WorldWideScience

Sample records for regulatory risks current

  1. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Current status of developmental neurotoxicity: regulatory view

    DEFF Research Database (Denmark)

    Hass, Ulla

    2003-01-01

    The need for developmental neurotoxicity testing has been recognized for decades and guidelines are available, as the USEPA guideline and the OECD draft TG 426. Regulatory testing of industrial chemicals for developmental neurotoxicity is required to some extent, especially for pesticides in the US....... Until recently, however, developmental neurotoxicity testing of industrial chemicals has not been a clear regulatory requirement in EU, probably due to the lack of an accepted OECD TG. The revised EU Technical Guidance Document for Risk Assessment (EU-TGD) has now included the OECD draft TG 426...... 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...

  7. Current regulatory approaches of bioequivalence testing.

    Science.gov (United States)

    Karalis, Vangelis; Macheras, Panos

    2012-08-01

    Nowadays, reducing medication costs is vital for health care agencies. Prescription of generic drug products can help lower these expenses. A generally accepted assumption is that therapeutic equivalence, between a generic and a brand-name medication, can be claimed if bioequivalence is demonstrated. This article reviews the current regulatory procedures on bioequivalence testing. Special focus is placed on the guidelines recommended by the European Medicines Agency and the US Food and Drug administration. The authors also describe the evolution of these issues and the alternatives proposed in the literature. Defining bioequivalence, as the condition of no significant differences in the extent and rate of absorption between the generic and the brand-name medication, sounds simple. However, the scientific and regulatory basis of bioequivalence appears rather complicated in practice. Even though the regulatory authorities have elucidated many issues, several aspects of bioequivalence assessment are still unresolved. Examples, of these open questions, in bioequivalence, include the assessment of complex drugs, such as biologics and iron-carbohydrates, the assessment of immunosuppressive agents as well as the role that pharmacogenomics plays in bioequivalence.

  8. Mission Risk Reduction Regulatory Change Management

    Science.gov (United States)

    Scroggins, Sharon

    2007-01-01

    NASA Headquarters Environmental Management Division supports NASA's mission to pioneer the future in space exploration, scientific discovery, and aeronautics research by integrating environmental considerations into programs and projects early-on, thereby proactively reducing NASA's exposure to institutional, programmatic and operational risk. As part of this effort, NASA established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) as a resource for detecting, analyzing, and communicating environmental regulatory risks to the NASA stakeholder community. The RRAC PC focuses on detecting emerging environmental regulations and other operational change drivers that may pose risks to NASA programs and facilities, and effectively communicating the potential risks. For example, regulatory change may restrict how and where certain activities or operations may be conducted. Regulatory change can also directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Regulatory change can result in significant adverse impacts to NASA programs and facilities due to NASA's stringent performance requirements for materials and components related to human-rated space vehicles. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented a system for proactively managing regulatory change to minimize potential adverse impacts to NASA programs and facilities. This presentation highlights the process utilized by the RRACPC to communicate regulatory change and the associated

  9. Regulatory cost-risk study

    Energy Technology Data Exchange (ETDEWEB)

    1983-04-01

    This study is intended to provide some quantitative perspective by selecting certain examples of criteria for which estimates of risks and costs can be obtained, and the balance of the various risks, (i.e., internal versus external risks), can be put into perspective. 35 refs., 39 tabs. (JDB)

  10. Backtesting for Risk-Based Regulatory Capital

    NARCIS (Netherlands)

    Kerkhof, F.L.J.; Melenberg, B.

    2002-01-01

    In this paper we present a framework for backtesting all currently popular risk measurement methods (including value-at-risk and expected shortfall) using the functional delta method.Estimation risk can be taken explicitly into account.Based on a simulation study we provide evidence that tests for

  11. Nanopesticides: guiding principles for regulatory evaluation of environmental risks.

    Science.gov (United States)

    Kookana, Rai S; Boxall, Alistair B A; Reeves, Philip T; Ashauer, Roman; Beulke, Sabine; Chaudhry, Qasim; Cornelis, Geert; Fernandes, Teresa F; Gan, Jay; Kah, Melanie; Lynch, Iseult; Ranville, James; Sinclair, Chris; Spurgeon, David; Tiede, Karen; Van den Brink, Paul J

    2014-05-14

    Nanopesticides or nano plant protection products represent an emerging technological development that, in relation to pesticide use, could offer a range of benefits including increased efficacy, durability, and a reduction in the amounts of active ingredients that need to be used. A number of formulation types have been suggested including emulsions (e.g., nanoemulsions), nanocapsules (e.g., with polymers), and products containing pristine engineered nanoparticles, such as metals, metal oxides, and nanoclays. The increasing interest in the use of nanopesticides raises questions as to how to assess the environmental risk of these materials for regulatory purposes. Here, the current approaches for environmental risk assessment of pesticides are reviewed and the question of whether these approaches are fit for purpose for use on nanopesticides is addressed. Potential adaptations to existing environmental risk assessment tests and procedures for use with nanopesticides are discussed, addressing aspects such as analysis and characterization, environmental fate and exposure assessment, uptake by biota, ecotoxicity, and risk assessment of nanopesticides in aquatic and terrestrial ecosystems. Throughout, the main focus is on assessing whether the presence of the nanoformulation introduces potential differences relative to the conventional active ingredients. The proposed changes in the test methodology, research priorities, and recommendations would facilitate the development of regulatory approaches and a regulatory framework for nanopesticides.

  12. Regulatory Reform: Low Risk, High Promise.

    Science.gov (United States)

    Tanenbaum, Morris

    The press of telecommunication technologies and their progeny have undermined the natural monopoly basis for long distance telecommunications and customer premise products, forced open regulatory doors, toppled barriers to market entry, and led to the reshaping of regulatory philosophy as regulators have seen new, wider horizons for the industry.…

  13. 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.

  14. Systematic identification of regulatory variants associated with cancer risk.

    Science.gov (United States)

    Liu, Song; Liu, Yuwen; Zhang, Qin; Wu, Jiayu; Liang, Junbo; Yu, Shan; Wei, Gong-Hong; White, Kevin P; Wang, Xiaoyue

    2017-10-23

    Most cancer risk-associated single nucleotide polymorphisms (SNPs) identified by genome-wide association studies (GWAS) are noncoding and it is challenging to assess their functional impacts. To systematically identify the SNPs that affect gene expression by modulating activities of distal regulatory elements, we adapt the self-transcribing active regulatory region sequencing (STARR-seq) strategy, a high-throughput technique to functionally quantify enhancer activities. From 10,673 SNPs linked with 996 cancer risk-associated SNPs identified in previous GWAS studies, we identify 575 SNPs in the fragments that positively regulate gene expression, and 758 SNPs in the fragments with negative regulatory activities. Among them, 70 variants are regulatory variants for which the two alleles confer different regulatory activities. We analyze in depth two regulatory variants-breast cancer risk SNP rs11055880 and leukemia risk-associated SNP rs12142375-and demonstrate their endogenous regulatory activities on expression of ATF7IP and PDE4B genes, respectively, using a CRISPR-Cas9 approach. By identifying regulatory variants associated with cancer susceptibility and studying their molecular functions, we hope to help the interpretation of GWAS results and provide improved information for cancer risk assessment.

  15. 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

  16. Development of regulatory technical rationale for risk monitoring program

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Chang Hyun; Kim, Ju Youl; Kim, Yoon Ik; Yang, Hui Chang; Lee, Yong Suk; Ahn, Kwang Won; Kim, Se Hyung [Seoul National Univ., Seoul (Korea, Republic of)

    2002-03-15

    In Korea, the risk monitoring program will be developed and applied to each plants till 2003 by the severe accident management plan to enhance the safety functions of the nuclear power plants. Through this plan, the risk monitoring for the full power and low power and shutdown operation will be performed. Therefore the development of consistent risk monitoring system and overall regulatory guides for the risk monitoring program are necessary. The objective of this study is the development of regulatory technical rationales for the nuclear power plant risk monitoring program and the derivation of the requirements need for the development of risk monitoring system. Through this the improvement of regulatory effectiveness to assure the safe operation of nuclear power plant, is expected.

  17. 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.

  18. A risk-informed approach to modifying regulatory requirements

    Energy Technology Data Exchange (ETDEWEB)

    Imbro, E.V. [U.S. Nuclear Regulatory Commission, Washington, DC (United States)

    2001-07-01

    The U. S. Nuclear Regulatory Commission is in the process of revising its regulations to make them more risk-informed. Presently, the Commission's regulations require that special treatments be applied to safety-related components uniformly regardless of their contribution to risk or their safety significance. ''Special treatment requirements'' are requirements unique to safety-related components installed in nuclear-powered electric generating stations that provide reasonable assurance that a system, structure or component will be able to perform its specified safety function. Examples of special treatment requirements include inservice testing and inspection of active and passive components, and seismic and environmental qualification. The Commission is considering eliminating or revising these special treatment requirements for safety-related components that are small contributors to risk. In this context, the Commission is evaluating the extent to which commercial practices typically used by nuclear-powered electric generating stations can by relied on to provide sufficient confidence that safety-related components that have a small contribution to risk will perform their specified design functions. This paper discusses the use of commercial practices, as opposed to special treatment requirements, as a means to provide confidence that safety-related components will function under the current design conditions. (author)

  19. Probabilistic risk assessment (PRA): status report and guidance for regulatory application. Draft report for comment

    Energy Technology Data Exchange (ETDEWEB)

    None

    1984-02-01

    This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed.

  20. A Synthesis of Current Issues in the Labour Regulatory Environment

    OpenAIRE

    Haroon Bhorat; Carlene van der Westhuizen

    2009-01-01

    During 2006 and 2007, a selection of research papers, in the main written by labour law experts, have provided critical input and guidance on the nature of the debate around the efficiency of the labour regulatory environment in South Africa. In November 2007, key stakeholders from government, labour and business attended a workshop on the Labour Regulatory Environment in South Africa at the Mount Grace Hotel, Magaliesberg, where the results of the aforementioned studies were presented and de...

  1. Sovereign Risk and Currently Returns

    DEFF Research Database (Denmark)

    Della Corte, Pasquale; Sarno, Lucio; Schmeling, Maik

    We empirically investigate the relation between sovereign risk and exchange rates for a broad set of currencies. An increase in the credit default swap (CDS) spread of a country is accompanied by a significant depreciation of the exchange rate. More generally, CDS spread changes have substantial...

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

    NARCIS (Netherlands)

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

    2007-01-01

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

  3. 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

  4. Task-based dermal exposure models for regulatory risk assessment

    NARCIS (Netherlands)

    Warren, N.D.; Marquart, H.; Christopher, Y.; Laitinen, J.; Hemmen, J.J. van

    2006-01-01

    The regulatory risk assessment of chemicals requires the estimation of occupational dermal exposure. Until recently, the models used were either based on limited data or were specific to a particular class of chemical or application. The EU project RISKOFDERM has gathered a considerable number of

  5. Regulatory uncertainty and the associated business risk for emerging technologies

    Science.gov (United States)

    Hoerr, Robert A.

    2011-04-01

    An oversight system specifically concerned with nanomaterials should be flexible enough to take into account the unique aspects of individual novel materials and the settings in which they might be used, while recognizing that heretofore unrecognized safety issues may require future modifications. This article considers a question not explicitly considered by the project team: what is the risk that uncertainty over how regulatory oversight will be applied to nanomaterials will delay or block the development of this emerging technology, thereby depriving human health of potential and substantial benefits? An ambiguous regulatory environment could delay the availability of valuable new technology and therapeutics for human health by reducing access to investment capital. Venture capitalists list regulatory uncertainty as a major reason not to invest at all in certain areas. Uncertainty is far more difficult to evaluate than risk, which lends itself to quantitative models and can be factored into projections of return on possible investments. Loss of time has a large impact on investment return. An examination of regulatory case histories suggests that an increase in regulatory resting requirement, where the path is well-defined, is far less costly than a delay of a year or more in achieving product approval and market launch.

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

    Science.gov (United States)

    Gingerich, Daniel B; Mauter, Meagan S

    2017-09-19

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

  7. Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems.

    Science.gov (United States)

    Sapsford, Kim E; Lauritsen, Kristina; Tyner, Katherine M

    2012-12-01

    The US FDA is the US agency responsible for regulating intelligent drug-delivery systems (IDDS). IDDS can be classified as a device, drug, biologic or combination product. In this perspective, the current regulatory framework for IDDS and future perspectives on how the field is expected to evolve from a regulatory standpoint is discussed.

  8. 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.

  9. 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.

  10. Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-08-01

    OAK B188 Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report. The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-formed approach for the design and regulation of nuclear power plants. This approach will include the development and/or confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRS) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go further by focusing on the design of new plants.

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

    DEFF Research Database (Denmark)

    Bartholdy, Jan; Justesen, Lene Gilje

    This study provides empirical evidence on the moral hazard implications of introducing deposit insurance into a strong regulatory environment. Denmark offers a unique setting because commercial banks and savings banks have different ownership structures, but are subject to the same set of 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...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-06-01

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

  13. 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

  14. 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.

  15. Global Risk Assessment of Aflatoxins in Maize and Peanuts: Are Regulatory Standards Adequately Protective?

    Science.gov (United States)

    Wu, Felicia

    2013-01-01

    The aflatoxins are a group of fungal metabolites that contaminate a variety of staple crops, including maize and peanuts, and cause an array of acute and chronic human health effects. Aflatoxin B1 in particular is a potent liver carcinogen, and hepatocellular carcinoma (HCC) risk is multiplicatively higher for individuals exposed to both aflatoxin and chronic infection with hepatitis B virus (HBV). In this work, we sought to answer the question: do current aflatoxin regulatory standards around the world adequately protect human health? Depending upon the level of protection desired, the answer to this question varies. Currently, most nations have a maximum tolerable level of total aflatoxins in maize and peanuts ranging from 4 to 20ng/g. If the level of protection desired is that aflatoxin exposures would not increase lifetime HCC risk by more than 1 in 100,000 cases in the population, then most current regulatory standards are not adequately protective even if enforced, especially in low-income countries where large amounts of maize and peanuts are consumed and HBV prevalence is high. At the protection level of 1 in 10,000 lifetime HCC cases in the population, however, almost all aflatoxin regulations worldwide are adequately protective, with the exception of several nations in Africa and Latin America. PMID:23761295

  16. Reading the Tea Leaves: How Utilities in the West Are Managing Carbon Regulatory Risk in their Resource Plans

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-02-01

    The long economic lifetime and development lead-time of many electric infrastructure investments requires that utility resource planning consider potential costs and risks over a lengthy time horizon. One long-term -- and potentially far-reaching -- risk currently facing the electricity industry is the uncertain cost of future carbon dioxide (CO2) regulations. Recognizing the importance of this issue, many utilities (sometimes spurred by state regulatory requirements) are beginning to actively assess carbon regulatory risk within their resource planning processes, and to evaluate options for mitigating that risk. However, given the relatively recent emergence of this issue and the rapidly changing political landscape, methods and assumptions used to analyze carbon regulatory risk, and the impact of this analysis on the selection of a preferred resource portfolio, vary considerably across utilities. In this study, we examine the treatment of carbon regulatory risk in utility resource planning, through a comparison of the most-recent resource plans filed by fifteen investor-owned and publicly-owned utilities in the Western U.S. Together, these utilities account for approximately 60percent of retail electricity sales in the West, and cover nine of eleven Western states. This report has two related elements. First, we compare and assess utilities' approaches to addressing key analytical issues that arise when considering the risk of future carbon regulations. Second, we summarize the composition and carbon intensity of the preferred resource portfolios selected by these fifteen utilities and compare them to potential CO2 emission benchmark levels.

  17. Current Research Status of KHNP for Site Risk

    Energy Technology Data Exchange (ETDEWEB)

    Oh, Kyemin; Jeon, Ho-Jun; Bahng, Ki-In; Na, Jang-Hwan [KHNP CRI, Daejeon (Korea, Republic of)

    2016-10-15

    In Korea, by the geographical characteristics, many Nuclear Power Plants (NPPs) have been constructed and operated at a single site. This is above average level or number of plants per site in the world. For this reason, the public concerns for the safety of nuclear facilities increased after Fukushima Daiichi accident. As a result, comprehensive risk assessment and management for the site which have multi-unit NPPs were strongly asked. Currently, to solve it, many researches and projects has carried out by various Korean companies, research centers, and regulatory authorities. In this paper, R and D plans of KHNP for multi-unit risk were summarized. Firstly, the needs of multi-unit PSA were reviewed. R and D activities and plans of KHNP were summarized in the last part. In this paper, we summarized the R and D plans of KHNP for assessing the multi-unit risk. Currently, multi-unit risk or multi-unit PSA are important and practical issues in both nuclear industry and national energy policy. After Fukushima accident, several countries stopped the construction and the operation of NPPs, other countries which is maintaining the NPPs are being strongly asked to assess the risk for multi-unit NPPs at the same site. Because of Korean geographical characteristics, the number of NPPs which are above average level or number of plants per site in the world is being constructed and operated at a single site. The population density nearby each site is considered to be higher than that of other countries.

  18. Ecological models for regulatory risk assessments of pesticides: Developing a strategy for the future.

    NARCIS (Netherlands)

    Thorbek, P.; Forbes, V.; Heimbach, F.; Hommen, U.; Thulke, H.H.; Brink, van den P.J.

    2010-01-01

    Ecological Models for Regulatory Risk Assessments of Pesticides: Developing a Strategy for the Future provides a coherent, science-based view on ecological modeling for regulatory risk assessments. It discusses the benefits of modeling in the context of registrations, identifies the obstacles that

  19. NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

    Science.gov (United States)

    Scroggins, Sharon; Duda, Kristen

    2008-01-01

    This viewgraph presentation gives an overview of NASA's risk analysis communication programs associated with changing environmental policies. The topics include: 1) NASA Program Transition; 2) Principal Center for Regulatory Risk Analysis and Communication (RRAC PC); and 3) Regulatory Tracking and Communication Process.

  20. Cleantech Venture Investors and Energy Policy Risk: An Exploratory Analysis of Regulatory Risk Management Strategies

    OpenAIRE

    Bürer, Mary Jean; Wüstenhagen, Rolf

    2008-01-01

    The energy industry is a typical example of a heavily regulated industry, and particularly large incumbent energy firms have developed significant expertise in non-market strategies (or corporate political activity). New entrants to the energy industry, such as clean energy technology ventures, are also exposed to regulatory risk (and opportunity), but they do not have the means to engage in non-market strategies to a similar extent as large incumbent firms. On the other hand, the success of ...

  1. An ensemble model of QSAR tools for regulatory risk assessment.

    Science.gov (United States)

    Pradeep, Prachi; Povinelli, Richard J; White, Shannon; Merrill, Stephen J

    2016-01-01

    Quantitative structure activity relationships (QSARs) are theoretical models that relate a quantitative measure of chemical structure to a physical property or a biological effect. QSAR predictions can be used for chemical risk assessment for protection of human and environmental health, which makes them interesting to regulators, especially in the absence of experimental data. For compatibility with regulatory use, QSAR models should be transparent, reproducible and optimized to minimize the number of false negatives. In silico QSAR tools are gaining wide acceptance as a faster alternative to otherwise time-consuming clinical and animal testing methods. However, different QSAR tools often make conflicting predictions for a given chemical and may also vary in their predictive performance across different chemical datasets. In a regulatory context, conflicting predictions raise interpretation, validation and adequacy concerns. To address these concerns, ensemble learning techniques in the machine learning paradigm can be used to integrate predictions from multiple tools. By leveraging various underlying QSAR algorithms and training datasets, the resulting consensus prediction should yield better overall predictive ability. We present a novel ensemble QSAR model using Bayesian classification. The model allows for varying a cut-off parameter that allows for a selection in the desirable trade-off between model sensitivity and specificity. The predictive performance of the ensemble model is compared with four in silico tools (Toxtree, Lazar, OECD Toolbox, and Danish QSAR) to predict carcinogenicity for a dataset of air toxins (332 chemicals) and a subset of the gold carcinogenic potency database (480 chemicals). Leave-one-out cross validation results show that the ensemble model achieves the best trade-off between sensitivity and specificity (accuracy: 83.8 % and 80.4 %, and balanced accuracy: 80.6 % and 80.8 %) and highest inter-rater agreement [kappa (κ): 0

  2. Current industrial practice of managing risks in product development project portfolios

    DEFF Research Database (Denmark)

    Weng, R.; Oehmen, Josef; Ben-Daya, M.

    2013-01-01

    Managing portfolios of development and engineering projects currently presents significant challenges to companies. This is even more the case in the management of portfolio risks, where both industry and academia currently lack a clear conceptual understanding of what portfolio risks are and what...... of interdependencies in PD project portfolios (Technology, Budget, Objectives and Requirements, Infrastructure and Equipment, Skillset and Human Resources, Process and Schedule, Supplier, Legal and Regulatory, and finally Market and Customer). Second, we investigate how risk management on the portfolio level...... influences them. The objective of this paper is two-fold: First, based on a literature review and industry focus group discussions, we introduce a new model for describing portfolio-level risks. It consists of three types of risks (escalated risks, common cause risks, and cascading risks) based on 9 types...

  3. Risk of tumorigenicity in mesenchymal stromal cell-based therapies--bridging scientific observations and regulatory viewpoints.

    Science.gov (United States)

    Barkholt, Lisbeth; Flory, Egbert; Jekerle, Veronika; Lucas-Samuel, Sophie; Ahnert, Peter; Bisset, Louise; Büscher, Dirk; Fibbe, Willem; Foussat, Arnaud; Kwa, Marcel; Lantz, Olivier; Mačiulaitis, Romaldas; Palomäki, Tiina; Schneider, Christian K; Sensebé, Luc; Tachdjian, Gérard; Tarte, Karin; Tosca, Lucie; Salmikangas, Paula

    2013-07-01

    In the past decade, the therapeutic value of mesenchymal stromal cells (MSCs) has been studied in various indications, thereby taking advantage of their immunosuppressive properties. Easy procurement from bone marrow, adipose tissue or other sources and conventional in vitro expansion culture have made their clinical use attractive. Bridging the gap between current scientific knowledge and regulatory prospects on the transformation potential and possible tumorigenicity of MSCs, the Cell Products Working Party and the Committee for Advanced Therapies organized a meeting with leading European experts in the field of MSCs. This meeting elucidated the risk of potential tumorigenicity related to MSC-based therapies from two angles: the scientific perspective and the regulatory point of view. The conclusions of this meeting, including the current regulatory thinking on quality, nonclinical and clinical aspects for MSCs, are presented in this review, leading to a clearer way forward for the development of such products. Copyright © 2013 International Society for Cellular Therapy. All rights reserved.

  4. 77 FR 52977 - Regulatory Capital Rules: Advanced Approaches Risk-Based Capital Rule; Market Risk Capital Rule

    Science.gov (United States)

    2012-08-30

    ... rule and the market risk rule to savings and loan holding companies, and the Board, FDIC, and OCC propose applying the market risk capital rule to savings and loan holding companies and to state and... Regulatory Capital Rules: Advanced Approaches Risk-Based Capital Rule; Market Risk Capital Rule; Proposed...

  5. The US FDA and animal cloning: risk and regulatory approach.

    Science.gov (United States)

    Rudenko, Larisa; Matheson, John C

    2007-01-01

    The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.

  6. Animal testing, 3R models and regulatory acceptance : Technology transition in a risk-averse context

    NARCIS (Netherlands)

    Schiffelers, M.J.W.A.

    2016-01-01

    Risk avoidance has resulted in a broad range of regulations to guarantee the safety of products such as pharmaceuticals and chemicals. Many of these regulations rely on animal tests. About 3 million laboratory animals are used annually in Europe to meet such regulatory requirements.Regulatory animal

  7. 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,

  8. 76 FR 72220 - Incorporation of Risk Management Concepts in Regulatory Programs

    Science.gov (United States)

    2011-11-22

    ... evolution from the risk-informed, performance-based philosophy that has governed many NRC regulatory... Commission, Washington, DC 20555-0001, or by Internet electronic mail to [email protected] ; and...

  9. [Current lines of methodology for risk assessment].

    Science.gov (United States)

    Rakhmanin, Iu A; Novikov, S M; Shashina, T A

    2007-01-01

    The paper presents the results of some guidance studies assessing the risk, recently conducted at the A. N. Sysin Research Institute of Human Ecology and Environmental Health, such as validation of toxicological and hygienic criteria for risk assessment upon short- and long-term human exposures to deleterious substances; development and introduction of methods for assessing health risk and damage, by applying computer technologies; elaboration of guidelines for establishing the cause-and-effect relationship of changes in health indices to those in the environment; characterization of damage caused by ambient air pollution in Russian cities and towns; possibilities of using the guidance for assessing the risk to improve sociohygienic monitoring. It also gives the results of testing scientific developments in the assessment of a multienvironmental risk in the areas exposed to emission from aluminum works (Khakasia) and chemical and petrochemical enterprises (Samara Region) and in the determination of contribution of emission from the Moscow fuel-and-energy complex to risks and damages to human health, caused by ambient air pollution. The urgent issues of further development of modern trends in risk guidance studies are determined.

  10. Expert views on regulatory preparedness for managing the risks of nanotechnologies.

    Science.gov (United States)

    Beaudrie, Christian E H; Satterfield, Terre; Kandlikar, Milind; Harthorn, Barbara H

    2013-01-01

    The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254) of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies' ability to oversee their growing use and application in society.

  11. [GMOs in food: risk assessment, scientific management and regulatory aspects].

    Science.gov (United States)

    Casse, F; Hervieu, F

    2003-03-01

    Genetic transformation constitutes a new tool for improvement of microorganisms, animals and plants used in food. We present foreseeable risks, as well as management measures to avoid unsuspected risks of GMOs. Few risks are specific to GMOs. Present elements of French and European regulations concerning placing on the market and follow up GMOs and other novel foods are described.

  12. Deregulation in the electricity sector: Understanding strategic and regulatory risk

    Energy Technology Data Exchange (ETDEWEB)

    Larsen, E.R. [City Univ. Business School, Dept. Management Systems and Information, London (United Kingdom); Bunn, D.W. [London Business School, London (United Kingdom)

    1999-08-01

    This paper is motivated by our experiences since 1990 with developing system simulation models to help UK companies in the restructured electricity industry understand the radically different market within which they must become competitive. When public utilities such as electricity have been restructured, deregulated and/or privatised, the process has often been associated with a major change in the competitive environment. As a consequence, the strategic and regulatory uncertainties ahead for these companies are unprecedented. In such a market there has been no historical evolution and all the participants including the regulatory institutions have very little understanding of how it will operate in the short term and evolve in the future. In this situation, the use of systems dynamic models appears to offer an attractive way of gaining insights into how aspects of the competitive market might evolve. In the absence of real experience and relevant analogies, learning from models assumes a key role. Such models cannot be validated empirically, but can be developed to represent how the system is designed to operate. From such a prototypical basis, sensitivity analysis can generate insights on the strategic opportunities created failings in the market design, or its potential instability to shocks and market imperfections. (au)

  13. A review of the current scientific and regulatory status of nanomedicines and the challenges ahead.

    Science.gov (United States)

    Hock, Sia Chong; Ying, Yan Mei; Wah, Chan Lai

    2011-01-01

    Nanomedicines refer to drugs, medical devices, and health products developed using nanotechnology with the aim of diagnosing, monitoring, and treating diseases at the molecular level. Due to their nano size, nanomedicines offer advantages over conventional medicines, including more effective targeting of difficult-to-reach sites, improved solubility and bioavailability, and reduced adverse effects. Hence, nanomedicines can be used to achieve the same therapeutic effect at smaller doses than their conventional counterparts. Three types of nanomedicines are described: nanocarriers used in drug delivery, nanosuspensions used in the improvement of drug solubility, and nanoparticles used in bioimaging. While nanomedicines offer promising benefits, there are concerns that the inherent properties of nanoparticles such as their size, shape, agglomeration/aggregation potential, and surface chemistry can adversely affect the safety and quality of nanomedicines. Furthermore, there are currently no regulatory guidelines developed specifically for nanomedicines due to limitations including inadequate knowledge regarding nanoparticle behavior, the absence of standardized nomenclature, test methods, and characterization of nanoparticles, as well as difficulty in determining primary jurisdiction for combination products. In addition, a shortage of trained personnel, a lack of a nanomedicine-specific safety protocol, and ineffective control of nanoparticle contamination challenge the current good manufacturing practice requirements governing the manufacture of nanomedicines. Regulatory authorities are in the midst of improving the current framework for controlling the manufacturing processes, product quality, and safety of nanomedicines. This paper proposes improvements through the adaptation of conventional regulations for nanoparticles, implementation of compulsory regulations for presently unregulated nanoparticle-containing products, and the establishment of an online database

  14. NASA's Agency-wide Strategy for Environmental Regulatory Risk Analysis and Communication

    Science.gov (United States)

    Duda, Kristen; Scroggins. Sharon

    2008-01-01

    NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage aPi'iications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross

  15. Current features on risk perception and risk communication of radiation

    Energy Technology Data Exchange (ETDEWEB)

    Kusama, Tomoko [Tokyo Univ. (Japan). Faculty of Medicine

    1997-03-01

    Health effects and risks of radiation and radionuclides are being misunderstood by many members of general public. Many peoples have fear and anxieties for radiation. So far, the health effects from radiation at low dose and low dose rate have not been cleared on biological aspects. Then, we have quantitatively estimated health risks of low-dose radiation on the basis of linear dose response relationship without threshold from the viewpoints of radiation protection by using both epidemiological data, such as atomic bomb survivors, and some models and assumptions. It is important for researchers and relevant persons in radiation protection to understand the process of risk estimation of radiation and to communicate an exact knowledge of radiation risks of the public members. (author)

  16. Regulatory risk and market reactions. Empirical evidence from Germany

    Energy Technology Data Exchange (ETDEWEB)

    Kobialka, Marek; Rammerstorfer, Margarethe [Inst. for Corporate Finance, Vienna Univ. of Economics and Business, Vienna (Austria)

    2009-07-01

    In this article we measure the effects of events on risk and return and analyze the persistence of the influencing variables on German energy companies. Therefore, we refer to event-study methods by means of the Capital Asset Pricing Model, GARCH-Modeling and Kalman filters. We find that the discussed events do not affect all companies in an equal manner. Moreover, we show that the impact on risk and returns is not persistent and does not lead to an increase in the overall systematic risk for the considered utility operators in Germany. (orig.)

  17. Basel II Approaches for the Calculation of the Regulatory Capital for Operational Risk

    Directory of Open Access Journals (Sweden)

    Ivana Valová

    2011-01-01

    Full Text Available The final version of the New Capital Accord, which includes operational risk, was released by the Basel Committee on Banking Supervision in June 2004. The article “Basel II approaches for the calculation of the regulatory capital for operational risk” is devoted to the issue of operational risk of credit financial institutions. The paper talks about methods of operational risk calculation, advantages and disadvantages of particular methods.

  18. Nuclear Energy Research Initiative. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants. Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Ritterbusch, S.E.

    2000-08-01

    The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-informed approach for the design and regulation of nuclear power plants. This approach will include the development and.lor confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRs) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go farther by focusing on the design of new plants.

  19. Risk definition and management strategies in retinoblastoma: current perspectives

    OpenAIRE

    Ghassemi, Fariba; Khodabande,Alireza

    2015-01-01

    Fariba Ghassemi, Alireza Khodabande Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Tehran Province, Islamic Republic of Iran Abstract: This manuscript focuses on high-risk factors of metastatic disease in retinoblastoma and evaluation of the current treatments of retinoblastoma. Presence of histopathologic high-risk factors is associated with a higher risk of local recurrence and systemic metastasis. Currently, globe-sparing therapies, including syste...

  20. Disinfection byproduct regulatory compliance surrogates and bromide-associated risk.

    Science.gov (United States)

    Kolb, Chelsea; Francis, Royce A; VanBriesen, Jeanne M

    2017-08-01

    Natural and anthropogenic factors can alter bromide concentrations in drinking water sources. Increasing source water bromide concentrations increases the formation and alters the speciation of disinfection byproducts (DBPs) formed during drinking water treatment. Brominated DBPs are more toxic than their chlorinated analogs, and thus have a greater impact on human health. However, DBPs are regulated based on the mass sum of DBPs within a given class (e.g., trihalomethanes and haloacetic acids), not based on species-specific risk or extent of bromine incorporation. The regulated surrogate measures are intended to protect against not only the species they directly represent, but also against unregulated DBPs that are not routinely measured. Surrogates that do not incorporate effects of increasing bromide may not adequately capture human health risk associated with drinking water when source water bromide is elevated. The present study analyzes trihalomethanes (THMs), measured as TTHM, with varying source water bromide concentrations, and assesses its correlation with brominated THM, TTHM risk and species-specific THM concentrations and associated risk. Alternative potential surrogates are evaluated to assess their ability to capture THM risk under different source water bromide concentration conditions. The results of the present study indicate that TTHM does not adequately capture risk of the regulated species when source water bromide concentrations are elevated, and thus would also likely be an inadequate surrogate for many unregulated brominated species. Alternative surrogate measures, including THM3 and the bromodichloromethane concentration, are more robust surrogates for species-specific THM risk at varying source water bromide concentrations. Copyright © 2017. Published by Elsevier B.V.

  1. EU risk governance of 'cloned food': regulatory uncertainty between trade and non-trade

    NARCIS (Netherlands)

    Weimer, M.; van Asselt, M.B.A.; Versluis, E.; Vos, E.

    2013-01-01

    This chapter analyzes the difficulties of creating a viable legal framework for ‘cloned food’ in the EU combining a legal perspective with insights from the interdisciplinary research on risk governance. Animal cloning offers an instructive example for the challenges of designing regulatory

  2. Bank risk taking and liquidity creation following regulatory interventions and capital support

    NARCIS (Netherlands)

    Berger, A.N.; Bouwman, C.H.S.; Kick, T.; Schaeck, K.

    2011-01-01

    During times of bank distress, authorities often engage in regulatory interventions and provide capital support to reduce bank risk taking. An unintended effect of such actions may be a reduction in bank liquidity creation, with possible adverse consequences for the economy as a whole. This paper

  3. Bank Risk Taking and Liquidity Creation Following Regulatory Interventions and Capital Support

    NARCIS (Netherlands)

    Berger, A.N.; Bouwman, C.H.S.; Kick, T.; Schaeck, K.

    2011-01-01

    During times of bank distress, authorities often engage in regulatory interventions and provide capital support to reduce bank risk taking. An unintended effect of such actions may be a reduction in bank liquidity creation, with possible adverse consequences for the economy as a whole. This paper

  4. Regulatory Mode and Risk-Taking: The Mediating Role of Anticipated Regret.

    Directory of Open Access Journals (Sweden)

    Angelo Panno

    Full Text Available We propose that decision maker's regulatory mode affects risk-taking through anticipated regret. In the Study 1 either a locomotion or an assessment orientation were experimentally induced, and in the Studies 2 and 3 these different orientations were assessed as chronic individual differences. To assess risk-taking we used two behavioral measures of risk: BART and hot-CCT. The results show that experimentally induced assessment orientation--compared to locomotion--leads to decreased risk-taking through increased anticipated regret (Study 1. People chronically predisposed to be in the assessment state take less risk through increased anticipated regret (Study 2 and Study 3. Study 2 results also show a marginally non-significant indirect effect of chronic locomotion mode on BART through anticipated regret. Differently, Study 3 shows that people chronically predisposed to be in the locomotion state take greater risk through decreased anticipated regret, when play a dynamic risk task triggering stronger emotional arousal. Through all three studies, the average effect size for the relationship of assessment with anticipated regret was in the moderate-large range, whereas for risk-taking was in the moderate range. The average effect size for the relationship of locomotion with anticipated regret was in the moderate range, whereas for risk-taking was in the small-moderate range. These results increase our understanding of human behavior under conditions of risk obtaining novel insights into regulatory mode theory and decision science.

  5. REGULATORY BENCHMARKING IN CENTRAL EUROPE: CURRENT PRACTICE AND POSSIBILITIES OF DEVELOPMENT FOR THE ENERGY SECTOR

    Directory of Open Access Journals (Sweden)

    Machek Ondrej

    2011-07-01

    Full Text Available Benchmarking is a technique of performance evaluation in which comparisons are made to benchmarks that represent external performance standards. In the field of regulation of public utilities, benchmarking can be used as an element of performance-based regulation or as a pure regulatory method, called yardstick competition. In the absence of competition, benchmarking can be used to simulate competitive pressures by comparing a regulated firm's performance against an efficient standard. The aim of this paper is to examine the Central European regulatory benchmarking practices in the energy sector, namely the electricity and natural gas distribution industries, and to analyse the possibilities of further development of regulatory benchmarking in this region. The countries onto which we focus are Czech Republic, Slovakia, Hungary, Poland, Germany, Austria and Switzerland. In the region of Central Europe there are still significant differences between countries, especially in terms of experiences in modern regulation, regulatory methods and practices, level of economic development etc. Differences are considerable especially between Western countries (Germany, Austria and Switzerland and the countries of former Eastern Bloc (Czech Republic, Slovakia, Hungary and Poland. As a result, the degree of the use of regulatory benchmarking is also very diverse within this region. In the first part of the paper, we develop basic theoretic concepts of economic regulation. Then we describe the most frequently used regulatory methods cost-of-service regulation, incentive regulation and yardstick competitionand we deal with common regulatory benchmarking techniques, describe their principles and main challenges. Subsequenty, we provide an overview of regulatory methods and benchmarking practices for each country in the region of interest. In the final part of the paper, we analyse the challenges and possibilities for further development of regulatory benchmarking

  6. Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.

    Science.gov (United States)

    Goodman, Joanne; Cowen, Simon; Devanarayan, Viswanath; Egging, David; Emrich, Thomas; Golob, Michaela; Kramer, Daniel; McNally, Jim; Munday, James; Nelson, Robert; Pedras-Vasconcelos, João A; Piironen, Timo; Sickert, Denise; Skibeli, Venke; Fjording, Marianne Scheel; Timmerman, Philip

    2018-02-01

    European Bioanalysis Forum Workshop, Lisbon, Portugal, September 2016: At the recent European Bioanalysis Forum Focus Workshop, 'current analysis of immunogenicity: best practices and regulatory hurdles', several important challenges facing the bioanalytical community in relation to immunogenicity assays were discussed through a mixture of presentations and panel sessions. The main areas of focus were the evolving regulatory landscape, challenges of assay interferences from either drug or target, cut-point setting and whether alternative assays can be used to replace neutralizing antibody assays. This workshop report captures discussions and potential solutions and/or recommendations made by the speakers and delegates.

  7. Improving the Clinical Pharmacologic Assessment of Abuse Potential: Part 1: Regulatory Context and Risk Management.

    Science.gov (United States)

    Sellers, Edward M

    2018-02-01

    This article brings to the attention of drug developers the Food and Drug Administration's (FDA's) recent final Guidance to Industry on Assessment of Abuse Potential and provides practical suggestions about compliance with the Guidance. The Guidance areas are reviewed, analyzed, and placed in the context of current scientific knowledge and best practices to mitigate regulatory risk. The Guidance provides substantial new detail on what needs to be done at all stages of drug development for central nervous system-active drugs. However, because many psychopharmacologic agents have unique preclinical and clinical features, the plan for each agent needs to be not only carefully prepared but also reviewed and approved by the FDA. Examples are provided where assumptions about interpretation of the Guidance can delay development. If the expertise and experience needed for assessing abuse potential during drug development do not exist within a company, external preclinical and clinical expert should be involved. Consultation with the FDA is encouraged and important because the specific requirements for each drug will vary.

  8. 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

  9. Current state of the regulatory trajectory for whole slide imaging devices in the USA

    Directory of Open Access Journals (Sweden)

    Esther Abels

    2017-01-01

    Full Text Available The regulatory field for digital pathology (DP has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI Systems recommended for a de novo. This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use.

  10. Current perspectives on herb-drug interactions in the European regulatory landscape.

    Science.gov (United States)

    Steinhoff, Barbara

    2012-09-01

    Herb-drug interactions have turned out not to be a major issue in the European regulatory landscape. For a minority of herbal preparations, herb-drug interactions are clinically relevant, e.g., between high-dose St.John's wort extracts and a number of chemical substances. The inclusion of adequate information on such interactions into the package leaflet is important for the safe use of the products. Information on potential interactions is also part of the official HMPC monographs. However, only for some herbal preparations described in these monographs, such a potential is known. Thus, in accordance with the relevant European guidance documents, potential interactions should be assessed critically for their clinical relevance, and a balanced assessment is required when regulatory documents are established or regulatory measures are implemented. Georg Thieme Verlag KG Stuttgart · New York.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-08-01

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

  12. The Role of Regulatory Pressure in Banks’ Capital and Risk Decisions

    Directory of Open Access Journals (Sweden)

    Alessandra Tanda

    2015-06-01

    Full Text Available Capital regulation represents the core of prudential regulation in banking. Despite the aim of the regulators to have a safer and more robust banking industry, the effects of capital regulation on banks’ capital and risk decisions appear ambiguous. The paper analyses the relationship between capital and risk changes and the impact of regulatory pressure for a sample of European banks during the period 2006–2010, which encompasses the start of the latest financial crisis. Results highlight that banks tend to adopt a different behaviour depending on the capital ratio considered, supporting the so-called ‘gamble for resurrection’ hypothesis. Evidence supports the rethinking of the regulatory framework, especially with reference to higher and stricter capital requirements.

  13. Non-Human Primate Regulatory T Cells: Current Biology and Implications for Transplantation

    Science.gov (United States)

    Dons, Eefje M.; Raimondi, Giorgio; Cooper, David K.C.; Thomson, Angus W.

    2010-01-01

    Regulatory T cells (Treg) offer potential for improving long-term outcomes in cell and organ transplantation. The non-human primate (NHP) model is a valuable resource for addressing issues concerning the transfer of Treg therapy to the clinic. Herein we discuss the properties of NHP Treg and prospects for their evaluation in allo- and xenotransplantation. PMID:20671597

  14. 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

  15. Geography of current and future global mammal extinction risk.

    Science.gov (United States)

    Davidson, Ana D; Shoemaker, Kevin T; Weinstein, Ben; Costa, Gabriel C; Brooks, Thomas M; Ceballos, Gerardo; Radeloff, Volker C; Rondinini, Carlo; Graham, Catherine H

    2017-01-01

    Identifying which species are at greatest risk, what makes them vulnerable, and where they are distributed are central goals for conservation science. While knowledge of which factors influence extinction risk is increasingly available for some taxonomic groups, a deeper understanding of extinction correlates and the geography of risk remains lacking. Here, we develop a predictive random forest model using both geospatial and mammalian species' trait data to uncover the statistical and geographic distributions of extinction correlates. We also explore how this geography of risk may change under a rapidly warming climate. We found distinctive macroecological relationships between species-level risk and extinction correlates, including the intrinsic biological traits of geographic range size, body size and taxonomy, and extrinsic geographic settings such as seasonality, habitat type, land use and human population density. Each extinction correlate exhibited ranges of values that were especially associated with risk, and the importance of different risk factors was not geographically uniform across the globe. We also found that about 10% of mammals not currently recognized as at-risk have biological traits and occur in environments that predispose them towards extinction. Southeast Asia had the most actually and potentially threatened species, underscoring the urgent need for conservation in this region. Additionally, nearly 40% of currently threatened species were predicted to experience rapid climate change at 0.5 km/year or more. Biological and environmental correlates of mammalian extinction risk exhibit distinct statistical and geographic distributions. These results provide insight into species-level patterns and processes underlying geographic variation in extinction risk. They also offer guidance for future conservation research focused on specific geographic regions, or evaluating the degree to which species-level patterns mirror spatial variation in the

  16. Geography of current and future global mammal extinction risk.

    Directory of Open Access Journals (Sweden)

    Ana D Davidson

    Full Text Available Identifying which species are at greatest risk, what makes them vulnerable, and where they are distributed are central goals for conservation science. While knowledge of which factors influence extinction risk is increasingly available for some taxonomic groups, a deeper understanding of extinction correlates and the geography of risk remains lacking. Here, we develop a predictive random forest model using both geospatial and mammalian species' trait data to uncover the statistical and geographic distributions of extinction correlates. We also explore how this geography of risk may change under a rapidly warming climate. We found distinctive macroecological relationships between species-level risk and extinction correlates, including the intrinsic biological traits of geographic range size, body size and taxonomy, and extrinsic geographic settings such as seasonality, habitat type, land use and human population density. Each extinction correlate exhibited ranges of values that were especially associated with risk, and the importance of different risk factors was not geographically uniform across the globe. We also found that about 10% of mammals not currently recognized as at-risk have biological traits and occur in environments that predispose them towards extinction. Southeast Asia had the most actually and potentially threatened species, underscoring the urgent need for conservation in this region. Additionally, nearly 40% of currently threatened species were predicted to experience rapid climate change at 0.5 km/year or more. Biological and environmental correlates of mammalian extinction risk exhibit distinct statistical and geographic distributions. These results provide insight into species-level patterns and processes underlying geographic variation in extinction risk. They also offer guidance for future conservation research focused on specific geographic regions, or evaluating the degree to which species-level patterns mirror spatial

  17. Managing the Risks of Shale Gas Development Using Innovative Legal and Regulatory Approaches

    OpenAIRE

    Olmstead, Sheila; Richardson, Nathan

    2014-01-01

    Booming production of oil and gas from shale, enabled by hydraulic fracturing technology, has led to tension between hoped-for economic benefits and feared environmental and other costs, with great associated controversy. Study of how policy can best react to these challenges and how it can balance risk and reward has focused on prescriptive regulatory responses and, to a somewhat lesser extent, voluntary industry best practices. While there is undoubtedly room for improved regulation, innova...

  18. Risk definition and management strategies in retinoblastoma: current perspectives

    Directory of Open Access Journals (Sweden)

    Ghassemi F

    2015-06-01

    Full Text Available Fariba Ghassemi, Alireza Khodabande Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Tehran Province, Islamic Republic of Iran Abstract: This manuscript focuses on high-risk factors of metastatic disease in retinoblastoma and evaluation of the current treatments of retinoblastoma. Presence of histopathologic high-risk factors is associated with a higher risk of local recurrence and systemic metastasis. Currently, globe-sparing therapies, including systemic chemotherapy, intra-arterial chemoreduction, intravitreal chemotherapy, focal consolidation, and combination therapies, are being used and investigated actively. Major advances are being made in the diagnosis and management of retinoblastoma that will lead to improved morbidity and mortality rates in patients with retinoblastoma. By saving the globes, fronting with some high-risk factors for metastasis would be inevitable. International multi-institutional prospective studies could resolve current uncertainties regarding the main tumor treatment regimens for each patient and indications for chemoprophylaxis for high-risk-factor-bearing retinoblastoma cases. Keywords: retinoblastoma, intra-arterial chemotherapy, systemic chemotherapy

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

    Science.gov (United States)

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

    2017-11-01

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

  20. Do Currently Available Blood Glucose Monitors Meet Regulatory Standards? 1-Day Public Meeting in Arlington, Virginia

    Science.gov (United States)

    Klonoff, David C.; Reyes, Juliet S.

    2013-01-01

    Blood glucose monitors (BGMs) are approved by regulatory agencies based on their performance during strict testing conducted by their manufacturers. However, after approval, there is uncertainty whether BGMs maintain the accuracy levels that were achieved in the initial data. The availability of inaccurate BGM systems pose a public health problem because their readings serve as a basis for treatment decisions that can be incorrect. Several articles have concluded that BGMs in the marketplace may not consistently provide accurate results in accordance with the regulatory standards that led to approval. To address this growing concern, Diabetes Technology Society organized and conducted a 1-day public meeting on May 21, 2013, in Arlington, VA, presided by its president, David Klonoff, M.D., FACP, Fellow AIMBE, to determine whether BGMs on the market meet regulatory standards. The meeting consisted of four sessions in which Food and Drug Administration diabetes experts as well as leading academic clinicians and clinical chemists participated: (1) How is BGM performance determined? (2) Do approved BGMs perform according to International Organization for Standardization standards? (3) How do approved BGMs perform when used by patients and health care professionals? (4) What could be the consequence of poor BGM performance? PMID:23911191

  1. Ecological models in support of regulatory risk assessments of pesticides: developing a strategy for the future.

    Science.gov (United States)

    Forbes, Valery E; Hommen, Udo; Thorbek, Pernille; Heimbach, Fred; Van den Brink, Paul J; Wogram, Jörn; Thulke, Hans-Hermann; Grimm, Volker

    2009-01-01

    This brief communication reports on the main findings of the LEMTOX workshop, held from 9 to 12 September 2007, at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. The workshop brought together a diverse group of stakeholders from academia, regulatory authorities, contract research organizations, and industry, representing Europe, the United States, and Asia, to discuss the role of ecological modeling in risk assessments of pesticides, particularly under the European regulatory framework. The following questions were addressed: What are the potential benefits of using ecological models in pesticide registration and risk assessment? What obstacles prevent ecological modeling from being used routinely in regulatory submissions? What actions are needed to overcome the identified obstacles? What recommendations should be made to ensure good modeling practice in this context? The workshop focused exclusively on population models, and discussion was focused on those categories of population models that link effects on individuals (e.g., survival, growth, reproduction, behavior) to effects on population dynamics. The workshop participants concluded that the overall benefits of ecological modeling are that it could bring more ecology into ecological risk assessment, and it could provide an excellent tool for exploring the importance of, and interactions among, ecological complexities. However, there are a number of challenges that need to be overcome before such models will receive wide acceptance for pesticide risk assessment, despite having been used extensively in other contexts (e.g., conservation biology). The need for guidance on Good Modeling Practice (on model development, analysis, interpretation, evaluation, documentation, and communication), as well as the need for case studies that can be used to explore the added value of ecological models for risk assessment, were identified as top priorities. Assessing recovery potential of exposed

  2. The Cold War legacy of regulatory risk analysis: The Atomic Energy Commission and radiation safety

    Science.gov (United States)

    Boland, Joseph B.

