    Science.gov (United States)

    Ries, Stefanie; Hilgenberg, Ellen; Lampropoulou, Vicky; Shen, Ping; Dang, Van Duc; Wilantri, Siska; Sakwa, Imme; Fillatreau, Simon

    2014-05-01

    B-cell depletion can improve disease in some patients with rheumatoid arthritis or multiple sclerosis, indicating the pathogenic contribution of B cells to autoimmunity. However, studies in mice have demonstrated that B cells have immunosuppressive functions as well, with IL-10 being a critical mediator of B-cell-mediated suppression. IL-10-secreting B cells have been shown to promote disease remission in some mouse models of autoimmune disorders. Human B cells also produce IL-10, and evidence is accumulating that human IL-10-producing B cells might inhibit immunity. There is considerable interest in identifying the phenotype of B cells providing IL-10 in a suppressive manner, which would facilitate the analysis of the molecular mechanisms controlling this B-cell property. Here, we review current knowledge on the B-cell subpopulations found to provide suppressive functions in mice, considering both the pathological context in which they were identified and the signals that control their induction. We discuss the phenotype of B cells that have IL-10-dependent regulatory activities in mice, which leads us to propose that antibody-secreting cells are, in some cases at least, the major source of B-cell-derived regulatory IL-10 in vivo. Anti-inflammatory cytokine production by antibody-secreting cells offers a novel mechanism for the coordination of innate and humoral immune responses.

  16. Microinterventions targeting regulatory focus and regulatory fit selectively reduce dysphoric and anxious mood.

    Science.gov (United States)

    Strauman, Timothy J; Socolar, Yvonne; Kwapil, Lori; Cornwell, James F M; Franks, Becca; Sehnert, Steen; Higgins, E Tory

    2015-09-01

    Depression and generalized anxiety, separately and as comorbid states, continue to represent a significant public health challenge. Current cognitive-behavioral treatments are clearly beneficial but there remains a need for continued development of complementary interventions. This manuscript presents two proof-of-concept studies, in analog samples, of "microinterventions" derived from regulatory focus and regulatory fit theories and targeting dysphoric and anxious symptoms. In Study 1, participants with varying levels of dysphoric and/or anxious mood were exposed to a brief intervention either to increase or to reduce engagement in personal goal pursuit, under the hypothesis that dysphoria indicates under-engagement of the promotion system whereas anxiety indicates over-engagement of the prevention system. In Study 2, participants with varying levels of dysphoric and/or anxious mood received brief training in counterfactual thinking, under the hypothesis that inducing individuals in a state of promotion failure to generate subtractive counterfactuals for past failures (a non-fit) will lessen their dejection/depression-related symptoms, whereas inducing individuals in a state of prevention failure to generate additive counterfactuals for past failures (a non-fit) will lessen their agitation/anxiety-related symptoms. In both studies, we observed discriminant patterns of reduction in distress consistent with the hypothesized links between dysfunctional states of the two motivational systems and dysphoric versus anxious symptoms.

  17. Laboratory tests for disorders of complement and complement regulatory proteins.

    Science.gov (United States)

    Shih, Angela R; Murali, Mandakolathur R

    2015-12-01

    The complement pathway is a cascade of proteases that is involved in immune surveillance and innate immunity, as well as adaptive immunity. Dysfunction of the complement cascade may be mediated by aberrations in the pathways of activation, complement regulatory proteins, or complement deficiencies, and has been linked to a number of hematologic disorders, including paroxysmal noctural hemoglobinuria (PNH), hereditary angioedema (HAE), and atypical hemolytic-uremic syndrome (aHUS). Here, current laboratory tests for disorders of the complement pathway are reviewed, and their utility and limitations in hematologic disorders and systemic diseases are discussed. Current therapeutic advances targeting the complement pathway in treatment of complement-mediated hematologic disorders are also reviewed.

  18. [Advanced therapy: from European regulatory framework to national regulatory framework].

    Science.gov (United States)

    Lucas-Samuel, S

    2013-05-01

    The European regulation n(o) 1394/2007/CE published on the 13th of November 2007 defined and harmonized the European regulatory framework for advanced therapy medicinal products. It creates a specialized committee located at the European Medicine Agency, in charge of the assessment of these medicinal products. The consequences of this regulation are introduced in the French regulation by the law n(o) 2011-302 published on the 22nd of March 2011. It detailed notably the possibility for public establishments (except health establishments) and nonprofit organisms to create pharmaceutical establishments. This law defined also a specific category of advanced therapy medicinal products, which fall under the "hospital exemption" framework. The rules regarding the authorizations of the establishments able to prepare these types of medicinal products and the authorization of the products are defined by the n(o) 2012-1236 decree published on the 6th of November 2012.

  19. Global Summit on Regulatory Science 2013.

    Science.gov (United States)

    Howard, Paul C; Tong, Weida; Weichold, Frank; Healy, Marion; Slikker, William

    2014-12-01

    Regulatory science has been defined as the science that is used to develop regulatory decisions by government bodies. Regulatory science encompasses many scientific disciplines that oversee many studies producing a wide array of data. These may include fundamental research into the cellular interaction or response to a particular chemical or substance, hazard-assessment and dose-response studies in animal species, neurophysiological or neurobehavioral studies, best practices for the generation and analysis of genomics data, bioinformatics approaches, and mathematical modeling of risk. The Global Summit on Regulatory Science is an international conference with a mission to explore emerging and innovative technologies, and provide a platform to enhance translation of basic science into regulatory applications. The Third Global Summit on Regulatory Science which focused on nanotechnology is discussed.

  20. iSLIM: a comprehensive approach to mapping and characterizing gene regulatory networks.

    Science.gov (United States)

    Rockel, Sylvie; Geertz, Marcel; Hens, Korneel; Deplancke, Bart; Maerkl, Sebastian J

    2013-02-01

    Mapping gene regulatory networks is a significant challenge in systems biology, yet only a few methods are currently capable of systems-level identification of transcription factors (TFs) that bind a specific regulatory element. We developed a microfluidic method for integrated systems-level interaction mapping of TF-DNA interactions, generating and interrogating an array of 423 full-length Drosophila TFs. With integrated systems-level interaction mapping, it is now possible to rapidly and quantitatively map gene regulatory networks of higher eukaryotes.