    From its inception in 1946 the Atomic Energy Commission pioneered the use of risk analysis as a mode of regulatory rationality and political rhetoric, yet historical treatments of risk analysis nearly always overlook the important role it played in the administration of atomic energy during the early Cold War. How this absence from history has been achieved and why it characterizes most historical accounts are the subjects of Chapter II. From there, this study goes on to develop the thesis that the advent of the atomic bomb was a world-shattering event that forced the Truman administration to choose between two novel alternatives: (1) movement towards global governance based initially on cooperative control of atomic energy or (2) unsparing pursuit of nuclear superiority. I refer to these as nuclear internationalism and nuclear nationalism, respectively. Each defined a social risk hierarchy. With the triumph of nuclear nationalism, nuclear annihilation was designated the greatest risk and a strong nuclear defense the primary means of prevention. The AEC's mission in the 1950s consisted of the rapid development of a nuclear arsenal, continual improvements in weapons technologies, and the promotion of nuclear power. The agency developed a risk-based regulatory framework through its dominant position within the National Committee on Radiation Protection. It embraced a technocratic model of risk analysis whose articulation and application it controlled, largely in secret. It used this to undergird a public rhetoric of reassurance and risk minimization. In practice, safety officials adjusted exposure levels within often wide parameters and with considerable fluidity in order to prevent safety concerns from interfering with operations. Secrecy, the political climate of the time, and a lack of accountability enabled the agency to meld technical assessments with social value judgments in a manner reflective of nuclear nationalism's risk hierarchy. In the late fifties

  3. Debate on GMOs health risks after statistical findings in regulatory tests.

    Science.gov (United States)

    de Vendômois, Joël Spiroux; Cellier, Dominique; Vélot, Christian; Clair, Emilie; Mesnage, Robin; Séralini, Gilles-Eric

    2010-10-05

    We summarize the major points of international debate on health risk studies for the main commercialized edible GMOs. These GMOs are soy, maize and oilseed rape designed to contain new pesticide residues since they have been modified to be herbicide-tolerant (mostly to Roundup) or to produce mutated Bt toxins. The debated alimentary chronic risks may come from unpredictable insertional mutagenesis effects, metabolic effects, or from the new pesticide residues. The most detailed regulatory tests on the GMOs are three-month long feeding trials of laboratory rats, which are biochemically assessed. The tests are not compulsory, and are not independently conducted. The test data and the corresponding results are kept in secret by the companies. Our previous analyses of regulatory raw data at these levels, taking the representative examples of three GM maize NK 603, MON 810, and MON 863 led us to conclude that hepatorenal toxicities were possible, and that longer testing was necessary. Our study was criticized by the company developing the GMOs in question and the regulatory bodies, mainly on the divergent biological interpretations of statistically significant biochemical and physiological effects. We present the scientific reasons for the crucially different biological interpretations and also highlight the shortcomings in the experimental protocols designed by the company. The debate implies an enormous responsibility towards public health and is essential due to nonexistent traceability or epidemiological studies in the GMO-producing countries.

  4. 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.

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

    Science.gov (United States)

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-01-01

    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. PMID:26344953

  6. 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.

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

    Science.gov (United States)

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

    2013-09-01

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

  8. 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).

  9. Smoothed nonparametric estimation for current status competing risks data

    OpenAIRE

    Chenxi Li; Jason P. Fine

    2013-01-01

    We study the nonparametric estimation of the cumulative incidence function and the cause-specific hazard function for current status data with competing risks via kernel smoothing. A smoothed naive nonparametric maximum likelihood estimator and a smoothed full nonparametric maximum likelihood estimator are shown to have pointwise asymptotic normality and faster convergence rates than the corresponding unsmoothed nonparametric likelihood estimators. Using the smoothed estimators and the plug-i...

  10. Current status of IL-10 and regulatory T-cells in cancer

    Science.gov (United States)

    Dennis, Kristen L.; Blatner, Nichole R.; Gounari, Fotini; Khazaie, Khashayarsha

    2014-01-01

    Purpose of review Tumor growth elicits antigen-specific cytotoxic as well as immune suppressive responses. Interleukin-10 (IL-10) is a key immune-suppressive cytokine produced by regulatory T-cells (Tregs) and by helper T-cells (TH). Here we review pleiotropic functions of IL-10 that impact the immune pathology of cancer. Recent findings The role of IL-10 in cancer has become less certain with knowledge of its immune stimulatory functions. IL-10 is needed for T-helper cell functions, T-cell immune surveillance, and suppression of cancer-associated inflammation. By promoting tumor specific immune surveillance and hindering pathogenic inflammation IL-10 is emerging as a key cytokine in the battle of the host against cancer. Summary IL-10 functions at the cross roads of immune stimulation and immune suppression in cancer. Immunological mechanisms of action of IL-10 can be ultimately exploited to develop novel and effective cancer therapies. PMID:24076584

  11. Scientists versus Regulators: Precaution, Novelty & Regulatory Oversight as Predictors of Perceived Risks of Engineered Nanomaterials

    Science.gov (United States)

    Beaudrie, Christian E. H.; Satterfield, Terre; Kandlikar, Milind; Harthorn, Barbara H.

    2014-01-01

    Engineered nanoscale materials (ENMs) present a difficult challenge for risk assessors and regulators. Continuing uncertainty about the potential risks of ENMs means that expert opinion will play an important role in the design of policies to minimize harmful implications while supporting innovation. This research aims to shed light on the views of ‘nano experts’ to understand which nanomaterials or applications are regarded as more risky than others, to characterize the differences in risk perceptions between expert groups, and to evaluate the factors that drive these perceptions. Our analysis draws from a web-survey (N = 404) of three groups of US and Canadian experts: nano-scientists and engineers, nano-environmental health and safety scientists, and regulatory scientists and decision-makers. Significant differences in risk perceptions were found across expert groups; differences found to be driven by underlying attitudes and perceptions characteristic of each group. Nano-scientists and engineers at the upstream end of the nanomaterial life cycle perceived the lowest levels of risk, while those who are responsible for assessing and regulating risks at the downstream end perceived the greatest risk. Perceived novelty of nanomaterial risks, differing preferences for regulation (i.e. the use of precaution versus voluntary or market-based approaches), and perceptions of the risk of technologies in general predicted variation in experts' judgments of nanotechnology risks. Our findings underscore the importance of involving a diverse selection of experts, particularly those with expertise at different stages along the nanomaterial lifecycle, during policy development. PMID:25222742

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

    Science.gov (United States)

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

    2017-11-01

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

  13. Money laundering regulatory risk evaluation using Bitmap Index-based Decision Tree

    Directory of Open Access Journals (Sweden)

    Vikas Jayasree

    2017-06-01

    Full Text Available This paper proposes to evaluate the adaptability risk in money laundering using Bitmap Index-based Decision Tree (BIDT technique. Initially, the Bitmap Index-based Decision Tree learning is used to induce the knowledge tree which helps to determine a company’s money laundering risk and improve scalability. A bitmap index in BIDT is used to effectively access large banking databases. In a BIDT bitmap index, account in a table is numbered in sequence with each key value, account number and a bitmap (array of bytes used instead of a list of row ids. Subsequently, BIDT algorithm uses the “select” query performance to apply count and bit-wise logical operations on AND. Query result coincides exactly to build a decision tree and more precisely to evaluate the adaptability risk in the money laundering operation. For the root node, the main account of the decision tree, the population frequencies are obtained by simply counting the total number of “1” in the bitmaps constructed on the attribute to predict money laundering and evaluate the risk factor rate. The experiment is conducted on factors such as regulatory risk rate, false positive rate, and risk identification time.

  14. The Impact on Athletes of the Current Regulatory Scheme for Dietary Supplements

    OpenAIRE

    Kruzer, Lyndsey

    2009-01-01

    This paper uses the popularity of dietary supplements among athletes and the possibility that such athletes may unknowingly fail drug tests because of said supplements as a lens for examining some of the weaknesses caused by the FDA’s current limited authority over the supplement industry. After providing an outline of both the current state of the law with respect to dietary supplements and the regulations and liability to which athletes are subject, I emphasize the impact and potential con...

  15. A review of human biomonitoring data used in regulatory risk assessment under Canada's Chemicals Management Program.

    Science.gov (United States)

    Zidek, Angelika; Macey, Kristin; MacKinnon, Leona; Patel, Mikin; Poddalgoda, Devika; Zhang, Yi

    2017-03-01

    As a part of the Chemicals Management Plan launched in 2006, the Government of Canada is assessing and managing, where appropriate, the potential health and ecological risks associated with approximately 4300 substances under the Canadian Environmental Protection Act (1999). Since that time, nearly 3000 substances have been assessed, with human biomonitoring (HBM) data playing an increasingly important role for some substances. Case studies are presented, including both inorganic and organic substances (i.e., selenium, triclosan, phthalates), which highlight the impact and overall role HBM has had in regulatory decision making in Canada for these three substances as well as criteria used in the application of HBM data in human health risk assessment. An overview of its limitations in terms of how and when HBM data can be applied, when assessing human health in a regulatory setting, is discussed as well as the role HBM data can play in priority setting. Crown Copyright © 2016. Published by Elsevier GmbH. All rights reserved.

  16. Evaluation of spot and passive sampling for monitoring, flux estimation and risk assessment of pesticides within the constraints of a typical regulatory monitoring scheme.

    Science.gov (United States)

    Zhang, Zulin; Troldborg, Mads; Yates, Kyari; Osprey, Mark; Kerr, Christine; Hallett, Paul D; Baggaley, Nikki; Rhind, Stewart M; Dawson, Julian J C; Hough, Rupert L

    2016-11-01

    In many agricultural catchments of Europe and North America, pesticides occur at generally low concentrations with significant temporal variation. This poses several challenges for both monitoring and understanding ecological risks/impacts of these chemicals. This study aimed to compare the performance of passive and spot sampling strategies given the constraints of typical regulatory monitoring. Nine pesticides were investigated in a river currently undergoing regulatory monitoring (River Ugie, Scotland). Within this regulatory framework, spot and passive sampling were undertaken to understand spatiotemporal occurrence, mass loads and ecological risks. All the target pesticides were detected in water by both sampling strategies. Chlorotoluron was observed to be the dominant pesticide by both spot (maximum: 111.8ng/l, mean: 9.35ng/l) and passive sampling (maximum: 39.24ng/l, mean: 4.76ng/l). The annual pesticide loads were estimated to be 2735g and 1837g based on the spot and passive sampling data, respectively. The spatiotemporal trend suggested that agricultural activities were the primary source of the compounds with variability in loads explained in large by timing of pesticide applications and rainfall. The risk assessment showed chlorotoluron and chlorpyrifos posed the highest ecological risks with 23% of the chlorotoluron spot samples and 36% of the chlorpyrifos passive samples resulting in a Risk Quotient greater than 0.1. This suggests that mitigation measures might need to be taken to reduce the input of pesticides into the river. The overall comparison of the two sampling strategies supported the hypothesis that passive sampling tends to integrate the contaminants over a period of exposure and allows quantification of contamination at low concentration. The results suggested that within a regulatory monitoring context passive sampling was more suitable for flux estimation and risk assessment of trace contaminants which cannot be diagnosed by spot

  17. Non-Chemical Stressors and Cumulative Risk Assessment: An Overview of Current Initiatives and Potential Air Pollutant Interactions

    Science.gov (United States)

    Lewis, Ari S.; Sax, Sonja N.; Wason, Susan C.; Campleman, Sharan L.

    2011-01-01

    Regulatory agencies are under increased pressure to consider broader public health concerns that extend to multiple pollutant exposures, multiple exposure pathways, and vulnerable populations. Specifically, cumulative risk assessment initiatives have stressed the importance of considering both chemical and non-chemical stressors, such as socioeconomic status (SES) and related psychosocial stress, in evaluating health risks. The integration of non-chemical stressors into a cumulative risk assessment framework has been largely driven by evidence of health disparities across different segments of society that may also bear a disproportionate risk from chemical exposures. This review will discuss current efforts to advance the field of cumulative risk assessment, highlighting some of the major challenges, discussed within the construct of the traditional risk assessment paradigm. Additionally, we present a summary of studies of potential interactions between social stressors and air pollutants on health as an example of current research that supports the incorporation of non-chemical stressors into risk assessment. The results from these studies, while suggestive of possible interactions, are mixed and hindered by inconsistent application of social stress indicators. Overall, while there have been significant advances, further developments across all of the risk assessment stages (i.e., hazard identification, exposure assessment, dose-response, and risk characterization) are necessary to provide a scientific basis for regulatory actions and effective community interventions, particularly when considering non-chemical stressors. A better understanding of the biological underpinnings of social stress on disease and implications for chemical-based dose-response relationships is needed. Furthermore, when considering non-chemical stressors, an appropriate metric, or series of metrics, for risk characterization is also needed. Cumulative risk assessment research will benefit

  18. Regulatory Forum commentary: alternative mouse models for future cancer risk assessment.

    Science.gov (United States)

    Morton, Daniel; Sistare, Frank D; Nambiar, Prashant R; Turner, Oliver C; Radi, Zaher; Bower, Nancy

    2014-07-01

    International regulatory and pharmaceutical industry scientists are discussing revision of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) S1 guidance on rodent carcinogenicity assessment of small molecule pharmaceuticals. A weight-of-evidence approach is proposed to determine the need for rodent carcinogenicity studies. For compounds with high human cancer risk, the product may be labeled appropriately without conducting rodent carcinogenicity studies. For compounds with minimal cancer risk, only a 6-month transgenic mouse study (rasH2 mouse or p53+/- mouse) or a 2-year mouse study would be needed. If rodent carcinogenicity testing may add significant value to cancer risk assessment, a 2-year rat study and either a 6-month transgenic mouse or a 2-year mouse study is appropriate. In many cases, therefore, one rodent carcinogenicity study could be sufficient. The rasH2 model predicts neoplastic findings relevant to human cancer risk assessment as well as 2-year rodent models, produces fewer irrelevant neoplastic outcomes, and often will be preferable to a 2-year rodent study. Before revising ICH S1 guidance, a prospective evaluation will be conducted to test the proposed weight-of-evidence approach. This evaluation offers an opportunity for a secondary analysis comparing the value of alternative mouse models and 2-year rodent studies in the proposed ICH S1 weight-of-evidence approach for human cancer risk assessment. © 2014 by The Author(s).

  19. Finding Groups Using Model-based Cluster Analysis: Heterogeneous Emotional Self-regulatory Processes and Heavy Alcohol Use Risk

    Science.gov (United States)

    Mun, Eun-Young; von Eye, Alexander; Bates, Marsha E.; Vaschillo, Evgeny G.

    2010-01-01

    Model-based cluster analysis is a new clustering procedure to investigate population heterogeneity utilizing finite mixture multivariate normal densities. It is an inferentially based, statistically principled procedure that allows comparison of non-nested models using the Bayesian Information Criterion (BIC) to compare multiple models and identify the optimum number of clusters. The current study clustered 36 young men and women based on their baseline heart rate (HR) and HR variability (HRV), chronic alcohol use, and reasons for drinking. Two cluster groups were identified and labeled High Alcohol Risk and Normative groups. Compared to the Normative group, individuals in the High Alcohol Risk group had higher levels of alcohol use and more strongly endorsed disinhibition and suppression reasons for use. The High Alcohol Risk group showed significant HRV changes in response to positive and negative emotional and appetitive picture cues, compared to neutral cues. In contrast, the Normative group showed a significant HRV change only to negative cues. Findings suggest that the individuals with autonomic self-regulatory difficulties may be more susceptible to heavy alcohol use and use alcohol for emotional regulation. PMID:18331138

  20. Regulatory Behaviors and Stress Reactivity among Infants at High Risk for Fetal Alcohol Spectrum Disorders: An Exploratory Study

    Science.gov (United States)

    Jirikowic, Tracy; Chen, Maida; Nash, Jennifer; Gendler, Beth; Olson, Heather Carmichael

    2016-01-01

    Introduction: This article examines regulatory behaviors and physiological stress reactivity among 6-15 month-old infants with moderate to heavy prenatal alcohol exposure (PAE), a group at very high risk for fetal alcohol spectrum disorders and self-regulation impairments, compared to low risk infants with no/low exposure. Participants: Eighteen…

  1. Risk management of seasonal influenza during pregnancy: current perspectives

    Directory of Open Access Journals (Sweden)

    Yudin MH

    2014-07-01

    Full Text Available Mark H Yudin The Department of Obstetrics and Gynecology, St Michael's Hospital, Li Ka Shing Knowledge Institute, University of Toronto, Toronto, ON, Canada Abstract: Influenza poses unique risks to pregnant women, who are particularly susceptible to morbidity and mortality. Historically, pregnant women have been overrepresented among patients with severe illness and complications from influenza, and have been more likely to require hospitalization and intensive care unit admission. An increased risk of adverse outcomes is also present for fetuses/neonates born to women affected by influenza during pregnancy. These risks to mothers and babies have been observed during both nonpandemic and pandemic influenza seasons. During the H1N1 influenza pandemic of 2009–2010, pregnant women were more likely to be hospitalized or admitted to intensive care units, and were at higher risk of death compared to nonpregnant adults. Vaccination remains the most effective intervention to prevent severe illness, and antiviral medications are an important adjunct to ameliorate disease when it occurs. Unfortunately, despite national guidelines recommending universal vaccination for women who are pregnant during influenza season, actual vaccination rates do not achieve desired targets among pregnant women. Pregnant women are also sometimes reluctant to use antiviral medications during pregnancy. Some of the barriers to use of vaccines and medications during pregnancy are a lack of knowledge of recommendations and of safety data. By improving knowledge and understanding of influenza and vaccination recommendations, vaccine acceptance rates among pregnant women can be improved. Currently, the appropriate use of vaccination and antiviral medications is the best line of defense against influenza and its sequelae among pregnant women, and strategies to increase acceptance are crucial. This article will review the importance of influenza in pregnancy, and discuss

  2. 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. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

  3. State risk discourse and the regulatory preservation of traditional medicine knowledge: The case of acupuncture in Ontario, Canada.

    Science.gov (United States)

    Ijaz, Nadine; Boon, Heather; Muzzin, Linda; Welsh, Sandy

    2016-12-01

    Several United Nations bodies have advised countries to actively preserve Traditional Medicine (TM) knowledge and prevent its misappropriation in regulatory structures. To help advance decision-making around this complex regulatory issue, we examine the relationship between risk discourse, epistemology and policy. This study presents a critical, postcolonial analysis of divergent risk discourses elaborated in two contrasting Ontario (Canada) government reports preceding that jurisdiction's regulation of acupuncture, the world's most widely practised TM therapy. The earlier (1996) report, produced when Ontario's regulatory lobby was largely comprised of Chinese medicine practitioners, presents a risk discourse inclusive of biomedical and TM knowledge claims, emphasizing the principle of regulatory 'equity' as well as historical and sociocultural considerations. Reflecting the interests of an increasingly biomedical practitioner lobby, the later (2001) report uses implicit discursive means to exclusively privilege Western scientific perspectives on risk. This report's policy recommendations, we argue, suggest misappropriation of TM knowledge. We advise regulators to consider equitable adaptations to existing policy structures, and to explicitly include TM evidentiary perspectives in their pre-regulatory assessments. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  4. Current and future flood risk to railway infrastructure in Europe

    Science.gov (United States)

    Bubeck, Philip; Kellermann, Patric; Alfieri, Lorenzo; Feyen, Luc; Dillenardt, Lisa; Thieken, Annegret H.

    2017-04-01

    CORINE, due to their line shapes. To assess current and future damage and risk to railway infrastructure in Europe, we apply the damage model RAIL -' RAilway Infrastructure Loss' that was specifically developed for railway infrastructure using empirical damage data. To adequately and comprehensively capture the line-shaped features of railway infrastructure, the assessment makes use of the open-access data set of openrailway.org. Current and future flood hazard in Europe is obtained with the LISFLOOD-based pan-European flood hazard mapping procedure combined with ensemble projections of extreme streamflow for the current century based on EURO-CORDEX RCP 8.5 climate scenarios. The presentation shows first results of the combination of the hazard data and the model RAIL for Europe.

  5. Botanicals in Dermatology: Essential Oils, Botanical Allergens, and Current Regulatory Practices.

    Science.gov (United States)

    Mortimer, Sarah; Reeder, Margo

    Largely because of their perceived safety, the use of essential oils and other botanically derived products has become increasingly popular. Recent evidence raises concern about the safety of these products, frequently found in cosmetics and sought as an alternative to standard medical treatments. Essential oils are challenging to standardize because of the variable growing conditions, genetics, and harvesting of botanicals. There exists a potential for adverse reactions, in particular allergic contact dermatitis. Furthermore, these products are often sold without prior Food and Drug Administration approval of efficacy and safety. This review focuses on the composition of essential oils, their common associated botanical allergens, and current regulation practices of botanical drug products in the United States and Europe.

  6. Migraine and Risk of Stroke: Review of Current Evidence

    Directory of Open Access Journals (Sweden)

    Sadeghi

    2014-07-01

    Full Text Available Context Migraine is a kind of primary headache that affects 10% to 20% of people worldwide. Recent studies have shown that migraines can be involved in strokes incidences, especially ischemic strokes.Hence, the current study aimed to review evidence in relation to migraine and risk of stroke. Evidence Acquisition A literature search was done for related articles dated between 1993 and 2013 on PubMed, Science Direct, Embase, Web of Science and Scopus for both English and non-English language articles by entering “migraine”, “migraine with aura”, “headache” and “ischemic and hemorrhagic stroke” as keywords. Results In most evaluated studies, there was a positive association between migraine with aura (MA and strokes incidences, especially ischemic strokes. Moreover, patients with high frequency of migraine attacks had greater odds of having a stroke compared with those who had low frequency of migraine attacks. Also, the association between migraine and stroke was more significant in subjects under 45 years old. Some migraine symptoms such as vomiting and nausea had a protective role in the development of ischemic strokes. Conclusions Migraine, especially MA, is a risk factor for incidences of strokes, especially ischemic strokes. However, due to conflicting results on the association between different types of migraine and stroke, more studies are needed in this field.

  7. Current topics on software use in medicinal chemistry: intellectual property, taxes, and regulatory issues.

    Science.gov (United States)

    Duardo-Sánchez, Aliuska; Patlewicz, Grace; López-Díaz, Antonio

    2008-01-01

    In recent times, there has been an increased use of software and computational models in Medicinal Chemistry, both for the prediction of effects such as drug-target interactions, as well as for the development of (Quantitative) Structure-Activity Relationships ((Q)SAR). Whilst the ultimate goal of Medicinal Chemistry research is for the discovery of new drug candidates, a secondary yet important outcome that results is in the creation of new computational tools. The adoption of computational tools by medicinal chemists is sadly, and all too often accompanied, by a lack of understanding of the legal aspects related to software and model use, that is, the copyright protection of new medicinal chemistry software and software-mediated discovered products. This article aims to provide a reference to the various legal avenues that are available for the protection of software, and the acceptance and legal treatment of scientific results and techniques derived from such software. An overview of relevant international tax issues is also presented. We have considered cases of patents protecting software, models, and/or new compounds discovered using methods such as molecular modeling or QSAR. This paper has been written and compiled by the authors as a review of current topics and trends on the legal issues in certain fields of Medicinal Chemistry and as such is not intended to be exhaustive.

  8. High risk of unprecedented UK rainfall in the current climate.

    Science.gov (United States)

    Thompson, Vikki; Dunstone, Nick J; Scaife, Adam A; Smith, Doug M; Slingo, Julia M; Brown, Simon; Belcher, Stephen E

    2017-07-24

    In winter 2013/14 a succession of storms hit the UK leading to record rainfall and flooding in many regions including south east England. In the Thames river valley there was widespread flooding, with clean-up costs of over £1 billion. There was no observational precedent for this level of rainfall. Here we present analysis of a large ensemble of high-resolution initialised climate simulations to show that this event could have been anticipated, and that in the current climate there remains a high chance of exceeding the observed record monthly rainfall totals in many regions of the UK. In south east England there is a 7% chance of exceeding the current rainfall record in at least one month in any given winter. Expanding our analysis to some other regions of England and Wales the risk increases to a 34% chance of breaking a regional record somewhere each winter.A succession of storms during the 2013-2014 winter led to record flooding in the UK. Here, the authors use high-resolution climate simulations to show that this event could have been anticipated and that there remains a high chance of exceeding observed record monthly rainfall totals in many parts of the UK.

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

    Science.gov (United States)

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

    2010-03-01

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

  10. Why different regulatory decisions when the scientific information base is similar?--Human risk assessment.

    Science.gov (United States)

    Nilsson, R; Tasheva, M; Jaeger, B

    1993-06-01

    The main objective of this analysis has been to characterize the role of science, in a broad sense, in relation to social, economical, political, and other factors in explaining why regulatory decisions vary in different countries, although they are based on more or less identical scientific data. Eleven countries from different geographical areas and with varying cultural background have provided information in response to an extensive questionnaire aimed at identifying procedures for registration, restricting, or banning registration for certain selected pesticides. Although many of these responses lacked sufficient detail in certain aspects, together with other documentary sources they nonetheless provided insight with respect to some of the main concerns among and between nations regarding decisions in pesticide management. Among the main conclusions presented in this analysis, the following deserves particular emphasis: The underlying reasons for introducing restrictions on pesticide use on the national level will have to be more explicitly stated and openly declared by regulatory bodies of all nations. Although more pronounced in some countries, there is a strong influence of nonscientific considerations in pesticide management, that is not always based on rational considerations. In the field of hazard and risk assessment differences in scientific opinion have primarily, but not exclusively been identified regarding the evaluation of carcinogenic effects in experimental animals. In this area debated issues are the interpretation of the significance for man of certain types of tumors, methods for dose-response extrapolation, genotoxic versus nongenotoxic carcinogens, the use of MTD in long-term studies, mechanistic approaches to interpret cancer induction, and others. Another area identified to cause divergence is exposure assessment. Evaluation of pesticides on the national level for the purpose of regulation involves a tremendous duplication of efforts that

  11. Food allergy and risk assessment: Current status and future directions

    Science.gov (United States)

    Remington, Benjamin C.

    2017-09-01

    Risk analysis is a three part, interactive process that consists of a scientific risk assessment, a risk management strategy and an exchange of information through risk communication. Quantitative risk assessment methodologies are now available and widely used for assessing risks regarding the unintentional consumption of major, regulated allergens but new or modified proteins can also pose a risk of de-novo sensitization. The risks due to de-novo sensitization to new food allergies are harder to quantify. There is a need for a systematic, comprehensive battery of tests and assessment strategy to identify and characterise de-novo sensitization to new proteins and the risks associated with them. A risk assessment must be attuned to answer the risk management questions and needs. Consequently, the hazard and risk assessment methods applied and the desired information are determined by the requested outcome for risk management purposes and decisions to be made. The COST Action network (ImpARAS, www.imparas.eu) has recently started to discuss these risk management criteria from first principles and will continue with the broader subject of improving strategies for allergen risk assessment throughout 2016-2018/9.

  12. Bank Interest Margin and Default Risk under Basel III Capped Capital Adequacy Accord and Regulatory Deposit Insurance Fund Protection

    OpenAIRE

    Chuen-Ping Chang; Shi Chen

    2015-01-01

    We study the optimal bank interest margin and default risk under the capped ratio schedule of government capital instruments in the Basel III Capital Adequacy Accord and the Deposit Insurance Fund arrangement program. We show that an increase in the capped ratio (a decrease in the capped government capital injection) increases the default risk in the bank¡¯s equity return at a reduced interest margin. Regulatory deposit insurance fund protection reinforces the reduced bank interest margin and...

  13. Canadian drug regulatory framework.

    Science.gov (United States)

    Kelly, L; Lazzaro, M; Petersen, C

    2007-03-01

    The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues.

  14. Calcium and phosphorus regulatory hormones and risk of incident symptomatic kidney stones.

    Science.gov (United States)

    Taylor, Eric N; Hoofnagle, Andrew N; Curhan, Gary C

    2015-04-07

    Calcium and phosphorus regulatory hormones may contribute to the pathogenesis of calcium nephrolithiasis. However, there has been no prospective study to date of plasma hormone levels and risk of kidney stones. This study aimed to examine independent associations between plasma levels of 1,25-dihydroxyvitamin D (1,25[OH]2D), 25-hydroxyvitamin D, 24,25-dihydroxyvitamin D, fibroblast growth factor 23 (FGF23), parathyroid hormone, calcium, phosphate, and creatinine and the subsequent risk of incident kidney stones. This study was a prospective, nested case-control study of men in the Health Professionals Follow-Up Study who were free of diagnosed nephrolithiasis at blood draw. During 12 years of follow-up, 356 men developed an incident symptomatic kidney stone. Using risk set sampling, controls were selected in a 2:1 ratio (n=712 controls) and matched for age, race, and year, month, and time of day of blood collection. Baseline plasma levels of 25-hydroxyvitamin D, 24,25-dihydroxyvitamin D, parathyroid hormone, calcium, phosphate, and creatinine were similar in cases and controls. Mean 1,25(OH)2D and median FGF23 levels were higher in cases than controls but differences were small and statistically nonsignificant (45.7 versus 44.2 pg/ml, P=0.07 for 1,25[OH]2D; 47.6 versus 45.1 pg/ml, P=0.08 for FGF23). However, after adjusting for body mass index, diet, plasma factors, and other covariates, the odds ratios of incident symptomatic kidney stones in the highest compared with lowest quartiles were 1.73 (95% confidence interval, 1.11 to 2.71; P for trend 0.01) for 1,25(OH)2D and 1.45 (95% confidence interval, 0.96 to 2.19; P for trend 0.03) for FGF23. There were no significant associations between other plasma factors and kidney stone risk. Higher plasma 1,25(OH)2D, even in ranges considered normal, is independently associated with higher risk of symptomatic kidney stones. Although of borderline statistical significance, these findings also suggest that higher FGF23 may be

  15. 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.

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

    Directory of Open Access Journals (Sweden)

    L Feris

    2006-05-01

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

  17. Does flood risk information held within at risk population always have a positive impact? An evaluation of the effects of French regulatory tools in Orleans

    Directory of Open Access Journals (Sweden)

    Jadot Julien

    2016-01-01

    Full Text Available French law on major risk preventive information for population setup the objective to make the citizen able to act for his own safety and to participate through his behaviour to the civil security. To reach this objective, the policymakers developed 4 regulatory tools that have to be implemented by the local authorities. These 4 tools do not meet the success factors of risk communication measures aiming at inducing behavioural adaptation to face risks. This, added to the fact that people who die in the last floods events in France lost their lives due to either a lack of knowledge of the risk or to a risk taking behaviour, led us to question the impact of the preventive information regulatory tools. For the needs of our study we developed a risk perception and behaviour scale, helping us to classify the people of our sample. Our evaluation in Orléans shows that very few people know the regulatory tools and that their impact is quite low, far from the policymakers’ expectations. This highlight the real necessity to innovate in the field of flood risk communication.

  18. Impacts of the regulatory model for market risk capital: application in a special savings company, an insurance company, and a pension fund

    Directory of Open Access Journals (Sweden)

    Betty Lilian Chan

    Full Text Available ABSTRACT In line with the regulation brought in by Solvency II, the Superintendence of Private Insurance (Susep introduced the market risk capital requirement at the end of 2015, with 50% of the minimum capital for this type of risk being required by December 31st 2016 and 100% the following year. This regulatory model consists of calculating parametric value at risk with a 99% confidence level and a three month time horizon, using the net exposure of expected cash flows from assets and liabilities and a covariance matrix updated with market data up to July 2014. One limitation of this regulatory approach is that the updating of the covariance matrix depends on prior approval by the National Council of Private Insurance, which can limit the frequency the covariance matrix is updated and the model’s adherence to the current market reality. As this matrix considers the period before the presidential election, the country’s loss of investment grade status, and the impeachment process, which all contributed to an increase in market volatility, this paper analyses the impacts of applying the regulatory model, considering the market volatility updated to December 31st 2015, for a special savings company (sociedade de capitalização, an insurance company, and an pension fund. Furthermore, the paper discusses the practical implications of the new market risk requirement for managing the investments of the entities supervised by Susep, listing the various assumptions that can be used in the regulated entities’ Asset and Liability Management decision models and possible trade-offs to be addressed in this process.

  19. Food allergy guidelines and assessing allergic reaction risks: a regulatory perspective.

    Science.gov (United States)

    Luccioli, Stefano

    2012-06-01

    To review information in food allergy guidelines and the literature on assessing and understanding food allergic reaction risks. Current food allergy guidelines have focused on tools for better diagnosis of food allergy and treatment of reactions. These guidelines have not addressed the growing body of literature on risk assessment and diagnostic tools being used to assess dose-response relationships in relation to food-allergen exposures. The literature includes substantial data from food-allergen challenges performed in sensitive individuals, and probabilistic modeling of these data may help to elucidate the relationship between allergen dose exposures, including thresholds, and reaction risk in allergic individuals. Understanding this relationship has potential to improve the health-related quality of life of allergic consumers. Recent findings in the literature have highlighted improved diagnostic tools and other information that can be used to assess risks for allergic reaction to low-dose allergen exposures (thresholds) and reaction severity in food allergic consumers. Recommendations to better define and stratify allergic reaction risks for consumers could be adopted into guidelines for the diagnosis and clinical management of food allergy.

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

    DEFF Research Database (Denmark)

    Peiser, M; Tralau, T; Heidler, J

    2012-01-01

    in the field of contact dermatitis. This included the epidemiology and molecular biology of contact allergy, as well as the development of new in vitro methods. Furthermore, it considered regulatory aspects aiming to reduce exposure to contact sensitisers. An estimated 15-20% of the general population suffers...... potential contact allergens. However, the local lymph node assay (LLNA) presently remains the validated method of choice for hazard identification and characterisation. At the workshop the use of the LLNA for regulatory purposes and for quantitative risk assessment was also discussed....

  1. The effects of message framing and risk perceptions for HPV vaccine campaigns: focus on the role of regulatory fit.

    Science.gov (United States)

    Park, Sun-Young

    2012-01-01

    This study investigates the effects of framing and risk perception, and their interaction effects on human papillomavirus (HPV) vaccination. Based on a 2 (message frames) × 2 (perceived risk) experimental design, the interaction effects reveal the effectiveness of loss- (vs. gain-) framed messages would be maximized for high (vs. low) perceived risk condition. Based on regulatory fit principles the synergy effects are shown in terms of attitudes toward advertising and HPV vaccination, HPV vaccination intention, and ad-promoted behavioral intention. The findings indicate right message appeals should be selected for the right target audiences in the setting of HPV vaccine promotions.

  2. Are Lead Exposures a Risk in European Fresh Waters? A Regulatory Assessment Accounting for Bioavailability.

    Science.gov (United States)

    Peters, Adam; Wilson, Iain; Merrington, Graham; Chowdhury, M Jasim

    2018-01-01

    An indicative compliance assessment of the Europe-wide bioavailable lead Environmental Quality Standard of 1.2 µg L-1 (EQS) was undertaken against regulatory freshwater monitoring data from six European member states and FOREGS database. Bio-met, a user-friendly tool based upon Biotic Ligand Models (BLMs) was used to account for bioavailability, along with the current European Water Framework Directive lead dissolved organic carbon correction approach. The outputs from both approaches were compared to the BLM. Of the 9054 freshwater samples assessed only 0.6% exceeded the EQS of 1.2 µg L-1 after accounting for bioavailability. The data showed that ambient background concentrations of lead across Europe are unlikely to influence general compliance with the EQS, although there may be isolated local issues. The waters showing the greatest sensitivity to potential lead exposures are characterized by relatively low DOC (< 0.5 mg L-1), regardless of the pH and calcium concentrations.

  3. Determinants of cardiovascular risk in current rheumatic practice

    NARCIS (Netherlands)

    Meek, I.L.

    2014-01-01

    The aim of this thesis was to study cardiovascular risk in arthritis: Firstly, how do different rheumatic diseases compare in the patients’ traditional cardiovascular (CV) risk factor profiles, and does this justify the general focus on rheumatoid arthritis regarding cardiovascular complications in

  4. The Current Status of Graduate Training in Suicide Risk Assessment

    Science.gov (United States)

    Liebling-Boccio, Dana E.; Jennings, Heather R.

    2013-01-01

    Directors and coordinators (n = 75) of graduate programs in school psychology approved by the National Association of School Psychologists (NASP) were surveyed regarding their training practices in suicide risk assessment. Respondents viewed the assessment of suicide risk as an important part of graduate instruction, and most believed that…

  5. New risk metrics and mathematical tools for risk analysis: Current and future challenges

    Energy Technology Data Exchange (ETDEWEB)

    Skandamis, Panagiotis N., E-mail: pskan@aua.gr; Andritsos, Nikolaos, E-mail: pskan@aua.gr; Psomas, Antonios, E-mail: pskan@aua.gr; Paramythiotis, Spyridon, E-mail: pskan@aua.gr [Laboratory of Food Quality Control and Hygiene, Department of Food Science and Technology, Agricultural University of Athens, Iera Odos 75, 118 55, Athens (Greece)

    2015-01-22

    The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) the Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total ‘failure’ that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user

  6. New risk metrics and mathematical tools for risk analysis: Current and future challenges

    Science.gov (United States)

    Skandamis, Panagiotis N.; Andritsos, Nikolaos; Psomas, Antonios; Paramythiotis, Spyridon

    2015-01-01

    The current status of the food safety supply world wide, has led Food and Agriculture Organization (FAO) and World Health Organization (WHO) to establishing Risk Analysis as the single framework for building food safety control programs. A series of guidelines and reports that detail out the various steps in Risk Analysis, namely Risk Management, Risk Assessment and Risk Communication is available. The Risk Analysis approach enables integration between operational food management systems, such as Hazard Analysis Critical Control Points, public health and governmental decisions. To do that, a series of new Risk Metrics has been established as follows: i) the Appropriate Level of Protection (ALOP), which indicates the maximum numbers of illnesses in a population per annum, defined by quantitative risk assessments, and used to establish; ii) Food Safety Objective (FSO), which sets the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. Given that ALOP is rather a metric of the public health tolerable burden (it addresses the total `failure' that may be handled at a national level), it is difficult to be interpreted into control measures applied at the manufacturing level. Thus, a series of specific objectives and criteria for performance of individual processes and products have been established, all of them assisting in the achievement of FSO and hence, ALOP. In order to achieve FSO, tools quantifying the effect of processes and intrinsic properties of foods on survival and growth of pathogens are essential. In this context, predictive microbiology and risk assessment have offered an important assistance to Food Safety Management. Predictive modelling is the basis of exposure assessment and the development of stochastic and kinetic models, which are also available in the form of Web-based applications, e.g., COMBASE and Microbial Responses Viewer), or introduced into user-friendly softwares

  7. Capsaicinoids Modulating Cardiometabolic Syndrome Risk Factors: Current Perspectives

    Directory of Open Access Journals (Sweden)

    Vijaya Juturu

    2016-01-01

    Full Text Available Capsaicinoids are bioactive nutrients present within red hot peppers reported to cut ad libitum food intake, to increase energy expenditure (thermogenesis and lipolysis, and to result in weight loss over time. In addition it has shown more benefits such as improvement in reducing oxidative stress and inflammation, improving vascular health, improving endothelial function, lowering blood pressure, reducing endothelial cytokines, cholesterol lowering effects, reducing blood glucose, improving insulin sensitivity, and reducing inflammatory risk factors. All these beneficial effects together help to modulate cardiometabolic syndrome risk factors. The early identification of cardiometabolic risk factors can help try to prevent obesity, hypertension, diabetes, and cardiovascular disease.

  8. Capsaicinoids Modulating Cardiometabolic Syndrome Risk Factors: Current Perspectives.

    Science.gov (United States)

    Juturu, Vijaya

    2016-01-01

    Capsaicinoids are bioactive nutrients present within red hot peppers reported to cut ad libitum food intake, to increase energy expenditure (thermogenesis) and lipolysis, and to result in weight loss over time. In addition it has shown more benefits such as improvement in reducing oxidative stress and inflammation, improving vascular health, improving endothelial function, lowering blood pressure, reducing endothelial cytokines, cholesterol lowering effects, reducing blood glucose, improving insulin sensitivity, and reducing inflammatory risk factors. All these beneficial effects together help to modulate cardiometabolic syndrome risk factors. The early identification of cardiometabolic risk factors can help try to prevent obesity, hypertension, diabetes, and cardiovascular disease.

  9. 75 FR 55619 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Proposed...

    Science.gov (United States)

    2010-09-13

    ... Theoretical Analysis and Numerical Simulations Risk Management Methodology September 7, 2010. Pursuant to... Simulations (``STANS'') risk management methodology. II. Self-Regulatory Organization's Statement of the... collateral eligible for incorporation in the STANS ] risk management methodology. Currently, OCC incorporates...

  10. Lipoprotein(a) as a cardiovascular risk factor: current status

    DEFF Research Database (Denmark)

    Nordestgaard, Børge G; Chapman, M John; Ray, Kausik

    2010-01-01

    The aims of the study were, first, to critically evaluate lipoprotein(a) [Lp(a)] as a cardiovascular risk factor and, second, to advise on screening for elevated plasma Lp(a), on desirable levels, and on therapeutic strategies.......The aims of the study were, first, to critically evaluate lipoprotein(a) [Lp(a)] as a cardiovascular risk factor and, second, to advise on screening for elevated plasma Lp(a), on desirable levels, and on therapeutic strategies....

  11. Improving the applicability of (Q)SARs for percutaneous penetration in regulatory risk assessment.

    NARCIS (Netherlands)

    Bouwman, T.; Cronin, M.T.; Bessems, J.G.; Sandt, J.J. van de

    2008-01-01

    The new regulatory framework REACH (Registration, Evaluation, and Authorisation of Chemicals) foresees the use of non-testing approaches, such as read-across, chemical categories, structure-activity relationships (SARs) and quantitative structure-activity relationships (QSARs). Although information

  12. Fracture Risk Analysis in Postmenopausal Women with the Current Methods

    Directory of Open Access Journals (Sweden)

    Salih Gultekin

    2014-03-01

    Full Text Available Aim: This study was conducted to assess the risk of fracture in postmenopausal women using dual x-ray absorptiometry bone mineral density (DEXA-BMD as a reference method and FRAX as a new clinical risk assessment tool. Material and Method: 168 postmenopausal women (> 50 years evaluating with DEXA-BMD and FRAX methods were included in the study. Femoral BMD (F-BMD, femoral T-score (F-Ts, lumbar spine BMD (L-BMD and lumbar spine T-score (L-Ts values of the patients were calculated. Fracture risk assessments were carried out using T-score values and FRAX 10-year hip fracture (HF and major osteoporotic fracture (MOF risk ratios. Data were analyzed statistically. Results: According to the results of F-Ts and L-Ts, 44/168 (26.2% and 65/168 (38.7% of patients had osteoporosis as compatible with high fracture risk. In osteoporotic patients, mean values for F-Ts L-Ts, F-BMD and L-BMD were -2.8 ± 0.4, -3.2 ± 0.5, 0.530 ± 0.049 and 0.682 ± 0.066, respectively. There were found to be high MOF risk in 16/168 (9.5% and high HF risk in 51/168 (30.4% of patients according to FRAX. Positive correlations were determined between F-Ts and L-Ts (moderate; rho = 0.424, p <0.05 and between HF and MOF (strong; rho = 0.958, p <0001. There were strong negative correlations among HF and MOF with F-Ts (respectively, rho = -0.897 and rho = -0.844, p <0.001 and moderate negative correlations among HF and MOF with L-Ts (respectively, rho = -0.535 and rho = - 0.567, p <0.05. Discussion: In postmenopausal women with osteoporosis, risk assessment by the FRAX besides the DXA-BMD measurements can be useful for not to be missed of patients with high risk of fracture.

  13. Reactive Metabolites: Current and Emerging Risk and Hazard Assessments.

    Science.gov (United States)

    Thompson, Richard A; Isin, Emre M; Ogese, Monday O; Mettetal, Jerome T; Williams, Dominic P

    2016-04-18

    Although idiosyncratic adverse drug reactions are rare, they are still a major concern to patient safety. Reactive metabolites are widely accepted as playing a pivotal role in the pathogenesis of idiosyncratic adverse drug reactions. While there are today well established strategies for the risk assessment of stable metabolites within the pharmaceutical industry, there is still no consensus on reactive metabolite risk assessment strategies. This is due to the complexity of the mechanisms of these toxicities as well as the difficulty in identifying and quantifying short-lived reactive intermediates such as reactive metabolites. In this review, reactive metabolite risk and hazard assessment approaches are discussed, and their pros and cons highlighted. We also discuss the nature of idiosyncratic adverse drug reactions, using acetaminophen and nefazodone to exemplify the complexity of the underlying mechanisms of reactive metabolite mediated hepatotoxicity. One of the key gaps moving forward is our understanding of and ability to predict the contribution of immune activation in idiosyncratic adverse drug reactions. Sections are included on the clinical phenotypes of immune mediated idiosyncratic adverse drug reactions and on the present understanding of immune activation by reactive metabolites. The advances being made in microphysiological systems have a great potential to transform our ability to risk assess reactive metabolites, and an overview of the key components of these systems is presented. Finally, the potential impact of systems pharmacology approaches in reactive metabolite risk assessments is highlighted.

  14. Using eye-tracking to examine how embedding risk corrective statements improves cigarette risk beliefs: Implications for tobacco regulatory policy.

    Science.gov (United States)

    Lochbuehler, Kirsten; Tang, Kathy Z; Souprountchouk, Valentina; Campetti, Dana; Cappella, Joseph N; Kozlowski, Lynn T; Strasser, Andrew A

    2016-07-01

    Tobacco companies have deliberately used explicit and implicit misleading information in marketing campaigns. The aim of the current study was to experimentally investigate whether the editing of explicit and implicit content of a print advertisement improves smokers' risk beliefs and smokers' knowledge of explicit and implicit information. Using a 2(explicit/implicit)×2(accurate/misleading) between-subject design, 203 smokers were randomly assigned to one of four advertisement conditions. The manipulation of graphic content was examined as an implicit factor to convey product harm. The inclusion of a text corrective in the body of the ad was defined as the manipulated explicit factor. Participants' eye movements and risk beliefs/recall were measured during and after ad exposure, respectively. Results indicate that exposure to a text corrective decreases false beliefs about the product (pcontent did not alter the harmfulness of the product. Independent of condition, smokers who focused longer on the warning label made fewer false inferences about the product (p=.01) and were more likely to correctly recall the warning information (pstrategy to convey health information to consumers, which can be mandated under the Tobacco Control Act. Eye-tracking results objectively demonstrate that text-only warnings are not viewed by smokers, thus minimizing their effectiveness for conveying risk information. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. Modifiable risk factors of ecstasy use: risk perception, current dependence, perceived control, and depression.

    Science.gov (United States)

    Leung, Kit Sang; Ben Abdallah, Arbi; Copeland, Jan; Cottler, Linda B

    2010-03-01

    Risk perception, perceived behavioral control of obtaining ecstasy (PBC-obtaining), current ecstasy dependence, and recent depression have been associated with past ecstasy use, however, their utility in predicting ecstasy use has not been demonstrated. This study aimed to determine whether these four modifiable risk factors could predict ecstasy use after controlling for socio-demographic covariates and recent polydrug use. Data from 601 ecstasy users in the National Institute on Drug Abuse-funded TriCity Study of Club Drug Use, Abuse and Dependence were analyzed using multivariate logistic regression. Participants were interviewed twice within a 2-week period using standardized instruments. Thirteen percent (n = 80) of the participants reported using ecstasy between the two interviews. Low risk perception, high PBC-obtaining (an estimated ecstasy procurement time depression was not a significant predictor. Despite not being a target predictor, recent polydrug use was also statistically associated with ecstasy use. The present findings may inform the development of interventions targeting ecstasy users. Copyright 2009 Elsevier Ltd. All rights reserved.

  16. High risk bladder cancer : current management and survival

    NARCIS (Netherlands)

    Leliveld-Kors, Anna; Bastiaannet, Esther; Doornweerd, Benjamin H J; Schaapveld, Michael; de Jong, Igle J

    2011-01-01

    Purpose: To evaluate the pattern of care in patients with high risk non muscle invasive bladder cancer (NMIBC) in the Comprehensive Cancer Center North-Netherlands (CCCN) and to assess factors associated with the choice of treatment, recurrence and progression free survival rates. Materials and

  17. Currently known risk factors for hypertrophic skin scarring : A review

    NARCIS (Netherlands)

    Butzelaar, L.; Ulrich, M. M W; Mink Van Der Molen, A. B.; Niessen, F. B.; Beelen, R. H J

    2016-01-01

    SummaryObjective The study aims to provide an overview of risk factors for hypertrophic scarring. Background Hypertrophic skin scarring remains a major concern in medicine and causes considerable morbidity. Despite extensive research on this topic, the precise mechanism of excessive scarring is

  18. Fruit flies risk analysis: Current situation and perspectives

    Science.gov (United States)

    Trade in fresh agricultural commodities involves probability of entry and establishment of exotic organisms into the importing region or country. The term "risk" includes the product of likelihood that exotic organisms will enter and become established (survive and reproduce) in the importing regio...

  19. Lipoprotein(a) as a cardiovascular risk factor : current status

    NARCIS (Netherlands)

    Nordestgaard, Børge G; Chapman, M John; Ray, Kausik; Borén, Jan; Andreotti, Felicita; Watts, Gerald F; Ginsberg, Henry; Amarenco, Pierre; Catapano, Alberico; Descamps, Olivier S; Fisher, Edward; Kovanen, Petri T; Kuivenhoven, Jan Albert; Lesnik, Philippe; Masana, Luis; Reiner, Zeljko; Taskinen, Marja-Riitta; Tokgözoglu, Lale; Tybjærg-Hansen, Anne

    2010-01-01

    AIMS: The aims of the study were, first, to critically evaluate lipoprotein(a) [Lp(a)] as a cardiovascular risk factor and, second, to advise on screening for elevated plasma Lp(a), on desirable levels, and on therapeutic strategies. METHODS AND RESULTS: The robust and specific association between

  20. Assessment of health risks resulting from early-life exposures: Are current chemical toxicity testing protocols and risk assessment methods adequate?

    Science.gov (United States)

    Felter, Susan P; Daston, George P; Euling, Susan Y; Piersma, Aldert H; Tassinari, Melissa S

    2015-03-01

    Abstract Over the last couple of decades, the awareness of the potential health impacts associated with early-life exposures has increased. Global regulatory approaches to chemical risk assessment are intended to be protective for the diverse human population including all life stages. However, questions persist as to whether the current testing approaches and risk assessment methodologies are adequately protective for infants and children. Here, we review physiological and developmental differences that may result in differential sensitivity associated with early-life exposures. It is clear that sensitivity to chemical exposures during early-life can be similar, higher, or lower than that of adults, and can change quickly within a short developmental timeframe. Moreover, age-related exposure differences provide an important consideration for overall susceptibility. Differential sensitivity associated with a life stage can reflect the toxicokinetic handling of a xenobiotic exposure, the toxicodynamic response, or both. Each of these is illustrated with chemical-specific examples. The adequacy of current testing protocols, proposed new tools, and risk assessment methods for systemic noncancer endpoints are reviewed in light of the potential for differential risk to infants and young children.

  1. Managing motivational conflict: how self-esteem and executive resources influence self-regulatory responses to risk.

    Science.gov (United States)

    Cavallo, Justin V; Holmes, John G; Fitzsimons, Gráinne M; Murray, Sandra L; Wood, Joanne V

    2012-09-01

    This article explores how self-esteem and executive resources interact to determine responses to motivational conflict. One correlational and 3 experimental studies investigated the hypothesis that high and low self-esteem people undertake different self-regulatory strategies in "risky" situations that afford opportunity to pursue competing goals and that carrying out these strategies requires executive resources. When such resources are available, high self-esteem people respond to risk by prioritizing and pursuing approach goals, whereas low self-esteem people prioritize avoidance goals. However, self-esteem does not influence responses to risk when executive resources are impaired. In these studies, risk was operationalized by exposing participants to a relationship threat (Studies 1 and 2), by using participants' self-reported marital conflict (Study 3), and by threatening academic competence (Study 4). Executive resources were operationalized as cognitive load (Studies 1 and 2), working memory capacity (Study 3), and resource depletion (Study 4). When executive resources were ample, high self-esteem people responded to interpersonal risk by making more positive relationship evaluations (Studies 1, 2, and 3) and making more risky social comparisons following a personal failure (Study 4) than did low self-esteem people. Self-esteem did not predict participants' responses when executive resources were impaired or when risk was absent. The regulatory function of self-esteem may be more resource-dependent than has been previously theorized.

  2. Modeling current climate conditions for forest pest risk assessment

    Science.gov (United States)

    Frank H. Koch; John W. Coulston

    2010-01-01

    Current information on broad-scale climatic conditions is essential for assessing potential distribution of forest pests. At present, sophisticated spatial interpolation approaches such as the Parameter-elevation Regressions on Independent Slopes Model (PRISM) are used to create high-resolution climatic data sets. Unfortunately, these data sets are based on 30-year...

  3. High risk bladder cancer: current management and survival

    Directory of Open Access Journals (Sweden)

    Anna M. Leliveld

    2011-04-01

    Full Text Available PURPOSE: To evaluate the pattern of care in patients with high risk non muscle invasive bladder cancer (NMIBC in the Comprehensive Cancer Center North-Netherlands (CCCN and to assess factors associated with the choice of treatment, recurrence and progression free survival rates. MATERIALS AND METHODS: Retrospective analysis of 412 patients with newly diagnosed high risk NMIBC. Clinical, demographic and follow-up data were obtained from the CCCN Cancer Registry and a detailed medical record review. Uni and multivariate analysis was performed to identify factors related to choice of treatment and 5 year recurrence and progression free survival. RESULTS: 74/412 (18% patients with high risk NMIBC underwent a transurethral resection (TUR as single treatment. Adjuvant treatment after TUR was performed in 90.7% of the patients treated in teaching hospitals versus 71.8 % in non-teaching hospitals (p 80 years OR 0.1 p = 0.001 and treatment in non-teaching hospitals (OR 0.25; p < 0.001 were associated with less adjuvant treatment after TUR. Tumor recurrence occurred in 191/392 (49% and progression in 84 /392 (21.4% patients. The mean 5-years progression free survival was 71.6% (95% CI 65.5-76.8. CONCLUSION: In this pattern of care study in high risk NMIBC, 18% of the patients were treated with TUR as single treatment. Age and treatment in non-teaching hospitals were associated with less adjuvant treatment after TUR. None of the variables sex, age, comorbidity, hospital type, stage and year of treatment was associated with 5 year recurrence or progression rates.

  4. Using Eye-tracking to Examine How Embedding Risk Corrective Statements Improves Cigarette Risk Beliefs: Implications for Tobacco Regulatory Policy

    Science.gov (United States)

    Lochbuehler, Kirsten; Tang, Kathy Z.; Souprountchouk, Valentina; Campetti, Dana; Cappella, Joseph N.; Kozlowski, Lynn T.; Strasser, Andrew A.

    2016-01-01

    Background Tobacco companies have deliberately used explicit and implicit misleading information in marketing campaigns. The aim of the current study was to experimentally investigate whether the editing of explicit and implicit content of a print advertisement improves smokers’ risk beliefs and smokers’ knowledge of explicit and implicit information. Methods Using a 2(explicit/implicit) x 2(accurate/misleading) between-subject design, 203 smokers were randomly assigned to one of four advertisement conditions. The manipulation of graphic content was examined as an implicit factor to convey product harm. The inclusion of a text corrective in the body of the ad was defined as the manipulated explicit factor. Participants’ eye movements and risk beliefs/recall were measured during and after ad exposure, respectively. Results Results indicate that exposure to a text corrective decreases false beliefs about the product (p < .01) and improves correct recall of information provided by the corrective (p < .05). Accurate graphic content did not alter the harmfulness of the product. Independent of condition, smokers who focused longer on the warning label made fewer false inferences about the product (p = .01) and were more likely to correctly recall the warning information (p < .01). Nonetheless, most smokers largely ignored the text warning. Conclusions Embedding a corrective statement in the body of the ad is an effective strategy to convey health information to consumers, which can be mandated under the Tobacco Control Act (2009). Eye-tracking results objectively demonstrate that text-only warnings are not viewed by smokers, thus minimizing their effectiveness for conveying risk information. PMID:27160034

  5. Groundwater contamination from waste management sites: The interaction between risk-based engineering design and regulatory policy: 1. Methodology

    Science.gov (United States)

    Massmann, Joel; Freeze, R. Allan

    1987-02-01

    This paper puts in place a risk-cost-benefit analysis for waste management facilities that explicitly recognizes the adversarial relationship that exists in a regulated market economy between the owner/operator of a waste management facility and the government regulatory agency under whose terms the facility must be licensed. The risk-cost-benefit analysis is set up from the perspective of the owner/operator. It can be used directly by the owner/operator to assess alternative design strategies. It can also be used by the regulatory agency to assess alternative regulatory policy, but only in an indirect manner, by examining the response of an owner/operator to the stimuli of various policies. The objective function is couched in terms of a discounted stream of benefits, costs, and risks over an engineering time horizon. Benefits are in the form of revenues for services provided; costs are those of construction and operation of the facility. Risk is defined as the cost associated with the probability of failure, with failure defined as the occurrence of a groundwater contamination event that violates the licensing requirements established for the facility. Failure requires a breach of the containment structure and contaminant migration through the hydrogeological environment to a compliance surface. The probability of failure can be estimated on the basis of reliability theory for the breach of containment and with a Monte-Carlo finite-element simulation for the advective contaminant transport. In the hydrogeological environment the hydraulic conductivity values are defined stochastically. The probability of failure is reduced by the presence of a monitoring network operated by the owner/operator and located between the source and the regulatory compliance surface. The level of reduction in the probability of failure depends on the probability of detection of the monitoring network, which can be calculated from the stochastic contaminant transport simulations. While

  6. Current knowledge on radon risk. Implications for practical radiation protection?

    Energy Technology Data Exchange (ETDEWEB)

    Mueller, Wolfgang-Ulrich [Universitaetsklinikum Essen, Institut fuer Medizinische Strahlenbiologie, Essen (Germany); Giussani, Augusto; Kreuzer, Michaela; Sobotzki, Christina [Federal Office for Radiation Protection, Oberschleissheim (Germany); Ruehm, Werner [German Research Center for Environmental Health, Institute of Radiation Protection, Helmholtz Zentrum Muenchen, Neuherberg (Germany); Lecomte, Jean-Francois [International Affaires Directorate, Institut de Radioprotection et de Surete Nucleaire, P.O. Box 17, Fontenay-aux-Roses (France); Harrison, John [Oxford Brookes University, Faculty of Health and Life Sciences, Oxford (United Kingdom); Breckow, Joachim [THM University of Applied Sciences, Institute of Medical Physics and Radiation Protection, Giessen (Germany)

    2016-08-15

    ICRP suggested a strategy based on the distinction between a protection approach for dwellings and one for workplaces in the previous recommendations on radon. Now, the Commission recommends an integrated approach for the protection against radon exposure in all buildings irrespective of their purpose and the status of their occupants. The strategy of protection in buildings, implemented through a national action plan, is based on the application of the optimisation principle below a derived reference level in concentration (maximum 300 Bq m{sup -3}). A problem, however, arises that due to new epidemiological findings and application of dosimetric models, ICRP 115 (Ann ICRP 40, 2010) presents nominal probability coefficients for radon exposure that are approximately by a factor of 2 larger than in the former recommendations of ICRP 65 (Ann ICRP 23, 1993). On the basis of the so-called epidemiological approach and the dosimetric approach, the doubling of risk per unit exposure is represented by a doubling of the dose coefficients, while the risk coefficient of ICRP 103 (2007) remains unchanged. Thus, an identical given radon exposure situation with the new dose coefficients would result in a doubling of dose compared with the former values. This is of serious conceptual implications. A possible solution of this problem was presented during the workshop. (orig.)

  7. Applying quantitative benefit-risk analysis to aid regulatory decision making in diagnostic imaging: methods, challenges, and opportunities.

    Science.gov (United States)

    Agapova, Maria; Devine, Emily Beth; Bresnahan, Brian W; Higashi, Mitchell K; Garrison, Louis P

    2014-09-01

    Health agencies making regulatory marketing-authorization decisions use qualitative and quantitative approaches to assess expected benefits and expected risks associated with medical interventions. There is, however, no universal standard approach that regulatory agencies consistently use to conduct benefit-risk assessment (BRA) for pharmaceuticals or medical devices, including for imaging technologies. Economics, health services research, and health outcomes research use quantitative approaches to elicit preferences of stakeholders, identify priorities, and model health conditions and health intervention effects. Challenges to BRA in medical devices are outlined, highlighting additional barriers in radiology. Three quantitative methods--multi-criteria decision analysis, health outcomes modeling and stated-choice survey--are assessed using criteria that are important in balancing benefits and risks of medical devices and imaging technologies. To be useful in regulatory BRA, quantitative methods need to: aggregate multiple benefits and risks, incorporate qualitative considerations, account for uncertainty, and make clear whose preferences/priorities are being used. Each quantitative method performs differently across these criteria and little is known about how BRA estimates and conclusions vary by approach. While no specific quantitative method is likely to be the strongest in all of the important areas, quantitative methods may have a place in BRA of medical devices and radiology. Quantitative BRA approaches have been more widely applied in medicines, with fewer BRAs in devices. Despite substantial differences in characteristics of pharmaceuticals and devices, BRA methods may be as applicable to medical devices and imaging technologies as they are to pharmaceuticals. Further research to guide the development and selection of quantitative BRA methods for medical devices and imaging technologies is needed. Copyright © 2014 AUR. Published by Elsevier Inc. All rights

  8. 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. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

  9. Ecological Models in Support of Regulatory Risk Assessments of Pesticides: Developing a Strategy for the Future

    NARCIS (Netherlands)

    Forbes, V.E.; Hommen, U.; Thorbek, P.; Heimbach, F.; Brink, van den P.J.; Wogram, J.; Thulke, H.H.; Grimm, V.

    2009-01-01

    This brief communication reports on the main findings of the LEMTOX workshop, held from 9 to 12 September 2007, at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. The workshop brought together a diverse group of stakeholders from academia, regulatory authorities, contract

  10. 77 FR 63763 - Regulatory Capital Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and...

    Science.gov (United States)

    2012-10-17

    ... Framework'' (Basel II), as revised by the BCBS between 2006 and 2009, as well as other proposals addressed... of Basel II, in December, 2010, the BCBS issued ``Basel III: A Global Regulatory Framework for More... revise their capital requirements to promote safe and sound banking practices, implement Basel II (as...

  11. Current state of copper stabilizers and methodology towards calculating risk

    CERN Document Server

    Koratzinos, M

    2011-01-01

    The talk will start by reviewing the landscape: a brief mention of the results of the warm copper stabilizer measurements and the results of the splice measurements at cold will be shown. The preliminary results of the recent RRR measurements will then be presented. Then, together with the limits presented from talk no. 2, the probability of an incident will be presented for beam energies between 3.5 and 5TeV. The available methods at our disposal for addressing the limiting factors and operating at a higher energy will then be reviewed: a complete circuit qualification method coined the Thermal Amplifier can define the maximum safe energy of the LHC in case of a quench next to a defective joint. Ways of avoiding magnet quenches, another critical element of the analysis, for instance by optimizing BLM settings will then be shown. Finally, a proposal of a strategy for running at the highest possible energy compatible with a pre-defined level of risk will be presented. As a case study, the method will also be a...

  12. Technical Risk Assessment. The Status of Current DoD Efforts

    Science.gov (United States)

    1986-04-01

    current efforts to ’dentify the technical risks X X X of new sistems ) 5 How are efforts to identify technical risk implenientecr X X x 6 What information on...D).C., January 198:3. NECMAN, Frederick *Ilow DCAA-- Uses Risk Analysis in Planning and Programming Audits." Internal Auditor , 36:3 (June 1979). 32

  13. Current Approaches to the Establishment of Credit Risk Specific Provisions

    Directory of Open Access Journals (Sweden)

    Ion Nitu

    2008-10-01

    Full Text Available The aim of the new Basel II and IFRS approaches is to make the operations of financial institutions more transparent and thus to create a better basis for the market participants and supervisory authorities to acquire information and make decisions. In the banking sector, a continuous debate is being led, related to the similarities and differences between IFRS approach on loan loss provisions and Basel II approach on calculating the capital requirements, judging against the classical method regarding loan provisions, currently used by the Romanian banks following the Central Bank’s regulations.Banks must take into consideration that IFRS and Basel II objectives are fundamentally different. While IFRS aims to ensure that the financial papers reflect adequately the losses recorded at each balance sheet date, the Basel II objective is to ensure that the bank has enough provisions or capital in order to face expected losses in the next 12 months and eventual unexpected losses.Consequently, there are clear differences between the objectives of the two models. Basel II works on statistical modeling of expected losses while IFRS, although allowing statistical models, requires a trigger event to have occurred before they can be used. IAS 39 specifically states that losses that are expected as a result of future events, no matter how likely, are not recognized. This is a clear and fundamental area of difference between the two frameworks.

  14. 77 FR 52887 - Regulatory Capital Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and...

    Science.gov (United States)

    2012-08-30

    ... companies, and the Board, FDIC, and OCC propose to apply the market risk capital rule (market risk rule) to... approaches banking organizations) or the market risk rule, and to savings and loan holding companies and... risk weights to certain exposures, including exposures to sovereigns, companies, and securitization...

  15. Global Risks as Factors that Affect the Current system of international Relations

    Directory of Open Access Journals (Sweden)

    Irina A. Zaitseva

    2017-01-01

    Full Text Available The problem of the globalization of risks is examined in this article. Based on the World Economic Forum (WEF report on global risks 2015-2017, the impact of global risks on the social and economic development of countries is examined. Economic, social, environmental, geopolitical, technological risks are analyzed in a coordinated fashion. The article notes that the main risks are in the field of environment and ecology. Anthropogenic pressure amplification, scientific and technological advance have an influence on the natural environment. The risks of infrastructure and environmental damage in danger zone are increased because of the growth of the frequency of extreme weather events. The measures for the protection of the environment are examined. The unilateral approach to solving international issues, instead of the collective efforts of the international community; the deployment of weapons of mass destruction (nuclear, chemical, biological and technologies for the production of radioactive materials; escalation of economic and resource nationalization (the desire of States to expropriate or restrict the export of important for the world economy of resources, etc. promote the increasing geopolitical risks.Economic risks include the risk in terms of their likelihood their impact on the macroeconomic, as from the financial systems and infrastructure to price volatility and regulatory issues. Social risks are the risks relating to instability of population dynamics, social crises and human survival.Technological risks include such problems as software defects, failure of important information systems, upon which today industrial production is depended, the services and communications sector; the escalation of large-scale cyber-attacks; theft of electronic information and the illegal usage of personal data. The trends that can intensify the global risks or to change the correlation between them are analyzed in this article.

  16. 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.

  17. Regulatory supply and market demand of risk management: Match or clash?

    Directory of Open Access Journals (Sweden)

    Christoph Van der Elst

    2011-03-01

    Full Text Available The paper raises questions as to whether the new risk governance requirements will be able to match the prerequisites for more balanced risk governance as part of the decision making process while fostering business entrepreneurship. Further, to comfort the market it will be necessary to report in accordance with market expectations adequate information about the financial and non-financial risks internal and external risks the companies is coping. Both questions will be addressed in this paper.

  18. On the Need for Rethinking Current Practice that Highlights Goal Achievement Risk in an Enterprise Context.

    Science.gov (United States)

    Aven, Eyvind; Aven, Terje

    2015-09-01

    This article addresses the issue of how performance and risk management can complement each other in order to enhance the management of an enterprise. Often, we see that risk management focuses on goal achievements and not the enterprise risk related to its activities in the value chain. The statement "no goal, no risk" is a common misconception. The main aim of the article is to present a normative model for describing the links between performance and risk, and to use this model to give recommendations on how to best structure and plan the management of an enterprise in situations involving risk and uncertainties. The model, which has several novel features, is based on the interaction between different types of risk management (enterprise risk management, task risk management, and personal risk management) and a structure where the enterprise risk management overrules both the task and personal risk management. To illustrate the model we use the metaphor of a ship, where the ship is loaded with cash-generating activities and has a direction over time determined by the overall strategic objectives. Compared to the current enterprise risk management practice, the model and related analysis are founded on a new perspective on risk, highlighting knowledge and uncertainties beyond probabilities. © 2015 Society for Risk Analysis.

  19. Environmental risk assessment of chemicals and nanomaterials — The best foundation for regulatory decision-making?

    DEFF Research Database (Denmark)

    Syberg, Kristian; Hansen, Steffen Foss

    2016-01-01

    Environmental risk assessment (ERA) is often considered as the most transparent, objective and reliable decision-making tool for informing the risk management of chemicals and nanomaterials. ERAs are based on the assumption that it is possible to provide accurate estimates of hazard and exposure...... and, subsequently, to quantify risk. In this paper we argue that since the quantification of risk is dominated by uncertainties, ERAs do not provide a transparent or an objective foundation for decision-making and they should therefore not be considered as a “holy grail” for informing risk management.......Webuild this thesis on the analysis of two case studies (of nonylphenol and nanomaterials) as well as a historical analysis in which we address the scientific Foundation for ERAs. The analyses show that ERAs do not properly address all aspects of actual risk, such as the mixture effect and the environmentally...

  20. Normal breast tissue DNA methylation differences at regulatory elements are associated with the cancer risk factor age.

    Science.gov (United States)

    Johnson, Kevin C; Houseman, E Andres; King, Jessica E; Christensen, Brock C

    2017-07-10

    The underlying biological mechanisms through which epidemiologically defined breast cancer risk factors contribute to disease risk remain poorly understood. Identification of the molecular changes associated with cancer risk factors in normal tissues may aid in determining the earliest events of carcinogenesis and informing cancer prevention strategies. Here we investigated the impact cancer risk factors have on the normal breast epigenome by analyzing DNA methylation genome-wide (Infinium 450 K array) in cancer-free women from the Susan G. Komen Tissue Bank (n = 100). We tested the relation of established breast cancer risk factors, age, body mass index, parity, and family history of disease, with DNA methylation adjusting for potential variation in cell-type proportions. We identified 787 cytosine-guanine dinucleotide (CpG) sites that demonstrated significant associations (Q value age. Notably, DNA methylation was not strongly associated with the other evaluated breast cancer risk factors. Age-related DNA methylation changes are primarily increases in methylation enriched at breast epithelial cell enhancer regions (P = 7.1E-20), and binding sites of chromatin remodelers (MYC and CTCF). We validated the age-related associations in two independent populations, using normal breast tissue samples (n = 18) and samples of normal tissue adjacent to tumor tissue (n = 97). The genomic regions classified as age-related were more likely to be regions altered in both pre-invasive (n = 40, P = 3.0E-03) and invasive breast tumors (n = 731, P = 1.1E-13). DNA methylation changes with age occur at regulatory regions, and are further exacerbated in cancer, suggesting that age influences breast cancer risk in part through its contribution to epigenetic dysregulation in normal breast tissue.

  1. "System Destroys Trust?"--Regulatory Institutions and Public Perceptions of Food Risks in Taiwan

    Science.gov (United States)

    Chou, Kuei-tien; Liou, Hwa-meei

    2010-01-01

    This article aims to explore public perceptions of global food risk issues and public attitudes towards government capacity to respond to concerns with technological and health uncertainties in an era of rapid economic development in newly industrialized countries. From cross-national comparative research on global food risk issues in the EU, UK,…

  2. Capability-Driven Design of Business Service Ecosystem to Support Risk Governance in Regulatory Ecosystems

    Directory of Open Access Journals (Sweden)

    Christophe Feltus

    2017-04-01

    Full Text Available Risk-based regulation and risk governance gain momentum in most sectorial ecosystems, should they be the finance, the healthcare or the telecommunications ecosystems. Although there is a profusion of tools to address this issue at the corporate level, worth is to note that no solution fulfils this function at the ecosystem level yet. Therefore, in this article, the Business Service Ecosystem (BSE metamodel is semantically extended, considering the Capability as a Service (CaaS theory, in order to raise the enterprise risk management from the enterprise level up to the ecosystem level. This extension allows defining a concrete ecosystem metamodel which is afterwards mapped with an information system risk management model to support risk governance at the ecosystem level. This mapping is illustrated and validated on the basis of an application case for the Luxembourgish financial sector applied to the most important concepts from the BSE: capability, resource, service and goal.

  3. 78 FR 36787 - Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug...

    Science.gov (United States)

    2013-06-19

    ... the current guidelines, and the importance of a uniform assay schema. Date and Time: The public... look like, the benefits and limitations of the current guidelines, and the importance of a uniform... employees and a limited number of speakers or organizers, registrants must pay a registration fee covering...

  4. Is cardiovascular risk in women with PCOS a real risk? Current insights.

    Science.gov (United States)

    Papadakis, Georgios; Kandaraki, Eleni; Papalou, Olga; Vryonidou, Andromachi; Diamanti-Kandarakis, Evanthia

    2017-12-01

    Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive aged women. PCOS incorporates not only symptoms related to the reproductive system but also a clustering of systemic metabolic abnormalities that are linked with increased risk for cardiovascular disease (CVD). More specifically, metabolic aberrations such as impaired glucose and lipid metabolism, accompanied by increased low-grade inflammation as well as elevated coagulation factors appear to contribute to the increased cardiovascular risk. Even though many studies have indicated a rise in surrogate biomarkers of CVD in women with PCOS, it is still doubtful to what extent and magnitude this elevation can be translated to real cardiovascular events. Furthermore, the cardiovascular risk factors appear to vary significantly in the different phenotypes of the syndrome. Women with PCOS have the potential for early atherosclerosis, myocardial and endothelial dysfunction. Whether PCOS women are at real cardiovascular risk compared to controls remains between the verge of theoretical and real threat for the PCOS women at any age but particularly in the post-menopausal state. Interestingly, although the presence of the CVD risk factors is well documented in PCOS women, their combination on different phenotypes may play a role, which eventually results in a spectrum of clinical manifestations of CVD with variable degree of severity. The present manuscript aims to review the interaction between PCOS and the combination of several cardiovascular risk factors.

  5. Where are we in risk assessment of food allergens? The regulatory view

    DEFF Research Database (Denmark)

    Madsen, Charlotte Bernhard

    2001-01-01

    these procedures when assessing the risk of food allergens. It is concluded that hazard identification is not a problem. The medical literature is full of descriptions of cases of food allergy where the offending food or even allergen is identified. More knowledge on the relationship between dose and response...... is needed and the possibility of using a safety factor. If we do not manage to establish thresholds for elicitation of allergic response in food allergy, risk assessment and management will be very difficult. It will be difficult to avoid labeling like "May contain peanuts" used with and without reason......Assessing the risk of exposure to chemicals is done every day worldwide. This assessment includes hazard identification, dose (concentration)-response (effect) assessment, exposure assessment and risk characterization. The present paper discusses the possibilities and limitations of using...

  6. [Current situation and countermeasures of medical damage risk sharing system in China].

    Science.gov (United States)

    Wen, Xuebin; Cao, Yanlin; Tian, Yongquan; Wei, Zhanying; Gao, Xinqiang; Zheng, Xueqian

    2015-01-01

    Although medical damage risks really exist, an effective medical risk sharing system is still not available in China right now. By analyzing the status quo of Chinese medical damage risks sharing system, the authors put forward the following suggestions to improve the current system: Upgrading the preventive strategy for medical disputes, establishing multi-level and multi-channel comprehensive medical damage risks sharing system, promoting the effective cooperation between insurance relief systems and mediation system for medical disputes, and constructing highly effective pathways to resolve the medical disputes.

  7. Limited output transcranial electrical stimulation (LOTES-2017): Engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk.

    Science.gov (United States)

    Bikson, Marom; Paneri, Bhaskar; Mourdoukoutas, Andoni; Esmaeilpour, Zeinab; Badran, Bashar W; Azzam, Robin; Adair, Devin; Datta, Abhishek; Fang, Xiao Hui; Wingeier, Brett; Chao, Daniel; Alonso-Alonso, Miguel; Lee, Kiwon; Knotkova, Helena; Woods, Adam J; Hagedorn, David; Jeffery, Doug; Giordano, James; Tyler, William J

    regard to output performance and standing regulation, the availability of tDCS, tACS, or tPCS to the public would not introduce risk, provided such devices are responsibly manufactured and legally marketed. In Part 3, we develop voluntary manufacturer guidance for limited output tES that is aligned with current regulatory standards. Based on established medical engineering and scientific principles, we outline a robust and transparent technical framework for ensuring limited output tES devices are designed to minimize risks, while also supporting access and innovation. Alongside applicable medical and government activities, this voluntary industry standard (LOTES-2017) further serves an important role in supporting informed decisions by the public. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Money laundering regulatory risk evaluation using Bitmap Index-based Decision Tree

    OpenAIRE

    Jayasree, Vikas; R.V. Siva Balan

    2017-01-01

    This paper proposes to evaluate the adaptability risk in money laundering using Bitmap Index-based Decision Tree (BIDT) technique. Initially, the Bitmap Index-based Decision Tree learning is used to induce the knowledge tree which helps to determine a company’s money laundering risk and improve scalability. A bitmap index in BIDT is used to effectively access large banking databases. In a BIDT bitmap index, account in a table is numbered in sequence with each key value, account number and a b...

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

    Science.gov (United States)

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

    2018-02-17

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

  10. Associations between depression risk, bullying and current smoking among Chinese adolescents: Modulated by gender.

    Science.gov (United States)

    Guo, Lan; Hong, Lingyao; Gao, Xue; Zhou, Jinhua; Lu, Ciyong; Zhang, Wei-Hong

    2016-03-30

    This school-based study aimed to investigate the prevalence of being at risk for depression, bullying behavior, and current smoking among Chinese adolescents in order to explore gender differences in the vulnerability of adolescents with these behaviors to develop a smoking habit. A total of 35,893 high school students sampled from high schools in eighteen cities in China participated in the study from 2011 to 2012. Overall, the prevalence of current smoking was estimated at 6.4%. In total, 1.7% (618) of the participants admitted to bullying others, 5.8% (2071) reported being bullied, 3.5% (1269) were involved in both bullying others and being bullied, and 5.6% (2017) were at high risk for depression. Logistic regression analysis indicated that among girls, with high depression risk, bullying others, being bullied, and both bullying others and being bullied were independently and positively associated with current smoking habits, while the final results among boys showed that bullying others and both bullying others and being bullied were independently associated with an increased risk of current smoking. School-based prevention programs are highly recommended, and we should focus on high-risk students, particularly girls with high risk of depression or involved in school bullying and boys who are involved in school bullying. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. Determinants of Dermal Exposure Relevant for Exposure Modelling in Regulatory Risk Assessment

    NARCIS (Netherlands)

    Marquart, J.; Brouwer, D.H.; Gijsbers, J.H.J.; Links, I.H.M.; Warren, N.; Hemmen, J.J. van

    2003-01-01

    Risk assessment of chemicals requires assessment of the exposure levels of workers. In the absence of adequate specific measured data, models are often used to estimate exposure levels. For dermal exposure only a few models exist, which are not validated externally. In the scope of a large European

  12. A CLCA regulatory protein present in the chemosensory cilia of olfactory sensory neurons induces a Ca2+-activated Cl-current when transfected into HEK293.

    Science.gov (United States)

    Mura, Casilda V; Delgado, Ricardo; Delgado, María Graciela; Restrepo, Diego; Bacigalupo, Juan

    2017-08-11

    CLCA is a family of metalloproteases that regulate Ca 2+ -activated Cl - fluxes in epithelial tissues. In HEK293 cells, CLCA1 promotes membrane expression of an endogenous Anoctamin 1 (ANO1, also termed TMEM16A)-dependent Ca 2+ -activated Cl - current. Motif architecture similarity with CLCA2, 3 and 4 suggested that they have similar functions. We previously detected the isoform CLCA4L in rat olfactory sensory neurons, where Anoctamin 2 is the principal chemotransduction Ca 2+ -activated Cl - channel. We explored the possibility that this protein plays a role in odor transduction. We cloned and expressed CLCA4L from rat olfactory epithelium in HEK293 cells. In the transfected HEK293 cells we measured a Cl - -selective Ca 2+ -activated current, blocked by niflumic acid, not present in the non-transfected cells. Thus, CLCA4L mimics the CLCA1 current on its ability to induce the ANO1-dependent Ca 2+ -activated Cl - current endogenous to these cells. By immunocytochemistry, a CLCA protein, presumably CLCA4L, was detected in the cilia of olfactory sensory neurons co-expressing with ANO2. These findings suggests that a CLCA isoform, namely CLCA4L, expressed in OSN cilia, might have a regulatory function over the ANO2-dependent Ca 2+ -activated Cl - channel involved in odor transduction.

  13. Novel biomarkers for cardiovascular risk assessment: current status and future directions.

    Science.gov (United States)

    MacNamara, James; Eapen, Danny J; Quyyumi, Arshed; Sperling, Laurence

    2015-09-01

    Cardiovascular disease (CVD) is the leading cause of mortality in the modern world. Traditional risk algorithms may miss up to 20% of CVD events. Therefore, there is a need for new cardiac biomarkers. Many fields of research are dedicated to improving cardiac risk prediction, including genomics, transcriptomics and proteomics. To date, even the most promising biomarkers have only demonstrated modest associations and predictive ability. Few have undergone randomized control trials. A number of biomarkers are targets to new therapies aimed to reduce cardiovascular risk. Currently, some of the most promising risk prediction has been demonstrated with panels of multiple biomarkers. This article reviews the current state and future of proteomic biomarkers and aggregate biomarker panels.

  14. Risk factors for current smoking among American and South Korean adolescents, 2005-2011.

    Science.gov (United States)

    Chung, Sung Suk; Joung, Kyoung Hwa

    2014-11-01

    Population data concerning smoking rates of adolescents and adults in the United States and Korea (South Korea) has highlighted the need for attention to this age group. This study compared the risk factors related to smoking and examined the gender differences with other risk factors in smoking among American and Korean adolescents between 2005 and 2011. Participants were students in grades 9-11 selected from nationally representative surveys conducted in 2005 and 2011. In 2011, similar risk factors for current smoking were identified in American and Korean adolescents. These included male gender, school grade, depression, experience of alcohol drinking, current use of alcohol, use of glue or other inhalants, and experience of sexual intercourse. Among Korean adolescents, weight perception and weight control were unique risk factors for current smoking. Interactions with gender and other risk factors in each nation were revealed. These risk factors, their change from earlier years, and gender differences should be recognized in the screening of vulnerable individuals for smoking and formulating effective intervention programs. These results will provide information for the design and implementation of cessation programs for adolescents in these countries. © 2014 Sigma Theta Tau International.

  15. Default values for assessment of potential dermal exposure of the hands to industrial chemicals in the scope of regulatory risk assessments

    NARCIS (Netherlands)

    Marquart, H.; Warren, N.D.; Laitinen, J.; Hemmen, J.J. van

    2006-01-01

    Dermal exposure needs to be addressed in regulatory risk assessment of chemicals. The models used so far are based on very limited data. The EU project RISKOFDERM has gathered a large number of new measurements on dermal exposure to industrial chemicals in various work situations, together with

  16. Regulatory risks in Brazil - obstacle to the development of new small hydropower plants; Riscos regulatorios no Brasil - obstaculo ao desenvolvimento de novas pequenas centrais hidroeletricas

    Energy Technology Data Exchange (ETDEWEB)

    Prado Junior, Fernando A. Almeida [Sinerconsult Consultoria Treinamento e Participacoes Ltda., Sao Paulo, SP (Brazil)]. E-mail: fernando@sinerconsult.com.br; Alves, Gilberto [Companhia Energetica de Sao Paulo (CESP), SP (Brazil)]. E-mail: gilberto@cesp.com.br; Yamagushi, Hugo R. [ARSESP - Agencia de Regulacao de Saneamento e Energia do Estado de Sao Paulo, Sao Paulo (Brazil)]. E-mail: hyamagushi@sp.gov.br; Braun, Paulo Victor C.B. [EMAE Empresa Metropolitana de Aguas e Energia Eletrica, Sao Paulo, SP (Brazil)]. E-mail: paulo.victor@emae.sp.gov.br

    2008-10-15

    The paper analyses the risks of legal and regulatory order that affect the activity of exploration of Small Power Hydro plants in Brazil. In the scope of the main administrative phases of these activities, namely, inventory, basic project, attainment of licenses and connection to the electric grid, the main difficulties faced by entrepreneurs are identified and analysed. (author)

  17. Status of Legislation and Regulatory Control of Public Health Pesticides in Countries Endemic with or at Risk of Major Vector-Borne Diseases

    NARCIS (Netherlands)

    Matthews, G.; Zaim, M.; Yadav, R.S.; Soares, A.; Hii, J.; Ameneshewa, B.; Mnzava, A.; Dash, A.P.; Ejov, M.; Tan, S.H.; Berg, van den H.

    2011-01-01

    BACKGROUND: Legislation and regulation of pesticides used in public health are essential for reducing risks to human health and the environment. OBJECTIVE: We assessed the global situation on legislation and regulatory control of public health pesticides. METHODS: A peer-reviewed and field-tested

  18. Suggested improvements for ship-installation collision risk models to reflect current collision avoidance systems

    OpenAIRE

    Flohberger, Margaret Loudon

    2010-01-01

    Master's thesis in Offshore technology Accurate quantification of risks for vessel-to-platform collisions has been a goal of the petroleum industry for many years; however, technological advances in collision avoidance systems have not been reflected in current models. Additionally, new modeling theories have been developed which capture the complexities of modern socio-technical systems. This paper recommends that a new collision model be developed to reflect current collision...

  19. Suggested improvements for ship-installation collision risk models to reflect current collision avoidance systems

    OpenAIRE

    Flohberger, Margaret Loudon

    2010-01-01

    Accurate quantification of risks for vessel-to-platform collisions has been a goal of the petroleum industry for many years; however, technological advances in collision avoidance systems have not been reflected in current models. Additionally, new modeling theories have been developed which capture the complexities of modern socio-technical systems. This paper recommends that a new collision model be developed to reflect current collision avoidance systems. Today’s navigati...

  20. Current practices for risk zoning around nuclear power plants in comparison to other industry sectors.

    Science.gov (United States)

    Kirchsteiger, Christian

    2006-08-25

    This paper analyses the background and current status of the information basis leading to the definition of risk and emergency zones around nuclear power plants (NPPs) in different countries in Europe and beyond. Although dependable plant-specific probabilistic safety assessment (PSA) of level 2 and/or level 3 could in principle provide sufficiently detailed input to define the geographical dimension of a NPP's risk and emergency zones, the analysis of the status in some European and other countries shows that other, "deterministic" approaches using a reference accident are actually used in practice. Regarding use of level 2 PSA for emergency planning, the approach so far has been to use the level 2 PSA information retrospectively to provide the justification for the choice of reference accident(s) used to define the emergency plans and emergency planning zones (EPZs). There are significant differences in the EPZs that are defined in different countries, ranging from a few up to 80km. There is a striking contrast in the extent of using probabilistic information to define emergency zones between the nuclear and other high risk industry sectors, such as the chemical process industry, and the reasons for these differences are not entirely clear, since the risk of chemical industry is similar as that of the nuclear sector. The differences seem to be more related to risk perception than to the actual risk potential. Therefore, there is a strong need to be able to communicate risk information to the Public both before and following an accident. In addition, there is a need to educate the Public so that they can understand risk information in a comparative sense. Finally, based on the consensus discussions at a recent JRC/OECD International Seminar on Risk and Emergency Zoning around NPPs, a set of recommendations is given in the areas of: -a more comprehensive use of the available risk information for risk zoning purposes, -risk communication; -comparative (energy) risk

  1. Addressing Emerging Risks: Scientific and Regulatory Challenges Associated with Environmentally Persistent Free Radicals

    Science.gov (United States)

    Dugas, Tammy R.; Lomnicki, Slawomir; Cormier, Stephania A.; Dellinger, Barry; Reams, Margaret

    2016-01-01

    Airborne fine and ultrafine particulate matter (PM) are often generated through widely-used thermal processes such as the combustion of fuels or the thermal decomposition of waste. Residents near Superfund sites are exposed to PM through the inhalation of windblown dust, ingestion of soil and sediments, and inhalation of emissions from the on-site thermal treatment of contaminated soils. Epidemiological evidence supports a link between exposure to airborne PM and an increased risk of cardiovascular and pulmonary diseases. It is well-known that during combustion processes, incomplete combustion can lead to the production of organic pollutants that can adsorb to the surface of PM. Recent studies have demonstrated that their interaction with metal centers can lead to the generation of a surface stabilized metal-radical complex capable of redox cycling to produce ROS. Moreover, these free radicals can persist in the environment, hence their designation as Environmentally Persistent Free Radicals (EPFR). EPFR has been demonstrated in both ambient air PM2.5 (diameter combustion sources. Thus, low-temperature, thermal treatment of soils can potentially increase the concentration of EPFR in areas in and around Superfund sites. In this review, we will outline the evidence to date supporting EPFR formation and its environmental significance. Furthermore, we will address the lack of methodologies for specifically addressing its risk assessment and challenges associated with regulating this new, emerging contaminant. PMID:27338429

  2. Addressing Emerging Risks: Scientific and Regulatory Challenges Associated with Environmentally Persistent Free Radicals

    Directory of Open Access Journals (Sweden)

    Tammy R. Dugas

    2016-06-01

    Full Text Available Airborne fine and ultrafine particulate matter (PM are often generated through widely-used thermal processes such as the combustion of fuels or the thermal decomposition of waste. Residents near Superfund sites are exposed to PM through the inhalation of windblown dust, ingestion of soil and sediments, and inhalation of emissions from the on-site thermal treatment of contaminated soils. Epidemiological evidence supports a link between exposure to airborne PM and an increased risk of cardiovascular and pulmonary diseases. It is well-known that during combustion processes, incomplete combustion can lead to the production of organic pollutants that can adsorb to the surface of PM. Recent studies have demonstrated that their interaction with metal centers can lead to the generation of a surface stabilized metal-radical complex capable of redox cycling to produce ROS. Moreover, these free radicals can persist in the environment, hence their designation as Environmentally Persistent Free Radicals (EPFR. EPFR has been demonstrated in both ambient air PM2.5 (diameter < 2.5 µm and in PM from a variety of combustion sources. Thus, low-temperature, thermal treatment of soils can potentially increase the concentration of EPFR in areas in and around Superfund sites. In this review, we will outline the evidence to date supporting EPFR formation and its environmental significance. Furthermore, we will address the lack of methodologies for specifically addressing its risk assessment and challenges associated with regulating this new, emerging contaminant.

  3. Addressing Emerging Risks: Scientific and Regulatory Challenges Associated with Environmentally Persistent Free Radicals.

    Science.gov (United States)

    Dugas, Tammy R; Lomnicki, Slawomir; Cormier, Stephania A; Dellinger, Barry; Reams, Margaret

    2016-06-08

    Airborne fine and ultrafine particulate matter (PM) are often generated through widely-used thermal processes such as the combustion of fuels or the thermal decomposition of waste. Residents near Superfund sites are exposed to PM through the inhalation of windblown dust, ingestion of soil and sediments, and inhalation of emissions from the on-site thermal treatment of contaminated soils. Epidemiological evidence supports a link between exposure to airborne PM and an increased risk of cardiovascular and pulmonary diseases. It is well-known that during combustion processes, incomplete combustion can lead to the production of organic pollutants that can adsorb to the surface of PM. Recent studies have demonstrated that their interaction with metal centers can lead to the generation of a surface stabilized metal-radical complex capable of redox cycling to produce ROS. Moreover, these free radicals can persist in the environment, hence their designation as Environmentally Persistent Free Radicals (EPFR). EPFR has been demonstrated in both ambient air PM2.5 (diameter < 2.5 µm) and in PM from a variety of combustion sources. Thus, low-temperature, thermal treatment of soils can potentially increase the concentration of EPFR in areas in and around Superfund sites. In this review, we will outline the evidence to date supporting EPFR formation and its environmental significance. Furthermore, we will address the lack of methodologies for specifically addressing its risk assessment and challenges associated with regulating this new, emerging contaminant.

  4. Analysis of Safety-Related Regulatory Actions for New Drugs in Japan by Nature of Identified Risks.

    Science.gov (United States)

    Fujikawa, Makoto; Ono, Shunsuke

    2017-01-01

    Mechanisms underlying safety events may be heterogeneous and depend on conditions of development and marketing, including the populations studied in clinical trials and the amount of data required for approval, especially under pathways for accelerated access. This study was conducted to investigate possible factors affecting the first post-marketing safety-related regulatory actions (SRRAs) after launch of new drugs in Japan. We studied 338 new molecular entities (NMEs) approved in Japan between 2004 and 2014. We focused on three different types of SRRAs: (1) all-SRRAs (i.e. SRRAs from domestic cases and other countries), (2) domestic-SRRAs (i.e. SRRAs from domestic cases) and (3) domestic unknown-SRRAs (i.e. SRRAs of unknown risks from domestic cases). Occurrences of the three types of SRRAs were analyzed using Kaplan-Meier analysis and Cox-regression. SRRAs tended to occur sooner for NMEs launched in recent years versus those launched towards the beginning of the study period. Risk of SRRA was high for antineoplastics. Drugs for cardiovascular diseases, central nervous system, and diabetes had positive associations with all-SRRAs, but the associations were weaker with domestic-SRRAs. Domestic-SRRAs were more likely for drugs with relatively novel modes of action (MOAs). Longer lag to Japanese launch after first global launch significantly lowered SRRA risks. While most of the variables showed similar associations across the three types of SRRAs, adoption of bridging strategies showed higher risks only for domestic-SRRAs, not for all-SRRAs. FDA safety labeling changes and non-orphan priority review drugs presented higher domestic-SRRA risks. The number of adverse drug reactions (ADRs) from spontaneous reports had positive correlations with the three types of SRRAs, whereas the number from company-led surveillance showed no association. Our results indicated that global clinical development pathways and marketing status should be considered more seriously in

  5. Pulmonary tuberculosis and lung cancer risk in current smokers: the Seoul Male Cancer Cohort Study.

    Science.gov (United States)

    Bae, Jong-Myon; Li, Zhong-Min; Shin, Myung-Hee; Kim, Dong-Hyun; Lee, Moo-Song; Ahn, Yoon-Ok

    2013-06-01

    Authors evaluated pulmonary tuberculosis (PTB) history as a risk factor for lung cancer in current male smokers in a prospective, population-based cohort study. The subjects were the 7,009 males among the participants in the Seoul Male Cancer Cohort Study for whom there was full information on PTB history and smoking habits. With a 16-yr follow-up, 93 cases of lung cancer occurred over the 99,965 person-years of the study. The estimated relative risk (RR) of PTB history of current smokers in lung cancer after adjusting for three confounders - intake of coffee and tomatoes, and age at entry - was 1.85 (95% CI: 1.08-3.19). The observed joint RRs and attributable risks (ARs) across strata of three confounders were greater than the expected, indicating a positive interaction. Thus a history of PTB in current smokers may be another risk factor for lung cancer. Based on a synergic interaction, a heavy male smoker with a PTB history would be expected to belong to the group at high risk of lung cancer.

  6. Current status data with competing risks : Limiting distribution of the MLE

    NARCIS (Netherlands)

    Groeneboom, P.; Maathuis, M.H.; Wellner, J.A.

    2008-01-01

    We study nonparametric estimation for current status data with competing risks. Our main interest is in the nonparametric maximum likelihood estimator (MLE), and for comparison we also consider a simpler “naive estimator.” Groeneboom, Maathuis and Wellner [Ann. Statist. (2008) 36 1031–1063] proved

  7. 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. Published by Elsevier Inc.

  8. Moderating the Influence of Current Intention to Improve Suicide Risk Prediction.

    Science.gov (United States)

    Zaher, Nawal A; Buckingham, Christopher D

    2016-01-01

    When assessors evaluate a person's risk of completing suicide, the person's expressed current intention is one of the most influential factors. However, ifpeople say they have no intention, this may not be true for a number of reasons. This paper explores the reliability of negative intention in data provided by mental-health services using the GRiST decision support system in England. It identifies features within a risk assessment record that can classify a negative statement regarding current intention of suicide as being reliable or unreliable. The algorithm is tested on previously conducted assessments, where outcomes found in later assessments do or do not match the initially stated intention. Test results show significant separation between the two classes. It means suicide predictions could be made more accurate by modifying the assessment process and associated risk judgement in accordance with a better understanding of the person's true intention.

  9. Methods for Management of Innovation Activity Risks in the Current Conditions

    Directory of Open Access Journals (Sweden)

    Pysmak Viktoriia O.

    2016-03-01

    Full Text Available The article considers theoretical foundations of management of innovation activity risks. Relevance of the selected topic of research in connection with both volatile external environment and crisis developments in the country's economy has been substantiated. A semantic analysis of the concept of «risk» has been done, showing the presence of both positive and negative sides of risk situations. A scheme for enterprise management in the light of implementing innovation activity has been elaborated. An improved classification of innovation activity has been provided, creating the opportunity to focus on identifying risks in the process of allocating a specific direction of innovation activity. The main stages of identification and analysis of risks of innovation activity has been allocated. Methods for management of innovation activity risks in the current conditions have been developed. A concept of «system for management of innovation activity risks» has been formulated, its major features for enterprise has been outlined. The main requirements for a system for management of innovation activity risks have been allocated.

  10. PERSPECTIVES OF RISK MANAGEMENT IN BANKING IN THE CONTEXT OF GLOBALIZATION AND CURRENT ECONOMIC CRISIS

    Directory of Open Access Journals (Sweden)

    Clara-Iulia, ZINCA (VOICULESCU

    2014-11-01

    Full Text Available The banking industry, as well as the entire financial services industry, has experienced significant changes due to the development of new technologies, government deregulation and globalization, generating both opportunities and risks. The range of financial products and services offered by the banks expanded by adding new ones previously offered by other types of entities in the financial services industry. At the same time, competition continuously increased, from both banks and from other segments of the financial industry. Thus, from risk management under traditional financial intermediation, it was reached a dynamic, active and complex risk management in terms of reduced government regulations and in an environment with higher risks. Moreover, the economic crisis triggered in 2007 brought new challenges for the banking system, revealing many weaknesses in banks' risk management practices. By using appropriate research methods, such as document analysis, interpretative methods, this paper aims to identify the challenges of risk management in banking institutions in the current context of globalization and economic crisis, when the banks should focus on a better understanding of risk and on development of new best practices to ensure efficiency of risk management and better adaptation to dynamic changes of the economic environment

  11. Risk factors for osteoarthritis and contributing factors to current arthritic pain in South Korean older adults.

    Science.gov (United States)

    Lee, Kyoung Min; Chung, Chin Youb; Sung, Ki Hyuk; Lee, Seung Yeol; Won, Sung Hun; Kim, Tae Gyun; Choi, Young; Kwon, Soon Sun; Kim, Yeon Ho; Park, Moon Seok

    2015-01-01

    Although previous studies have focused on risk factors for osteoarthritis, there is some debate on this issue. Furthermore, associated factors with arthritic symptom (arthralgia) have not been sufficiently investigated, despite its clinical importance in the management of osteoarthritis. This study was performed to examine the risk factors for osteoarthritis and the contributing factors to current arthritic pain in older adults. The Fourth Korean National Health and Nutrition Examination Surveys was conducted in 2009. Therein, 720 males and 1008 females aged 65 years and older were included. Comprehensive data on habitual, socioeconomic, medical, nutritional, and psychological factors were collected along with the presence of osteoarthritis and arthritic pain. After univariate analysis, binary logistic regression analysis was performed to identify risk factors for osteoarthritis and contributing factors to current arthritic pain. Age (p=0.005), female gender (prisk factors for osteoarthritis, while higher education level (p=0.025) was a protective factor for osteoarthritis. Higher BMI (p=0.047), lack of weekly moderate intensity activity (pfactors contributing to current arthritic pain among subjects with osteoarthritis. Both osteoarthritis and current arthritic pain adversely affected health related quality of life. Higher BMI, lack of weekly moderate intensity activity, and unfavorable subjective health status were significant factors contributing to current arthritic pain. More attention needs to be paid to psychiatric effects on osteoarthritis and joint related pain.

  12. Evaluation of organ weights for rodent and non-rodent toxicity studies: a review of regulatory guidelines and a survey of current practices.

    Science.gov (United States)

    Michael, Bindhu; Yano, Barry; Sellers, Rani S; Perry, Rick; Morton, Daniel; Roome, Nigel; Johnson, Julie K; Schafer, Ken; Pitsch, Sue

    2007-08-01

    The Society of Toxicologic Pathology convened a working group to evaluate current practices regarding organ weights in toxicology studies. A survey was distributed to pharmaceutical, veterinary, chemical, food/nutritional and consumer product companies in Europe, North America, and Japan. Responses were compiled to identify organs routinely weighed for various study types in rodent and non-rodent species, compare methods of organ weighing, provide perspectives on the value of organ weights and identify the scientist(s) responsible for organ weight data interpretation. Data were evaluated as a whole as well as by industry type and geographic location. Regulatory guidance documents describing organ weighing practices are generally available, however, they differ somewhat dependent on industry type and regulatory agency. While questionnaire respondents unanimously stated that organ weights were a good screening tool to identify treatment-related effects, opinions varied as to which organ weights are most valuable. The liver, kidneys, and testes were commonly weighed and most often considered useful by most respondents. Other organs that break were commonly weighed included brain, adrenal glands, ovaries, thyroid glands, uterus, heart, and spleen. Lungs, lymph nodes, and other sex organs were weighed infrequently in routine studies, but were often weighed in specialized studies such as inhalation, immunotoxicity, and reproduction studies. Organ-to-body weight ratios were commonly calculated and were considered more useful when body weights were affected. Organ to brain weight ratios were calculated by most North American companies, but rarely according to respondents representing veterinary product or European companies. Statistical analyses were generally performed by most respondents. Pathologists performed interpretation of organ weight data for the majority of the industries.

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

    Directory of Open Access Journals (Sweden)

    Maria Kekic

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

  14. Current Roles and Future Applications of Cardiac CT: Risk Stratification of Coronary Artery Disease

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Yeonyee Elizabeth [Department of Cardiology, Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam 463-707 (Korea, Republic of); Lim, Tae-Hwan [Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 138-736 (Korea, Republic of)

    2014-07-01

    Cardiac computed tomography (CT) has emerged as a noninvasive modality for the assessment of coronary artery disease (CAD), and has been rapidly integrated into clinical cares. CT has changed the traditional risk stratification based on clinical risk to image-based identification of patient risk. Cardiac CT, including coronary artery calcium score and coronary CT angiography, can provide prognostic information and is expected to improve risk stratification of CAD. Currently used conventional cardiac CT, provides accurate anatomic information but not functional significance of CAD, and it may not be sufficient to guide treatments such as revascularization. Recently, myocardial CT perfusion imaging, intracoronary luminal attenuation gradient, and CT-derived computed fractional flow reserve were developed to combine anatomical and functional data. Although at present, the diagnostic and prognostic value of these novel technologies needs to be evaluated further, it is expected that all-in-one cardiac CT can guide treatment and improve patient outcomes in the near future.

  15. Towards a future with large penetration of distributed generation: Is the current regulation of electricity distribution ready? Regulatory recommendations under a European perspective

    Energy Technology Data Exchange (ETDEWEB)

    Cossent, Rafael [Instituto de Investigacion Tecnologica, Escuela Tecnica Superior de Ingenieria, Universidad Pontificia Comillas, C/ Quintana 21, 28008 Madrid (Spain)], E-mail: Rafael.Cossent@iit.upcomillas.es; Gomez, Tomas; Frias, Pablo [Instituto de Investigacion Tecnologica, Escuela Tecnica Superior de Ingenieria, Universidad Pontificia Comillas, C/ Quintana 21, 28008 Madrid (Spain)

    2009-03-15

    The European Energy Policy promotes renewable energy sources and energy efficiency as means to mitigate environmental impact, increase security of supply and ensure economic competitiveness. As a result, the penetration levels of distributed generation (DG) in electricity networks are bound to increase. Distribution networks and distribution system operators (DSOs) will be especially affected by growing levels of DG. This paper reviews the current regulation of distribution in the European Union Member States, focusing on those aspects that might hinder the future integration of DG. Several regulatory issues that may hinder a successful integration of DG have been identified. Recommendations to improve the current situation are proposed. Regarding economic signals sent to DG, connection charges and cost-reflective use-of-system charges together with incentives to provide ancillary services are the key aspects. Concerning DSOs regulation, unbundling from generation and supply according to the European Electricity Directive, incentives for optimal planning and network operation considering DG, including energy losses and quality of service, and innovation schemes to migrate to active networks are the most relevant topics.

  16. Towards a future with large penetration of distributed generation. Is the current regulation of electricity distribution ready? Regulatory recommendations under a European perspective

    Energy Technology Data Exchange (ETDEWEB)

    Cossent, Rafael; Gomez, Tomas; Frias, Pablo [Instituto de Investigacion Tecnologica, Escuela Tecnica Superior de Ingenieria, Universidad Pontificia Comillas, C/ Quintana 21, 28008 Madrid (Spain)

    2009-03-15

    The European Energy Policy promotes renewable energy sources and energy efficiency as means to mitigate environmental impact, increase security of supply and ensure economic competitiveness. As a result, the penetration levels of distributed generation (DG) in electricity networks are bound to increase. Distribution networks and distribution system operators (DSOs) will be especially affected by growing levels of DG. This paper reviews the current regulation of distribution in the European Union Member States, focusing on those aspects that might hinder the future integration of DG. Several regulatory issues that may hinder a successful integration of DG have been identified. Recommendations to improve the current situation are proposed. Regarding economic signals sent to DG, connection charges and cost-reflective use-of-system charges together with incentives to provide ancillary services are the key aspects. Concerning DSOs regulation, unbundling from generation and supply according to the European Electricity Directive, incentives for optimal planning and network operation considering DG, including energy losses and quality of service, and innovation schemes to migrate to active networks are the most relevant topics. (author)

  17. Reduced neonatal regulatory T cell response to microbial stimuli associates with subsequent eczema in high-risk infants.

    Science.gov (United States)

    Ismail, Intan H; Boyle, Robert J; Mah, Li-Jeen; Licciardi, Paul V; Tang, Mimi L K

    2014-11-01

    Regulatory T cells (Treg) play an essential role in early immune programming and shaping the immune response towards a pro-allergic or tolerant state. We evaluated cord blood Treg and cytokine responses to microbial and non-microbial stimuli in infants at high risk of allergic disease and their associations with development of allergic disease in the first year. Cord blood mononuclear cells from 72 neonates were cultured with toll-like receptors (TLR2) ligands: lipoteichoic acid (LTA) and heat-killed Lactobacillus rhamnosus GG (HKL); TLR4 ligand: lipopolysaccharide (LPS); ovalbumin (OVA); anti-CD3; or media for 48 h. Treg numbers and Treg cytokines were assessed in relation to allergic disease outcomes during the first year of life (eczema and atopic sensitization). Infants with eczema (n = 24) had reduced percentages of FoxP3(hi)CD25(hi) Treg in LTA (p = 0.01, adj p = 0.005) and HKL (p = 0.04, adj p = 0.02) stimulated cultures as well as reduced IL-10 (p = 0.01) production following HKL stimulation compared to those without eczema (n = 48). No differences in Treg or cytokine responses to LPS, OVA or anti-CD3 were seen. Infants who developed sensitization had lower percentages of Treg following TLR2 stimulation (but not other stimuli) compared to non-sensitized infants. High-risk children who develop allergic disease in the first year of life have deficient Treg responses to microbial stimuli but not allergen from the time of birth, which may contribute to failure of immune tolerance development in infancy. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Risk Factors for Osteoarthritis and Contributing Factors to Current Arthritic Pain in South Korean Older Adults

    Science.gov (United States)

    Lee, Kyoung Min; Sung, Ki Hyuk; Lee, Seung Yeol; Won, Sung Hun; Kim, Tae Gyun; Choi, Young; Kwon, Soon-Sun; Kim, Yeon Ho; Park, Moon Seok

    2015-01-01

    Purpose Although previous studies have focused on risk factors for osteoarthritis, there is some debate on this issue. Furthermore, associated factors with arthritic symptom (arthralgia) have not been sufficiently investigated, despite its clinical importance in the management of osteoarthritis. This study was performed to examine the risk factors for osteoarthritis and the contributing factors to current arthritic pain in older adults. Materials and Methods The Fourth Korean National Health and Nutrition Examination Surveys was conducted in 2009. Therein, 720 males and 1008 females aged 65 years and older were included. Comprehensive data on habitual, socioeconomic, medical, nutritional, and psychological factors were collected along with the presence of osteoarthritis and arthritic pain. After univariate analysis, binary logistic regression analysis was performed to identify risk factors for osteoarthritis and contributing factors to current arthritic pain. Results Age (p=0.005), female gender (posteoarthritis, while higher education level (p=0.025) was a protective factor for osteoarthritis. Higher BMI (p=0.047), lack of weekly moderate intensity activity (posteoarthritis. Both osteoarthritis and current arthritic pain adversely affected health related quality of life. Conclusion Higher BMI, lack of weekly moderate intensity activity, and unfavorable subjective health status were significant factors contributing to current arthritic pain. More attention needs to be paid to psychiatric effects on osteoarthritis and joint related pain. PMID:25510755

  19. The 12-lead electrocardiogram and risk of sudden death: current utility and future prospects.

    Science.gov (United States)

    Narayanan, Kumar; Chugh, Sumeet S

    2015-10-01

    More than 100 years after it was first invented, the 12-lead electrocardiogram (ECG) continues to occupy an important place in the diagnostic armamentarium of the practicing clinician. With the recognition of relatively rare but important clinical entities such as Wolff-Parkinson-White and the long QT syndrome, this clinical tool was firmly established as a test for assessing risk of sudden cardiac death (SCD). However, over the past two decades the role of the ECG in risk prediction for common forms of SCD, for example in patients with coronary artery disease, has been the focus of considerable investigation. Especially in light of the limitations of current risk stratification approaches, there is a renewed focus on this broadly available and relatively inexpensive test. Various abnormalities of depolarization and repolarization on the ECG have been linked to SCD risk; however, more focused work is needed before they can be deployed in the clinical arena. The present review summarizes the current knowledge on various ECG risk markers for prediction of SCD and discusses some future directions in this field. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  20. Current drinking and health-risk behaviors among male high school students in central Thailand

    Directory of Open Access Journals (Sweden)

    Pichainarong Natchaporn

    2011-04-01

    Full Text Available Abstract Background Alcohol drinking is frequently related to behavioral problems, which lead to a number of negative consequences. This study was to evaluate the characteristics of male high school students who drink, the drinking patterns among them, and the associations between current drinking and other health risk behaviors which focused on personal safety, violence-related behaviors, suicide and sexual behaviors. Method A cross-sectional study was conducted to explore current alcohol drinking and health-risk behaviors among male high school students in central Thailand. Five thousand one hundred and eighty four male students were classified into 2 groups according to drinking in the previous 30 days (yes = 631, no = 4,553. Data were collected by self-administered, anonymous questionnaire which consisted of 3 parts: socio-demographic factors, health-risk behaviors and alcohol drinking behavior during the past year from December 2007 to February 2008. Results The results showed that the percent of current drinking was 12.17. Most of them were 15-17 years (50.21%. Socio-demographic factors such as age, educational level, residence, cohabitants, grade point average (GPA, having a part time job and having family members with alcohol/drug problems were significantly associated with alcohol drinking (p Conclusions An increased risk of health-risk behaviors, including driving vehicles after drinking, violence-related behaviors, sad feelings and attempted suicide, and sexual behaviors was higher among drinking students that led to significant health problems. Effective intervention strategies (such as a campaign mentioning the adverse health effects and social consequences to the risk groups, and encouraging parental and community efforts to prevent drinking among adolescents should be implemented to prevent underage drinking and adverse consequences.

  1. Regulatory Physiology

    Science.gov (United States)

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

    1999-01-01

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

  2. Does thimerosal or other mercury exposure increase the risk for autism? A review of current literature.

    Science.gov (United States)

    Schultz, Stephen T

    2010-01-01

    This report reviews current literature regarding the association of the pharmaceutical preservative thimerosal and other mercury exposures with the risk for autism. The evidence presented here does not support a causal association between autism and mercury exposure from the preservative thimerosal. The risk for autism from other mercury exposures such as from dental amalgam restorations or environmental mercury release into the atmosphere is ambiguous. Since mercury is a known neurotoxin, more research should be done to ensure that mercury exposure from any source does not contribute to autism.

  3. Current limitations in the management of cardiovascular risk in rheumatoid arthritis.

    Science.gov (United States)

    Scott, Ian C; Ibrahim, Fowzia; Johnson, Deborah; Scott, David L; Kingsley, Gabrielle H

    2012-01-01

    Rheumatoid arthritis (RA) is associated with excess cardiovascular (CV) disease. Many studies have shown subclinical atherosclerosis in RA is associated with CV risk factors and inflammation. Their relationship with CV events has however received less attention. Furthermore, except for hypertension CV risk factor management has not been examined in a UK RA population. We therefore evaluated the contribution of RA specific and CV risk factors to CV events alongside the management of CV risk factors in RA patients. We assessed the prevalence, screening and treatment of CV risk factors in a cross-sectional survey of RA patients consecutively attending specialist clinics. We used binary logistic regression to examine relationships between CV events and RA and CV risk factors. We enrolled 309 patients (81% female; median age 60 years; median disease duration 8 years). 27 (9%) had previous CV events. 56% had hypertension, 42% hyperlipidaemia, 11% diabetes, 52% were ex/current smokers and 26% obese. Lipid status was unknown in one third. 47% of patients on anti-hypertensive agents were undertreated. CV events were associated with hyperlipidaemia (OR 13.5; 95% CI 3.9, 45.9), hypertension (OR 6.4; 95% CI 1.9, 21.9), having ever smoked (OR 2.7; 95% CI 1.1, 6.5), RA duration (OR 1.09; 95% CI 1.06, 1.13) and erosions (OR 2.9; 95% CI 1.1, 8.2). CV events are prevalent in RA. They are associated with CV risks and RA factors. Despite this burden we found CV risk factors were inadequately managed. A robust system to identify and treat CV risks in RA is required.

  4. Increased risk of breast cancer in neurofibromatosis type 1: current insights.

    Science.gov (United States)

    Howell, Sacha J; Hockenhull, Kimberley; Salih, Zena; Evans, D Gareth

    2017-01-01

    Neurofibromatosis type 1 (NF1) is an autosomal dominant condition caused by mutation/deletion of the NF1 gene. The gene product, neurofibromin, is a tumor suppressor which represses the activity of the Ras oncogene. Central nervous system (CNS) tumors have long been associated with NF1, but their association with several other malignancies has been demonstrated. In this review, we summarize the epidemiological data that irrefutably support a link between NF1 and an increased risk of early-onset breast cancer, to levels at which annual mammography is currently recommended in national high-risk screening programs. We discuss the reasons for the observed adverse breast cancer prognosis in NF1 cases, including late presentation and more aggressive tumor subtypes, and recommend that a collaborative breast screening study be initiated to better serve this currently underserved population of women.

  5. 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.

  6. [Current aspects of risk factors in early stage cancer of the oral cavity].

    Science.gov (United States)

    Scutariu, Monica Mihaela; Voroneanu, Maria

    2006-01-01

    Understanding opinions, attitudes and practices of dental healthcare professionals is vital in order to assess their effectiveness in the prevention and early detection of oral cancer, thus helping to reduce its mortality and morbidity. There is current debate on whether the implementation of screening and detecting of risk factors as a separate procedure from the daily routine work of dental healthcare professionals would be an effective measure for the early detection and prevention of oral cancer. Being able to routinely detect oral cancer at an early stage and counsel patients in prevention is a continuous challenge for the dental profession. Dentists must be familiar with the risk factors and clinical signs and symptoms of oral cancer if they are to be effective in identifying, referring and counseling high-risk patients.

  7. Current Conditions Risk Assessment for the 300-FF-5 Groundwater Operable Unit

    Energy Technology Data Exchange (ETDEWEB)

    Miley, Terri B.; Bunn, Amoret L.; Napier, Bruce A.; Peterson, Robert E.; Becker, James M.

    2007-11-01

    This report updates a baseline risk assessment for the 300 Area prepared in 1994. The update includes consideration of changes in contaminants of interest and in the environment that have occurred during the period of interim remedial action, i.e., 1996 to the present, as well as the sub-regions, for which no initial risk assessments have been conducted. In 1996, a record of decision (ROD) stipulated interim remedial action for groundwater affected by releases from 300 Area sources, as follows: (a) continued monitoring of groundwater that is contaminated above health-based levels to ensure that concentrations continue to decrease, and (b) institutional controls to ensure that groundwater use is restricted to prevent unacceptable exposure to groundwater contamination. In 2000, the groundwater beneath the two outlying sub-regions was added to the operable unit. In 2001, the first 5-year review of the ROD found that the interim remedy and remedial action objectives were still appropriate, although the review called for additional characterization activities. This report includes a current conditions baseline ecological and human health risk assessment using maximum concentrations in the environmental media of the 300-FF-5 Operable Unit and downstream conditions at the City of Richland, Washington. The scope for this assessment includes only current measured environmental concentrations and current use scenarios. Future environmental concentrations and future land uses are not considered in this assessment.

  8. Unmet needs and current and future approaches for osteoporotic patients at high risk of hip fracture.

    Science.gov (United States)

    Ferrari, Serge; Reginster, Jean-Yves; Brandi, Maria Luisa; Kanis, John A; Devogelaer, Jean-Pierre; Kaufman, Jean-Marc; Féron, Jean-Marc; Kurth, Andreas; Rizzoli, René

    2016-12-01

    This review provides a critical analysis of currently available approaches to increase bone mass, structure and strength through drug therapy and of possible direct intra-osseous interventions for the management of patients at imminent risk of hip fracture. Osteoporotic hip fractures represent a particularly high burden in morbidity-, mortality- and health care-related costs. There are challenges and unmet needs in the early prevention of hip fractures, opening the perspective of new developments for the management of osteoporotic patients at imminent and/or at very high risk of hip fracture. Amongst them, preventive surgical intervention needs to be considered. A European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)/International Osteoporosis Foundation (IOF) working group reviewed the presently available intervention modalities including preventive surgical options for hip fragility. This paper represents a summary of the discussions. Prevention of hip fracture is currently based on regular physical activity; prevention of falls; correction of nutritional deficiencies, including vitamin D repletion; and pharmacological intervention. However, efficacy of these various measures to reduce hip fractures is at most 50% and may need months or years before becoming effective. To face the challenges of early prevention of hip fractures for osteoporotic patients at imminent and/or at very high risk of hip fracture, preventive surgical intervention needs further investigation. Preventive surgical intervention needs to be appraised for osteoporotic patients at imminent and/or at very high risk of hip fracture.

  9. 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.

  10. Wildlife risks associated with passage of contaminated, anadromous fish at Federal Energy Regulatory Commission Licensed Dams in Michigan

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — The purpose of this paper is to assess the issue of anadromous fish passage at Federal Energy Regulatory Commission (FERC) licensed hydropower dams in Michigan and...

  11. Current and Future Potential Risk of Establishment of Grapholita molesta (Lepidoptera: Tortricidae) in Washington State.

    Science.gov (United States)

    Neven, Lisa G; Kumar, Sunil; Yee, Wee L; Wakie, Tewodros

    2018-02-17

    The oriental fruit moth, Grapholita molesta (Busck) (Lepidoptera: Tortricidae), is a primary pest of stone fruits that cause significant economic damage. Larvae, which enter the host plant through shoot tips, damage shoots, and ripe fruits. Native to Asia, this pest now occurs in many fruit-growing countries, including the United States and Canada. Though the pest was previously reported from many states within the United States, its current distribution and the environmental variables that influence its distribution are not properly identified. The objectives of this study were to 1) identify the environmental factors associated with G. molesta current distribution, 2) predict the current distribution of G. molesta in Washington State (WA) using Maxent and Climex models, 3) identify those areas within WA best suited for establishment of pest free zones, areas of low pest prevalence, and pest free production areas, and 4) identify regions most at risk for further expansion of G. molesta populations as a function of climate change. The current models predicted a small portion of central WA is suitable to support G. molesta, which is consistent with observed distributions. However, climate change models predict that more areas will become suitable for the pest. These results indicate that action should be taken to monitor and reduce current populations of G. molesta to stem its potential expansion into the major commercial tree fruit production areas in the state.

  12. Food and feed chemical contaminants in the European Union: Regulatory, scientific, and technical issues concerning chemical contaminants occurrence, risk assessment, and risk management in the European Union.

    Science.gov (United States)

    Silano, Marco; Silano, Vittorio

    2017-07-03

    A priority of the European Union is the control of risks possibly associated with chemical contaminants in food and undesirable substances in feed. Following an initial chapter describing the main contaminants detected in food and undesirable substances in feed in the EU, their main sources and the factors which affect their occurrence, the present review focuses on the "continous call for data" procedure that is a very effective system in place at EFSA to make possible the exposure assessment of specific contaminants and undesirable substances. Risk assessment of contaminants in food atances in feed is carried currently in the European Union by the CONTAM Panel of EFSA according to well defined methodologies and in collaboration with competent international organizations and with Member States.

  13. 78 FR 69604 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Science.gov (United States)

    2013-11-20

    ... Preventive Controls for Human Food; Extension of Comment Periods AGENCY: Food and Drug Administration, HHS... 3646), entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive... rule entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive...

  14. 78 FR 24691 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Science.gov (United States)

    2013-04-26

    ... Preventive Controls for Human Food; Extension of Comment Periods AGENCY: Food and Drug Administration, HHS... the proposed rule, ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive... rule entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive...

  15. Risk factors associated with suicide in current and former US military personnel.

    Science.gov (United States)

    LeardMann, Cynthia A; Powell, Teresa M; Smith, Tyler C; Bell, Michael R; Smith, Besa; Boyko, Edward J; Hooper, Tomoko I; Gackstetter, Gary D; Ghamsary, Mark; Hoge, Charles W

    2013-08-07

    Beginning in 2005, the incidence of suicide deaths in the US military began to sharply increase. Unique stressors, such as combat deployments, have been assumed to underlie the increasing incidence. Previous military suicide studies, however, have relied on case series and cross-sectional investigations and have not linked data during service with postservice periods. To prospectively identify and quantify risk factors associated with suicide in current and former US military personnel including demographic, military, mental health, behavioral, and deployment characteristics. Prospective longitudinal study with accrual and assessment of participants in 2001, 2004, and 2007. Questionnaire data were linked with the National Death Index and the Department of Defense Medical Mortality Registry through December 31, 2008. Participants were current and former US military personnel from all service branches, including active and Reserve/National Guard, who were included in the Millennium Cohort Study (N = 151,560). Death by suicide captured by the National Death Index and the Department of Defense Medical Mortality Registry. Through the end of 2008, findings were 83 suicides in 707,493 person-years of follow-up (11.73/100,000 person-years [95% CI, 9.21-14.26]). In Cox models adjusted for age and sex, factors significantly associated with increased risk of suicide included male sex, depression, manic-depressive disorder, heavy or binge drinking, and alcohol-related problems. None of the deployment-related factors (combat experience, cumulative days deployed, or number of deployments) were associated with increased suicide risk in any of the models. In multivariable Cox models, individuals with increased risk for suicide were men (hazard ratio [HR], 2.14; 95% CI, 1.17-3.92; P = .01; attributable risk [AR], 3.5 cases/10,000 persons), and those with depression (HR, 1.96; 95% CI, 1.05-3.64; P = .03; AR, 6.9/10,000 persons), manic-depressive disorder (HR, 4.35; 95% CI, 1

  16. Hedging Financial Risks in the Economic Practices of Small Business: Current Imperatives

    Directory of Open Access Journals (Sweden)

    Kolomiyets Ganna M.

    2017-04-01

    Full Text Available The article considers the need to update approaches to hedging the financial risks of small businesses. Reducing the probability of financial costs and losses is of continuing relevance. It appears to be especially critical for small businesses. Small business plays a significant role in the country’s economic system as creator of jobs and as a producer of goods and services that adapts quickly to changing consumer requirements. However, its access to credit resources has certain limitations. The instability of the economic environment by individual factors can affect small businesses not less, and sometimes even more than large and medium-sized businesses. Design of the risk-management in terms of small business needs to be updated. In the current context, there is a need in re-evaluating that the efficient financial risk management can only be carried out in a complex of all the enterprise’s risks, with an increase in the planning horizon and the identification of obstacles to achieving the objective set.

  17. Smoke exposure as a risk factor for asthma in childhood: a review of current evidence.

    Science.gov (United States)

    Ferrante, Giuliana; Antona, Roberta; Malizia, Velia; Montalbano, Laura; Corsello, Giovanni; La Grutta, Stefania

    2014-01-01

    Asthma is a common chronic multifactorial disease that affects >300 million people worldwide. Outdoor and indoor pollution exposure has been associated with respiratory health effects in adults and children. Smoking still represents a huge public health problem and millions of children suffer the detrimental effects of passive smoke exposure. This study was designed to review the current evidences on exposure to passive smoke as a risk factor for asthma onset in childhood. A review of the most recent studies on this topic was undertaken to provide evidence about the magnitude of the effect of passive smoking on the risk of incidence of asthma in children. The effects of passive smoking are different depending on individual and environmental factors. Environmental tobacco smoke (ETS) is one of the most important indoor air pollutants and can interact with other air pollutants in eliciting respiratory outcomes during childhood. The increased risk of respiratory outcomes in children exposed to prenatal and early postnatal passive smoke might be caused by an adverse effect on both the immune system and the structural and functional development of the lung; this may explain the subsequent increased risk of incident asthma. The magnitude of the exposure is quite difficult to precisely quantify because it is significantly influenced by the child's daily activities. Because exposure to ETS is a likely cause for asthma onset in childhood, there is a strong need to prevent infants and children from breathing air contaminated with tobacco smoke.

  18. Current and past cigarette smoking significantly increase risk for microscopic colitis.

    Science.gov (United States)

    Yen, Eugene F; Pokhrel, Bhupesh; Du, Hongyan; Nwe, Steven; Bianchi, Laura; Witt, Benjamin; Hall, Curtis

    2012-10-01

    Cigarette smoking is an important environmental factor affecting inflammatory bowel disease. The role of smoking has not been rigorously studied in microscopic colitis (MC). The aim of this study was to compare the association of cigarette smoking in individuals with MC compared to a control population without MC. We reviewed the records of patients with a clinical and histologic diagnosis of collagenous colitis (CC) or lymphocytic colitis (LC). Clinical history, including alcohol and smoking status at the time of diagnosis of MC, were reviewed. In this case-control study, age- and gender-matched patients without diarrhea presenting for outpatient colonoscopy served as the control population. We analyzed a total of 340 patients with MC: 124 with CC and 216 with LC. Overall, any smoking status (former or current) was associated with MC (odds ratio [OR] 2.12, 95% confidence interval [CI]: 1.56-2.88). This risk was more prominent in current smokers (adjusted OR 5.36, 3.81, and 4.37 for CC, LC, and all MC, respectively, 95% CI all greater than 1). The association of smoking was not significantly affected by gender or average alcohol consumption. In our study population, cigarette smoking is a risk factor for the development of both forms of microscopic colitis. There were no significant differences between LC and CC, and current smoking and the development of microscopic colitis affected men and women similarly. We feel that these data are sufficient to discuss the potential risks of tobacco use in patients with microscopic colitis. Copyright © 2011 Crohn's & Colitis Foundation of America, Inc.

  19. Addressing Occupational Fatigue in Nurses: Current State of Fatigue Risk Management in Hospitals, Part 2.

    Science.gov (United States)

    Steege, Linsey M; Pinekenstein, Barbara J; Rainbow, Jessica G; Arsenault Knudsen, Élise

    2017-10-01

    The aim of this article is to describe the current state of fatigue risk management systems (FRMSs) to address nurse fatigue in hospitals. Little is known about the current state of FRMS implementation and adoption of national recommendations in nursing work systems. This study used a sequential exploratory mixed-methods design including a survey of nurse leaders from across the United States. Adoption of evidence-based policies to address fatigue is both limited and variable depending on the policy. Nurse leaders indicate that while nurse fatigue is an important issue and has negative consequences, the social norms of fatigue have not allowed the elevation of this topic to trigger sweeping organizational change. This study provides a framework for implementation of FRMSs as an innovation, highlighting the critical role of nurse leaders in adoption and dissemination. Raising the visibility of fatigue across the organization is a critical 1st step.

  20. Risk Analysis and Forecast Service for Geomagnetically Induced Currents in Europe

    Science.gov (United States)

    Wik, Magnus; Pirjola, Risto; Viljanen, Ari; Lundstedt, Henrik

    Geomagnetically induced currents (GIC), occurring during magnetic storms, pose a widespread natural disaster risk to the reliable operation of electric power transmission grids, oil and gas pipelines, telecommunication cables and railway systems. The solar magnetic activity is the cause of GIC. Solar coronal holes can cause recurrent inter-vals of raised geomagnetic activity, and coronal mass ejections (CME) at the Sun, sometimes producing very high speed plasma clouds with enhanced magnetic fields and particle densities, can cause the strongest geomagnetic storms. When the solar wind interacts with the geomag-netic field, energy is transferred to the magnetosphere, driving strong currents in the ionosphere. When these currents change in time a geoelectric field is induced at the surface of the Earth and in the ground. Finally, this field drives GIC in the ground and in any technological conductor systems. The worst consequence of a severe magnetic storm within a power grid is a complete blackout, as happened in the province of Québec, Canada, in March 1989, and in the city of Malmü, Sweden, in October 2003. Gas and oil pipelines are not regarded as vulnerable to the immediate impact of GIC, but the corrosion rate of buried steel pipes can increase due to GIC, which may thus shorten the lifetime of a pipe. European Risk from Geomagnetically Induced Currents (EURISGIC) is an EU project, that, if approved, will produce the first European-wide real-time prototype forecast service of GIC in power systems, based on in-situ solar wind observations and comprehensive simulations of the Earth's magnetosphere. This project focuses on high-voltage power transmission networks, which are probably currently the most susceptible to GIC effects. Geomagnetic storms cover large geographical regions, at times the whole globe. Consequently, power networks are rightly described as being European critical infrastructures whose disruption or destruction could have a significant impact

  1. 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

  2. Robotic radical prostatectomy in high-risk prostate cancer: current perspectives.

    Science.gov (United States)

    Canda, Abdullah Erdem; Balbay, Mevlana Derya

    2015-01-01

    Around 20%-30% of patients diagnosed with prostate cancer (PCa) still have high-risk PCa disease (HRPC) that requires aggressive treatment. Treatment of HRPC is controversial, and multimodality therapy combining surgery, radiation therapy, and androgen deprivation therapy have been suggested. There has been a trend toward performing radical prostatectomy (RP) in HRPC and currently, robot-assisted laparoscopic RP (RARP) has become the most common approach. Number of publications related to robotic surgery in HRPC is limited in the literature. Tissue and Tumor characteristics might be different in HRPC patients compared to low-risk group and increased surgical experience for RARP is needed. Due to the current literature, RARP seems to have similar oncologic outcomes including surgical margin positivity, biochemical recurrence and recurrence-free survival rates, additional cancer therapy needs and lymph node (LN) yields with similar complication rates compared to open surgery in HRPC. In addition, decreased blood loss, lower rates of blood transfusion and shorter duration of hospital stay seem to be the advantages of robotic surgery in this particular patient group. RARP in HRPC patients seems to be safe and technically feasible with good intermediate-term oncologic results, acceptable morbidities, excellent short-term surgical and pathological outcomes and satisfactory functional results.

  3. Robotic radical prostatectomy in high-risk prostate cancer: current perspectives

    Directory of Open Access Journals (Sweden)

    Abdullah Erdem Canda

    2015-01-01

    Full Text Available Around 20%-30% of patients diagnosed with prostate cancer (PCa still have high-risk PCa disease (HRPC that requires aggressive treatment. Treatment of HRPC is controversial, and multimodality therapy combining surgery, radiation therapy, and androgen deprivation therapy have been suggested. There has been a trend toward performing radical prostatectomy (RP in HRPC and currently, robot-assisted laparoscopic RP (RARP has become the most common approach. Number of publications related to robotic surgery in HRPC is limited in the literature. Tissue and Tumor characteristics might be different in HRPC patients compared to low-risk group and increased surgical experience for RARP is needed. Due to the current literature, RARP seems to have similar oncologic outcomes including surgical margin positivity, biochemical recurrence and recurrence-free survival rates, additional cancer therapy needs and lymph node (LN yields with similar complication rates compared to open surgery in HRPC. In addition, decreased blood loss, lower rates of blood transfusion and shorter duration of hospital stay seem to be the advantages of robotic surgery in this particular patient group. RARP in HRPC patients seems to be safe and technically feasible with good intermediate-term oncologic results, acceptable morbidities, excellent short-term surgical and pathological outcomes and satisfactory functional results.

  4. Hepatocellular carcinoma: current trends in worldwide epidemiology, risk factors, diagnosis, and therapeutics

    Directory of Open Access Journals (Sweden)

    Dhanasekaran R

    2012-05-01

    Full Text Available Renumathy Dhanasekaran, Alpna Limaye, Roniel CabreraDivision of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, University of Florida, Gainesville, FL, USAAbstract: Hepatocellular carcinoma (HCC is a common malignancy in developing countries and its incidence is on the rise in the developing world. The epidemiology of this cancer is unique since its risk factors, including hepatitis C and B, have been clearly established. The current trends in the shifting incidence of HCC in different regions of the world can be explained partly by the changing prevalence of hepatitis. Early detection offers the only hope for curative treatment for patients with HCC, hence effective screening strategies for high-risk patients is of utmost importance. Liver transplantation and surgical resection remains the cornerstone of curative treatment. But major advances in locoregional therapies and molecular-targeted therapies for the treatment of advanced HCC have occurred recently. In this review, current trends in the worldwide epidemiology, surveillance, diagnosis, standard treatments, and the emerging therapies for HCC are discussed.Keywords: liver cancer, sorafenib, hepatitis C, TACE

  5. Current surgical instrument labeling techniques may increase the risk of unintentionally retained foreign objects: a hypothesis.

    Science.gov (United States)

    Ipaktchi, Kyros; Kolnik, Adam; Messina, Michael; Banegas, Rodrigo; Livermore, Meryl; Price, Connie

    2013-09-30

    Marking of surgical instruments is essential to ensure their proper identification after sterile processing. The National Quality Forum defines unintentionally retained foreign objects in a surgical patient as a serious reportable event also called "never event." We hypothesize that established practices of surgical instrument identification using unkempt tape labels and plastic tags may expose patients to "never events" from retained disintegrating labels. We demonstrate the near miss of a "never event" during a surgical case in which the breakage of an instrument label remained initially unwitnessed. A fragment of the plastic label was accidentally found in the wound upon closing. Further clinical testing of the occurrence of this "never event" appears not feasible. As the name implies a patient should never be exposed to the risk of fragmenting labels. Current practice does not mandate verifying intact instrument markers as part of the instrument count. The clinical confirmation of our hypothesis mandates a change in perioperative practice: Mechanical labels need to undergo routine inspection and maintenance. The perioperative count must not only verify the quantity of surgical instruments but also the intactness of labels to ensure that no part of an instrument is left behind. Proactive maintenance of taped and dipped labels should be performed routinely. The implementation of newer labeling technologies - such as laser engraved codes - appears to eliminate risks seen in traditional mechanical labels.This article reviews current instrument marking technologies, highlights shortcomings and recommends safe instrument handling and marking practices implementing newer available technologies.

  6. Test of the depression distress amplification model in young adults with elevated risk of current suicidality.

    Science.gov (United States)

    Capron, Daniel W; Lamis, Dorian A; Schmidt, Norman B

    2014-11-30

    Suicide is a leading cause of death among young adults and the rate of suicide has been increasing for decades. A depression distress amplification model posits that young adults with comorbid depression and anxiety have elevated suicide rates due to the intensification of their depressive symptoms by anxiety sensitivity cognitive concerns. The current study tested the effects of anxiety sensitivity subfactors as well as the depression distress amplification model in a very large sample of college students with elevated suicide risk. Participants were 721 college students who were at elevated risk of suicidality (scored>0 on the Beck Scale for Suicide Ideation). Consistent with prior work, anxiety sensitivity cognitive concerns, but not physical or social concerns, were associated with suicidal ideation. Consistent with the depression distress amplification model, in individuals high in depression, anxiety sensitivity cognitive concerns predicted elevated suicidal ideation but not among those with low depression. The results of this study corroborate the role of anxiety sensitivity cognitive concerns and the depression distress amplification model in suicidal ideation among a large potentially high-risk group of college students. The depression distress amplification model suggests a specific mechanism, anxiety sensitivity cognitive concerns, that may be responsible for increased suicide rates among those with comorbid anxiety and depression. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  7. Defining Established and Emerging Microbial Risks in the Aquatic Environment: Current Knowledge, Implications, and Outlooks

    Directory of Open Access Journals (Sweden)

    Neil J. Rowan

    2011-01-01

    Full Text Available This timely review primarily addresses important but presently undefined microbial risks to public health and to the natural environment. It specifically focuses on current knowledge, future outlooks and offers some potential alleviation strategies that may reduce or eliminate the risk of problematic microbes in their viable but nonculturable (VBNC state and Cryptosporidium oocysts in the aquatic environment. As emphasis is placed on water quality, particularly surrounding efficacy of decontamination at the wastewater treatment plant level, this review also touches upon other related emerging issues, namely, the fate and potential ecotoxicological impact of untreated antibiotics and other pharmaceutically active compounds in water. Deciphering best published data has elucidated gaps between science and policy that will help stakeholders work towards the European Union's Water Framework Directive (2000/60/EC, which provides an ambitious legislative framework for water quality improvements within its region and seeks to restore all water bodies to “good ecological status” by 2015. Future effective risk-based assessment and management, post definition of the plethora of dynamic inter-related factors governing the occurrence, persistence and/or control of these presently undefined hazards in water will also demand exploiting and harnessing tangential advances in allied disciplines such as mathematical and computer modeling that will permit efficient data generation and transparent reporting to be undertaken by well-balanced consortia of stakeholders.

  8. Current and Future Impact Risks from Small Debris to Operational Satellites

    Science.gov (United States)

    Liou, Jer-Chyi; Kessler, Don

    2011-01-01

    The collision between Iridium 33 and Cosmos 2251 in 2009 signaled the potential onset of the collision cascade effect, commonly known as the "Kessler Syndrome", in the low Earth orbit (LEO) region. Recent numerical simulations have shown that the 10 cm and larger debris population in LEO will continue to increase even with a good implementation of the commonly-adopted mitigation measures. This increase is driven by collisions involving large and massive intacts, i.e., rocket bodies and spacecraft. Therefore, active debris removal (ADR) of large and massive intacts with high collision probabilities has been argued as a direct and effective means to remediate the environment in LEO. The major risk for operational satellites in the environment, however, comes from impacts with debris just above the threshold of the protection shields. In general, these are debris in the millimeter to centimeter size regime. Although impacts by these objects are insufficient to lead to catastrophic breakup of the entire vehicle, the damage is certainly severe enough to cause critical failure of the key instruments or the entire payload. The focus of this paper is to estimate the impact risks from 5 mm and 1 cm debris to active payloads in LEO (1) in the current environment and (2) in the future environment based on different projection scenarios, including ADR. The goal of the study is to quantify the benefits of ADR in reducing debris impact risks to operational satellites.

  9. Pregnancy and inflammatory bowel diseases: Current perspectives, risks and patient management

    Science.gov (United States)

    Hosseini-Carroll, Pegah; Mutyala, Monica; Seth, Abhishek; Nageeb, Shaheen; Soliman, Demiana; Boktor, Moheb; Sheth, Ankur; Chapman, Jonathon; Morris, James; Jordan, Paul; Manas, Kenneth; Becker, Felix; Alexander, Jonathan Steven

    2015-01-01

    Inflammatory bowel diseases (IBD) are chronic idiopathic inflammatory conditions characterized by relapsing and remitting episodes of inflammation which can affect several different regions of the gastrointestinal tract, but also shows extra-intestinal manifestations. IBD is most frequently diagnosed during peak female reproductive years, with 25% of women with IBD conceiving after their diagnosis. While IBD therapy has improved dramatically with enhanced surveillance and more abundant and powerful treatment options, IBD disease can have important effects on pregnancy and presents several challenges for maintaining optimal outcomes for mothers with IBD and the developing fetus/neonate. Women with IBD, the medical team treating them (both gastroenterologists and obstetricians/gynecologists) must often make highly complicated choices regarding conception, pregnancy, and post-natal care (particularly breastfeeding) related to their choice of treatment options at different phases of pregnancy as well as post-partum. This current review discusses current concerns and recommendations for pregnancy during IBD and is intended for gastroenterologists, general practitioners and IBD patients intending to become, (or already) pregnant, and their families. We have addressed patterns of IBD inheritance, effects of IBD on fertility and conception (in both men and women), the effects of IBD disease activity on maintenance of pregnancy and outcomes, risks of diagnostic procedures during pregnancy and potential risks and complications associated with different classes of IBD therapeutics. We also have evaluated the clinical experience using “top-down” care with biologics, which is currently the standard care at our institution. Post-partum care and breastfeeding recommendations are also addressed. PMID:26558150

  10. An approach for the anticipatory and participatory management of current and future flood risks

    Science.gov (United States)

    Luther, J.

    2012-04-01

    Despite the fact that many measures to attenuate flood hazards and reduce vulnerabilities are being implemented, adverse effects of floods are ever-increasing in most parts of the world. On the one hand this holds true for economically and/or demographically growing regions. On the other hand this applies also to areas that face population shrinkage and economic problems. Such flood risks occur in human-environment systems and are subject to dynamics caused by a number of drivers such as climate change, land-use changes, and others. Many drivers evolve slowly over time or show time-lag effects and long return periods. Moreover, certain decisions may determine the control actions of the following decades. At present, current flood risks are mostly determined based on historic developments and the ex post analysis of flood events. Approaches that look at the future dynamics of both hazards and vulnerable elements ex ante in an integrated manner are rare. Instead, future hazard scenarios are often just overlaid with current socio-economic data, which poses a strong inconsistency. Usually the focus lies on rather short-term, specific or local problems. But many developments and measures show their effects only after long time periods and when considering the whole catchment area. This calls for a holistic and long-term view into the future and implies the challenge of dealing with many uncertainties due to the system's complexity. In order to anticipate and react to these developments, this contribution suggests developing a flexible, yet holistic approach to design, analyse and evaluate alternative futures of such human-environment systems. These futures follow a scenario understanding that considers both specific (current) factor constellations as well as consistent assumptions on autonomous developments (so-called development frameworks) and potentials for control (strategic alternatives) of the interacting entities that influence flood risk. Different scenario

  11. Affective bias and current, past and future adolescent depression: A familial high risk study

    Science.gov (United States)

    Kilford, Emma J.; Foulkes, Lucy; Potter, Robert; Collishaw, Stephan; Thapar, Anita; Rice, Frances

    2015-01-01

    Background Affective bias is a common feature of depressive disorder. However, a lack of longitudinal studies means that the temporal relationship between affective bias and depression is not well understood. One group where studies of affective bias may be particularly warranted is the adolescent offspring of depressed parents, given observations of high rates of depression and a severe and impairing course of disorder in this group. Methods A two wave panel design was used in which adolescent offspring of parents with recurrent depression completed a behavioural task assessing affective bias (The Affective Go/No Go Task) and a psychiatric interview. The affective processing of adolescents with current, prior and future depressive disorder was compared to that of adolescents free from disorder. Results Adolescents with current depression and those who developed depression at follow-up made more commission errors for sad than happy targets compared to adolescents free from disorder. There was no effect of prior depression on later affective processing. Limitations Small cell sizes meant we were unable to separately compare those with new onset and recurrent depressive disorder. Conclusions Valence-specific errors in behavioural inhibition index future vulnerability to depression in adolescents already at increased risk and may represent a measure of affective control. Currently depressed adolescents show a similar pattern of affective bias or deficits in affective control. PMID:25527997

  12. Affective bias and current, past and future adolescent depression: a familial high risk study.

    Science.gov (United States)

    Kilford, Emma J; Foulkes, Lucy; Potter, Robert; Collishaw, Stephan; Thapar, Anita; Rice, Frances

    2015-03-15

    Affective bias is a common feature of depressive disorder. However, a lack of longitudinal studies means that the temporal relationship between affective bias and depression is not well understood. One group where studies of affective bias may be particularly warranted is the adolescent offspring of depressed parents, given observations of high rates of depression and a severe and impairing course of disorder in this group. A two wave panel design was used in which adolescent offspring of parents with recurrent depression completed a behavioural task assessing affective bias (The Affective Go/No Go Task) and a psychiatric interview. The affective processing of adolescents with current, prior and future depressive disorder was compared to that of adolescents free from disorder. Adolescents with current depression and those who developed depression at follow-up made more commission errors for sad than happy targets compared to adolescents free from disorder. There was no effect of prior depression on later affective processing. Small cell sizes meant we were unable to separately compare those with new onset and recurrent depressive disorder. Valence-specific errors in behavioural inhibition index future vulnerability to depression in adolescents already at increased risk and may represent a measure of affective control. Currently depressed adolescents show a similar pattern of affective bias or deficits in affective control. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

  13. The use of current risk analysis tools evaluated towards preventing external domino accidents

    NARCIS (Netherlands)

    Reniers, Genserik L L; Dullaert, W.; Ale, B. J.M.; Soudan, K.

    Risk analysis is an essential tool for company safety policy. Risk analysis consists of identifying and evaluating all possible risks. The efficiency of risk analysis tools depends on the rigueur of identifying and evaluating all possible risks. The diversity in risk analysis procedures is such that

  14. Nonparametric inference for competing risks current status data with continuous, discrete or grouped observation times.

    Science.gov (United States)

    Maathuis, M H; Hudgens, M G

    2011-06-01

    New methods and theory have recently been developed to nonparametrically estimate cumulative incidence functions for competing risks survival data subject to current status censoring. In particular, the limiting distribution of the nonparametric maximum likelihood estimator and a simplified naive estimator have been established under certain smoothness conditions. In this paper, we establish the large-sample behaviour of these estimators in two additional models, namely when the observation time distribution has discrete support and when the observation times are grouped. These asymptotic results are applied to the construction of confidence intervals in the three different models. The methods are illustrated on two datasets regarding the cumulative incidence of different types of menopause from a cross-sectional sample of women in the United States and subtype-specific HIV infection from a sero-prevalence study in injecting drug users in Thailand.

  15. [Current status on storage, processing and risk communication of medical radioactive waste in Japan].

    Science.gov (United States)

    Watanabe, Hiroshi; Yamaguchi, Ichiro; Kida, Tetsuo; Hiraki, Hitoshi; Fujibuchi, Toshioh; Maehara, Yoshiaki; Tsukamoto, Atsuko; Koizumi, Mitsue; Kimura, Yumi; Horitsugi, Genki

    2013-03-01

    Decay-in-storage for radioactive waste including that of nuclear medicine has not been implemented in Japan. Therefore, all medical radioactive waste is collected and stored at the Japan Radioisotope Association Takizawa laboratory, even if the radioactivity has already decayed out. To clarify the current situation between Takizawa village and Takizawa laboratory, we investigated the radiation management status and risk communication activities at the laboratory via a questionnaire and site visiting survey in June 2010. Takizawa laboratory continues to maintain an interactive relationship with local residents. As a result, Takizawa village permitted the acceptance of new medical radioactive waste containing Sr-89 and Y-90. However, the village did not accept any non-medical radioactive waste such as waste from research laboratories. To implement decay-in-storage in Japan, it is important to obtain agreement with all stakeholders. We must continue to exert sincere efforts to acquire the trust of all stakeholders.

  16. Genetic Vulnerability as a Distal Risk Factor for Suicidal Behaviour: Historical Perspective and Current Knowledge.

    Science.gov (United States)

    Andriessen, Karl; Videtic-Paska, Alja

    2015-09-01

    Suicide is a multidimensional problem. Observations of family history of suicide suggest the existence of a genetic vulnerability to suicidal behaviour. Starting with a historical perspective, the article reviews current knowledge of a genetic vulnerability to suicidal behaviour, distinct from the genetic vulnerability to psychiatric disorders, focused on clinical and population-based studies, and findings from recent molecular genetics association studies. The review includes peer-reviewed research articles and review papers from the professional literature in English language, retrieved from PubMed/Medline and PsycINFO. The research literature confirms a existence of a genetic vulnerability to suicidal behaviour. Even though the results of individual studies are difficult to compare, genetic influences could explain up to half of the variance of the occurrence of suicide. Genetic vulnerability could be a distal risk factor for suicide, which helps us to understand the occurrence of suicide among vulnerable people. Ethical implications of such vulnerability are highlighted.

  17. 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

  18. 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.

  19. The legacy of pesticide pollution: An overlooked factor in current risk assessments of freshwater systems.

    Science.gov (United States)

    Rasmussen, Jes J; Wiberg-Larsen, Peter; Baattrup-Pedersen, Annette; Cedergreen, Nina; McKnight, Ursula S; Kreuger, Jenny; Jacobsen, Dean; Kristensen, Esben A; Friberg, Nikolai

    2015-11-01

    We revealed a history of legacy pesticides in water and sediment samples from 19 small streams across an agricultural landscape. Dominant legacy compounds included organochlorine pesticides, such as DDT and lindane, the organophosphate chlorpyrifos and triazine herbicides such as terbutylazine and simazine which have long been banned in the EU. The highest concentrations of legacy pesticides were found in streams draining catchments with a large proportion of arable farmland suggesting that they originated from past agricultural applications. The sum of toxic units (SumTUD.magna) based on storm water samples from agriculturally impacted streams was significantly higher when legacy pesticides were included compared to when they were omitted. Legacy pesticides did not significantly change the predicted toxicity of water samples to algae or fish. However, pesticide concentrations in bed sediment and suspended sediment samples exceeded safety thresholds in 50% of the samples and the average contribution of legacy pesticides to the SumTUC.riparius was >90%. Our results suggest that legacy pesticides can be highly significant contributors to the current toxic exposure of stream biota, especially macroinvertebrate communities, and that those communities were primarily exposed to legacy pesticides via the sediment. Additionally, our results suggest that neglecting legacy pesticides in the risk assessment of pesticides in streams may severely underestimate the risk of ecological effects. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Expressed Emotion in Mothers of Currently Depressed, Remitted, High-Risk, and Low-Risk Youth: Links to Child Depression Status and Longitudinal Course

    Science.gov (United States)

    Silk, Jennifer S.; Ziegler, Melissa L.; Whalen, Diana J.; Dahl, Ronald E.; Ryan, Neal D.; Dietz, Laura J.; Birmaher, Boris; Axelson, David A.; Williamson, Douglas E.

    2009-01-01

    This study examined expressed emotion in the families of children and adolescents who were (a) in a current episode of Major Depressive Disorder (MDD), (b) in remission from a past episode of MDD, (c) at high familial risk for developing MDD, and (d) low-risk controls. Participants were 109 mother-child dyads (children ages 8-19). Expressed…

  1. 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.

  2. NPP financial and regulatory risks-Importance of a balanced and comprehensive nuclear law for a newcomer country considering nuclear power programme

    Science.gov (United States)

    Manan, J. A. N. Abd; Mostafa, N. A.; Salim, M. F.

    2015-04-01

    The nature of Nuclear Power Plant (NPP) projects are: long duration (10-15 years for new build), high capital investment, reasonable risks and highly regulated industries to meet national & international requirement on Safety, Security, Safeguards (3S) and Liabilities. It requires long term planning and commitment from siting to final disposal of waste/spent fuel. Potential financial and regulatory risks are common in massive NPP projects and will be magnified in the case of using unproven technology. If the risks are not properly managed, it can lead to high project and operation costs, and, fail to fulfil its objectives to provide compatible electricity prices and. energy security. To ensure successful, the government and investors need to ensure that the NPP project is bankable with low cost of project and funding, have fair treatment and proper risk mitigation, and able to complete on time with no cost overrun. One of the requirements as prerequisite for the development of NPP as stipulated by the International Atomic Energy Agency (IAEA) is the establishment of a Legal and Regulatory Framework. The main objective of nuclear law is to ensure that the activities and projects carried-out in the country are legal and compliant to national and international requirements. The law should also be able to provide fair treatment of risks on its activities that is acceptable to investors. The challenge for a newcomer country is to develop a balanced and comprehensive national nuclear law that meet these objectives while taking into consideration various stakeholders' interest without compromising on safety, security, safeguard, liability requirements and other international obligations. This paper highlights the nature of NPP projects, its potential and associated financial and regulatory risks, and its major concerns and challenges. It proposes possible risks treatment and mitigation through the formulation of a balanced and comprehensive legislation by clear

  3. 78 FR 11611 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Science.gov (United States)

    2013-02-19

    ... Preventive Controls for Human Food; Extension of Comment Period for Information Collection Provisions AGENCY... Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' that appeared in the... ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food...

  4. High concentrations of protein test substances may have non-toxic effects on Daphnia magna: implications for regulatory study designs and ecological risk assessments for GM crops.

    Science.gov (United States)

    Raybould, Alan; Burns, Andrea; Hamer, Mick

    2014-01-01

    Laboratory testing for possible adverse effects of insecticidal proteins on non-target organisms (NTOs) is an important part of many ecological risk assessments for regulatory decision-making about the cultivation of insect-resistant genetically modified (IRGM) crops. To increase confidence in the risk assessments, regulatory guidelines for effects testing specify that representative surrogate species for NTOs are exposed to concentrations of insecticidal proteins that are in excess of worst-case predicted exposures in the field. High concentrations in effects tests are achieved by using protein test substances produced in microbes, such as Escherichia coli. In a study that exposed Daphnia magna to a single high concentration of a microbial test substance containing Vip3Aa20, the insecticidal protein in MIR162 maize, small reductions in growth were observed. These effects were surprising as many other studies strongly suggest that the activity of Vip3Aa20 is limited to Lepidoptera. A plausible explanation for the effect on growth is that high concentrations of test substance have a non-toxic effect on Daphnia, perhaps by reducing its feeding rate. A follow-up study tested that hypothesis by exposing D. magna to several concentrations of Vip3Aa20, and a high concentration of a non-toxic protein, bovine serum albumin (BSA). Vip3Aa20 and BSA had sporadic effects on the reproduction and growth of D. magna. The pattern of the effects suggests that they result from non-toxic effects of high concentrations of protein, and not from toxicity. The implications of these results for regulatory NTO effects testing and ERA of IRGM crops are discussed.

  5. Immune regulatory gene polymorphisms as predisposing risk factors for the development of factor VIII inhibitors in Indian severe haemophilia A patients.

    Science.gov (United States)

    Pinto, P; Ghosh, K; Shetty, S

    2012-09-01

    Development of inhibitors to factor VIII, a serious complication of replacement therapy in haemophilia A patients, leads to increased bleeding, morbidity and mortality. There is no data on the risk factors for inhibitor development in Indian patients with severe haemophilia A. Our aim was to study the role of immune regulatory gene polymorphisms in the development of inhibitors. Fourteen immune regulatory gene polymorphisms (IL1β, IL4, IL10, TNFA and CTLA4) were analysed in 120 patients with severe haemophilia A, i.e. 50 inhibitor positive patients, and 70 inhibitor negative control patients, by PCR-RFLP, DNA sequencing and allele-specific PCRs. The IL10 promoter 'GCC' haplotypes overall (P: 0.002, OR: 3.452, 95% CI: 1.607-7.416), and 'GCC/ATA' (P: 0.011, OR: 3.492, 95% CI: 1.402-8.696) haplotype, associated with high and intermediate IL10 production, respectively, were significantly higher in inhibitor positive patients, whereas the 'non-GCC' haplotypes overall (P: 0.002,OR: 0.290, 95% CI 0.135-0.622) and 'ATA/ATA' haplotype (P: 0.025, OR: 0.278, 95% CI: 0.096-0.802), associated with low IL10 synthesis, were significantly higher among inhibitor negative patients. The TNFA rs1799724 C/T heterozygote prevalence was significantly higher in the inhibitor positive group (P: 0.021, OR: 3.190, 95% CI: 1.273-7.990), whereas the other polymorphisms showed no statistically significant association with the presence of inhibitors. Different immune regulatory gene polymorphisms play a significant role as possible risk factors for the development of inhibitors in severe haemophilia A patients. © 2012 Blackwell Publishing Ltd.

  6. Status of Legislation and Regulatory Control of Public Health Pesticides in Countries Endemic with or at Risk of Major Vector-Borne Diseases

    Science.gov (United States)

    Matthews, Graham; Zaim, Morteza; Soares, Agnes; Hii, Jeffrey; Ameneshewa, Birkinesh; Mnzava, Abraham; Dash, Aditya Prasad; Ejov, Mikhail; Tan, Soo Hian; van den Berg, Henk

    2011-01-01

    Background: Legislation and regulation of pesticides used in public health are essential for reducing risks to human health and the environment. Objective: We assessed the global situation on legislation and regulatory control of public health pesticides. Methods: A peer-reviewed and field-tested questionnaire was distributed to 142 member states of the World Health Organization (WHO); 113 states completed the questionnaire. Results: Legislation on public health pesticides was absent in 25% of the countries. Where present, legislation often lacked comprehensiveness, for example, on basic aspects such as labeling, storage, transport, and disposal of public health pesticides. Guidelines or essential requirements for the process of pesticide registration were lacking in many countries. The capacity to enforce regulations was considered to be weak across WHO regions. Half of all countries lacked pesticide quality control laboratories, and two-thirds reported high concern over quality of products on the market. National statistics on production and trade of pesticides and poisoning incidents were lacking in many countries. Despite the shortcomings, WHO recommendations were considered to constitute a supportive or sole basis in national registration. Also, some regions showed high participation of countries in regional schemes to harmonize pesticide registration requirements. Conclusions: Critical deficiencies are evident in the legislative and regulatory framework for public health pesticides across regions, posing risks to human health and the environment. Recent experience in some countries with situational analysis, needs assessment, action planning, and regional collaboration has signaled a promising way forward. PMID:21742577

  7. Thromboembolic risk in 16 274 atrial fibrillation patients undergoing direct current cardioversion with and without oral anticoagulant therapy

    DEFF Research Database (Denmark)

    Hansen, Morten Lock; Jepsen, Rikke Malene H G; Olesen, Jonas Bjerring

    2015-01-01

    AIMS: To study the risk of thromboembolism in a nationwide cohort of atrial fibrillation patients undergoing direct current (DC) cardioversion with or without oral anticoagulant coverage. METHODS AND RESULTS: A retrospective study of 16 274 patients in Denmark discharged from hospital after a first...... therapy was 2.21; 95% CI, 0.79-6.77 and 2.40; 95% CI, 1.46-3.95 with CHA2DS2-VASc score 0-1 and CHA2DS2-VASc score 2 or more, respectively. CONCLUSION: Direct current cardioversion for atrial fibrillation without oral anticoagulation is associated with a high risk of thromboembolism. Notably, the risk...

  8. Covering Risks in the Public Administration – an In-Depth Analysis of the Regulatory Changes in Romania

    Directory of Open Access Journals (Sweden)

    Madalina Cocosatu

    2011-05-01

    Full Text Available The paper aims at analyzing in a trans-disciplinary manner the institutional and functional changesof the public administration under crisis. The current analysis looks in depth of the financial, economic, and,more importantly, social crisis in relation to the reforms imposed by both the internal and externalstakeholders. The decision-makers have not taken into account the risk factors, triggering legislativeincoherence and instability due to the challenging and approval as non-constitutional of many such normativeacts by the Romanian Constitutional Court. The research objectives search to clear up the measures’coherence in the context of a declining public budget and a negative growth period, when the shrunk publicfunds need to be properly allocated. Therefore, the answer that our research is looking for should pertain tothe following concern: can the government’s actions be considered solutions to the problems raised by thecurrent context? The answers shall aim at both restoring the legal and economic balance, as defined in theworking hypothesis. The lax fiscal policy of the expenditures brings about an involuntary fiscal contraction inthe event of an economic downturn (Rosen and Gayer, 2010, as it was the case in Romania. Those lack ofprudence shall be addressed in our analysis, with specific reference to the already established literatureexplanations involving the decision-makers trust in the „good days shall be around forever”, which triggers abelief that the expenditures’ expansion can be permanent. Regarding the paper methodology, this study isproceeding via bibliographical research, so that the reasoning behind the paper is clearly underlined as thisresearch is actually triggered by the radical changes made by both legislatures and practitioners as a responseto crisis. Further, the manuscript makes use of direct observation and legislative analysis and extensivedocumentary research of national tax policy and statistics relevant

  9. An eQTL mapping approach reveals that rare variants in the SEMA5A regulatory network impact autism risk.

    Science.gov (United States)

    Cheng, Ye; Quinn, Jeffrey Francis; Weiss, Lauren Anne

    2013-07-15

    To date, genome-wide single nucleotide polymorphism (SNP) and copy number variant (CNV) association studies of autism spectrum disorders (ASDs) have led to promising signals but not to easily interpretable or translatable results. Our own genome-wide association study (GWAS) showed significant association to an intergenic SNP near Semaphorin 5A (SEMA5A) and provided evidence for reduced expression of the same gene. In a novel GWAS follow-up approach, we map an expression regulatory pathway for a GWAS candidate gene, SEMA5A, in silico by using population expression and genotype data sets. We find that the SEMA5A regulatory network significantly overlaps rare autism-specific CNVs. The SEMA5A regulatory network includes previous autism candidate genes and regions, including MACROD2, A2BP1, MCPH1, MAST4, CDH8, CADM1, FOXP1, AUTS2, MBD5, 7q21, 20p, USH2A, KIRREL3, DBF4B and RELN, among others. Our results provide: (i) a novel data-derived network implicated in autism, (ii) evidence that the same pathway seeded by an initial SNP association shows association with rare genetic variation in ASDs, (iii) a potential mechanism of action and interpretation for the previous autism candidate genes and genetic variants that fall in this network, and (iv) a novel approach that can be applied to other candidate genes for complex genetic disorders. We take a step towards better understanding of the significance of SEMA5A pathways in autism that can guide interpretation of many other genetic results in ASDs.

  10. DRUG RISK: A CROSS-SECTIONAL EXPLORATION OF THE INFLUENCE OF FAMILY-OF-ORIGIN AND CURRENT SITUATIONAL CIRCUMSTANCES.

    Science.gov (United States)

    Perkins, Molly; Elifson, Kirk W; Sterk, Claire E

    2010-04-01

    The main objective of this paper is to investigate potential predictors of drug risk among a community-based sample of individuals who are exposed to illicit drugs. The four domains of interest are individual socio-demographic and social-psychological attributes, current situational circumstances and family-of-origin characteristics. Interviews were conducted with 242 individuals who were recruited in Atlanta, Georgia. Initial descriptive analyses were followed by multivariate analyses. The final model predicted 60% of the variance in drug risk. Current situational circumstances were statistically significant regarding drug risk. Family-of-origin characteristics also were significant, even when entered into the predictive model after current situational circumstances. In addition to individual social-psychological characteristics such as depression and self-esteem, the impact of childhood emotional abuse is noted. The findings indicate a need for considering proximal as well as more distal influences on drug risk behavior when designing drug use prevention and intervention programs.

  11. Risk Management in Product Design: Current State, Conceptual Model and Future Research

    OpenAIRE

    Oehmen, Josef; Seering, Warren; Ben-Daya, Mohamed; Al-Salamah, Muhammad

    2010-01-01

    Risk management is an important element of product design. It helps to minimize the project- and product-related risks such as project budget and schedule overrun, or missing product cost and quality targets. Risk management is especially important for complex, international product design projects that involve a high degree of novel technology. This paper reviews the literature on risk management in product design. It examines the newly released international standard ISO 31000 “Risk managem...

  12. Risk Management Practices by Barbadian Banks

    Directory of Open Access Journals (Sweden)

    Anthony Wood

    2013-07-01

    The main findings of the paper are: risk managers perceive risk management as critical to their banks’ performance; the types of risks causing the greatest exposures are credit risk, operational risk, country/sovereign risk, interest rate risk and market risk; there was a high level of success with current risk management practices and these practices have evolved over time in line with the changing economic environment and regulatory updates. Overall, the findings suggest strongly that in light of the current depressed economic climate, banks operating in Barbados are indeed risk-focused or might we say “risk intelligent”.

  13. Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

    Science.gov (United States)

    King, Cheryl A.; Kramer, Anne C.

    2008-01-01

    Intervention research with youths at elevated risk for suicidal behavior and suicide--a vulnerable and high risk population--presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated…

  14. Best Clinical Practice: Current Controversies in Evaluation of Low-Risk Chest Pain-Part 1.

    Science.gov (United States)

    Long, Brit; Koyfman, Alex

    2016-12-01

    Chest pain is a common presentation to the emergency department (ED), though the majority of patients are not diagnosed with acute coronary syndrome (ACS). Many patients are admitted to the hospital due to fear of ACS. Our aim was to investigate controversies in low-risk chest pain evaluation, including risk of missed ACS, stress test, and coronary computed tomography angiography (CCTA). Chest pain accounts for 10 million ED visits in the United States annually. Many patients are at low risk for a major cardiac adverse event (MACE). With negative troponin and nonischemic electrocardiogram (ECG), the risk of MACE and myocardial infarction (MI) is evaluation in low- to intermediate-risk patients within 72 h. These modalities add little to further risk stratification. These evaluations do not appropriately risk stratify patients who are already at low risk, nor do they diagnose acute MI. CCTA is an anatomic evaluation of the coronary vasculature with literature support to decrease ED length of stay, though it is associated with downstream testing. Literature is controversial concerning further risk stratification in already low-risk patients. With nonischemic ECG and negative cardiac biomarker, the risk of ACS approaches chest pain patients is controversial. These tests may allow prognostication but do not predict ACS risk beyond ECG and troponin. CCTA may be useful for intermediate-risk patients, though further studies are required. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Mapping current research trends on anterior cruciate ligament injury risk against the existing evidence: In vivo biomechanical risk factors.

    Science.gov (United States)

    Sharir, Raihana; Rafeeuddin, Radin; Staes, Filip; Dingenen, Bart; George, Keith; Vanrenterghem, Jos; Robinson, Mark A

    2016-08-01

    Whilst many studies measure large numbers of biomechanical parameters and associate these to anterior cruciate ligament injury risk, they cannot be considered as anterior cruciate ligament injury risk factors without evidence from prospective studies. A review was conducted to systematically assess the in vivo biomechanical literature to identify biomechanical risk factors for non-contact anterior cruciate ligament injury during dynamic sports tasks; and to critically evaluate the research trends from retrospective and associative studies investigating non-contact anterior cruciate ligament injury risk. An electronic literature search was undertaken on studies examining in vivo biomechanical risk factors associated with non-contact anterior cruciate ligament injury. The relevant studies were assessed by classification; level 1 - a prospective cohort study, level 2 - a retrospective study or level 3 - an associative study. An initial search revealed 812 studies but this was reduced to 1 level 1 evidence study, 20 level 2 evidence studies and 175 level 3 evidence studies that met all inclusion criteria. Level 1 evidence showed that the knee abduction angle, knee abduction moment and ground reaction force were biomechanical risk factors. Nine level 2 studies and eighty-three level 3 studies used these to assess risk factors in their study. Inconsistencies in results and methods were observed in level 2 and 3 studies. There is a lack of high quality, prospective level 1 evidence related to biomechanical risk factors for non-contact anterior cruciate ligament injury. More prospective cohort studies are required to determine risk factors and provide improved prognostic capability. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Fatigue risk management in aviation maintenance : current best practices and potential future countermeasures.

    Science.gov (United States)

    2011-06-01

    The unregulated hours and frequent night work characteristic of maintenance can produce significant levels of : employee fatigue, with a resultant risk of maintenance error. Fatigue Risk Management Systems (FRMS) are : widely used to manage fatigue a...

  17. Current views on risk communication and their implications for crisis and reputation management

    NARCIS (Netherlands)

    Gutteling, Jan M.

    2001-01-01

    Organizations prepare for crisis communication by designing, implementing, and evaluating procedures, scenarios, and emergency measures. In addition to crisis communication, risk communication is a concern for many organizations as well. Risk communication is viewed as an interactive, multi-actor

  18. Regulatory elements in molecular networks.

    Science.gov (United States)

    Doane, Ashley S; Elemento, Olivier

    2017-05-01

    Regulatory elements determine the connectivity of molecular networks and mediate a variety of regulatory processes ranging from DNA looping to transcriptional, posttranscriptional, and posttranslational regulation. This review highlights our current understanding of the different types of regulatory elements found in molecular networks with a focus on DNA regulatory elements. We highlight technical advances and current challenges for the mapping of regulatory elements at the genome-wide scale, and describe new computational methods to uncover these elements via reconstructing regulatory networks from large genomic datasets. WIREs Syst Biol Med 2017, 9:e1374. doi: 10.1002/wsbm.1374 For further resources related to this article, please visit the WIREs website. © 2017 Wiley Periodicals, Inc.

  19. Online media coverage of air pollution risks and current policies in India: A content analysis.

    Science.gov (United States)

    Murukutla, Nandita; Negi, Nalin S; Puri, Pallavi; Mullin, Sandra; Onyon, Lesley

    2017-09-01

    Background Air pollution is of particular concern in India, which contains 11 of the 20 most polluted cities in the world. Media coverage of air pollution issues plays an important role in influencing public opinion and increasing citizen demand for action on clean air policy. Hence, this study was designed to assess news coverage of air pollution in India and its implications for policy advancement. Methods Articles published online between 1 January 2014 and 31 October 2015 that discussed air pollution in India were systematically content analysed. From 6435 articles in the national media and 271 articles in the international media, a random selection of 500 articles (400 from national and 100 from international media) were analysed and coded by two independent coders, after high inter-rater reliability (kappa statistic above 0.8) was established. Results There was an increase in the number of news stories on air pollution in India in the national media over the study period; 317 (63%) stories described the risk to health from air pollution as moderately to extremely severe, and 393 (79%) stories described the situation as needing urgent action. Limited information was provided on the kinds of illnesses that can result from exposure. Less than 30% of stories in either media specifically mentioned the common illnesses resulting from air pollution. Very few articles in either media mentioned the population groups most at risk from air pollution, such as children or older people. Vehicles were presented most often as the cause of air pollution in India (in over 50% of articles in both national and international media). Some of the most important sources of air pollution were mentioned less often: 6% of national and 18% of international media articles mentioned unclean sources of household energy; 3% of national and 9% of international media articles mentioned agricultural field burning. Finally, the majority of articles (405; 81%) did not mention any specific

  20. Regulatory B Cell Function Is Suppressed by Smoking and Obesity in H. pylori-Infected Subjects and Is Correlated with Elevated Risk of Gastric Cancer.

    Science.gov (United States)

    Li, Guanggang; Wulan, Hasi; Song, Zongchang; Paik, Paul A; Tsao, Ming L; Goodman, Gary M; MacEachern, Paul T; Downey, Robert S; Jankowska, Anna J; Rabinowitz, Yaron M; Learch, Thomas B; Song, David Z; Yuan, Ji J; Zheng, Shihang; Zheng, Zhendong

    2015-01-01

    Helicobacter pylori infection occurs in more than half of the world's population and is the main cause for gastric cancer. A series of lifestyle and nutritional factors, such as tobacco smoking and obesity, have been found to elevate the risk for cancer development. In this study, we sought to determine the immunological aspects during H. pylori infection and gastric cancer development. We found that B cells from H. pylori-infected patients presented altered composition and function compared to uninfected patients. IL-10-expressing CD24+CD38+ B cells were upregulated in H. pylori-infected patients, contained potent regulatory activity in inhibiting T cell pro-inflammatory cytokine secretion, and responded directly to H. pylori antigen stimulation. Interestingly, in H. pylori-infected smoking subjects and obese subjects, the number of IL-10+ B cells and CD24+CD38+ B cells were reduced compared to H. pylori-infected asymptomatic subjects. Regulatory functions mediated by CD24+CD38+ B cells were also impaired. In addition, gastric cancer positive patients had reduced IL-10-producing B cell frequencies after H. pylori-stimulation. Altogether, these data suggest that in H. pylori-infection, CD24+CD38+ B cell is upregulated and plays a role in suppressing pro-inflammatory responses, possibly through IL-10 production, a feature that was not observed in smoking and obese patients.

  1. Regulatory B Cell Function Is Suppressed by Smoking and Obesity in H. pylori-Infected Subjects and Is Correlated with Elevated Risk of Gastric Cancer.

    Directory of Open Access Journals (Sweden)

    Guanggang Li

    Full Text Available Helicobacter pylori infection occurs in more than half of the world's population and is the main cause for gastric cancer. A series of lifestyle and nutritional factors, such as tobacco smoking and obesity, have been found to elevate the risk for cancer development. In this study, we sought to determine the immunological aspects during H. pylori infection and gastric cancer development. We found that B cells from H. pylori-infected patients presented altered composition and function compared to uninfected patients. IL-10-expressing CD24+CD38+ B cells were upregulated in H. pylori-infected patients, contained potent regulatory activity in inhibiting T cell pro-inflammatory cytokine secretion, and responded directly to H. pylori antigen stimulation. Interestingly, in H. pylori-infected smoking subjects and obese subjects, the number of IL-10+ B cells and CD24+CD38+ B cells were reduced compared to H. pylori-infected asymptomatic subjects. Regulatory functions mediated by CD24+CD38+ B cells were also impaired. In addition, gastric cancer positive patients had reduced IL-10-producing B cell frequencies after H. pylori-stimulation. Altogether, these data suggest that in H. pylori-infection, CD24+CD38+ B cell is upregulated and plays a role in suppressing pro-inflammatory responses, possibly through IL-10 production, a feature that was not observed in smoking and obese patients.

  2. Identification of 19 new risk loci and potential regulatory mechanisms influencing susceptibility to testicular germ cell tumor.

    Science.gov (United States)

    Litchfield, Kevin; Levy, Max; Orlando, Giulia; Loveday, Chey; Law, Philip J; Migliorini, Gabriele; Holroyd, Amy; Broderick, Peter; Karlsson, Robert; Haugen, Trine B; Kristiansen, Wenche; Nsengimana, Jérémie; Fenwick, Kerry; Assiotis, Ioannis; Kote-Jarai, ZSofia; Dunning, Alison M; Muir, Kenneth; Peto, Julian; Eeles, Rosalind; Easton, Douglas F; Dudakia, Darshna; Orr, Nick; Pashayan, Nora; Bishop, D Timothy; Reid, Alison; Huddart, Robert A; Shipley, Janet; Grotmol, Tom; Wiklund, Fredrik; Houlston, Richard S; Turnbull, Clare

    2017-07-01

    Genome-wide association studies (GWAS) have transformed understanding of susceptibility to testicular germ cell tumors (TGCTs), but much of the heritability remains unexplained. Here we report a new GWAS, a meta-analysis with previous GWAS and a replication series, totaling 7,319 TGCT cases and 23,082 controls. We identify 19 new TGCT risk loci, roughly doubling the number of known TGCT risk loci to 44. By performing in situ Hi-C in TGCT cells, we provide evidence for a network of physical interactions among all 44 TGCT risk SNPs and candidate causal genes. Our findings implicate widespread disruption of developmental transcriptional regulators as a basis of TGCT susceptibility, consistent with failed primordial germ cell differentiation as an initiating step in oncogenesis. Defective microtubule assembly and dysregulation of KIT-MAPK signaling also feature as recurrently disrupted pathways. Our findings support a polygenic model of risk and provide insight into the biological basis of TGCT.

  3. T helper-2 cytokine/regulatory T-cell gene polymorphisms and their relation with risk of psoriasis in a South Indian Tamil cohort.

    Science.gov (United States)

    Indhumathi, Sundar; Rajappa, Medha; Chandrashekar, Laxmisha; Ananthanarayanan, Palghat Hariharan; Thappa, Devinder Mohan; Negi, Vir Singh

    2017-02-01

    Psoriasis is known to be associated with an up-regulation of T-helper (Th)-1 & Th-17 cytokines and a relative down-regulation of Th-2 and T-regulatory (T-reg) cytokines. Certain allelic variants of these cytokine genes may alter Th1/Th17 and Th2/T-reg balance and may be associated with the risk of psoriasis. Hence we aimed to determine the association of IL-4 (rs2243250), IL-10 (rs1800871 and rs1800896) and FOXP3 (rs3761548) gene polymorphisms with risk of psoriasis in South Indian Tamils. A total of 360 cases of psoriasis and 360 healthy controls were recruited. The polymorphism in IL-4 (rs2243250) & IL-10 (rs1800871) were typed by ARMS-PCR and IL-10 (rs1800896) & FOXP3 (rs3761548) were typed by TaqMan 5'allele discrimination assay. We observed that IL-4 (rs2243250) had a reduced risk of psoriasis, while the IL-10 (rs1800871) conferred an increased susceptibility to psoriasis, as compared with controls. However, IL-10 (rs1800896) and FOXP3 (rs3761548) gene polymorphisms were not associated with psoriasis risk. The plasma IL-4 levels was not different between the cases and controls, however the heterozygous CT genotype demonstrated significant high IL-4 levels. Plasma IL-10 levels were significantly increased in cases compared to controls, however none of the genotypes were associated with the plasma IL-10 levels. Our results suggest that IL-4 (rs2243250) polymorphism is protective against psoriasis, while IL-10 (rs1800871) polymorphism confers increased risk of psoriasis in South Indian Tamils. Detection of these genetic variants as predictive risk factors may lead to the selection of patient-tailored therapy to maximize the effectiveness of therapy. Copyright © 2016 American Society for Histocompatibility and Immunogenetics. Published by Elsevier Inc. All rights reserved.

  4. 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.

  5. Rainwater harvesting in American Samoa: current practices and indicative health risks.

    Science.gov (United States)

    Kirs, Marek; Moravcik, Philip; Gyawali, Pradip; Hamilton, Kerry; Kisand, Veljo; Gurr, Ian; Shuler, Christopher; Ahmed, Warish

    2017-05-01

    Roof-harvested rainwater (RHRW) is an important alternative source of water that many island communities can use for drinking and other domestic purposes when groundwater and/or surface water sources are contaminated, limited, or simply not available. The aim of this pilot-scale study was to investigate current RHRW practices in American Samoa (AS) and to evaluate and compare the quality of water from common potable water sources including RHRW stored in tanks, untreated stream water, untreated municipal well water, and treated municipal tap water samples. Samples were analyzed using culture-based methods, quantitative polymerase chain reaction (qPCR), and 16S amplicon sequencing-based methods. Based on indicator bacteria (total coliform and Escherichia coli) concentrations, the quality of RHRW was slightly lower than well and chlorinated tap water but exceeded that of untreated stream water. Although no Giardia or Leptospira spp. were detected in any of the RHRW samples, 86% of the samples were positive for Cryptosporidium spp. All stream water samples tested positive for Cryptosporidium spp. Opportunistic pathogens (Pseudomonas aeruginosa and Mycobacterium intracellulare) were also detected in the RHRW samples (71 and 21% positive samples, respectively). Several potentially pathogenic genera of bacteria were also detected in RHRW by amplicon sequencing. Each RHRW system was characterized by distinct microbial communities, 77% of operational taxonomic units (OTUs) were detected only in a single tank, and no OTU was shared by all the tanks. Risk of water-borne illness increased in the following order: chlorinated tap water/well water water. Frequent detection of opportunistic pathogens indicates that RHRW should be treated before use. Stakeholder education on RHRW system design options as well as on importance of regular cleaning and proper management techniques could improve the quality of the RHRW in AS.

  6. Current lifestyle factors that increase risk of T2DM in China.

    Science.gov (United States)

    Zhang, N; Du, S M; Ma, G S

    2017-07-01

    The Report on the Status of Nutrition and Chronic Diseases of Chinese residents (2015) indicated that the prevalence of diabetes was 9.7% among adults aged ⩾18 years, which markedly increased from 2.6% in 2002 within 10 years. In addition to the social economic factors, transitions in food consumption, behavioral and lifestyle playing the important roles in the fast increase of type 2 diabetes mellitus (T2DM). In 2010-2012, the cereal food consumption of Chinese residents was 337 g/d, vegetables consumption 269 g/d, fruit consumption 41 g/d, legume and legume products 11 g/d, dairy and dairy products consumption 25 g/d, meat consumption 90 g/d, edible oil consumption 42 g/d and dietary fiber 10.8 g/d. The traditional Chinese dietary pattern (high consumption of rice, pork and vegetables) is shifting towards a dietary pattern with high consumption of meats and edible oil but low consumption of cereals and vegetables. Smoking, breakfast omitting and high consumption of sugar-sweetened beverages became popular. Insufficient physical activity rate was 31.7%. Less sleep duration and poorer sleep quality was also common for Chinese residents. Concerning early life factors, residents exposed to the Chinese famine (1959-1961) during fetal life and childhood had an increased risk of hyperglycemia. As a conclusion, current unhealthy lifestyle has inversely effect on the incidence and development of T2DM, especially for the increased intake of fat and carbohydrate, the transition of dietary pattern, the extension of sedentary time and the increasing rate of obesity. Lifestyle management should be taken seriously as a part of diabetes prevention.

  7. Eruptive history, current activity and risk estimation using geospatial information in the Colima volcano, Mexico

    Science.gov (United States)

    Suarez-Plascencia, C.; Camarena-Garcia, M.; Nunez-Cornu, F. J.; Flores-Peña, S.

    2013-12-01

    avocado orchards and fruits like blueberries, raspberries, and blackberries within the radius of 15 km from the crater. The population dynamics in the Colima volcano area had a population of 552,954 inhabitants in 2010, and a growth at an annual rate of 1.6 percent of the total population. 60 percent of the populations live in 105 towns with a population less than 250 inhabitants. Also, the region showed an increase in vulnerability for the development of economic activities, supported by the highway, railway, natural gas pipelines and electrical infrastructure that connect to the Port of Manzanillo to Guadalajara city. With the use of geospatial information quantify the vulnerability, together with the hazard maps and exposure, enabled us to build the following volcanic risk maps: a) Exclusion areas and moderate hazard for explosive events (ballistic) and pyroclastic flows, b) Hazard map of lahars and debris flow, and c) Hazard map of ash-fall. The geospatial database, a GIS mapping and current volcano monitoring, are the basis of the Operational Plan Colima Volcano. Civil Protection by the state of Jalisco and the updating of urban development plans of municipalities converge on the volcano. These instruments of land planning will help reduce volcanic risk in the region.

  8. The impact of passive smoking on the risk of colorectal neoplasia in never, former, and current smokers.

    Science.gov (United States)

    Jung, Yoon Suk; Kim, Nam Hee; Yang, Hyo-Joon; Park, Soo-Kyung; Park, Jung Ho; Park, Dong Il; Sohn, Chong Il

    2017-10-19

    Active smoking is well known to be a risk factor for colorectal neoplasia (CRN). However, it remains unclear whether passive smoking is also related to the risk of CRN. This study investigated the effect of passive smoking on the risk of CRN in never, former, and current smokers. A cross-sectional study was performed on asymptomatic examinees who underwent colonoscopy as part of a health check-up. Of 136 707 participants, 33 052 (24.2%) were never passive smokers, and 103 655 (75.8%) were ever passive smokers. The mean age of the study population was 41.0 years. The proportion of never, former, and current smokers was 56.9%, 21.4%, and 24.8%, respectively, and the proportion of overall CRN and advanced CRN (ACRN) was 15.4% and 1.7%, respectively. Ever passive smoke exposure was associated with an increased risk of overall CRN in never smokers (adjusted odds ratio [AOR] 1.08; 95% confidence interval [CI] 1.02-1.13) and former smokers (AOR 1.08; 95% CI 1.00-1.17) but not in current smokers (AOR 1.02; 95% CI 0.94-1.11). Additionally, it significantly increased the risk of ACRN among never smokers (AOR 1.17; 95% CI 1.01-1.35) and tended to increase the risk of ACRN among former smokers (AOR 1.26; 95% CI 0.99-1.61). Moreover, the risk of CRN increased with increasing frequency and duration of passive smoking in never and former smokers. Passive smoking was an independent risk factor for CRN in never and former smokers. Never and former smokers who are highly exposed to passive smoke as well as current smokers should be given priority for colonoscopy. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  9. Parents' physical victimization in childhood and current risk of child maltreatment: the mediator role of psychosomatic symptoms.

    Science.gov (United States)

    Lamela, Diogo; Figueiredo, Bárbara

    2013-08-01

    To test the potential mediation effect of psychosomatic symptoms on the relationship between parents' history of childhood physical victimization and current risk for child physical maltreatment. Data from the Portuguese National Representative Study of Psychosocial Context of Child Abuse and Neglect were used. Nine-hundred and twenty-four parents completed the Childhood History Questionnaire, the Psychosomatic Scale of the Brief Symptom Inventory, and the Child Abuse Potential Inventory. Mediation analysis revealed that the total effect of the childhood physical victimization on child maltreatment risk was significant. The results showed that the direct effect from the parents' history of childhood physical victimization to their current maltreatment risk was still significant once parents' psychosomatic symptoms were added to the model, indicating that the increase in psychosomatic symptomatology mediated in part the increase of parents' current child maltreatment risk. The mediation analysis showed parents' psychosomatic symptomatology as a causal pathway through which parents' childhood history of physical victimization exerts its effect on increased of child maltreatment risk. Somatization-related alterations in stress and emotional regulation are discussed as potential theoretical explanation of our findings. A cumulative risk perspective is also discussed in order to elucidate about the mechanisms that contribute for the intergenerational continuity of child physical maltreatment. Copyright © 2013 Elsevier Inc. All rights reserved.

  10. CURRENT RESEARCHES OF NOTION “CREATIVITY” IN PSYCHOLOGY AND ITS RELATION TO RISK

    OpenAIRE

    NATALJA MIHEJEVA

    2011-01-01

    The article considers theoretical sources for the purpose of systematization of notion “creativity”, as well as its related notion “risk appetite”. The author analyzes classical and the latest studies of the creativity and its related phenomena, remaining within a focus of research concerned with social instability The author studies scope of an inquiry of creativity and creative individuals, as well as the risk appetite and scope of an inquiry of risk in psychology. It is suggested that crea...

  11. [A brief of gestational diabetes mellitus, risk factors and current criteria of diagnosis].

    Science.gov (United States)

    Al-Aissa, Zahra; Hadarits, Orsolya; Rosta, Klára; Zóka, András; Rigó, János; Firneisz, Gábor; Somogyi, Anikó

    2017-02-01

    Diabetes is one of the most common metabolic disorders that may cause pathological pregnancy. Treating diabetes recognized during pregnancy results in lowering maternal and fetal complications. These patients present higher risk for excessive weight gain, preeclampsia, delivery with cesarean sections, high risk of developing type 2 diabetes and cardiovascular disease in the future. Fetuses of mothers with gestational diabetes are at higher risk for macrosomia and birth trauma, after delivery they present higher risk of developing neonatal hypoglycemia, hyperbilirubinemia, and respiratory distress syndrome. There is still no consensus in the recommendations for the diagnosis of gestational diabetes mellitus by expert committees. Orv. Hetil., 2017, 158(8), 283-290.

  12. Genome-wide association studies of autoimmune vitiligo identify 23 new risk loci and highlight key pathways and regulatory variants

    Science.gov (United States)

    Jin, Ying; Andersen, Genevieve; Yorgov, Daniel; Ferrara, Tracey M; Ben, Songtao; Brownson, Kelly M; Holland, Paulene J; Birlea, Stanca A; Siebert, Janet; Hartmann, Anke; Lienert, Anne; van Geel, Nanja; Lambert, Jo; Luiten, Rosalie M; Wolkerstorfer, Albert; van der Veen, JP Wietze; Bennett, Dorothy C; Taïeb, Alain; Ezzedine, Khaled; Kemp, E Helen; Gawkrodger, David J; Weetman, Anthony P; Kõks, Sulev; Prans, Ele; Kingo, Külli; Karelson, Maire; Wallace, Margaret R; McCormack, Wayne T; Overbeck, Andreas; Moretti, Silvia; Colucci, Roberta; Picardo, Mauro; Silverberg, Nanette B; Olsson, Mats; Valle, Yan; Korobko, Igor; Böhm, Markus; Lim, Henry W.; Hamzavi, Iltefat; Zhou, Li; Mi, Qing-Sheng; Fain, Pamela R.; Santorico, Stephanie A; Spritz, Richard A

    2016-01-01

    Vitiligo is an autoimmune disease in which depigmented skin results from destruction of melanocytes1, with epidemiologic association with other autoimmune diseases2. In previous linkage and genome-wide association studies (GWAS1, GWAS2), we identified 27 vitiligo susceptibility loci in patients of European (EUR) ancestry. We carried out a third GWAS (GWAS3) in EUR subjects, with augmented GWAS1 and GWAS2 controls, genome-wide imputation, and meta-analysis of all three GWAS, followed by an independent replication. The combined analyses, with 4,680 cases and 39,586 controls, identified 23 new loci and 7 suggestive loci, most encoding immune and apoptotic regulators, some also associated with other autoimmune diseases, as well as several melanocyte regulators. Bioinformatic analyses indicate a predominance of causal regulatory variation, some corresponding to eQTL at these loci. Together, the identified genes provide a framework for vitiligo genetic architecture and pathobiology, highlight relationships to other autoimmune diseases and melanoma, and offer potential targets for treatment. PMID:27723757

  13. Aging and Cardiometabolic Risk in European HEMS Pilots: An Assessment of Occupational Old-Age Limits as a Regulatory Risk Management Strategy.

    Science.gov (United States)

    Bauer, Hans; Nowak, Dennis; Herbig, Britta

    2017-12-11

    Old-age limits are imposed in some occupations in an effort to ensure public safety. In aviation, the "Age 60 Rule" limits permissible flight operations conducted by pilots aged 60 and over. Using a retrospective cohort design, we assessed this rule's validity by comparing age-related change rates of cardiometabolic incapacitation risk markers in European helicopter emergency medical service (HEMS) pilots near age 60 with those in younger pilots. Specifically, individual clinical, laboratory, and electrocardiogram (ECG)-based risk markers and an overall cardiovascular event risk score were determined from aeromedical examination records of 66 German, Austrian, Polish, and Czech HEMS pilots (average follow-up 8.52 years). Risk marker change rates were assessed using linear mixed models and generalized additive models. Body mass index increases over time were slower in pilots near age 60 compared to younger pilots, and fasting glucose levels increased only in the latter. Whereas the lipid profile remained unchanged in the latter, it improved in the former. An ECG-based arrhythmia risk marker increased in younger pilots, which persisted in the older pilots. Six-month risk of a fatal cardiovascular event (in or out of cockpit) was estimated between 0% and 0.3%. Between 41% and 95% of risk marker variability was due to unexplained time-stable between-person differences. To conclude, the cardiometabolic risk marker profile of HEMS pilots appears to improve over time in pilots near age 60, compared to younger pilots. Given large stable interindividual differences, we recommend individualized risk assessment of HEMS pilots near age 60 instead of general grounding. © 2017 Society for Risk Analysis.

  14. Genetic variability in the regulatory region of presenilin 1 associated with risk for Alzheimer's disease and variable expression

    NARCIS (Netherlands)

    J. Theuns (Jessie); J. Del-Favero (Jurgen); B. Dermaut (Bart); C.M. van Duijn (Cock); S. Serneels (Sally); E. Corsmit; M. Cruts (Marc); H. Backhovens (Hubert); M. van den Broeck (Marleen); C. van Broeckhoven (Christine)

    2000-01-01

    textabstractMutations in the presenilin 1 ( PSEN1 ) gene have been implicated in 18-50% of autosomal dominant cases with early-onset Alzheimer's disease (EOAD). Also, PSEN1 has been suggested as a potential risk gene in late-onset AD cases. We recently showed genetic association in

  15. Promoting Risk-Taking and Physically Challenging Play in Australian Early Childhood Settings in a Changing Regulatory Environment

    Science.gov (United States)

    Little, Helen

    2017-01-01

    This article presents data from a survey of Early Childhood Education and Care services in Australia. The study investigated outdoor play provision in terms of space, resources and planning for risk-taking in play. Overall, the results indicate that the participating centres are well-resourced to promote physical play, but vary in terms of…

  16. Performance of four current risk algorithms in predicting cardiovascular events in patients with early rheumatoid arthritis

    NARCIS (Netherlands)

    Arts, E.E.A.; Popa, C.; Broeder, A.A. den; Semb, A.G.; Toms, T.; Kitas, G.D.; Riel, P.L.C.M. van; Fransen, J.

    2015-01-01

    OBJECTIVE: This study was undertaken to assess the predictive ability of 4 established cardiovascular (CV) risk models for the 10-year risk of fatal and non-fatal CV diseases in European patients with rheumatoid arthritis. METHODS: Prospectively collected data from the Nijmegen early rheumatoid

  17. Regulatory cells, cytokine pattern and clinical risk factors for asthma in infants and young children with recurrent wheeze.

    Science.gov (United States)

    Borrego, L M; Arroz, M J; Videira, P; Martins, C; Guimarães, H; Nunes, G; Papoila, A L; Trindade, H

    2009-08-01

    Several risk factors for asthma have been identified in infants and young children with recurrent wheeze. However, published literature has reported contradictory findings regarding the underlying immunological mechanisms. This study was designed to assess and compare the immunological status during the first 2 years in steroid-naive young children with >or= three episodes of physician-confirmed wheeze (n=50), with and without clinical risk factors for developing subsequent asthma (i.e. parental asthma or a personal history of eczema and/or two of the following: wheezing without colds, a personal history of allergic rhinitis and peripheral blood eosinophilia >4%), with age-matched healthy controls (n=30). Peripheral blood CD4(+)CD25(+) and CD4(+)CD25(high) T cells and their cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), GITR and Foxp3 expression were analysed by flow cytometry. Cytokine (IFN-gamma, TGF-beta and IL-10), CTLA-4 and Foxp3 mRNA expression were evaluated (real-time PCR) after peripheral blood mononuclear cell stimulation with phorbol 12-myristate 13-acetate (PMA) (24 h) and house dust mite (HDM) extracts (7th day). Flow cytometry results showed a significant reduction in the absolute number of CD4(+)CD25(high) and the absolute and percentage numbers of CD4(+)CD25(+)CTLA-4(+) in wheezy children compared with healthy controls. Wheezy children at a high risk of developing asthma had a significantly lower absolute number of CD4(+)CD25(+) (P=0.01) and CD4(+)CD25(high) (P=0.04), compared with those at a low risk. After PMA stimulation, CTLA-4 (P=0.03) and Foxp3 (P=0.02) expression was diminished in wheezy children compared with the healthy children. After HDM stimulation, CTLA-4 (P=0.03) and IFN-gamma (P=0.04) expression was diminished in wheezy children compared with healthy children. High-risk children had lower expression of IFN-gamma (P=0.03) compared with low-risk and healthy children and lower expression of CTLA-4 (P=0.01) compared with healthy

  18. Mammographic density and breast cancer risk: current understanding and future prospects

    Science.gov (United States)

    2011-01-01

    Variations in percent mammographic density (PMD) reflect variations in the amounts of collagen and number of epithelial and non-epithelial cells in the breast. Extensive PMD is associated with a markedly increased risk of invasive breast cancer. The PMD phenotype is important in the context of breast cancer prevention because extensive PMD is common in the population, is strongly associated with risk of the disease, and, unlike most breast cancer risk factors, can be changed. Work now in progress makes it likely that measurement of PMD will be improved in the near future and that understanding of the genetics and biological basis of the association of PMD with breast cancer risk will also improve. Future prospects for the application of PMD include mammographic screening, risk prediction in individuals, breast cancer prevention research, and clinical decision making. PMID:22114898

  19. [Current problems of estimation of genetic risk of human exposure to radiation].

    Science.gov (United States)

    Shevchenko, V A

    2000-01-01

    The methodology of assessing the genetic risk of radiation exposure is based on the concept of "hitting the target" in development of which N.V. Timofeeff-Ressovsky has played and important role. To predict genetic risk posed by irradiation, the UN Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) has worked out direct and indirect methods of assessment, extrapolational, integral and populational criteria of risk analysis that together permit calculating the risk from human exposure on the basis of data obtained for mice. Laboratory mice are the main objects in studying radiation mutagenesis due to the fact that the data on the frequency of radiation-induced human mutations are rather scarce. The method of doubling dose based on the determination of a dose doubling the level of natural mutational process in humans is the main one used to predict the genetic risk. The evolution of views about the genetics risk of human exposure to radiation for last 40 years is considered. Till 1972 the main model for assessing the genetic risk was the "human/mouse" model (the use of data on the spontaneous human variability and data on the frequency of induced mutations in mice). In the period form 1972 till 1994 the "mouse/mouse" model was intensively elaborated in many laboratories. This model was also used in this period by UNSCEAR experts to analyze the genetic risk from human irradiation. Recent achievements associated with the study of the molecular nature of many hereditary human diseases as well as the criticism of number fundamental principles of the "mouse/mouse" model for estimating the genetic risk on a new basis. The estimates of risk for the different classes of genetic diseases have been obtained using the doubling-dose method. The estimate of doubling dose used in the calculations is 1 Gy for low dose/chronic low-LET radiation conditions.

  20. The prevalence and risk indicators of symptoms of common mental disorders among current and former Dutch elite athletes

    NARCIS (Netherlands)

    Gouttebarge, Vincent; Jonkers, Ruud; Moen, Maarten; Verhagen, Evert; Wylleman, Paul; Kerkhoffs, Gino

    2017-01-01

    The aim of the study was to determine the prevalence and comorbidity of symptoms of common mental disorders (distress, anxiety/depression, sleep disturbance, eating disorders, adverse alcohol use) among current and former Dutch elite athletes, and to explore the inference between potential risk

  1. Current Age, Age at First Sex, Age at First Homelessness, and HIV Risk Perceptions Predict Sexual Risk Behaviors among Sexually Active Homeless Adults

    Directory of Open Access Journals (Sweden)

    Diane Santa Maria

    2018-01-01

    Full Text Available While HIV disproportionately impacts homeless individuals, little is known about the prevalence of HIV risk behaviors in the southwest and how age factors and HIV risk perceptions influence sexual risk behaviors. We conducted a secondary data analysis (n = 460 on sexually active homeless adults from a cross-sectional study of participants (n = 610 recruited from homeless service locations, such as shelters and drop-in centers, in an understudied region of the southwest. Covariate-adjusted logistic regressions were used to assess the impact of age at homelessness onset, current age, age at first sex, and HIV risk perceptions on having condomless sex, new sexual partner(s, and multiple sexual partners (≥4 sexual partners in the past 12 months. Individuals who first experienced homelessness by age 24 were significantly more likely to report condomless sex and multiple sexual partners in the past year than those who had a later onset of their first episode of homelessness. Individuals who were currently 24 years or younger were more likely to have had condomless sex, new sexual partners, and multiple sexual partners in the past 12 months than those who were 25 years or older. Those who had low perceived HIV risk had lower odds of all three sexual risk behaviors. Social service and healthcare providers should consider a younger age at homelessness onset when targeting HIV prevention services to youth experiencing homelessness.

  2. Gene-based analysis of regulatory variants identifies 4 putative novel asthma risk genes related to nucleotide synthesis and signaling.

    Science.gov (United States)

    Ferreira, Manuel A R; Jansen, Rick; Willemsen, Gonneke; Penninx, Brenda; Bain, Lisa M; Vicente, Cristina T; Revez, Joana A; Matheson, Melanie C; Hui, Jennie; Tung, Joyce Y; Baltic, Svetlana; Le Souëf, Peter; Montgomery, Grant W; Martin, Nicholas G; Robertson, Colin F; James, Alan; Thompson, Philip J; Boomsma, Dorret I; Hopper, John L; Hinds, David A; Werder, Rhiannon B; Phipps, Simon

    2017-04-01

    Hundreds of genetic variants are thought to contribute to variation in asthma risk by modulating gene expression. Methods that increase the power of genome-wide association studies (GWASs) to identify risk-associated variants are needed. We sought to develop a method that aggregates the evidence for association with disease risk across expression quantitative trait loci (eQTLs) of a gene and use this approach to identify asthma risk genes. We developed a gene-based test and software package called EUGENE that (1) is applicable to GWAS summary statistics; (2) considers both cis- and trans-eQTLs; (3) incorporates eQTLs identified in different tissues; and (4) uses simulations to account for multiple testing. We applied this approach to 2 published asthma GWASs (combined n = 46,044) and used mouse studies to provide initial functional insights into 2 genes with novel genetic associations. We tested the association between asthma and 17,190 genes that were found to have cis- and/or trans-eQTLs across 16 published eQTL studies. At an empirical FDR of 5%, 48 genes were associated with asthma risk. Of these, for 37, the association was driven by eQTLs located in established risk loci for allergic disease, including 6 genes not previously implicated in disease cause (eg, LIMS1, TINF2, and SAFB). The remaining 11 significant genes represent potential novel genetic associations with asthma. The association with 4 of these replicated in an independent GWAS: B4GALT3, USMG5, P2RY13, and P2RY14, which are genes involved in nucleotide synthesis or nucleotide-dependent cell activation. In mouse studies, P2ry13 and P2ry14-purinergic receptors activated by adenosine 5-diphosphate and UDP-sugars, respectively-were upregulated after allergen challenge, notably in airway epithelial cells, eosinophils, and neutrophils. Intranasal exposure with receptor agonists induced the release of IL-33 and subsequent eosinophil infiltration into the lungs. We identified novel associations between

  3. Bleeding risk and safety profile related to the use of eptifibatide: a current review.

    Science.gov (United States)

    Saab, Fadi; Ionescu, Costin; Schweiger, Marc J

    2012-03-01

    Eptifibatide is a glycoprotein IIb/IIIa inhibitor that blocks the final common pathway of platelet aggregation. Its major adverse effect is bleeding. Balancing its safety and efficacy is paramount for its appropriate usage. The development of eptifibatide and its mechanism of action are explored. Clinical trials evaluating its efficacy and safety in a variety of clinical settings, as well as newer dosing regimens, are discussed. Readers will be able to understand the bleeding risks of eptifibatide in specific patient populations. The risk of bleeding with eptifibatide needs to be weighed against the potential benefits. Understanding which patients are at higher risk of bleeding will help the clinician make appropriate decisions.

  4. Industry practices in credit risk modeling and internal capital allocations: implications for a models-based regulatory capital standard

    OpenAIRE

    Jones, David M.; Mingo, John J

    1998-01-01

    This paper was presented at the conference "Financial services at the crossroads: capital regulation in the twenty-first century" as part of session 2, "Credit risk modeling." The conference, held at the Federal Reserve Bank of New York on February 26-27, 1998, was designed to encourage a consensus between the public and private sectors on an agenda for capital regulation in the new century.

  5. Evaluation of regulatory genetic variants in POU5F1 and risk of congenital heart disease in Han Chinese

    Science.gov (United States)

    Lin, Yuan; Ding, Chenyue; Zhang, Kai; Ni, Bixian; da, Min; Hu, Liang; Hu, Yuanli; Xu, Jing; Wang, Xiaowei; Chen, Yijiang; Mo, Xuming; Cui, Yugui; Shen, Hongbing; Sha, Jiahao; Liu, Jiayin; Hu, Zhibin

    2015-10-01

    OCT4 is a transcription factor of the POU family, which plays a key role in embryonic development and stem cell pluripotency. Previous studies have shown that Oct4 is required for cardiomyocyte differentiation in mice and its depletion could result in cardiac morphogenesis in embryo. However, whether the genetic variations in OCT4 coding gene, POU5F1, confer the predisposition to congenital heart disease (CHD) is unclear. This study sought to investigate the associations between low-frequency (defined here as having minor allele frequency (MAF) between 0.1%-5%) and rare (MAF below 0.1%) variants with potential function in POU5F1 and risk of CHD. We conducted association analysis in a two-stage case-control study with a total of 2,720 CHD cases and 3,331 controls in Chinese. The low-frequency variant rs3130933 was observed to be associated with a significantly increased risk of CHD [additive model: adjusted odds ratio (OR) = 2.15, adjusted P = 3.37 × 10-6]. Furthermore, luciferase activity assay showed that the variant A allele led to significantly lower expression levels as compared to the G allele. These findings indicate for the first time that low-frequency functional variant in POU5F1 may contribute to the risk of congenital heart malformations.

  6. Treatment of Amblyopia and Amblyopia Risk Factors Based on Current Evidence.

    Science.gov (United States)

    Koo, Euna B; Gilbert, Aubrey L; VanderVeen, Deborah K

    2017-01-01

    Amblyopia is a leading cause of low vision and warrants timely management during childhood. We performed a literature review of the management of amblyopia and potential risk factors for amblyopia. Literature review of the management of amblyopia and risk factors for amblyopia. Common amblyopia risk factors include anisometropic or high refractive error, strabismus, cataract, and ptosis. Often a conservative approach with spectacles is enough to prevent amblyopia. However, surgery may be necessary to clear the visual axis or align the eyes. Amblyopia risk factors should be managed early. Though amblyopia treatment is more likely to be successful at a younger age, those who are older but treatment-naïve may still respond to treatment. Promoting binocular or dichoptic experiences may be the future direction of amblyopia management.

  7. Friend or foe? The current epidemiologic evidence on selenium and human cancer risk.

    Science.gov (United States)

    Vinceti, Marco; Crespi, Catherine M; Malagoli, Carlotta; Del Giovane, Cinzia; Krogh, Vittorio

    2013-01-01

    Scientific opinion on the relationship between selenium and the risk of cancer has undergone radical change over the years, with selenium first viewed as a possible carcinogen in the 1940s then as a possible cancer preventive agent in the 1960s-2000s. More recently, randomized controlled trials have found no effect on cancer risk but suggest possible low-dose dermatologic and endocrine toxicity, and animal studies indicate both carcinogenic and cancer-preventive effects. A growing body of evidence from human and laboratory studies indicates dramatically different biological effects of the various inorganic and organic chemical forms of selenium, which may explain apparent inconsistencies across studies. These chemical form-specific effects also have important implications for exposure and health risk assessment. Overall, available epidemiologic evidence suggests no cancer preventive effect of increased selenium intake in healthy individuals and possible increased risk of other diseases and disorders.

  8. Regulatory Information by Topic: Emergency Management

    Science.gov (United States)

    Regulatory information about emergencies, including chemical accident prevention, risk management plans (RMPs), chemical reporting, community right to know, and oil spills and hazardous substances releases.

  9. Fracture Risk in Type 2 Diabetes: Current Perspectives and Gender Differences

    Directory of Open Access Journals (Sweden)

    Giuseppina T. Russo

    2016-01-01

    Full Text Available Type 2 diabetes mellitus (T2DM is associated with an increased risk of osteoporotic fractures, resulting in disabilities and increased mortality. The pathophysiological mechanisms linking diabetes to osteoporosis have not been fully explained, but alterations in bone structure and quality are well described in diabetic subjects, likely due to a combination of different factors. Insulin deficiency and dysfunction, obesity and hyperinsulinemia, altered level of oestrogen, leptin, and adiponectin as well as diabetes-related complications, especially peripheral neuropathy, orthostatic hypotension, or reduced vision due to retinopathy may all be associated with an impairment in bone metabolism and with the increased risk of fractures. Finally, medications commonly used in the treatment of T2DM may have an impact on bone metabolism and on fracture risk, particularly in postmenopausal women. When considering the impact of hypoglycaemic drugs on bone, it is important to balance their potential direct effects on bone quality with the risk of falling-related fractures due to the associated hypoglycaemic risk. In this review, experimental and clinical evidence connecting bone metabolism and fracture risk to T2DM is discussed, with particular emphasis on hypoglycaemic treatments and gender-specific implications.

  10. Association of nutritional risk index with metabolic biomarkers, appetite-regulatory hormones and inflammatory biomarkers and outcome in patients with chronic heart failure.

    Science.gov (United States)

    Gouya, G; Voithofer, P; Neuhold, S; Storka, A; Vila, G; Pacher, R; Wolzt, M; Hülsmann, M

    2014-11-01

    We aimed to evaluate the association of the nutritional status by using the nutritional risk index (NRI) with metabolic and inflammatory biomarkers, and appetite-regulatory hormones in a cohort of stable patients with heart failure (HF), and to analyse its prognostic value. In this prospective observational cohort study, we included 137 stable chronic HF patients (median age, 60 years; median body mass index, 27 kg/m(2) ) with optimised medical treatment. Baseline NRI of index (r = 0.444; p risk of all-cause mortality (log rank = 0.031). We propose that the NRI is a useful and easily applicable tool for the early identification of nutritional depletion in patients with chronic HF as it discriminates metabolic changes prior to the clinical manifestation of body wasting. Furthermore, poor nutritional status, represented as a low NRI, is associated with an increased incidence of death in such cases. © 2014 John Wiley & Sons Ltd.

  11. Quantitative assessment of current and future risks related rainfall in processing tomato in the Guadiana river basin (SW Spain)

    Science.gov (United States)

    Castañeda-Vera, Alba; Garrido, Alberto; Ruiz-Ramos, Margarita; Sánchez-Sánchez, Enrique; Inés Mínguez, M.

    2013-04-01

    An extension of risk coverages in the insurance policies for processing tomato, mainly related to rainfall events, has resulted in an important increase in claims. This suggests that damages related to extreme or ill-timed showers have been underestimated in previous years. An estimation of damages related to rainfall in the last thirty years and the impact of climate change in the risk related to rainfall in processing tomato crops in the Guadiana river basin (SW Spain) were studied through a risk index. First, the risk index was defined with temperature and relative humidity thresholds related to different damage magnitudes. Then, this index was applied to current climate and to future climate scenarios in nine weather stations representative of the studied area to determine the trends in losses related to extreme or inopportune rainfall events. Thresholds of temperature and relative humidity were obtained from cross-checking agricultural insurance records and meteorological data from local weather stations (REDAREX, http://sw-aperos.juntaex.es/redarex). To consider longer time series, the reanalysis database ERA-INTERIM (Dee et al., 2011) was used. Simulated climate was obtained from the European Project ENSEMBLES (http://www.ensembles-eu.org/). Trends in climatic risk were analysed by applying the risk index to three sets of data defining current climate (1980-2010), mid-future climate (2010-2040) and long-term future climate (2040-2070). An algorithm to choose the surrounding cell that minimizes the temperature and precipitation climatic biases and maximizes seasonal correlation when comparing ENSEMBLES regional climate model simulations and observed climate was applied before index calculation. The results show the trends in frequency and magnitude of the risk of suffering damages related to rainfall events. The methodology decreased the uncertainty on risk levels. Results contribute to detect the periods during the growing season with larger risk of damage

  12. 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....

  13. Current status and associated human health risk of vanadium in soil in China.

    Science.gov (United States)

    Yang, Jie; Teng, Yanguo; Wu, Jin; Chen, Haiyang; Wang, Guoqiang; Song, Liuting; Yue, Weifeng; Zuo, Rui; Zhai, Yuanzheng

    2017-03-01

    A detailed assessment of vanadium contamination characteristics in China was conducted based on the first national soil pollution survey. The map overlay analysis was used to evaluate the contamination level of vanadium and the non-carcinogenic risk assessment model was calculated to quantify the vanadium exposure risks to human health. The results showed that, due to the drastically increased mining and smelting activities, 26.49% of soils were contaminated by vanadium scattered in southwest of China. According to Canadian soil quality guidelines, about 8.6% of the national soil pollution survey samples were polluted, and pose high non-carcinogenic risks to the public, especially to children living in the vicinity of heavily polluted mining areas. We propose the area near the boundary of Yunnan, Guizhou, Guangxi, and Sichuan provinces as priority control areas due to their higher geochemical background or higher health risks posed to the public. Finally, recommendations for management are proposed, including minimization of contaminant inputs, establishing stringent monitoring program, using phytoremediation, and strengthening the enforcement of relevant laws. Therefore, this study provides a comprehensive assessment of soil vanadium contamination in China, and the results will provide valuable information for China's soil vanadium management and risk avoidance. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Comparison of current US risk strategy to screen for hepatitis C virus with a hypothetical targeted birth cohort strategy.

    Science.gov (United States)

    Tomaszewski, Kenneth J; Deniz, Baris; Tomanovich, Peter; Graham, Camilla S

    2012-11-01

    We compared the theoretical performance of a 1-time, birth cohort strategy with the currently recommended risk strategy for screening for hepatitis C virus (HCV) infection, which is undetected in an estimated 75% of 4 million affected people in the United States. We applied current American Association for the Study of Liver Disease risk screening guidelines and a targeted birth cohort strategy to National Health and Nutrition Examination Survey data from 2003 to 2006 to estimate their performance in identifying HCV cases. Risk guidelines would recommend testing 25% of the US population aged 20 years or older and, if fully implemented, identify 82% of the projected HCV-exposed population. A targeted birth cohort (1946-1964) strategy would test 45% of the same population and identify 76% of the projected HCV population. In this ideal-world simulation, birth year and risk screening had similar theoretical performances for predicting HCV infection. However, actual implementation of risk screening has not achieved its theoretical performance, and birth cohort screening might increase HCV testing rates.

  15. Health co-benefits and risks of public health adaptation strategies to climate change: a review of current literature.

    Science.gov (United States)

    Cheng, June J; Berry, Peter

    2013-04-01

    Many public health adaptation strategies have been identified in response to climate change. This report reviews current literature on health co-benefits and risks of these strategies to gain a better understanding of how they may affect health. A literature review was conducted electronically using English language literature from January 2000 to March 2012. Of 812 articles identified, 22 peer-reviewed articles that directly addressed health co-benefits or risks of adaptation were included in the review. The co-benefits and risks identified in the literature most commonly relate to improvements in health associated with adaptation actions that affect social capital and urban design. Health co-benefits of improvements in social capital have positive influences on mental health, independently of other determinants. Risks included reinforcing existing misconceptions regarding health. Health co-benefits of urban design strategies included reduced obesity, cardiovascular disease and improved mental health through increased physical activity, cooling spaces (e.g., shaded areas), and social connectivity. Risks included pollen allergies with increased urban green space, and adverse health effects from heat events through the use of air conditioning. Due to the current limited understanding of the full impacts of the wide range of existing climate change adaptation strategies, further research should focus on both unintended positive and negative consequences of public health adaptation.

  16. Current directions in risk research: new developments in psychology and sociology.

    Science.gov (United States)

    Taylor-Gooby, Peter; Zinn, Jens O

    2006-04-01

    This article reviews the main approaches to risk in psychology and sociology and considers recent developments. It shows that research continues from a wide range of perspectives. Some developments in psychological thinking have recently acknowledged the importance of the cultural framing of risk perceptions and responses and the positive power of emotions to manage uncertainties, while some streams of work in sociology have moved toward more individualist approaches. These converging processes open opportunities for cross-fertilization and for using insights from both disciplines in the development of research.

  17. Risk Adjusted Valuation of the Current Military Retirement and the CY2018 Retirement System

    Science.gov (United States)

    2016-06-01

    of disability (DOD Office of the Actuary, 2015b). Those wounded in the Indian campaigns who could not earn a livelihood were provided aid in...spread across the G, F, C, S, and I Funds to provide diversification and is adjusted over time to meet changing risk profiles. When combined with the

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

    DEFF Research Database (Denmark)

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

    2017-01-01

    Societies worldwide are investing considerable resources into the safe development and use of nanomaterials. Although each of these protective efforts is crucial for governing the risks of nanomaterials, they are insufficient in isolation. What is missing is a more integrative governance approach...

  19. Assessing Current and Future Freshwater Flood Risk from North Atlantic Tropical Cyclones via Insurance Claims

    Science.gov (United States)

    Czajkowski, Jeffrey; Villarini, Gabriele; Montgomery, Marilyn; Michel-Kerjan, Erwann; Goska, Radoslaw

    2017-02-01

    The most recent decades have witnessed record breaking losses associated with U.S. landfalling tropical cyclones (TCs). Flood-related damages represent a large portion of these losses, and although storm surge is typically the main focus in the media and of warnings, much of the TC flood losses are instead freshwater-driven, often extending far inland from the landfall locations. Despite this actuality, knowledge of TC freshwater flood risk is still limited. Here we provide for the first time a comprehensive assessment of the TC freshwater flood risk from the full set of all significant flood events associated with U.S. landfalling TCs from 2001 to 2014. We find that the areas impacted by freshwater flooding are nearly equally divided between coastal and inland areas. We determine the statistical relationship between physical hazard and residential economic impact at a community level for the entire country. These results allow us to assess the potential future changes in TC freshwater flood risk due to changing climate pattern and urbanization in a more heavily populated U.S. Findings have important implications for flood risk management, insurance and resilience.

  20. Mercury risk from fluorescent lamps in China: current status and future perspective.

    Science.gov (United States)

    Hu, Yuanan; Cheng, Hefa

    2012-09-01

    Energy-efficient lighting is one of the key measures for addressing electric power shortages and climate change mitigation, and fluorescent lamps are expected to dominate the lighting market in China over the next several years. This review presents an overview on the emissions and risk of mercury from fluorescent lamps during production and disposal, and discusses measures for reducing the mercury risk through solid waste management and source reduction. Fluorescent lamps produced in China used to contain relatively large amounts of mercury (up to 40 mg per lamp) due to the prevalence of liquid mercury dosing, which also released significant amounts of mercury to the environment. Upgrade of the mercury dosing technologies and manufacturing facilities had significantly reduced the mercury contents in fluorescent lamps, with most of them containing less than 10 or 5mg per lamp now. Occupational hygiene studies showed that mercury emissions occurred during fluorescent lamp production, particularly in the facilities using liquid mercury dosing, which polluted the environmental media at and surrounding the production sites and posed chronic health risk to the workers by causing neuropsychological and motor impairments. It is estimated that spent fluorescent lamps account for approximately 20% of mercury input in the MSW in China. Even though recycling of fluorescent lamps presents an important opportunity to capture the mercury they contain, it is difficult and not cost-effective at reducing the mercury risk under the broader context of mercury pollution control in China. In light of the significant mercury emissions associated with electricity generation in China, we propose that reduction of mercury emissions and risk associated with fluorescent lamps should be achieved primarily through lowering their mercury contents by the manufacturers while recycling programs should focus on elemental mercury-containing waste products instead of fluorescent lamps to recapture

  1. 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.)

  2. Risk assessment of thujone in foods and medicines containing sage and wormwood--evidence for a need of regulatory changes?

    Science.gov (United States)

    Lachenmeier, Dirk W; Uebelacker, Michael

    2010-12-01

    Thujone is a natural substance found in plants commonly used in foods and beverages, such as wormwood and sage, as well as in herbal medicines. The current limits for thujone in food products are based on short-term animal studies from the 1960s, which provided evidence for a threshold-based mechanism, yet only allowed for the derivation of preliminary values for acceptable daily intakes (ADI) based on the no-observed effect level (NOEL). While the 2008 European Union Regulation on flavourings deregulated the food use of thujone, the European Medicines Agency introduced limits for the substance in 2009. The present study re-evaluates the available evidence using the benchmark dose (BMD) approach instead of NOEL, and for the first time includes data from a long-term chronic toxicity study of the National Toxicology Program (NTP). The NTP data provide similar results to the previous short-term studies. Using dose-response modelling, a BMD lower confidence limit for a benchmark response of 10% (BMDL10) was calculated as being 11 mg/kg bw/day for clonic seizures in male rats. Based on this, we propose an ADI of 0.11 mg/kg bw/day, which would not be reachable even for consumers of high-levels of thujone-containing foods (including absinthe). While fewer data are available concerning thujone exposure from medicines, we estimate that between 2 and 20 cups of wormwood or sage tea would be required to reach this ADI, and view that the short-term medicinal use of these herbs can also be regarded as safe. In conclusion, the evidence does not point to any need for changes in regulations but confirms the current limits as sufficiently protective for consumers. Copyright © 2010 Elsevier Inc. All rights reserved.

  3. Perceived risks and benefits of hippotherapy among parents of children currently engaged in or waiting for hippotherapy: A pilot study.

    Science.gov (United States)

    Léveillé, Audrey; Rochette, Annie; Mainville, Carolyne

    2017-04-01

    Explore the perceived risks and benefits of hippotherapy among parents of children currently engaged in or waiting rehabilitation using hippotherapy. Phenomenological qualitative exploratory pilot study. An interview guide validated by experts was used to conduct the interviews. Summaries were written to capture first impressions. One team member coded the transcripts and the coding was validated by the research team through discussion until consensus was reached. The average age of the participants (n = 4) was 37.3 ± 6.6 years. The few risks they perceived related to physical injuries. Lack of knowledge of contraindications, lack of fear, minimization of risks, and risk-attenuation factors also emerged as important themes. Benefits accounted for a large part of the content of the interviews and were grouped under 13 themes, including motor and postural control, enjoyment and the development of a special relationship. Minimization of the perceived risks compared to the numerous perceived benefits could create clinical issues such as the client putting self at risk of injuries (e.g., bites, falls, and kicks) if not cautious enough or complications insufficiently prevented, which suggests the need to develop educational activities for an informed consent to this type of rehabilitation.

  4. Sensitivity and evaluation of current fire risk and future projections due to climate change: the case study of Greece

    OpenAIRE

    A. Karali; M. Hatzaki; C. Giannakopoulos; A. Roussos; G. Xanthopoulos; V. Tenentes

    2013-01-01

    Current trends in the Mediterranean climate and more specifically in Greece indicate longer and more intense summer droughts that even extend out of season. In connection to this, the frequency of forest fire occurrence and intensity is on the rise. In the present study, the Canadian Fire Weather Index (FWI) is used in order to investigate the relationship between fire risk and meteorological conditions in Greece. FWI is a meteorologically-based index designed in Canada and ...

  5. DRUG RISK: A CROSS-SECTIONAL EXPLORATION OF THE INFLUENCE OF FAMILY-OF-ORIGIN AND CURRENT SITUATIONAL CIRCUMSTANCES1

    OpenAIRE

    Perkins, Molly; Elifson, Kirk W.; Sterk, Claire E.

    2010-01-01

    The main objective of this paper is to investigate potential predictors of drug risk among a community-based sample of individuals who are exposed to illicit drugs. The four domains of interest are individual socio-demographic and social-psychological attributes, current situational circumstances and family-of-origin characteristics. Interviews were conducted with 242 individuals who were recruited in Atlanta, Georgia. Initial descriptive analyses were followed by multivariate analyses. The f...

  6. The Very High Background Radiation Area in Ramsar, Iran: Public Health Risk or Signal for a Regulatory Paradigm Shift?

    Energy Technology Data Exchange (ETDEWEB)

    Karam, P. Andrew [Univ. of Rochester, Rochester, NY (United States); Mortazavi, S.M. Javad [Rafsanjan Univ. of Medical Sciences (Iran, Islamic Republic of). Medical Physics Dept.

    2001-07-01

    leukemia, breast and lung is no higher than in control areas. These facts suggest there is no public health advantage to measures such as relocating Ramsar's inhabitants. This conclusion brings with it a corollary question: Do our public health policies require revision if Ramsar's inhabitants are unaffected by these high radiation levels? If on-going studies confirm that the cancer rates and life spans of Ramsar's inhabitants do not differ significantly from areas those of other areas, then the effort of a large relocation is unnecessary. In addition, such findings would also suggest that our current radiation safety policies are overly conservative, requiring 'protective' measures that, in actuality, offer no benefit. If this is the case many nations may be wasting time and money in preventing non-problems. In this paper, we will discuss the factors responsible for Ramsar's high natural radiation levels. We then present the evidence accumulated thus far that suggests these radiation levels have no measurable effect on the health of Ramsar's inhabitants. Finally, we discuss how these findings, if confirmed by studies currently in progress, may call for a re-evaluation of current radiation safety recommendations.

  7. Risk assessment of mixtures of pesticides. Current approaches and future strategies

    DEFF Research Database (Denmark)

    Reffstrup, Trine Klein; Larsen, John Christian; Meyer, Otto A.

    2010-01-01

    The risk assessment of pesticide residues in food is based on toxicological evaluation of the single compounds and no internationally accepted procedure exists for evaluation of cumulative exposure to multiple residues of pesticides in crops, except for a few groups of pesticides sharing a group...... ADI. However, several attempts have been suggested during the last decade. This paper gives an overview of the various approaches. It is of paramount importance to consider whether there will be either no interaction or interaction between the compounds in the mixture. When there are no interactions...... several approaches are available for the risk assessment of mixtures of pesticides. However, no single simple approach is available to judge upon potential interactions at the low doses that humans are exposed to from pesticide residues in food. In these cases, PBTK models could be useful as tools...

  8. Risk Factors, Protective Factors, and Current Recommendations to Reduce Sudden Infant Death Syndrome: A Review.

    Science.gov (United States)

    Carlin, Rebecca F; Moon, Rachel Y

    2017-02-01

    Sudden infant death syndrome remains the leading cause of death in infants aged 1 month to 1 year in the United States. While its exact cause is unknown, sudden infant death syndrome is believed to be multifactorial, ie, occurs in infants with underlying biological vulnerability who experience an exogenous stressor, such as prone/side sleeping or soft bedding, during a critical developmental period. Much genetic and physiologic evidence points to impaired arousal responses to hypercarbia and hypoxia, which ultimately leads to asphyxia. Known risk factors for infants include prone and side sleeping, soft bedding, bed sharing, inappropriate sleep surfaces (including sofas), exposure to tobacco smoke, and prematurity; protective factors include breastfeeding, pacifier use, room sharing, and immunizations. Despite our improved understanding of the physiologic mechanisms that cause sudden infant death, the mainstay of risk reduction continues to be a safe sleep environment, as most infants who die suddenly and unexpectedly do so in unsafe sleep environments.

  9. Elevated body mass index as a risk factor for chronic kidney disease: current perspectives

    Directory of Open Access Journals (Sweden)

    Garl

    2014-07-01

    Full Text Available Jocelyn S Garland Department of Medicine, Queen's University, Kingston, ON, Canada Abstract: Chronic kidney disease (CKD is defined by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative as the presence of reduced kidney function or kidney damage for a period of 3 months or greater. Obesity is considered a risk factor for CKD development, but its precise role in contributing to CKD and end stage kidney disease is not fully elucidated. In this narrative review, the objectives are to describe the pathogenesis of CKD in obesity, including the impact of altered adipokine secretion in obesity and CKD, and to provide an overview of the clinical studies assessing the risk of obesity and CKD development. Keywords: obesity, chronic renal disease, adipokine

  10. 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.

  11. Current and Remitted Depression and Anxiety Disorders as Risk Factors for Medication Nonadherence

    NARCIS (Netherlands)

    Bet, Pierre M.; Penninx, Brenda W. J. H.; van Laer, Stag D.; Hoogendijk, Witte J. G.; Hugtenburg, Jacqueline G.

    Objective: To investigate the impact of current and remitted depression and anxiety disorders and sociodemographic and other related factors on medication nonadherence in a large cohort study. Method: The Medication Adherence Rating Scale was used to assess medication nonadherence of 1,890

  12. Part of celiac population still at risk despite current gluten thresholds

    NARCIS (Netherlands)

    Bruins Slot, I.D.; Bremer, M.G.E.G.; Hamer, R.J.; Fels, van der Ine

    2015-01-01

    In order to assist celiac disease (CD) patients in making safe food choices, gluten-free food products are labelled as such. The exact meaning of the gluten-free label differs throughout the world. This paper discusses the different thresholds that are currently used to label products gluten-free

  13. Primary small bowel adenocarcinoma: current view on clinical features, risk and prognostic factors, treatment and outcome.

    Science.gov (United States)

    Lech, Gustaw; Korcz, Wojciech; Kowalczyk, Emilia; Słotwiński, Robert; Słodkowski, Maciej

    2017-11-01

    Small bowel adenocarcinoma (SBA) is a rare but increasing cause of gastrointestinal malignancy, being both a diagnostic and therapeutic challenge. The goal of treatment is margin negative resection of a lesion and local lymphadenectomy, followed by modern adjuvant chemotherapy combinations in selected cases. Improved outcomes in patients with SBA are encouraging, but elucidation of mechanisms of carcinogenesis and risk factors as well as improved treatment for this malignancy is very needed.

  14. Relevant risk factors, current eating psychopathology, body shape concern and psychological functioning in eating disorders

    OpenAIRE

    Carretero García, Anna

    2010-01-01

    Objective: The first aim of this study is to assess retrospectively the relevant risk factors in patients with Eating Disorders (EDs). The second aim is the assessment of eating psychopathology, body shape concern and psychological functioning in different groups of eating disorders. Method: Evaluation prior to intervention of 73 patients with bulimia nervosa of the purging type (BN-P; n=29), binge eating disorder (BED; n=6), eating disorder not otherwise specified purging type (EDNOS-P; n=17...

  15. Export and import activity of the wine industry: tendencies, current risks

    OpenAIRE

    Bondarenko Svitlana Anatoliyivna; Nizyayeva Viktoria Romanivna

    2017-01-01

    The article studies state of wine industry’s export-import activity, analyzes tendencies, which provide to reveal peculiar regulations andmain modern risks, which are necessary to be considered for appropriate level of the sector export capability. Export-import activity of wine industry is analyzed; capacity dynamics and market openness degree are estimated. It has been proved that redulatory impact on the winemaking and wine industry development has to be based, on the onehand, on the work ...

  16. Using climate model simulations to assess the current climate risk to maize production

    Science.gov (United States)

    Kent, Chris; Pope, Edward; Thompson, Vikki; Lewis, Kirsty; Scaife, Adam A.; Dunstone, Nick

    2017-05-01

    The relationship between the climate and agricultural production is of considerable importance to global food security. However, there has been relatively little exploration of climate-variability related yield shocks. The short observational yield record does not adequately sample natural inter-annual variability thereby limiting the accuracy of probability assessments. Focusing on the United States and China, we present an innovative use of initialised ensemble climate simulations and a new agro-climatic indicator, to calculate the risk of severe water stress. Combined, these regions provide 60% of the world’s maize, and therefore, are crucial to global food security. To probe a greater range of inter-annual variability, the indicator is applied to 1400 simulations of the present day climate. The probability of severe water stress in the major maize producing regions is quantified, and in many regions an increased risk is found compared to calculations from observed historical data. Analysis suggests that the present day climate is also capable of producing unprecedented severe water stress conditions. Therefore, adaptation plans and policies based solely on observed events from the recent past may considerably under-estimate the true risk of climate-related maize shocks. The probability of a major impact event occurring simultaneously across both regions—a multi-breadbasket failure—is estimated to be up to 6% per decade and arises from a physically plausible climate state. This novel approach highlights the significance of climate impacts on crop production shocks and provides a platform for considerably improving food security assessments, in the present day or under a changing climate, as well as development of new risk based climate services.

  17. NASA's Current Evidence and Hypothesis for the Visual Impairment and Intracranial Pressure Risk

    Science.gov (United States)

    Otto, Christian A.; Norsk, Peter; Oubre, Cherie M.; Pass, Anastas F.; Tarver, William

    2012-01-01

    While 40 years of human spaceflight exploration has reported visual decrement to a certain extent in a subgroup of astronauts, recent data suggests that there is indeed a subset of crewmembers that experience refraction changes (hyperoptic shift), cotton wool spot formation, choroidal fold development, papilledema, optic nerve sheath distention and/or posterior globe flattening with varying degrees of severity and permanence. Pre and postflight ocular measures have identified a potential risk of permanent visual changes as a result of microgravity exposure, which has been defined as the Visual Impairment and Intracranial Pressure risk (VIIP). The combination of symptoms are referred to as the VIIP syndrome. It is thought that the ocular structural and optic nerve changes are caused by events precipitated by the cephalad fluid shift crewmembers experience during long-duration spaceflight. Three important systems, ocular, cardiovascular, and central nervous, seem to be involved in the development of symptoms, but the etiology is still under speculation. It is believed that some crewmembers are more susceptible to these changes due to genetic/anatomical predisposition or lifestyle (fitness) related factors. Future research will focus on determining the etiology of the VIIP syndrome and development of mechanisms to mitigate the spaceflight risk.

  18. Growing up as a part of teenage communities: Current trends and risks

    Directory of Open Access Journals (Sweden)

    G H Azashikov

    2015-12-01

    Full Text Available The article describes teenage communities as a special space of growing up. The authors examine some major transformations of the contemporary society and socialization risks generated by them in teenage communities for today’s high parental employment outside the home makes peer groups the most important agent of socialization and a key space for teenagers’ growing up. The article identifies the main socio-psychological conceptions of group dynamics, types of relationships among teenagers and functions of peer communities that provide teens a chance to grow up in a system of intergroup communications. The authors emphasize the fact that traditionally peer relationships serve as a “school” of social experience necessary for the normal format of growing up, but today communicational and recreational practices of teens and youth are increasingly “constructed” by the consumption industry. The article considers tendencies of consumerism and virtualization in teenage communities that are changing not only the shape but also the very essence of interactions and relationships among teens and youngsters; discusses the criminalization risks in these groups due to today’s mass media impact, and the risks associated with the Internet activity, such as intellectual primitivization and infantilization due to the overreliance on the Internet.

  19. Current obstacles in replicating risk assessment findings: a systematic review of commonly used actuarial instruments.

    Science.gov (United States)

    Rossegger, Astrid; Gerth, Juliane; Seewald, Katharina; Urbaniok, Frank; Singh, Jay P; Endrass, Jérôme

    2013-01-01

    An actuarial risk assessment instrument can be considered valid if independent investigations using novel samples can replicate the findings of the instrument's development study. In order for a study to qualify as a replication, it has to adhere to the methodological protocol of the development study with respect to key design characteristics, as well as ensuring that manual-recommended guidelines of test administration have been followed. A systematic search was conducted to identify predictive validity studies (N = 84) on three commonly used actuarial instruments: the Violence Risk Appraisal Guide (VRAG), the Sex Offender Risk Appraisal Guide (SORAG), and the Static-99. Sample (sex, age, criminal history) and design (follow-up, attrition, recidivism) characteristics, as well as markers of assessment integrity (scoring reliability, item omissions, prorating procedure), were extracted from 84 studies comprising 108 samples. None of the replications matched the development study of the instrument they were attempting to cross-validate with respect to key sample and design characteristics. Furthermore none of the replications strictly followed the manual-recommended guidelines for the instruments' administration. Additional replication studies that follow the methodological protocols outlined in actuarial instruments' development studies are needed before claims of generalizability can be made. Copyright © 2013 John Wiley & Sons, Ltd.

  20. Expression-based network biology identifies alteration in key regulatory pathways of type 2 diabetes and associated risk/complications.

    Directory of Open Access Journals (Sweden)

    Urmi Sengupta

    Full Text Available Type 2 diabetes mellitus (T2D is a multifactorial and genetically heterogeneous disease which leads to impaired glucose homeostasis and insulin resistance. The advanced form of disease causes acute cardiovascular, renal, neurological and microvascular complications. Thus there is a constant need to discover new and efficient treatment against the disease by seeking to uncover various novel alternate signalling mechanisms that can lead to diabetes and its associated complications. The present study allows detection of molecular targets by unravelling their role in altered biological pathways during diabetes and its associated risk factors and complications. We have used an integrated functional networks concept by merging co-expression network and interaction network to detect the transcriptionally altered pathways and regulations involved in the disease. Our analysis reports four novel significant networks which could lead to the development of diabetes and other associated dysfunctions. (a The first network illustrates the up regulation of TGFBRII facilitating oxidative stress and causing the expression of early transcription genes via MAPK pathway leading to cardiovascular and kidney related complications. (b The second network demonstrates novel interactions between GAPDH and inflammatory and proliferation candidate genes i.e., SUMO4 and EGFR indicating a new link between obesity and diabetes. (c The third network portrays unique interactions PTPN1 with EGFR and CAV1 which could lead to an impaired vascular function in diabetic nephropathy condition. (d Lastly, from our fourth network we have inferred that the interaction of beta-catenin with CDH5 and TGFBR1 through Smad molecules could contribute to endothelial dysfunction. A probability of emergence of kidney complication might be suggested in T2D condition. An experimental investigation on this aspect may further provide more decisive observation in drug target identification and better

  1. Cost tradeoffs in consequence management at nuclear power plants: A risk based approach to setting optimal long-term interdiction limits for regulatory analyses

    Energy Technology Data Exchange (ETDEWEB)

    Mubayi, V.

    1995-05-01

    The consequences of severe accidents at nuclear power plants can be limited by various protective actions, including emergency responses and long-term measures, to reduce exposures of affected populations. Each of these protective actions involve costs to society. The costs of the long-term protective actions depend on the criterion adopted for the allowable level of long-term exposure. This criterion, called the ``long term interdiction limit,`` is expressed in terms of the projected dose to an individual over a certain time period from the long-term exposure pathways. The two measures of offsite consequences, latent cancers and costs, are inversely related and the choice of an interdiction limit is, in effect, a trade-off between these two measures. By monetizing the health effects (through ascribing a monetary value to life lost), the costs of the two consequence measures vary with the interdiction limit, the health effect costs increasing as the limit is relaxed and the protective action costs decreasing. The minimum of the total cost curve can be used to calculate an optimal long term interdiction limit. The calculation of such an optimal limit is presented for each of five US nuclear power plants which were analyzed for severe accident risk in the NUREG-1150 program by the Nuclear Regulatory Commission.

  2. Fatalism, current life satisfaction, and risk for HIV infection among gay and bisexual men.

    Science.gov (United States)

    Kalichman, S C; Kelly, J A; Morgan, M; Rompa, D

    1997-08-01

    This study surveyed 430 men at an urban gay pride celebration to assess fatalism, current life satisfaction, and perceived expected years of life among men who have sex with men. Analyses showed that men who engaged in unprotected anal intercourse outside of exclusive relationships reported a greater fatalistic outlook, were more dissatisfied with life, and perceived a shorter life for themselves than men who practiced only safer sex and men who were in exclusive relationships. Gay men in exclusive relationships scored higher than nonexclusively partnered gay men on the measure of current life satisfaction. These results suggest that efforts to prevent HIV infection among gay men should include building personal self-worth, support of long-term relationships, and future goal orientations.

  3. Current Status and Future Challenges in Risk-Based Radiation Engineering

    Science.gov (United States)

    Pellish, Jonathan A.

    2017-01-01

    This presentation covers the basis and challenges for radiation effects in electronic systems. The three main types of radiation effects in electronics are: 1) total ionizing dose (TID), 2) total non-ionizing dose (TNID) / displacement damage dose (DDD), and 3) single-event effect (SEE). Some content on relevant examples of effects, current concerns, and possible environmental model-driven solutions are also included.

  4. Issues and current applications of interspecies extrapolation of carcinogenic potency as a component of risk assessment.

    OpenAIRE

    Visek, W. J.

    1988-01-01

    The Life Sciences Research Office (LSRO) of the Federation of American Societies for Experimental Biology (FASEB) is conducting this symposium under contract with the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA). The FDA has requested information on the strengths and weaknesses of current interspecies extrapolation methods using metabolic and pharmacokinetic data, identity of data for these methods, bases for choice of extrapolation method and...

  5. The prevalence and risk indicators of symptoms of common mental disorders among current and former Dutch elite athletes.

    Science.gov (United States)

    Gouttebarge, Vincent; Jonkers, Ruud; Moen, Maarten; Verhagen, Evert; Wylleman, Paul; Kerkhoffs, Gino

    2017-11-01

    The aim of the study was to determine the prevalence and comorbidity of symptoms of common mental disorders (distress, anxiety/depression, sleep disturbance, eating disorders, adverse alcohol use) among current and former Dutch elite athletes, and to explore the inference between potential risk indicators (severe injury, surgery, life events, sport career dissatisfaction, social support) and the outcomes measures under investigation. Cross-sectional analyses were conducted on baseline questionnaires from an ongoing prospective cohort study among 203 current and 282 former elite Dutch athletes (response rate: 28% among current athletes and 95% among former athletes). Based on validated scales, an electronic questionnaire was set up and distributed. Prevalence (4-week) ranged from 6% for adverse alcohol use to 45% for anxiety/depression among current elite athletes, and from 18% for distress to 29% for anxiety/depression among former elite athletes. A higher number of past severe injuries, higher number of past surgeries, higher number of recent life events, higher level of career dissatisfaction and lower level of social support were related to the occurrence of symptoms of common mental disorders among both current and former elite athletes. On average, the 4-week prevalence of common mental disorders as shown in our study among current and former Dutch elite athletes were similar to the ones found among athletes from other sports disciplines and does compare with the lifetime prevalence estimates in the general population of the Netherlands.

  6. Hiding the tobacco power wall reduces cigarette smoking risk in adolescents: using an experimental convenience store to assess tobacco regulatory options at retail point-of-sale.

    Science.gov (United States)

    Shadel, William G; Martino, Steven C; Setodji, Claude M; Scharf, Deborah M; Kusuke, Daniela; Sicker, Angela; Gong, Min

    2015-11-23

    This experiment tested whether changing the location or visibility of the tobacco power wall in a life sized replica of a convenience store had any effect on adolescents' susceptibility to future cigarette smoking. The study was conducted in the RAND StoreLab (RSL), a life sized replica of a convenience store that was developed to experimentally evaluate how changing aspects of tobacco advertising displays in retail point-of-sale environments influences tobacco use risk and behaviour. A randomised, between-subjects experimental design with three conditions that varied the location or visibility of the tobacco power wall within the RSL was used. The conditions were: cashier (the tobacco power wall was located in its typical position behind the cash register counter); sidewall (the tobacco power wall was located on a sidewall away from the cash register); or hidden (the tobacco power wall was located behind the cashier but was hidden behind an opaque wall). The sample included 241 adolescents. Hiding the tobacco power wall significantly reduced adolescents' susceptibility to future cigarette smoking compared to leaving it exposed (ie, the cashier condition; p=0.02). Locating the tobacco power wall on a sidewall away from the cashier had no effect on future cigarette smoking susceptibility compared to the cashier condition (p=0.80). Hiding the tobacco power wall at retail point-of-sale locations is a strong regulatory option for reducing the impact of the retail environment on cigarette smoking risk in adolescents. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Previous Preterm Birth and Current Maternal Complications as a Risk Factor of Subsequent Stillbirth

    Directory of Open Access Journals (Sweden)

    Boubakari Ibrahimou

    2015-01-01

    Full Text Available Purpose. To examine the association between previous preterm birth and the risk of stillbirth. Methods. This population-based retrospective cohort study analyzed live births and stillbirth records in Missouri (1989–1997. The main outcome of interest was stillbirth occurrence while the exposures were prior preterm birth. Adjusted odds ratios and 95% confidence intervals were computed using logistic regression. Results. Women who had a previous preterm birth have 63% increased odds of stillbirth in singleton pregnancies and 75% increased odds in twins as compared to those who did not have a preterm birth in a prior pregnancy (AOR = 1.63, 95% CI = 1.41–1.88 and AOR = 1.75, 95% CI = 1.20–2.56, respectively. The most significant risk factor for stillbirth in singleton pregnancies was uterine bleeding (AOR = 5.89, 95% CI = 5.13–6.76. In twin pregnancies, it was the condition hydramnios/oligohydramnios (AOR = 4.72, 95% CI = 3.70–6.02. Eclampsia was associated with a heightened risk of stillbirth in singletons (AOR = 2.45, 95% CI = 1.41–4.12, but not in twins (AOR = 0.96, 95% CI = 0.13–7.00. Black mothers were more likely than white to experience stillbirth (AOR = 2.10, 95% CI = 1.99–2.22 for singletons and AOR = 1.51, 95% CI = 1.27–1.79 for twins. Conclusion. Stillbirth is a vital public health issue and its etiology is not well understood. Previous history of preterm birth was found to be associated with future stillbirth. Targeted early medical and obstetric care and interventions among women with preterm birth history may potentially reduce the likelihood of stillbirth.

  8. 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.

  9. Current (food) Allergenic Risk Assessment: Is It Fit for Novel Foods? Status Quo and Identification of Gaps.

    Science.gov (United States)

    Mazzucchelli, Gabriel; Holzhauser, Thomas; Cirkovic-Velickovic, Tanja; Diaz-Perales, Araceli; Molina, Elena; Roncada, Paola; Rodrigues, Pedro; Verhoeckx, Kitty; Hoffmann-Sommergruber, Karin

    2017-09-19

    Food allergies are recognised as a global health concern. In order to protect allergic consumers from severe symptoms, allergenic risk assessment for well known foods and foods containing genetically modified ingredients was installed. However, population is steadily growing and there is a rising need to provide adequate protein-based foods, including novel sources, not yet used for human consumption. In this context safety issues such as a potential increased allergenic risk need to be assessed before marketing novel food sources. Therefore, the established allergenic risk assessment for genetically modified organisms needs to be re-evaluated for its applicability for risk assessment of novel food proteins. Two different scenarios of allergic sensitization have to be assessed. The first scenario is the presence of already known allergenic structures in novel foods. For this a comparative assessment can be performed and the range of cross-reactivity can be explored, while in the second scenario allergic reactions are observed towards so far novel allergenic structures and no reference material is available. This review summarises the current analytical methods for allergenic risk assessment, highlighting the strengths and limitations of each method and discussing the gaps in this assessment that need to be addressed in the near future. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  10. High-grade prostatic intraepithelial neoplasia in needle biopsy as risk factor for detection of adenocarcinoma: current level of risk in screening population.

    Science.gov (United States)

    Gokden, Neriman; Roehl, Kimberly A; Catalona, William J; Humphrey, Peter A

    2005-03-01

    To assess the current incidence of prostate carcinoma detection in serial biopsies in a prostate-specific antigen-based screening population after a diagnosis of isolated high-grade prostatic intraepithelial neoplasia (HG-PIN) in needle biopsy tissue. We retrospectively identified 190 men with a diagnosis of isolated HG-PIN in needle biopsy tissue. Most men (86%) were diagnosed from 1996 to 2000. Logistic regression analysis was used to predict the presence of carcinoma in these 190 men and in a control group of 1677 men with only benign prostatic tissue in needle biopsy tissue. The cumulative risk of detection of carcinoma on serial sextant follow-up biopsies was 30.5% for those with isolated HG-PIN compared with 26.2% for the control group (P = 0.2). Patient age (P = 0.03) and serum prostate-specific antigen level (P = 0.02) were significantly linked to the risk of cancer detection, but suspicious digital rectal examination findings (P = 0.1), the presence of HG-PIN (P = 0.2), and the histologic attributes of PIN were not (all with nonsignificant P values). HG-PIN found on the first repeat biopsy was associated with a 41% risk of subsequent detection of carcinoma compared with an 18% risk if benign prostatic tissue was found on the first repeat biopsy (P = 0.01). The results of our study have shown that the current level of risk for the detection of prostate carcinoma in a screened population is 30.5% after a diagnosis of isolated HG-PIN in a needle biopsy. This risk level is lower than the previously reported risk of 33% to 50%. HG-PIN is a risk factor for carcinoma detection only when found on consecutive sextant biopsies. The data presented here should prompt reconsideration of repeat biopsy strategies for HG-PIN, and re-evaluation of the absolute necessity of repeat biopsy for all patients with HG-PIN.

  11. Does breastfeeding influence the risk of developing diabetes mellitus in children? A review of current evidence

    Directory of Open Access Journals (Sweden)

    Patricia Feliciano Pereira

    2014-01-01

    Full Text Available OBJECTIVE: The aim of this study was to perform a review to investigate the influence of breastfeeding as a protective agent against the onset of diabetes in children. SOURCES: Non-systematic review of SciELO, LILACS, MEDLINE, Scopus, and VHL databases, and selection of the 52 most relevant studies. A total of 21 articles, specifically on the topic, were analyzed (nine related to type 1 diabetes and 12 to type 2 diabetes. DATA SYNTHESIS: The duration and exclusivity of breastfeeding, as well as the early use of cow's milk, have been shown to be important risk factors for developing diabetes. It is believed that human milk contains substances that promote the maturation of the immune system, which protect against the onset of type 1 diabetes. Moreover, human milk has bioactive substances that promote satiety and energy balance, preventing excess weight gain during childhood, thus protecting against the development of type 2 diabetes. Although the above mentioned benefits have not been observed by some researchers, inaccuracies on dietary habit reports during childhood and the presence of interfering factors have been considered responsible for the lack of identification of beneficial effects. CONCLUSION: Given the scientific evidence indicated in most published studies, it is believed that the lack of breastfeeding can be a modifiable risk factor for both type 1 and type 2 diabetes. Strategies aiming at the promotion and support of breastfeeding should be used by trained healthcare professionals in order to prevent the onset of diabetes.

  12. How to manage the biological risk in a dental clinic: current and future perspectives.

    Science.gov (United States)

    Saccucci, Matteo; Ierardo, Gaetano; Protano, Carmela; Vitali, Matteo; Polimeni, Antonella

    2017-10-01

    Dental personnel (DP) may be exposed to pathogens during dental treatment, either through contact contaminated equipment, or with blood and respiratory secretion. On the other hand, health care professionals are constantly exposed to pathogens and opportunists in their work environment. Consequently, the dental healthcare environment is connected with the risk of exposure to biological agents both for patients and dental workers, and involves a wide number of microorganisms that can be present in biological matrices (gingival fluids, saliva, blood), contaminated and/or non-sanitized surfaces, water used in the dental unit, or emitted by patients suffering or carrier of a transmissible disease. The main determinants of exposure to biological agents in dentistry are related, therefore, to several factors, such as the lack in the application of disinfection/sterilization procedures for surfaces, reusable tools, water, etc.; the lack in the use of protective equipment by workers; an insufficient or inefficient training of personnel; the use of non-targeted, too diluted, or expired biocides. Therefore, each single patient needs to be treated as a potential communicable infectious disease carrier and each case must receive high level of attention in compliance with preventive and hygiene standards, following disinfection and sterilization procedures, and always wearing personal protective equipment. The goal of this article was to discuss on the infection risks related to dental practice both for patients and workers, and to evaluate the state of the art and future perspectives, with particular attention to disinfection procedures, for occupational biological hazards and HAIs prevention in this setting.

  13. A comparative analysis of current microbial water quality risk assessment and management practices in British Columbia and Ontario, Canada.

    Science.gov (United States)

    Dunn, Gemma; Harris, Leila; Cook, Christina; Prystajecky, Natalie

    2014-01-15

    Bacteria, protozoa and viruses are ubiquitous in aquatic environments and may pose threats to water quality for both human and ecosystem health. Microbial risk assessment and management in the water sector is a focus of governmental regulation and scientific inquiry; however, stark gaps remain in their application and interpretation. This paper evaluates how water managers practice microbial risk assessment and management in two Canadian provinces (BC and Ontario). We assess three types of entities engaged in water management along the source-to-tap spectrum (watershed agencies, water utilities, and public health authorities). We analyze and compare the approaches used by these agencies to assess and manage microbial risk (including scope, frequency, and tools). We evaluate key similarities and differences, and situate them with respect to international best practices derived from literatures related to microbial risk assessment and management. We find considerable variability in microbial risk assessment frameworks and management tools in that approaches 1) vary between provinces; 2) vary within provinces and between similar types of agencies; 3) have limited focus on microbial risk assessment for ecosystem health and 4) diverge considerably from the literature on best practices. We find that risk assessments that are formalized, routine and applied system-wide (i.e. from source-to-tap) are limited. We identify key limitations of current testing methodologies and looking forward consider the outcomes of this research within the context of new developments in microbial water quality monitoring such as tests derived from genomics and metagenomics based research. © 2013 Elsevier B.V. All rights reserved.

  14. Methicillin-resistant Staphylococcus aureus colonization and infection risks from companion animals: current perspectives

    Directory of Open Access Journals (Sweden)

    Petinaki E

    2015-11-01

    Full Text Available Efthimia Petinaki,1 Iris Spiliopoulou21Department of Microbiology, School of Medicine, University of Thessalia, Larissa, 2Department of Microbiology, School of Medicine, University of Patras, Patras, GreeceAbstract: Methicillin-resistant Staphylococcus aureus (MRSA remains one of the most virulent human pathogens and has also recently been recognized as such in the veterinary settings. Companion animals, including dogs, cats, horses, small exotic animals, wildlife animals, and livestock, may constitute a reservoir for MRSA transmission to humans and vice versa. The evolution, emergence, and risk factors for MRSA transmission among colonized or infected animals are reviewed in the present paper, and infection control practices are discussed.Keywords: methicillin-resistant Staphylococcus aureus, companion animals, close contacts

  15. Energy Drinks and the Risk of Cardiovascular Disease: A Review of Current Literature.

    Science.gov (United States)

    Mangi, Muhammad A; Rehman, Hiba; Rafique, Muhammad; Illovsky, Michael

    2017-06-07

    Energy drinks (EDs) are commonly used as a dietary supplement by young adolescents and adults. They are often used as a source of energy in order to enhance physical and mental performance. EDs contain a variety of substances, but caffeine is the main component. Safety has been the biggest concern associated with consuming EDs. Case reports, observational studies, and meta-analyses have been done in order to determine the effects of EDs on cardiovascular changes. The detrimental effects of EDs are cardiac arrhythmias, myocardial infarction, prolonged QT interval, aortic dissection, and death. In this article, we review case reports, observational studies, and meta-analyses of EDs and the risk of cardiovascular events and mortality. We also review active ingredients, pharmacokinetics, and the mechanism of action of EDs.

  16. Diminishing Risk for Age-Related Macular Degeneration with Nutrition: A Current View

    Directory of Open Access Journals (Sweden)

    Allen Taylor

    2013-07-01

    Full Text Available Age-related macular degeneration (AMD is the leading cause of blindness in the elderly. Clinical hallmarks of AMD are observed in one third of the elderly in industrialized countries. Preventative interventions through dietary modification are attractive strategies, because they are more affordable than clinical therapies, do not require specialists for administration and many studies suggest a benefit of micro- and macro-nutrients with respect to AMD with few, if any, adverse effects. The goal of this review is to provide information from recent literature on the value of various nutrients, particularly omega-3 fatty acids, lower glycemic index diets and, perhaps, some carotenoids, with regard to diminishing risk for onset or progression of AMD. Results from the upcoming Age-Related Eye Disease Study (AREDS II intervention trial should be particularly informative.

  17. Transcranial Alternating Current Stimulation: A potential risk for genetic generalized epilepsy patients (Study Case

    Directory of Open Access Journals (Sweden)

    Daniel San Juan Orta

    2016-11-01

    Full Text Available Transcranial alternating current stimulation (tACS is a re-emergent neuromodulation technique that consists in the external application of oscillating electrical currents that induces changes in cortical excitability. We present the case of a 16-year-old female with pharmaco-resistant juvenile myoclonic epilepsy to three antiepileptic’s drugs characterized by four myoclonic and 20 absence seizures monthly. She received tACS at 1mA@3Hz pulse train during 60 minutes over Fp1-Fp2 (10-20 EEG international system position during 4 consecutive days using an Endeavor™ IOM Systems device® (Natus Medical Incorporated, Middleton, WI, USA. At the one-month follow-up, she reported a 75% increase in seizures frequency (only myoclonic and tonic-clonic events and developed a 24h myoclonic status epilepticus that resolved with oral clonazepam and intravenous valproate. At the two-month follow-up, the patient reported a 15-day seizure-free period.

  18. Does breastfeeding influence the risk of developing diabetes mellitus in children? A review of current evidence.

    Science.gov (United States)

    Pereira, Patrícia Feliciano; Alfenas, Rita de Cássia G; Araújo, Raquel Maria A

    2014-01-01

    The aim of this study was to perform a review to investigate the influence of breastfeeding as a protective agent against the onset of diabetes in children. non-systematic review of SciELO, LILACS, MEDLINE, Scopus, and VHL databases, and selection of the 52 most relevant studies. A total of 21 articles, specifically on the topic, were analyzed (nine related to type 1 diabetes and 12 to type 2 diabetes). The duration and exclusivity of breastfeeding, as well as the early use of cow's milk, have been shown to be important risk factors for developing diabetes. It is believed that human milk contains substances that promote the maturation of the immune system, which protect against the onset of type 1 diabetes. Moreover, human milk has bioactive substances that promote satiety and energy balance, preventing excess weight gain during childhood, thus protecting against the development of type 2 diabetes. Although the above mentioned benefits have not been observed by some researchers, inaccuracies on dietary habit reports during childhood and the presence of interfering factors have been considered responsible for the lack of identification of beneficial effects. Given the scientific evidence indicated in most published studies, it is believed that the lack of breastfeeding can be a modifiable risk factor for both type 1 and type 2 diabetes. Strategies aiming at the promotion and support of breastfeeding should be used by trained healthcare professionals in order to prevent the onset of diabetes. Copyright © 2013 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

  19. Risks and benefits of bupropion treatment in schizophrenia: a systematic review of the current literature.

    Science.gov (United States)

    Englisch, Susanne; Morgen, Katrin; Meyer-Lindenberg, Andreas; Zink, Mathias

    2013-01-01

    Bupropion inhibits the reuptake of norepinephrine and dopamine, which are involved in the pathogenesis of affective, cognitive, and psychomotor impairment in schizophrenia. Because of reports on bupropion-associated psychoses, it is reluctantly used in schizophrenic patients. Risks and benefits, however, have never been comprehensively reviewed. The objectives of this study were to evaluate the efficacy of bupropion on depression, negative symptoms, cognition, and smoking habits in schizophrenia and to appraise safety aspects. MEDLINE OVID/PubMed, scholar.google.com and the Cochrane Database were screened for the keywords ("bupropion"/"wellbutrin"/"elontril"/"zyban") and ("psychosis"/"schizophrenia"/"psychotic disorder"). A total of 13 randomized controlled trials (28 publications), 3 open prospective evaluations, 5 multiple case reports, 22 single case reports, and 6 review articles were incorporated in the final analysis. Information on patient population, age, diagnosis, bupropion dose and formulation, antipsychotic and concomitant medication, adverse events and treatment outcomes regarding psychosis, affective and negative symptoms, cognition, and smoking habits were collected from the published reports. A total of 30 cases of bupropion-induced psychoses have been published, 17 (57%) of which were associated with the immediate-release drug formulation and 28 (93%) of which occurred without concomitant antipsychotic medication. In comparison, 229 schizophrenic patients on stable antipsychotic regimens were successfully treated with bupropion and experienced marked clinical improvement without developing psychosis. Pharmacokinetic interactions with antipsychotics were rare, whereas electroencephalographic abnormalities occurred frequently. In schizophrenic patients treated with bupropion in addition to antipsychotics, the risk for bupropion-induced psychoses seems negligible. The efficacy of a combined dopamine and norepinephrine agonist in schizophrenia is

  20. 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 Immediate Effectiveness of Proposed Rule Change To Amend the Security Futures Risk Disclosure Statement... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on August 16, 2010, Financial Industry Regulatory...

  1. Time Matters: Framing Antismoking Messages Using Current Smokers' Preexisting Perceptions of Temporal Distance to Smoking-Related Health Risks.

    Science.gov (United States)

    Kim, Kyongseok; Kim, Hyang-Sook

    2017-01-17

    This study examined the effects of temporal framing used in messages about the future likelihood of developing smoking-related diseases on intention to quit smoking. Based on construal level theory (CLT), a causal model delineating the relationships among four variables-perceived temporal distance, personal relevance, perceived susceptibility, and behavioral intention-was proposed. The model was validated by an online experiment with a sample of 222 current smokers, revealing the effects of perceived temporal distance on behavioral intention via personal relevance and perceived susceptibility. Following the CLT-grounded model, the effects of different temporal frames (near future vs. distant future) on the four variables were tested. The near-future frame featured a risk perceived to be more temporally proximal (i.e., heart attack), and the distant-future frame featured a risk perceived to be more temporally distant (i.e., larynx cancer) among current smokers. Participants exposed to the near-future frame reported significantly shorter perceived temporal distance, greater personal relevance and perceived susceptibility to the risk portrayed in the message, and greater intention to quit smoking than participants exposed to the distant-future frame. Implications for antismoking communications are discussed.

  2. Relevant associations of the glucokinase regulatory protein/glucokinase gene variation with TAG concentrations in a high-cardiovascular risk population: modulation by the Mediterranean diet.

    Science.gov (United States)

    Sotos-Prieto, Mercedes; Guillén, Marisa; Vicente Sorli, Jose; Portolés, Olga; Guillem-Saiz, Patricia; Ignacio Gonzalez, Jose; Qi, Lu; Corella, Dolores

    2013-01-28

    The SNP rs1260326 (P446L) and rs1799884 (-30G>A) for the glucokinase regulatory protein (GCKR) and glucokinase (GCK) genes, respectively, have been associated with opposing effects on TAG and glucose concentrations. However, their genetic modulation by diet (dietary patterns or foods) remains to be investigated. We studied 945 high-cardiovascular risk subjects aged 67 (sd 6) years who participated in the PREvención con DIeta MEDiterránea-Valencia Study. Demographic, clinical, biochemical and genetic data were obtained. Adherence to the Mediterranean diet (MD) and food intake were measured by validated questionnaires. Carriers of the L allele of GKCR had significantly higher TAG concentrations (PP: 1.34 (SD 0.05) mmol/l v. PL+LL: 1.54 (SD 0.03) mmol/l; P= 0.014) and LL carriers had lower glucose concentrations (PL+PP: 6.85 (SD 0.08) mmol/l v. LL: 6.40 (SD 0.16) mmol/l; P= 0.032) after multivariate adjustment. Conversely, homozygous subjects for the variant allele (A) in the GCK gene had significantly lower TAG (GG+GA: 1.48 (SD 0.03) mmol/l v. AA: 1.17 (SD 0.18) mmol/l; P= 0.033) and a higher risk of diabetes (OR 3.3, 95 % CI 1.2, 9.2). Combined effects for both SNP increased TAG concentrations by 37 % (P= 0.033). Adherence to the MD modulated the effects of GCKR polymorphism on TAG: subjects with genetic risk had lower TAG (L-allele carriers; PP: 1.48 (SD 0.14) mmol/l v. PL+LL: 1.51 (SD 0.08) mmol/l; P= 0.917) compared with those with a higher adherence. Analysis of the joint effects of the GCKR and individual food items identified significant associations (olive oil (P= 0.035), vegetables (P= 0.012), red meat (P= 0.017), butter (P= 0.039), sweetened carbonated beverages (P= 0.036) and nuts (P= 0.038)). In conclusion, we found that rs1260326 (GCKR) is significantly associated with higher TAG concentrations, but is modulated by adherence to the MD.

  3. The legacy of pesticide pollution: An overlooked factor in current risk assessments of freshwater systems

    DEFF Research Database (Denmark)

    Rasmussen, Jes Jessen; Wiberg-Larsen, Peter; Baattrup-Pedersen, Annette

    2015-01-01

    water samples from agriculturally impacted streams was significantly higher when legacy pesticides were included compared to when they were omitted. Legacy pesticides did not significantly change the predicted toxicity of water samples to algae or fish. However, pesticide concentrations in bed sediment...... and simazine which have long been banned in the EU. The highest concentrations of legacy pesticides were found in streams draining catchments with a large proportion of arable farmland suggesting that they originated from past agricultural applications. The sum of toxic units (SumTUD.magna) based on storm...... and suspended sediment samples exceeded safety thresholds in 50% of the samples and the average contribution of legacy pesticides to the SumTUC.riparius was >90%. Our results suggest that legacy pesticides can be highly significant contributors to the current toxic exposure of stream biota, especially...

  4. Zika virus infection in Vietnam: current epidemic, strain origin, spreading risk, and perspective.

    Science.gov (United States)

    Chu, Dinh-Toi; Ngoc, Vo Truong Nhu; Tao, Yang

    2017-11-01

    Zika virus infection and its associated microcephaly have being receiving global concern. This infection has spread widely since the first outbreak was recorded in Africa in 1952. Now, it has been reported in over 70 countries on five continents including Africa, North and South America, Asia, and Europe. Vietnam is one of the most recent countries which had cases of Zika virus infection at the end of 2016. This country has also reported the first case of a microcephaly-born baby which was probably linked to Zika virus infection. However, information on the Zika virus epidemic in Vietnam is still limited. This brief report intends to update the current Zika virus epidemic, and to discuss challenges and perspectives in controlling this infection in Vietnam.

  5. Risk factors for secondary transmission of Shigella infection within households: implications for current prevention policy

    Directory of Open Access Journals (Sweden)

    Boveé Lian

    2012-12-01

    Full Text Available Abstract Background Internationally, guidelines to prevent secondary transmission of Shigella infection vary widely. Cases, their contacts with diarrhoea, and those in certain occupational groups are frequently excluded from work, school, or daycare. In the Netherlands, all contacts attending pre-school (age 0–3 and junior classes in primary school (age 4–5, irrespective of symptoms, are also excluded pending microbiological clearance. We identified risk factors for secondary Shigella infection (SSI within households and evaluated infection control policy in this regard. Methods This retrospective cohort study of households where a laboratory confirmed Shigella case was reported in Amsterdam (2002–2009 included all households at high risk for SSI (i.e. any household member under 16 years. Cases were classified as primary, co-primary or SSIs. Using univariable and multivariable binomial regression with clustered robust standard errors to account for household clustering, we examined case and contact factors (Shigella serotype, ethnicity, age, sex, household size, symptoms associated with SSI in contacts within households. Results SSI occurred in 25/ 337 contacts (7.4%: 20% were asymptomatic, 68% were female, and median age was 14 years (IQR: 4–38. In a multivariable model adjusted for case and household factors, only diarrhoea in contacts was associated with SSI (IRR 8.0, 95% CI:2.7-23.8. In a second model, factors predictive of SSI in contacts were the age of case (0–3 years (IRRcase≥6 years:2.5, 95% CI:1.1-5.5 and 4–5 years (IRRcase≥6 years:2.2, 95% CI:1.1-4.3 and household size (>6 persons (IRR2-4 persons 3.4, 95% CI:1.2-9.5. Conclusions To identify symptomatic and asymptomatic SSI, faecal screening should be targeted at all household contacts of preschool cases (0–3 years and cases attending junior class in primary school (4–5 years and any household contact with diarrhoea. If screening was limited to these groups, only

  6. Current problems in communication from the weather forecast in the prevention of hydraulic and hydrogeological risk

    Science.gov (United States)

    Fazzini, Massimiliano; Vaccaro, Carmela

    2014-05-01

    The Italian territory is one of the most fragile hydraulic and hydro geologic of the world, due to its complexity physiographic, lithological and above meteo-climatic too. Moreover, In recent years, the unhappy urbanization, the abandonment of mountain areas and countryside have fostered hydro geological instability, ever more devastating, in relation to the extremes of meteorological events. After the dramatic floods and landscapes of the last 24 months - in which more than 50 people died - it is actually open a public debate on the issues related to prevention, forecasting and management of hydro-meteorological risk. Aim of the correct weather forecasting at different spatial and temporal scales is to avoid or minimize the potential occurrence of damage or human losses resulting from the increasingly of frequent extreme weather events. In Italy, there are two major complex problems that do not allow for effective dissemination of the correct weather forecasting. First, the absence of a national meteorological service - which can ensure the quality of information. In this regard, it is at an advanced stage the establishment of a unified national weather service - formed by technicians to national and regional civil protection and the Meteorological Service of the Air Force, which will ensure the quality of the prediction, especially through exclusive processing of national and local weather forecasting and hydro geological weather alert. At present, however, this lack favors the increasing diffusion of meteorological sites more or less professional - often totally not "ethical" - which, at different spatial scales, tend to amplify the signals from the weather prediction models, describing them the users of the web such as exceptional or rare phenomena and often causing unjustified alarmism. This behavior is almost always aimed at the desire of give a forecast before other sites and therefore looking for new commercial sponsors, with easy profits. On the other hand

  7. Current evidence on risk factors for knee osteoarthritis in older adults: a systematic review and meta-analysis.

    Science.gov (United States)

    Silverwood, V; Blagojevic-Bucknall, M; Jinks, C; Jordan, J L; Protheroe, J; Jordan, K P

    2015-04-01

    Osteoarthritis (OA) is a leading cause of pain and disability and leads to a reduced quality of life. The aim was to determine the current evidence on risk factors for onset of knee pain/OA in those aged 50 and over. A systematic review and meta-analysis was conducted of cohort studies for risk factors for the onset of knee pain. Two authors screened abstracts and papers and completed data extraction. Where possible, pooled odds ratios (OR) were calculated via random effects meta-analysis and population attributable fractions (PAFs) derived. 6554 papers were identified and after screening 46 studies were included. The main factors associated with onset of knee pain were being overweight (pooled OR 1.98, 95% confidence intervals (CI) 1.57-2.20), obesity (pooled OR 2.66 95% CI 2.15-3.28), female gender (pooled OR 1.68, 95% CI 1.37-2.07), previous knee injury (pooled OR 2.83, 95% CI 1.91-4.19). Hand OA (pooled OR 1.30, 95% CI 0.90-1.87) was found to be non-significant. Smoking was found not to be a statistically significant risk or protective factor (pooled OR 0.92, 95% CI 0.83-1.01). PAFs indicated that in patients with new onset of knee pain 5.1% of cases were due to previous knee injury and 24.6% related to being overweight or obese. Clinicians can use the identified risk factors to identify and manage patients at risk of developing or increasing knee pain. Obesity in particular needs to be a major target for prevention of development of knee pain. More research is needed into a number of potential risk factors. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  8. Combining aneuploidy and dysplasia for colitis' cancer risk assessment outperforms current surveillance efficiency: a meta-analysis.

    Science.gov (United States)

    Meyer, Rüdiger; Freitag-Wolf, Sandra; Blindow, Silke; Büning, Jürgen; Habermann, Jens K

    2017-02-01

    Cancer risk assessment for ulcerative colitis patients by evaluating histological changes through colonoscopy surveillance is still challenging. Thus, additional parameters of high prognostic impact for the development of colitis-associated carcinoma are necessary. This meta-analysis was conducted to clarify the value of aneuploidy as predictor for individual cancer risk compared with current surveillance parameters. A systematic web-based search identified studies published in English that addressed the relevance of the ploidy status for individual cancer risk during surveillance in comparison to neoplastic mucosal changes. The resulting data were included into a meta-analysis, and odds ratios (OR) were calculated for aneuploidy or dysplasia or aneuploidy plus dysplasia. Twelve studies addressing the relevance of aneuploidy compared to dyplasia were comprehensively evaluated and further used for meta-analysis. The meta-analysis revealed that aneuploidy (OR 5.31 [95 % CI 2.03, 13.93]) is an equally effective parameter for cancer risk assessment in ulcerative colitis patients as dysplasia (OR 4.93 [1.61, 15.11]). Strikingly, the combined assessment of dysplasia and aneuploidy is superior compared to applying each parameter alone (OR 8.99 [3.08, 26.26]). This meta-analysis reveals that aneuploidy is an equally effective parameter for individual cancer risk assessment in ulcerative colitis as the detection of dysplasia. More important, the combined assessment of dysplasia and aneuploidy outperforms the use of each parameter alone. We suggest image cytometry for ploidy assessment to become an additional feature of consensus criteria to individually assess cancer risk in UC.

  9. Current understanding of the toxicological risk posed to the fetus following maternal exposure to nanoparticles.

    Science.gov (United States)

    Zhang, Yanli; Wu, Junrong; Feng, Xiaoli; Wang, Ruolan; Chen, Aijie; Shao, Longquan

    2017-12-01

    With the broad use of nanotechnology, the number and variety of nanoparticles that humans can be exposed to has further increased. Consequently, there is growing concern about the potential effect of maternal exposure to various nanoparticles during pregnancy on a fetus. However, the nature of this risk is not fully known. Areas covered: In this review, materno-fetal transfer of nanoparticles through the placenta is described. Both prenatal and postnatal adverse effects, such as fetal resorption, malformation and injury to various organs in mice exposed to nanoparticles are reviewed. The potential mechanisms of toxicity are also discussed. Expert opinion: The toxicology and safe application of recently developed nanoparticles has attracted much attention in the past few years. Although many studies have demonstrated the toxicology of nanoparticles in various species, only a small number of studies have examined the effect on a fetus after maternal exposure to nanoparticles. This is particularly important, because the developing fetus is especially vulnerable to the toxic effects of nanoparticles during fetal development due to the unique physical stage of the fetus. Nanoparticles may directly or indirectly impair fetal development and growth after maternal exposure to nanoparticles.

  10. Mobile phone use and possible cancer risk: Current perspectives in India.

    Science.gov (United States)

    Meena, Jitendra Kumar; Verma, Anjana; Kohli, Charu; Ingle, Gopal Krishna

    2016-01-01

    Mobile communication is now essentially ruling our daily lives through better connectivity and intelligent smartphone services. There has been a tremendous growth in Indian communication industry along with growing concerns regarding health effects of mobile radiation exposure. Concerns posed are especially regarding carcinogenesis and other health-related effects of mobile radiation exposure. In the effort to establish or refute any such concerns, many studies have been undertaken in the past three decades, mostly case-control designs or cross-sectional surveys. However, most of them considerably failed to establish causal association primarily owing to potential biases and errors in their conduct and analysis. Past cohort studies have provided contradictory results leading to continued uncertainty regarding tumorigenic potential of mobile radiation exposure. In India, there remains a huge knowledge gap pertaining to this particular topic and only few studies are presently underway such as the Indian Council of Medical Research (ICMR) cell phone study in the National capital region (NCR). International Agency for Research on Cancer (IARC) has classified radiofrequency electromagnetic fields associated with wireless phone use as possibly carcinogenic to humans (Group 2B), causing major concerns worldwide among mobile companies and subscribers equivocally. The World Health Organization (WHO) is presently carrying formal risk assessment of all studied health outcomes from radio frequency field's exposures and is likely to publish it by the year 2016.

  11. Current Biochemical Monitoring and Risk Management of Immunosuppressive Therapy after Transplantation

    Directory of Open Access Journals (Sweden)

    Catić-Đorđević Aleksandra

    2017-01-01

    Full Text Available Immunosuppressive drugs play a crucial role in the inhibition of immune reaction and prevention of graft rejection as well as in the pharmacotherapy of autoimmune disorders. Effective immunosuppression should provide an adequate safety profile and improve treatment outcomes and the patients’ quality of life. High-risk transplant recipients may be identified, but a definitive prediction model has still not been recognized. Therapeutic drug monitoring (TDM for immunosuppressive drugs is an essential, but at the same time insufficient tool due to low predictability of drug exposition and marked pharmacokinetic variability. Parallel therapeutic, biochemical and clinical monitoring may successfully optimize and individualize therapy for transplanted recipients, providing optimal medical outcomes. Modern pharmacotherapy management should include new biomarkers with better sensitivity and specificity that can identify early cell damage. The aim of this study was to point out the importance of finding new biomarkers that would enable early detection of adverse drug events and cell damage in organ transplant recipients. We wanted to confirm the importance of routine biochemical monitoring in improving the safety of immunosuppressive treatment.

  12. Rabies--risk of exposure and current trends in prevention of human cases.

    Science.gov (United States)

    Haupt, W

    1999-03-26

    According to official WHO data more than 2.5 billion people are at risk in over 100 countries reporting the disease. Rabies mortality ranks ten in all infectious diseases worldwide. There are still about 50,000 to 60,000 human deaths annually although effective vaccines for post-exposure treatment are available. Most affected are the tropical countries in Africa, Asia, South America, and Oceania. The mortality figures range from about 0.001 per 100,000 for the US to 18 per 100,000 in Ethiopia. The vast majority (95-98%) of the 60,000 annual human death cases worldwide occur in canine (dog rabies) endemic regions with large stray dog population. Control of the disease is hampered by cultural, social and economic realities. In the rabies infested developing countries modern cell culture vaccines are hardly affordable. Dangerous neural tissue derived vaccines are still used. Three dose-saving treatment schedules have been developed: The reduced dose intramuscular 2-1-1 regimen, the two-site intradermal and the 8-site intradermal regimen. There is a critical shortage of human and purified equine rabies immunoglobulins, which are essential biologicals in the treatment of severe exposures.

  13. Export and import activity of the wine industry: tendencies, current risks

    Directory of Open Access Journals (Sweden)

    Bondarenko Svitlana Anatoliyivna

    2017-06-01

    Full Text Available The article studies state of wine industry’s export-import activity, analyzes tendencies, which provide to reveal peculiar regulations andmain modern risks, which are necessary to be considered for appropriate level of the sector export capability. Export-import activity of wine industry is analyzed; capacity dynamics and market openness degree are estimated. It has been proved that redulatory impact on the winemaking and wine industry development has to be based, on the onehand, on the work with consumer, forming his national awareness of the domestic production from wine industry, and on the other hand, on the country import restructuring. Development of the wine industry state support in Ukraine, considering the world experience, is an important step to form the market of grape and its products, which is characterized with losing tendency. The revealed tendency concerning import price prevail over export, requires special measures for contraction. The main tools to fight with European wine producers for Ukrainian consumer to increase quality, creative, budgets increase for direct access to consumer via winery tasty rooms, tourists’ involvement to vineyards and productive capacities, including to the tourist routes. Therefore the main purpose is necessity for native consumer’s upbringing, wine culture growing, to teach to make considerable choice, but not a choice in favor of foreign container.

  14. Racial/ethnic differences in electronic cigarette knowledge, social norms, and risk perceptions among current and former smokers.

    Science.gov (United States)

    Webb Hooper, Monica; Kolar, Stephanie K

    2017-04-01

    Psychosocial factors that may affect electronic cigarette (e-cigarette) initiation or maintenance among racial/ethnic minorities are not well-understood. This study examined racial/ethnic differences in e-cigarette knowledge, risk perceptions, and social norms among current and former smokers. Individuals with a tobacco smoking history and an awareness of e-cigarettes (N=285) were recruited from the community from June to August 2014. Telephone-administered surveys assessed demographics, smoking status, and e-cigarette knowledge, risk perceptions, and normative beliefs. Analyses of covariance and multinomial logistic regression tested associations by race/ethnicity. Controlling for sociodemographics and smoking status, White participants scored significantly higher on e-cigarette knowledge, compared to both Hispanics and African Americans/Blacks. Knowledge was lower among African Americans/Blacks compared to Hispanics. Compared to both Whites and Hispanics, African American/Black participants held lower perceptions regarding e-cigarette health risks and were less likely to view e-cigarettes as addictive. Normative beliefs did not differ by race/ethnicity. In conclusion, e-cigarette knowledge, health risk perceptions, and perceived addictiveness differed by race/ethnicity. The variation in e-cigarette knowledge and beliefs among smokers and former smokers has implications for use, and potentially, dual use. Understanding these relationships in unrepresented populations can inform future research and practice. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. Sensitivity and evaluation of current fire risk and future projections due to climate change: the case study of Greece

    Science.gov (United States)

    Karali, A.; Hatzaki, M.; Giannakopoulos, C.; Roussos, A.; Xanthopoulos, G.; Tenentes, V.

    2014-01-01

    Current trends in the Mediterranean climate, and more specifically in Greece, indicate longer and more intense summer droughts that even extend out of season. In connection to this, the frequency of forest fire occurrence and intensity is on the rise. In the present study, the Canadian Fire Weather Index (FWI) is used in order to investigate the relationship between fire risk and meteorological conditions in Greece. FWI is a meteorologically based index designed in Canada and used worldwide, including the Mediterranean Basin, to estimate fire danger in a generalised fuel type based solely on weather observations. Here, an evaluation of the index is initially performed for the Greek territory using fire observations that cover a 15 yr period. Three critical fire risk threshold values are established for the area of Greece based on daily mean meteorological data: FWI = 15, FWI = 30 and FWI = 45, increasing from the northwest to the southeast. Subsequently, a regional climate model is employed providing input for the FWI system to investigate the impacts of climate change on fire risk for two future time periods, 2021-2050 and 2071-2100, under the A1B emissions scenario. Days with critical fire risk are expected to increase by as many as 50 days per year by the end of the century.

  16. How artificial intelligence tools can be used to assess individual patient risk in cardiovascular disease: problems with the current methods

    Directory of Open Access Journals (Sweden)

    Grossi Enzo

    2006-05-01

    Full Text Available Abstract Background In recent years a number of algorithms for cardiovascular risk assessment has been proposed to the medical community. These algorithms consider a number of variables and express their results as the percentage risk of developing a major fatal or non-fatal cardiovascular event in the following 10 to 20 years Discussion The author has identified three major pitfalls of these algorithms, linked to the limitation of the classical statistical approach in dealing with this kind of non linear and complex information. The pitfalls are the inability to capture the disease complexity, the inability to capture process dynamics, and the wide confidence interval of individual risk assessment. Artificial Intelligence tools can provide potential advantage in trying to overcome these limitations. The theoretical background and some application examples related to artificial neural networks and fuzzy logic have been reviewed and discussed. Summary The use of predictive algorithms to assess individual absolute risk of cardiovascular future events is currently hampered by methodological and mathematical flaws. The use of newer approaches, such as fuzzy logic and artificial neural networks, linked to artificial intelligence, seems to better address both the challenge of increasing complexity resulting from a correlation between predisposing factors, data on the occurrence of cardiovascular events, and the prediction of future events on an individual level.

  17. 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.

  18. [Restenosis of carotid arteries after carotid endarterectomy: current aspects of the problem: (local and systemic risk factors). Part 1].

    Science.gov (United States)

    Losev, R Z; Kulikova, A N; Bakhmet'ev, A S

    2012-01-01

    Carotid endarterectomy is currently the most effective surgical means of preventing ischaemic stroke. Despite the fact that this type of intervention is widely used, there seems to be no tendency toward decreased incidence of such a complication as restenosis of carotid arteries.The present review deals with the results of analyzing the literature on the problem concerning carotid artery restenosis after carotid endarterectomy. Considered herein are the problems of epidemiology and prevalence of the complication involved. Special attention is paid to local and systemic risk factors for the development of restenosis. Studying risk factors of restenosis after carotid endarterectomy is of considerable importance for both prevention and choice of pathogenetically targeted treatment of patients presenting with atherosclerotic lesions of brachiocephalic vessels.

  19. The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods

    Directory of Open Access Journals (Sweden)

    Bernabe Rosemarie D L C

    2012-04-01

    Full Text Available Abstract Background Research ethics committees (RECs are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis. Discussion By looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision. Conclusion As such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task.

  20. Major depressive disorder and current psychological distress moderate the effect of polygenic risk for obesity on body mass index.

    Science.gov (United States)

    Clarke, T-K; Hall, L S; Fernandez-Pujals, A M; MacIntyre, D J; Thomson, P; Hayward, C; Smith, B H; Padmanabhan, S; Hocking, L J; Deary, I J; Porteous, D J; McIntosh, A M

    2015-06-30

    Major depressive disorder (MDD) and obesity are frequently co-morbid and this correlation is partly due to genetic factors. Although specific genetic risk variants are associated with body mass index (BMI) and with larger effect sizes in depressed individuals, the genetic overlap and interaction with depression has not been addressed using whole-genome data. Polygenic profile scores for MDD and BMI were created in 13,921 members of Generation Scotland: the Scottish Family Health Study and tested for their association with BMI, MDD, neuroticism and scores on the General Health Questionnaire (GHQ) (current psychological distress). The association between BMI polygenic profile scores and BMI was tested fitting GHQ, neuroticism or MDD status as an interaction term to test for a moderating effect of mood disorder. BMI polygenic profile scores were not associated with lifetime MDD status or neuroticism although a significant positive association with GHQ scores was found (P = 0.0001, β = 0.034, r(2) = 0.001). Polygenic risk for MDD was not associated with BMI. A significant interaction between BMI polygenic profile scores and MDD (P = 0.0003, β = 0.064), GHQ (P = 0.0005, β = 0.027) and neuroticism (P = 0.003, β = 0.023) was found when BMI was the dependent variable. The effect of BMI-increasing alleles was greater in those with MDD, high neuroticism or current psychological distress. MDD, neuroticism and current psychological distress amplify the effect of BMI polygenic profile scores on BMI. Depressed individuals with a greater polygenic load for obesity are at greater risk of becoming obese than control individuals.

  1. Type 2 diabetes as a risk factor for cognitive impairment: current insights

    Directory of Open Access Journals (Sweden)

    Umegaki H

    2014-06-01

    Full Text Available Hiroyuki Umegaki Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan Abstract: Type 2 diabetes mellitus (T2DM is a risk factor for cognitive dysfunction and dementia in the elderly. T2DM has been thought to be associated with vascular diseases, eventually leading to vascular dementia, but recent studies have established that T2DM is also associated with Alzheimer’s disease (AD. With the increase in the number of elderly individuals with T2DM, the number of diabetic patients with cognitive dysfunction has been increasing. T2DM may accelerate AD-associated pathologies through insulin resistance. Vascular pathologies may also be associated with cognitive dysfunction and dementia in T2DM subjects. Several other mechanisms also seem to be involved in T2DM-related cognitive dysfunction. More investigations to clarify the association of T2DM with cognitive impairment are warranted. These investigations may help to increase our understanding of AD and open a new door to the development of therapeutics. Recent pharmaceutical advancement in T2DM treatment has resulted in the availability of a wide range of antidiabetics. Some evidence has suggested that antidiabetic therapies help to prevent cognitive dysfunction. At present, however, the optimal level of blood glucose control and the best combination of medications to achieve it in terms of cognitive preservation have not been established. More investigation is warranted. Cognitive dysfunction is an emerging new complication of T2DM that requires further study. Keywords: insulin resistance, dementia, blood glucose, amyloid ß, tau, small vascular disease

  2. Risks of ocean acidification in the California Current food web and fisheries: ecosystem model projections.

    Science.gov (United States)

    Marshall, Kristin N; Kaplan, Isaac C; Hodgson, Emma E; Hermann, Albert; Busch, D Shallin; McElhany, Paul; Essington, Timothy E; Harvey, Chris J; Fulton, Elizabeth A

    2017-04-01

    The benefits and ecosystem services that humans derive from the oceans are threatened by numerous global change stressors, one of which is ocean acidification. Here, we describe the effects of ocean acidification on an upwelling system that already experiences inherently low pH conditions, the California Current. We used an end-to-end ecosystem model (Atlantis), forced by downscaled global climate models and informed by a meta-analysis of the pH sensitivities of local taxa, to investigate the direct and indirect effects of future pH on biomass and fisheries revenues. Our model projects a 0.2-unit drop in pH during the summer upwelling season from 2013 to 2063, which results in wide-ranging magnitudes of effects across guilds and functional groups. The most dramatic direct effects of future pH may be expected on epibenthic invertebrates (crabs, shrimps, benthic grazers, benthic detritivores, bivalves), and strong indirect effects expected on some demersal fish, sharks, and epibenthic invertebrates (Dungeness crab) because they consume species known to be sensitive to changing pH. The model's pelagic community, including marine mammals and seabirds, was much less influenced by future pH. Some functional groups were less affected to changing pH in the model than might be expected from experimental studies in the empirical literature due to high population productivity (e.g., copepods, pteropods). Model results suggest strong effects of reduced pH on nearshore state-managed invertebrate fisheries, but modest effects on the groundfish fishery because individual groundfish species exhibited diverse responses to changing pH. Our results provide a set of projections that generally support and build upon previous findings and set the stage for hypotheses to guide future modeling and experimental analysis on the effects of OA on marine ecosystems and fisheries. © 2017 John Wiley & Sons Ltd.

  3. Current perspectives on neonatal hypoglycemia, its management, and cerebral injury risk

    Directory of Open Access Journals (Sweden)

    Chandran S

    2015-02-01

    Full Text Available Suresh Chandran,1–4 Victor Samuel Rajadurai,1–3 Abdul Alim Abdul Haium,1–3 Khalid Hussain5,6 1Department of Neonatology, KK Women’s and Children’s Hospital, Singapore; 2Duke-NUS Graduate School of Medicine, Singapore; 3Yong Loo Lin School of Medicine, National University of Singapore, Singapore; 4Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore; 5Department of Paediatric Endocrinology, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, 6The Institute of Child Health, University College London, London, UK Abstract: Glucose is an essential substrate for mammalian cells; in particular, the brain needs glucose continuously as a primary source of energy. Hypoglycemia is the most common biochemical finding in the neonatal period. However, despite the common occurrence, there is still controversy on the definition of hypoglycemia in the newborn period. This has led to the development of guidelines designed to identify infants “at-risk” and the implementation of an “operational threshold” for physicians to consider intervention. In healthy term infants, the optimal hormonal and metabolic adaptations during the immediate neonatal period ensure an adequate energy substrate for the vital organs, whereas the abnormal glucose homeostasis observed in preterm and growth-retarded infants is multifactorial in origin. For these high-risk infants, it is important to identify, screen, and prevent significant hypoglycemia. Detailed investigations are warranted in infants with severe and persistent hypoglycemia. Neonatal hypoglycemia is a major cause of brain injury. The speculated mechanisms of cellular injury include excitatory neurotoxins active at N-methyl-D-aspartate receptors, increased mitochondrial free radical generation with initiation of apoptosis and altered cerebral energetic characteristics. This hypoglycemic brain injury predominantly affects parieto-occipital regions causing

  4. Economic evaluation of universal prenatal HIV screening compared with current 'at risk' policy in a very low prevalence country.

    Science.gov (United States)

    Chowers, Michal; Shavit, Oren

    2017-03-01

    Our objective was to economically evaluate universal HIV prenatal screening in Israel, a very low prevalence country (0.1%), compared with the current policy of testing only women belonging to high-risk (HR) groups. A cost-effectiveness analytical model was constructed. Life expectancies, direct medical costs and utility weights of an HIV-positive newborn and a healthy newborn were derived from the literature. Screening was assessed using fourth-generation combo tests. Structural uncertainties were discussed with leading Israeli HIV experts. Univariate and multivariate sensitivity analyses were conducted to account for uncertainty of the model's parameters. Under the current policy, about 2700 women are tested annually identifying 27 HIV-positive women. With the universal screening, 171 000 women would be tested yearly identifying 37 as HIV positive. The analysis included the increased life expectancy of vertically infected children based on current standards of care. Over the lifetime expectancy, universal screening is projected to grant 15 additional quality-adjusted life years and save $177 521 when compared with the current HR only policy. Universal prenatal HIV screening is projected to be cost saving in Israel, despite a very low HIV prevalence in the general population. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  5. Regulação de Riscos e Proteção de Infraestruturas Críticas: os novos ventos do fenômeno regulatório / Risk Regulation and Critical Infrastructure Protection: The New Winds of the Regulatory Phenomenon

    Directory of Open Access Journals (Sweden)

    Egon C. Guterres

    2016-05-01

    Full Text Available Purpose – This article analyzes the origins of the Risk Regulation Theory and Critical Infrastructure Protection Programs, and shows their contribution to the Brazilian regulatory experience. Methodology/approach/design – Through several examples, this study presents regulatory policies that emerged as responses to events that caused a significant impact on society. Findings – The unique way that the Critical Infrastructure Protection Programs evolved within the Brazilian regulatory experience is greatly attributable to demands of major international sporting events.

  6. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

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

  7. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

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

  8. TU-EF-204-09: A Preliminary Method of Risk-Informed Optimization of Tube Current Modulation for Dose Reduction in CT

    Energy Technology Data Exchange (ETDEWEB)

    Gao, Y; Liu, B; Kalra, M; Caracappa, P [Rensselaer Polytechnic Institute, Troy, NY (United States); Liu, T; Li, X [Massachusetts General Hospital, Boston, MA (United States); Xu, X [Rensselaer Polytechnic Inst., Troy, NY (United States)

    2015-06-15

    Purpose: X-rays from CT scans can increase cancer risk to patients. Lifetime Attributable Risk of Cancer Incidence for adult patients has been investigated and shown to decrease as patient age. However, a new risk model shows an increasing risk trend for several radiosensitive organs for middle age patients. This study investigates the feasibility of a general method for optimizing tube current modulation (TCM) functions to minimize risk by reducing radiation dose to radiosensitive organs of patients. Methods: Organ-based TCM has been investigated in literature for eye lens dose and breast dose. Adopting the concept in organ-based TCM, this study seeks to find an optimized tube current for minimal total risk to breasts and lungs by reducing dose to these organs. The contributions of each CT view to organ dose are determined through simulations of CT scan view-by-view using a GPU-based fast Monte Carlo code, ARCHER. A Linear Programming problem is established for tube current optimization, with Monte Carlo results as weighting factors at each view. A pre-determined dose is used as upper dose boundary, and tube current of each view is optimized to minimize the total risk. Results: An optimized tube current is found to minimize the total risk of lungs and breasts: compared to fixed current, the risk is reduced by 13%, with breast dose reduced by 38% and lung dose reduced by 7%. The average tube current is maintained during optimization to maintain image quality. In addition, dose to other organs in chest region is slightly affected, with relative change in dose smaller than 10%. Conclusion: Optimized tube current plans can be generated to minimize cancer risk to lungs and breasts while maintaining image quality. In the future, various risk models and greater number of projections per rotation will be simulated on phantoms of different gender and age. National Institutes of Health R01EB015478.

  9. Critical study of current situation of Vrănicioara tailing pond on Cavnicului Valley, risks and consequences

    Science.gov (United States)

    Bud, I.; Duma, S.; Gusat, D.; Pasca, I.; Bud, A.

    2017-05-01

    In northern Romania, there are numerous tailing ponds, resulting from mining activities that present significant environmental risks. Some of them, including Vrănicioara tailing pond, were the subject of technical projects for ecological rehabilitation. Vrănicioara pond is located on the right side of Cavnic Valley, downstream Cavnic town, about 4 kilometers far. It has about 500 m length and is located parallel to the road linking Baia Sprie and Cavnic localities. Chemical and physical stability of the tailing pond before rehabilitation interest the research, analysis and conclusions were published in several scientific meetings. In addition, close to the pond at less than 100 m, an open pit has developed, exploiting andesite by mining blast, increasing the risk of physical stability by continuous exposure to vibration. This activity currently continues, advancing towards the tailing pond body. The critical study addresses the current state of Vrănicioara Tailing Pond, analysis of some rehabilitation works done incorrectly, analysis of chemical stability that was not a priority during rehabilitation. Research intention is heading to water analysis confirming the existence of acid drainage that was not stopped or at least reduced. The scientific approach is based on the Technical Standards for Waste Deposits, in force in Romania, providing the rules to ensure physical and chemical stability.

  10. [Current status and associated risk factors of child abuse on children aged 7-12 in rural areas of Ningxia].

    Science.gov (United States)

    Chang, Ling; Dong, Min; Yu, Rongbin; Sun, Chao; Zeng, Lingxia

    2014-08-01

    To describe the current status and associated risk factors on child abuse in children aged 7-12 in rural areas of Ningxia. Using multistage sampling method to select townships and villages. Children aged 7-12 and their guardians were selected by random sampling method in those villages. Current status on child abuse was described under related percentage while logistic regression model was used to evaluate the risk factors associated with child abuse. A total number of 704 children aged 7-12 from 15 villages in two counties were interviewed. Among them, 359 (50.2%) children had experienced child abuse (include physical abuse, negligence, emotional/physical abuse and sexual abuse) in the past year. Physical abuse (44.6%) was the most frequent one in all the child abuse cases. Only 10 (1.4%) children had a comprehensive understanding of 'child abuse'. 55.5% of the children had ever reported this problem to their parents or teachers when suffered from abuse episodes. Results from the logistic regression model showed that factors as: being boys (OR = 1.37, 95% CI: 1.01-1.85), under Han nationality (OR = 1.49, 95% CI: 1.06-2.08), at younger age (OR = 1.16, 95% CI: 1.05-1.28), staying with single parent (OR = 2.05, 95% CI: 1.16-3.64) and from wealthy family (OR = 1.55, 95% CI: 1.03-2.33) were at risk for child abuse. Child abuse in rural areas in Ningxia was a serious problem, Children's cognitive to child abuse was very low. More attention should be paid to children with the following characteristics as: being boys, under Han nationality, at younger age, staying with single parent.

  11. Decomposing P300 into correlates of genetic risk and current symptoms in schizophrenia: An inter-trial variability analysis.

    Science.gov (United States)

    Kim, Minah; Lee, Tak Hyung; Kim, Ji-Hun; Hong, Hanwoom; Lee, Tae Young; Lee, Youngjo; Salisbury, Dean F; Kwon, Jun Soo

    2017-04-08

    The P300 event-related potential (ERP) component, which reflects cognitive processing, is a candidate biomarker for schizophrenia. However, the role of P300 in the pathophysiology of schizophrenia remains unclear because averaged P300 amplitudes reflect both genetic predisposition and current clinical status. Thus, we sought to identify which aspects of P300 are associated with genetic risk versus symptomatic status via an inter-trial variability analysis. Auditory P300, clinical symptoms, and neurocognitive function assessments were obtained from forty-five patients with schizophrenia, thirty-two subjects at genetic high risk (GHR), thirty-two subjects at clinical high risk (CHR), and fifty-two healthy control (HC) participants. Both conventional averaging and inter-trial variability analyses were conducted for P300, and results were compared across groups using analysis of variance (ANOVA). Pearson's correlation was utilized to determine associations among inter-trial variability for P300, current symptoms and neurocognitive status. Average P300 amplitude was reduced in the GHR, CHR, and schizophrenia groups compared with that in the HC group. P300 inter-trial variability was elevated in the CHR and schizophrenia groups but relatively normal in the GHR and HC groups. Furthermore, P300 inter-trial variability was significantly related to negative symptom severity and neurocognitive performance results in schizophrenia patients. These results suggest that P300 amplitude is an endophenotype for schizophrenia and that greater inter-trial variability of P300 is associated with more severe negative and cognitive symptoms in schizophrenia patients. Copyright © 2016. Published by Elsevier B.V.

  12. Prevalence of insulin resistance and risk of diabetes mellitus in HIV-infected patients receiving current antiretroviral drugs.

    Science.gov (United States)

    Araujo, Susana; Bañón, Sara; Machuca, Isabel; Moreno, Ana; Pérez-Elías, María J; Casado, José L

    2014-11-01

    HIV-infected patients had a higher prevalence of insulin resistance (IR) and risk of diabetes mellitus (DM) than that observed in healthy controls, but there are no data about the current prevalence considering the changes in HIV presentation and the use of newer antiretroviral drugs. Longitudinal study which involved 265 HIV patients without DM, receiving first (n=71) and advanced lines of antiretroviral therapy (n=194). Prevalence of IR according to clinical and anthropometric variables, including dual X-ray absorptiometry (DXA) scan evaluation. IR was defined as homeostasis model assessment of IR≥3.8. Incident DM was assessed during the follow-up. First-line patients had a short time of HIV infection, less hepatitis C virus coinfection, and received mainly an efavirenz-based regimen. Overall, the prevalence of IR was 21% (55 patients, 6% in first-line, 27% in pretreated). In a logistic regression analysis, significant associations were found between the waist/hip circumference ratio (RR 10; 95% CI 1.66-16; P<0.01, per unit), and central fat in percentage (RR 1.08; 95% CI 1.01-1.17; P=0.04, per unit) as evaluated by DXA, and IR. During 770.8 patient-years, DM was diagnosed in 8% (22 patients), mostly in pretreated patients (10 vs 4%; P=0.1). Thus, the overall rate of incident DM was 2.85 per 100 person-years, mostly in previous IR (10.39 vs 0.82/100 person-years; P=0.01). A lower prevalence of IR is observed in the current HIV-infected patients with fewer risk factors and receiving newer antiretroviral drugs. IR continues to identify patients at high risk for developing DM in the short term. © 2014 European Society of Endocrinology.

  13. National Strategy for Modernizing the Regulatory System for Biotechnology Products

    Science.gov (United States)

    This National Strategy for Modernizing the Regulatory System for Biotechnology Products sets forth a vision for ensuring that the federal regulatory system is prepared to efficiently assess the risks, if any, of the future products of biotechnology.

  14. FDA's expanding postmarket authority to monitor and publicize food and consumer health product risks: the need for procedural safeguards to reduce "transparency" policy harms in the post-9/11 regulatory environment.

    Science.gov (United States)

    Roller, Sarah Taylor; Pippins, Raqiyyah R; Ngai, Jennifer W

    2009-01-01

    This article provides a summary of the expansion of FDA's discretionary authority in the post-9/11 period, particularly with respect to FDA's authority to monitor and publicize potential health risks linked to food, dietary supplements, nonprescription drugs, and other consumer health products. In addition, this article evaluates the need for FDA to establish procedural safeguards to reduce the significant risks of unintended and undue harm to people and regulated companies that can result from adverse publicity in the more "transparent" post 9/11 FDA regulatory environment. Specifically, Part I summarizes the amendments to the FDCA enacted during the post-9/11 period that have expanded FDA's postmarket authority to monitor, evaluate, and publicize potential health risks linked to food, dietary supplements, nonprescription drugs and other consumer health products marketed in the United States, in conjunction with FDA's Sentinel Initiative, Reportable Food Registry, and other adverse event reporting requirements. Part II discusses the convergence of FDA's expanded postmarket authority to publicize product-related risks with President Obama's transparency initiative aimed at fostering "open government" through increased public access to government information. In addition, Part II considers the nature of the procedural safeguards needed in the post-9/11 FDA regulatory environment, in view of FDA's historical record and illustrative cases that help expose how adverse "transparency" surrounding FDA warning letters, recalls and safety alerts concerning products in the marketplace can have undue and unintended prejudicial and harmful effects for the people and companies that are legally responsible for such products. Finally, based on these analysis, this article concludes with some observations concerning the nature of the procedural safeguards needed to reduce the significant risks of "transparency" policy harms in the pos-9/11 regulatory environment.

  15. 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......-reactive T cells that recognize such targets may be activated due to the strong activation signal given by their cognate targets. The current review describes the existing knowledge regarding these self-reactive anti-Tregs, providing examples of antigen-specific anti-Tregs and discussing their possible roles...

  16. Current smoking is an independent risk factor for new-onset diabetes mellitus during highdose glucocorticoid treatment.

    Science.gov (United States)

    Sugiyama, Takao; Sugimoto, Toyohiko; Suzuki, Sawako; Sato, Yuta; Tanaka, Tomoaki; Tatsuno, Ichiro

    2015-08-01

    Although high-dose glucocorticoids have been reported to cause new-onset diabetes mellitus (glucocorticoid-induced diabetes mellitus), its risk factors have remained to be determined. We investigated the risk factors related to glucocorticoid-induced diabetes mellitus diagnosed within 2 months after the high-dose treatment (newly treated with an initial high dose of > 20 mg prednisolone (PSL) equivalent per day for at least more than 6 months) in collagen vascular diseases. A total of 2,631 patients with collagen vascular diseases was registered between 1986 and 2006 in the Chiba-Shimoshizu Rheumatic Cohort. We analyzed 681 patients newly treated with high-dose glucocorticoid who did not have diabetes mellitus and/or its previous diagnosis (age: 46.3 ± 16.7 years, PSL dose: 40.0 ± 14.1 mg/day). Glucocorticoid-induced diabetes mellitus was diagnosed by two or more glucose measurements in patients with fasting glycaemia ≥ 7 mmol/L and 120 minutes post-load glycaemia ≥ 11.1 mmol/L. Glucocorticoid-induced diabetes mellitus was observed in 26.3% of patients, and the glucocorticoid-induced diabetes mellitus group had higher age, higher BMI, lower rates of females and systemic lupus erythematosus, higher rates of smoking, alcohol use, and microscopic polyangiitis. Multivariate logistic regression analysis demonstrated that the risk of glucocorticoid-induced diabetes mellitus was independently higher in every 10-year increment of initial age with adjusted odds ratio (OR) 1.556 (95% confidence interval: 1.359 - 1.783), in every 1 kg/m2 increment of BMI with OR 1.062 (1.002 - 1.124), in current smoking with OR 1.664 (1.057 - 2.622), and in every 10 mg increment of initial dose of prednisolone with OR 1.250 (1.074 - 1.454). High-dose glucocorticoids caused diabetes mellitus with high prevalence within a short period, and current smokers should be considered at higher risk of glucocorticoidinduced diabetes mellitus in addition to age, BMI, and initial dose.

  17. Regulatory aspects on nanomedicines.

    Science.gov (United States)

    Sainz, Vanessa; Conniot, João; Matos, Ana I; Peres, Carina; Zupancic, Eva; Moura, Liane; Silva, Liana C; Florindo, Helena F; Gaspar, Rogério S

    2015-12-18

    Nanomedicines have been in the forefront of pharmaceutical research in the last decades, creating new challenges for research community, industry, and regulators. There is a strong demand for the fast development of scientific and technological tools to address unmet medical needs, thus improving human health care and life quality. Tremendous advances in the biomaterials and nanotechnology fields have prompted their use as promising tools to overcome important drawbacks, mostly associated to the non-specific effects of conventional therapeutic approaches. However, the wide range of application of nanomedicines demands a profound knowledge and characterization of these complex products. Their properties need to be extensively understood to avoid unpredicted effects on patients, such as potential immune reactivity. Research policy and alliances have been bringing together scientists, regulators, industry, and, more frequently in recent years, patient representatives and patient advocacy institutions. In order to successfully enhance the development of new technologies, improved strategies for research-based corporate organizations, more integrated research tools dealing with appropriate translational requirements aiming at clinical development, and proactive regulatory policies are essential in the near future. This review focuses on the most important aspects currently recognized as key factors for the regulation of nanomedicines, discussing the efforts under development by industry and regulatory agencies to promote their translation into the market. Regulatory Science aspects driving a faster and safer development of nanomedicines will be a central issue for the next years. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Does high level youth sports participation increase the risk of femoroacetabular impingement? A review of the current literature.

    Science.gov (United States)

    de Silva, Viran; Swain, Michael; Broderick, Carolyn; McKay, Damien

    2016-03-11

    Sports participation can be an integral part of adolescent development with numerous positive short and long-term effects. Despite these potential benefits very high levels of physical activity, during skeletal maturation, have been proposed as a possible cause of cam-type femoroacetabular impingement (FAI). The influence of physical activity on the developing physis has been previously described both in animal studies and epidemiological studies of adolescent athletes. It is therefore important to determine whether the development of FAI is secondary to excessive physical activity or a combination of a vulnerable physis and a set level of physical activity. A review of the current literature suggests that adolescent males participating in ice-hockey, basketball and soccer, training at least three times a week, are at greater risk than their non-athletic counterparts of developing the femoral head-neck deformity associated with femoroacetabular impingement.

  19. RFID in healthcare environment: electromagnetic compatibility regulatory issues.

    Science.gov (United States)

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

    2010-01-01

    Several wireless technology applications (RFID, WiFi, GSM, GPRS) have been developed to improve patient care, reaching a significant success and diffusion in healthcare. Given the potential development of such a technology, care must be paid on the potential risks deriving from the use of wireless device in healthcare, among which one of the most important is the electromagnetic interference with medical devices. The analysis of the regulatory issues concerning the electromagnetic compatibility of medical devices is essential to evaluate if and how the application of the current standards allows an effective control of the possible risks associated to the electromagnetic interference on medical devices.

  20. Risk factors and current recommendations for prevention of infections associated with central venous catheters: a literature review

    Directory of Open Access Journals (Sweden)

    Danielle de Mendonça Henrique

    2013-10-01

    Full Text Available Backgound and Objectives: Infections related to central venous catheter (CVC use constitute an important a problem. It is estimated that approximately 90% of bloodstream infections (BSI are caused by CVC use. This study aims at reviewing the risk factors and current recommendations for prevention of infections associated with central venous catheter use. Methods: A total of 12 articles published in the last 5 years and indexed in the databases of the Latin American and Caribbean Literature on Health Sciences (LILACS, Nursing Database (BDENF, International Literature on Health Sciences (Medline/Pubmed were selected, as well as publications related to the recommendations for BSI prevention, such as: Institute for Healthcare Improvement (IHI, Centers for Disease Control and Prevention (CDC and the National Health Surveillance Agency (ANVISA. Results: Two categories were identified: prevention and control measures and risk factors for BSI associated with central venous catheter use. Conclusions: Some recommendations that were well-defined over the years have been questioned by some authors and continuing training and education of the multidisciplinary team are the most important factors for the prevention of bloodstream infections associated with CVC use.

  1. Social life and sanitary risks: evolutionary and current ecological conditions determine waste management in leaf-cutting ants.

    Science.gov (United States)

    Farji-Brener, Alejandro G; Elizalde, Luciana; Fernández-Marín, Hermógenes; Amador-Vargas, Sabrina

    2016-05-25

    Adequate waste management is vital for the success of social life, because waste accumulation increases sanitary risks in dense societies. We explored why different leaf-cutting ants (LCA) species locate their waste in internal nest chambers or external piles, including ecological context and accounting for phylogenetic relations. We propose that waste location depends on whether the environmental conditions enhance or reduce the risk of infection. We obtained the geographical range, habitat and refuse location of LCA from published literature, and experimentally determined whether pathogens on ant waste survived to the high soil temperatures typical of xeric habitats. The habitat of the LCA determined waste location after phylogenetic correction: species with external waste piles mainly occur in xeric environments, whereas those with internal waste chambers mainly inhabit more humid habitats. The ancestral reconstruction suggests that dumping waste externally is less derived than digging waste nest chambers. Empirical results showed that high soil surface temperatures reduce pathogen prevalence from LCA waste. We proposed that LCA living in environments unfavourable for pathogens (i.e. xeric habitats) avoid digging costs by dumping the refuse above ground. Conversely, in environments suitable for pathogens, LCA species prevent the spread of diseases by storing waste underground, presumably, a behaviour that contributed to the colonization of humid habitats. These results highlight the adaptation of organisms to the hygienic challenges of social living, and illustrate how sanitary behaviours can result from a combination of evolutionary history and current environmental conditions. © 2016 The Author(s).

  2. Intestinal parasitic infections: Current prevalence and risk factors among schoolchildren in capital area of the Republic of Marshall Islands.

    Science.gov (United States)

    Liao, Chien-Wei; Chuang, Ting-Wu; Huang, Ying-Chieh; Chou, Chia-Mei; Chiang, Chia-Lien; Lee, Fei-Peng; Hsu, Yun-Ting; Lin, Jia-Wei; Briand, Kennar; Tu, Chia-Ying; Fan, Chia-Kwung

    2017-12-01

    Intestinal parasitic infections (IPIs) among schoolchildren in Republic of Marshall Islands (RMI) largely remains unknown, thus investigation on IPIs status to establish the baseline data is urgently needed. This cross-sectional study intended to investigate the current IPIs status and associated risk factors among schoolchildren at capital of RMI. Single stool sample from 400 schoolchildren (207 boys and 193 girls) aged 9.73±2.50 yrs old was examined by employing merthiolate-iodine-formaldehyde concentration method. Demographic characteristics, uncomfortable symptoms and risk factors were obtained by questionnaires investigation. The overall prevalence of IPIs in schoolchildren was 22.8% (91/400), of them 24.2% harbored at least 2 different parasites. Notably, the majority was infected by waterborne protozoan parasites (82.4%, 75/91). Nine different intestinal parasites have been identified, of which six were pathogenic including Hook worm, Trichuris trichiura, Enterobius vermicularis, Entamoeba histolytica/dispar, Giardia intestinalis and Blastocystis hominis. Schoolchildren who ever complained dizziness or headache showed a significant higher prevalence of pathogenic IPIs than those who did not (prisk factors were identified to be associated with pathogenic IPIs. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Performance of Current Thromboembolism Risk Assessment Tools in Patients With Gastric Cancer and Validity After First Treatment.

    Science.gov (United States)

    Fuentes, Harry E; Paz, L H; Wang, Y; Oramas, D M; Simons, C R; Tafur, A J

    2017-01-01

    Patients with gastric cancer (GC) are at higher risk of thromboembolism when compared to other solid tumors. We aim to determine the predictive performance of current venous thromboembolism (VTE) predictive tools and their variability and validity after first treatment. Single institution cohort of GC-treated patients (2010*15). We abstracted predictive tools, validated for VTE prediction in patient with cancer; including the Khorana Score (KRS), platelet to lymphocyte ratio (PLR), and neutrophil to lymphocyte ratio (NLR). The primary outcome was CAT prediction. We included 112 patients who were predominantly men (66%), 58 (51-64)-year-olds, with adenocarcinoma (84%) and advanced disease (59%). The median follow-up was 21.3 months (9.5-42.6). The VTE occurrence was 12%. The median time from diagnosis to VTE occurrence was 59 days (36-258). In our cohort, performance status (PS; hazard ratio [HR], 8.02; 95% confidence interval [CI], 2.37-27.14; P tool to identify patients with GC at high risk of VTE after first cancer treatment.

  4. Social life and sanitary risks: evolutionary and current ecological conditions determine waste management in leaf-cutting ants

    Science.gov (United States)

    Farji-Brener, Alejandro G.; Elizalde, Luciana; Amador-Vargas, Sabrina

    2016-01-01

    Adequate waste management is vital for the success of social life, because waste accumulation increases sanitary risks in dense societies. We explored why different leaf-cutting ants (LCA) species locate their waste in internal nest chambers or external piles, including ecological context and accounting for phylogenetic relations. We propose that waste location depends on whether the environmental conditions enhance or reduce the risk of infection. We obtained the geographical range, habitat and refuse location of LCA from published literature, and experimentally determined whether pathogens on ant waste survived to the high soil temperatures typical of xeric habitats. The habitat of the LCA determined waste location after phylogenetic correction: species with external waste piles mainly occur in xeric environments, whereas those with internal waste chambers mainly inhabit more humid habitats. The ancestral reconstruction suggests that dumping waste externally is less derived than digging waste nest chambers. Empirical results showed that high soil surface temperatures reduce pathogen prevalence from LCA waste. We proposed that LCA living in environments unfavourable for pathogens (i.e. xeric habitats) avoid digging costs by dumping the refuse above ground. Conversely, in environments suitable for pathogens, LCA species prevent the spread of diseases by storing waste underground, presumably, a behaviour that contributed to the colonization of humid habitats. These results highlight the adaptation of organisms to the hygienic challenges of social living, and illustrate how sanitary behaviours can result from a combination of evolutionary history and current environmental conditions. PMID:27226469

  5. 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

  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. Elevated resting heart rate is associated with greater risk of cardiovascular and all-cause mortality in current and former smokers

    DEFF Research Database (Denmark)

    Jensen, Magnus T; Marott, Jacob L; Jensen, Gorm B

    2010-01-01

    . Current and former smokers had, irrespective of tobacco consumption, greater relative risk of elevated RHR compared to never smokers. The relative risk of all-cause mortality per 10bpm increase in RHR was (95% CI): 1.06 (1.01-1.10) in never smokers, 1.11 (1.07-1.15) in former smokers, 1.13 (1...

  8. Taxi Regulatory Revision in Portland, Oregon : A Case Study

    Science.gov (United States)

    1982-09-01

    Interest in taxi regulatory revision stems from the taxicab's potential to complement or to be an alternative to conventional fixed-route transit. Taxi regulatory revision in Portland, Oregon, and other cities reflects the current awareness to reduce...

  9. Regulatory transparency: social, technical, and ethical aspects of clinical trial data access.

    Science.gov (United States)

    Sousa, Varley Dias; Silveira, Dâmaris

    2015-06-01

    In the field of health regulation, enabling public access to data from clinical trials is a process currently undergoing consolidation by the principal regulators worldwide. This paper discusses recent developments in public policy regarding regulatory transparency, and the risks and benefits of a regulatory impact-analysis on clinical trial reports, from the perspective of the key stakeholders (i.e., patients, prescribers, government, society, industry, and regulators). Additionally, the social, technical, and ethical aspects of the datasharing process are highlighted, including access limits, commercially-confidential data and patent rights, privacy of research subjects, arrangements and publicity tools, and clinical trials registration. Furthermore, perspectives on improvement and expansion of regulatory transparency policies are presented, contextualizing North American, Latin American, and European experiences, and highlighting in-teragency cooperation and collaboration initiatives that aim to harmonize health programs and regulatory convergence.

  10. Are Metals Emitted from Electronic Cigarettes a Reason for Health Concern? A Risk-Assessment Analysis of Currently Available Literature

    Directory of Open Access Journals (Sweden)

    Konstantinos E. Farsalinos

    2015-05-01

    Full Text Available Background: Studies have found that metals are emitted to the electronic cigarette (EC aerosol. However, the potential health impact of exposure to such metals has not been adequately defined. The purpose of this study was to perform a risk assessment analysis, evaluating the exposure of electronic cigarette (EC users to metal emissions based on findings from the published literature. Methods: Two studies were found in the literature, measuring metals emitted to the aerosol from 13 EC products. We estimated that users take on average 600 EC puffs per day, but we evaluated the daily exposure from 1200 puffs. Estimates of exposure were compared with the chronic Permissible Daily Exposure (PDE from inhalational medications defined by the U.S. Pharmacopeia (cadmium, chromium, copper, lead and nickel, the Minimal Risk Level (MRL defined by the Agency for Toxic Substances and Disease Registry (manganese and the Recommended Exposure Limit (REL defined by the National Institute of Occupational Safety and Health (aluminum, barium, iron, tin, titanium, zinc and zirconium. Results: The average daily exposure from 13 EC products was 2.6 to 387 times lower than the safety cut-off point of PDEs, 325 times lower than the safety limit of MRL and 665 to 77,514 times lower than the safety cut-off point of RELs. Only one of the 13 products was found to result in exposure 10% higher than PDE for one metal (cadmium at the extreme daily use of 1200 puffs. Significant differences in emissions between products were observed. Conclusions: Based on currently available data, overall exposure to metals from EC use is not expected to be of significant health concern for smokers switching to EC use, but is an unnecessary source of exposure for never-smokers. Metal analysis should be expanded to more products and exposure can be further reduced through improvements in product quality and appropriate choice of materials.

  11. Are metals emitted from electronic cigarettes a reason for health concern? A risk-assessment analysis of currently available literature.

    Science.gov (United States)

    Farsalinos, Konstantinos E; Voudris, Vassilis; Poulas, Konstantinos

    2015-05-15

    Studies have found that metals are emitted to the electronic cigarette (EC) aerosol. However, the potential health impact of exposure to such metals has not been adequately defined. The purpose of this study was to perform a risk assessment analysis, evaluating the exposure of electronic cigarette (EC) users to metal emissions based on findings from the published literature. Two studies were found in the literature, measuring metals emitted to the aerosol from 13 EC products. We estimated that users take on average 600 EC puffs per day, but we evaluated the daily exposure from 1200 puffs. Estimates of exposure were compared with the chronic Permissible Daily Exposure (PDE) from inhalational medications defined by the U.S. Pharmacopeia (cadmium, chromium, copper, lead and nickel), the Minimal Risk Level (MRL) defined by the Agency for Toxic Substances and Disease Registry (manganese) and the Recommended Exposure Limit (REL) defined by the National Institute of Occupational Safety and Health (aluminum, barium, iron, tin, titanium, zinc and zirconium). The average daily exposure from 13 EC products was 2.6 to 387 times lower than the safety cut-off point of PDEs, 325 times lower than the safety limit of MRL and 665 to 77,514 times lower than the safety cut-off point of RELs. Only one of the 13 products was found to result in exposure 10% higher than PDE for one metal (cadmium) at the extreme daily use of 1200 puffs. Significant differences in emissions between products were observed. Based on currently available data, overall exposure to metals from EC use is not expected to be of significant health concern for smokers switching to EC use, but is an unnecessary source of exposure for never-smokers. Metal analysis should be expanded to more products and exposure can be further reduced through improvements in product quality and appropriate choice of materials.

  12. m-government legal and regulatory framework

    African Journals Online (AJOL)

    Wondwossen Mulugeta

    CURRENT E-GOVERNMENT. REGULATORY ELEMENTS. In an attempt to regulate the e-Government and. ICT related initiatives the Ethiopian government has been engaged in producing some regulatory and legal documents. These legal document include: e-Signature law, e-Commerce law, data protection act, value ...

  13. 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. Published by Elsevier Inc.

  14. Development of new diabetes risk scores on the basis of the current definition of diabetes in Japanese subjects [Rapid Communication].

    Science.gov (United States)

    Miyakoshi, Takahiro; Oka, Rie; Nakasone, Yasuto; Sato, Yuka; Yamauchi, Keishi; Hashikura, Rie; Takayama, Masayuki; Hirayama, Yudai; Hirabayashi, Kazuko; Koike, Hideo; Aizawa, Toru

    2016-09-30

    To develop diabetes risk score (RS) based on the current definition of diabetes, we retrospectively analyzed consecutive 4,159 health examinees who were non-diabetic at baseline. Diabetes, diagnosed by fasting plasma glucose (FPG) ≥7.0 mmol/L, 2hPG ≥11.1 mmol/L and/or HbA1c ≥6.5% (48 mmol/mol), developed in 279 of them during the mean period of 4.9 years. A full RS (RS Full ), a RS without 2hPG (RS -2hPG ) and a non-invasive RS (RS NI ) were created on the basis of multivariate Cox proportional model by weighted grading based on hazard ratio in half the persons assigned. The RSs were verified in the remaining half of the participants. Positive family history (FH), male sex, smoking and higher age, systolic blood pressure (SBP), FPG, 2hPG and HbA1c were independent predictors for RS Full . For RS -2hPG , 7 independent predictors, exclusive of 2hPG and smoking but inclusive of elevated triglycerides (TG) comparing to RS Full , were selected. FH, male sex, and higher age, SBP and HbA1c were independent predictors in RS NI . In the validation cohort, C-statistic (95%CI) of RS Full , RS -2hPG and RS NI were 0.80 (0.76-0.84), 0.75 (0.70-0.78) and 0.68 (0.63-0.72), respectively, which were significantly different from each other (P <0.01). Absolute percentage difference between predicted probability and observed diabetes were 1.9%, 0.7% and 0.9%, by the three scores, respectively, and not significantly different from each other. In conclusion, diabetes defined by the current criteria was predicted by the new diabetes risk scores with reasonable accuracy. Nonetheless, RS Full with a postchallenge glucose value performed superior to RS -2hPG and RS NI .

  15. The NRC's SPAR Models: Current Status, Future Development, and Modeling Issues

    Energy Technology Data Exchange (ETDEWEB)

    Robert F. Buell

    2008-09-01

    Probabilistic risk assessments (PRAs) play an increasingly important role in the regulatory framework of the U.S. nuclear power industry. The Nuclear Regulatory Commission (NRC) relies on a set of plant-specific Standardized Plant Analysis Risk (SPAR) models to provide critical risk-based input to the regulatory process. The Significance Determination Process (SDP), Management Directive 8.3 - NRC Incident Investigation Program, Accident Sequence Precursor (ASP) and Mitigating Systems Performance Index (MSPI) programs are among the regulatory initiatives that receive significant input from the SPAR models. Other uses of the SPAR models include: Screening & Resolution of Generic Safety Issues, License Amendment reviews and Notice of Enforcement Discretion (NOEDs). This paper presents the current status of SPAR model development activities, future development objectives, and issues related to the development, verification and maintenance of the SPAR models.

  16. 78 FR 68849 - Draft Current Intelligence Bulletin “Update of NIOSH Carcinogen Classification and Target Risk...

    Science.gov (United States)

    2013-11-15

    ... HUMAN SERVICES Centers for Disease Control and Prevention Draft Current Intelligence Bulletin ``Update... following draft document for public comment entitled ``Current Intelligence Bulletin: Update of NIOSH... obtain comments on the draft document, ``Current Intelligence Bulletin: Update of NIOSH Carcinogen...

  17. Colloid-Facilitated Radionuclide Transport: Current State of Knowledge from a Nuclear Waste Repository Risk Assessment Perspective

    Energy Technology Data Exchange (ETDEWEB)

    Reimus, Paul William [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Zavarin, Mavrik [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Wang, Yifeng [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2017-01-25

    This report provides an overview of the current state of knowledge of colloid-facilitated radionuclide transport from a nuclear waste repository risk assessment perspective. It draws on work that has been conducted over the past 3 decades, although there is considerable emphasis given to work that has been performed over the past 3-5 years as part of the DOE Used Fuel Disposition Campaign. The timing of this report coincides with the completion of a 3-year DOE membership in the Colloids Formation and Migration (CFM) partnership, an international collaboration of scientists studying colloid-facilitated transport of radionuclides at both the laboratory and field-scales in a fractured crystalline granodiorite at the Grimsel Test Site in Switzerland. This Underground Research Laboratory has hosted the most extensive and carefully-controlled set of colloid-facilitated solute transport experiments that have ever been conducted in an in-situ setting, and a summary of the results to date from these efforts, as they relate to transport over long time and distance scales, is provided in Chapter 3 of this report.

  18. What is the Current Knowledge About the Cardiovascular Risk for Users of Cannabis-Based Products? A Systematic Review.

    Science.gov (United States)

    Jouanjus, Emilie; Raymond, Valentin; Lapeyre-Mestre, Maryse; Wolff, Valérie

    2017-06-01

    The purpose of the study was to examine the published evidence on the cardiovascular risk related to the use of cannabis-based products by performing a systematic review of recent literature. The World Health Organization (WHO) emphasizes that cannabis use represents a risky behavior as it may lead to many adverse effects, and in particular, cardiovascular effects. A systematic review of articles published between January 1, 2011 and May 31, 2016 was performed in agreement with the PRISMA statement. Articles presenting data on humans exposed to cannabis-based products and suffering from any cardiovascular condition were eligible for inclusion. The inclusion process was based on a search algorithm and performed in a blinded standardized manner. Overall, 826 articles were found in the literature search, 115 of which remained after performing the inclusion procedure. These were 81 case reports, 29 observational studies, 3 clinical trials, and 2 experimental studies. A total of 116 individuals was the subject of case reports. The mean age was 31 years (95%CI = 29-34), and patients were more frequently men (81.9%) than women (18.1%). They mainly suffered from ischemic strokes or myocardial infarctions. Data provided by the 29 included observational studies evidenced an association between exposure to cannabis-based products and cardiovascular disease. Currently, this evidence is stronger for ischemic strokes than for any other cardiovascular diseases. While the data are limited, there is some suggestion that cannabis use may have negative cardiovascular consequences, particularly at large doses.

  19. Current issues in ALS epidemiology: Variation of ALS occurrence between populations and physical activity as a risk factor.

    Science.gov (United States)

    Luna, J; Logroscino, G; Couratier, P; Marin, B

    2017-05-01

    Amyotrophic lateral sclerosis (ALS) is a rare neurodegenerative disease with a fatal outcome. This review aims to report key epidemiological features of ALS in relation to the hypothesis of variation between populations, to summarize environmental hypothesis and to highlight current issues that deserve much considerations. Epidemiological ALS studies have shown a variation of incidence, mortality and prevalence between geographical areas and different populations. These data could support the notion that genetic factors, especially populations' ancestries, along with environmental and lifestyle factors, play a significant role in the occurrence of the disease. To date, there is no strong evidence to confirm an association between a particular environmental factor and ALS. Physical activity (PA) has been extensively evaluated. Recent studies support with the best evidence level that PA in general population is not a risk factor for ALS. However, further research is needed to clarify the association of PA in some occupations and some athletic activities. Epidemiological research based on multicenter international collaboration is essential to provide new data on ALS especially in some regions of the world that are to date poorly represented in the ALS literature. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  20. Activation of the prefrontal cortex by unilateral transcranial direct current stimulation leads to an asymmetrical effect on risk preference in frames of gain and loss.

    Science.gov (United States)

    Ye, Hang; Huang, Daqiang; Wang, Siqi; Zheng, Haoli; Luo, Jun; Chen, Shu

    2016-10-01

    Previous brain imaging and brain stimulation studies have suggested that the dorsolateral prefrontal cortex may be critical in regulating risk-taking behavior, although its specific causal effect on people's risk preference remains controversial. This paper studied the independent modulation of the activity of the right and left dorsolateral prefrontal cortex using various configurations of transcranial direct current stimulation. We designed a risk-measurement table and adopted a within-subject design to compare the same participant's risk preference before and after unilateral stimulation when presented with different frames of gain and loss. The results confirmed a hemispheric asymmetry and indicated that the right dorsolateral prefrontal cortex has an asymmetric effect on risk preference regarding frames of gain and loss. Enhancing the activity of the right dorsolateral prefrontal cortex significantly decreased the participants' degree of risk aversion in the gain frame, whereas it increased the participants' degree of risk aversion in the loss frame. Our findings provide important information regarding the impact of transcranial direct current stimulation on the risk preference of healthy participants. The effects observed in our experiment compared with those of previous studies provide further evidence of the effects of hemispheric and frame-dependent asymmetry. These findings may be helpful in understanding the neural basis of risk preference in humans, especially when faced with decisions involving possible gain or loss relative to the status quo. Copyright © 2016 Elsevier B.V. All rights reserved.

  1. Current Data on Risk Factor Estimates Does Not Explain the Difference in Rates of Melanoma between Hispanics and Non-Hispanic Whites

    Directory of Open Access Journals (Sweden)

    Sonia Kamath

    2016-01-01

    Full Text Available United States Hispanics have seven times lower melanoma incidence rates than non-Hispanic whites (NHW. It is unclear whether this difference can be explained solely by phenotypic risk factors, like darker skin, or whether modifiable risk factors, like sun exposure, also play a role. The purpose of this paper is to summarize what is currently known about melanoma risk factors among Hispanics and NHWs, and whether or not those differences could explain the difference in melanoma incidence. Through literature review, relative risks and prevalence of melanoma risk factors in Hispanics and NHWs were identified and used to calculate the expected rate in Hispanics and rate ratio compared to NHWs. We found that melanoma risk factors either have similar frequency in Hispanics and NHWs (e.g., many large nevi or are less frequent in Hispanics but do not explain a high proportion of disease variation (e.g., red hair. Considering current knowledge of risk factor prevalence, we found that melanoma incidence rates in the two groups should actually be similar. Sun exposure behavior among Hispanics may contribute to the explanation for the 7-fold difference in melanoma rates. Currently, limited data exist on sun exposure behavior among Hispanics, but possibilities for improving primary prevention by further studying these practices are substantial.

  2. 78 FR 5516 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing Advance Notice To...

    Science.gov (United States)

    2013-01-25

    ... COMMISSION Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing Advance Notice To... change the current Largest Provisional Net Credit (``LPNC'') risk management control in order to increase... modify its Rules as they relate to the Issuing/Paying Agent's (``IPA's'') refusal to pay process. DTC is...

  3. Regulatory physiology discipline science plan

    Science.gov (United States)

    1991-01-01

    The focus of the Regulatory Physiology discipline of the Space Physiology and Countermeasures Program is twofold. First, to determine and study how microgravity and associated factors of space flight affect the regulatory mechanisms by which humans adapt and achieve homeostasis and thereby regulate their ability to respond to internal and external signals; and, second, to study selected physiological systems that have been demonstrated to be influenced by gravity. The Regulatory Physiology discipline, as defined here, is composed of seven subdisciplines: (1) Circadian Rhythms, (2) Endocrinology, (3) Fluid and Electrolyte Regulation, (4) Hematology, (5) Immunology, (6) Metabolism and Nutrition, and (7) Temperature Regulation. The purpose of this Discipline Science Plan is to provide a conceptual strategy for NASA's Life Sciences Division research and development activities in the area of regulatory physiology. It covers the research areas critical to NASA's programmatic requirements for the Extended-Duration Orbiter, Space Station Freedom, and exploration mission science activities. These science activities include ground-based and flight; basic, applied, and operational; and animal and human research and development. This document summarizes the current status of the program, outlines available knowledge, establishes goals and objectives, identifies science priorities, and defines critical questions in regulatory physiology. It contains a general plan that will be used by both NASA Headquarters Program Offices and the field centers to review and plan basic, applied, and operational intramural and extramural research and development activities in this area.

  4. Anti-regulatory T cells.

    Science.gov (United States)

    Andersen, Mads Hald

    2017-04-01

    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, including indoleamine 2,3-dioxygenase (IDO), tryptophan 2,6-dioxygenase (TDO), programmed death-ligand 1 (PD-L1), and forkhead box P3 (Foxp3). These proteins are highly expressed in professional antigen-presenting cells under various physiological conditions, such as inflammation and stress. Therefore, self-reactive T cells that recognize such targets may be activated due to the strong activation signal given by their cognate targets. The current review describes the existing knowledge regarding these self-reactive anti-Tregs, providing examples of antigen-specific anti-Tregs and discussing their possible roles in immune homeostasis and their potential future clinical applications.

  5. Health risk factors and mental health among US women with and without chronic physical disabilities by whether women are currently pregnant.

    Science.gov (United States)

    Iezzoni, Lisa I; Yu, Jun; Wint, Amy J; Smeltzer, Suzanne C; Ecker, Jeffrey L

    2015-06-01

    Growing numbers of reproductive-age US women with chronic physical disabilities (CPD) raise questions about their pregnancy experiences. Little is known about the health risks of women with versus without CPD by current pregnancy status. We analyzed cross-sectional, nationally-representative National Health Interview Survey data from 2006 to 2011, which includes 47,629 civilian, noninstitutionalized women ages 18-49. NHIS asks about specified movement difficulties, current pregnancy, and various health and health risk indicators, including tobacco use and body mass index (BMI). We used responses from eight movement difficulty and other questions to identify women with mobility difficulties caused by chronic physical health conditions. Across all women regardless of CPD, women reporting current pregnancy are significantly less likely to currently smoke tobacco and report certain mental health problems. Among currently pregnant women only, women with CPD are more likely to smoke cigarettes every day (12.2 %) versus 6.3 % for pregnant women without CPD (p ≤ 0.001). Among currently pregnant women, 17.7 % of women with CPD have BMIs in the non-overweight range, compared with 40.1 % of women without CPD (p ≤ 0.0001). Currently pregnant women with CPD are significantly more likely to report having any mental health problems, 66.6 % compared with 29.7 % among women without CPD (p ≤ 0.0001). For all women, currently pregnant women appear to have fewer health risks and mental health concerns than nonpregnant women. Among pregnant women, women with CPD have higher rates than other women of health risk factors that could affect maternal and infant outcomes.

  6. The Role of Cytotoxic T-lymphocyte-associated Protein 4 (CTLA-4) Gene, Thyroid Stimulating Hormone Receptor (TSHR) Gene and Regulatory T-cells as Risk Factors for Relapse in Patients with Graves Disease.

    Science.gov (United States)

    Eliana, Fatimah; Suwondo, Pradana; Asmarinah, Asmarinah; Harahap, Alida; Djauzi, Samsuridjal; Prihartono, Joedo; Pemayun, Tjokorda Gde Dalem

    2017-07-01

    graves' disease (GD) is the most common condition of thyrotoxicosis. The management of GD is initiated with the administration of antithyroid drugs; however, it requires a long time to achieve remission. In reality more than 50% of patients who had remission may be at risk for relapse after the drug is stopped. This study aimed to evaluate the role of clinical factors such as smoking habit, degree of ophtalmopathy, degree of thyroid enlargement; genetic factors such as CTLA-4 gene on nucleotide 49 at codon 17 of exon 1, CTLA-4 gene of promotor -318, TSHR gene polymorphism rs2268458 of intron 1; and immunological factors such as regulatory T cells (Treg) and thyroid receptor antibody (TRAb); that affecting the relapse of patients with Graves' disease in Indonesia. this was a case-control study, that compared 72 subjects who had relapse and 72 subjects without relapse at 12 months after cessation of antithyroid treatment, who met the inclusion criteria. Genetic polymorphism examination was performed using PCR-RFLP. The number of regulatory T cells was counted using flow cytometry analysis and ELISA was used to measure TRAb. The logistic regression was used since the dependent variables were categorical variables. the analysis of this study demonstrated that there was a correlation between relapse of disease and family factors (p=0.008), age at diagnosis (p=0.021), 2nd degree of Graves' ophthalmopathy (p=0.001), enlarged thyroid gland, which exceeded the lateral edge of the sternocleidomastoid muscles (p=0.040), duration of remission period (p=0.029), GG genotype of CTLA-4 gene on the nucleotide 49 at codon 17 of exon 1 (p=0.016), CC genotype of TSHR gene on the rs2268458 of intron 1 (p=0.003), the number of regulatory T cells (p=0.001) and TRAb levels (p=0.002). genetic polymorphisms of CTLA-4 gene on the nucleotide 49 at codon 17 of exon 1, TSHR gene SNP rs2268458 of intron 1, number of regulatory T cells and TRAb levels play a role as risk factors for relapse in

  7. Regulatory Fit Improves Fitness for People With Low Exercise Experience.

    Science.gov (United States)

    Kay, Sophie A; Grimm, Lisa R

    2017-04-01

    Considering only 20.8% of American adults meet current physical activity recommendations, it is important to examine the psychological processes that affect exercise motivation and behavior. Drawing from regulatory fit theory, this study examined how manipulating regulatory focus and reward structures would affect exercise performance, with a specific interest in investigating whether exercise experience would moderate regulatory fit effects. We predicted that regulatory fit effects would appear only for participants with low exercise experience. One hundred and sixty-five young adults completed strength training exercise tasks (i.e., sit-ups, squats, plank, and wall-sit) in regulatory match or mismatch conditions. Consistent with predictions, only participants low in experience in regulatory match conditions exercised more compared with those in regulatory mismatch conditions. Although this is the first study manipulating regulatory fit in a controlled setting to examine exercise behavior, findings suggest that generating regulatory fit could positively influence those low in exercise experience.

  8. Voluntary sport and highway risks in adolescents and youths (following current French and Canadian periodical publications of 2000th

    Directory of Open Access Journals (Sweden)

    Rabinovich M.I.

    2013-06-01

    Full Text Available In this article we discuss some personal traits of adolescents and young people, disposed to different types of risky behavior. We describe correlations between different types of risky behavior in one individual. We discuss also the gender aspect of risk taking in adolescents and youth. Some modern theories of risk taking are recapitulated. Finally, we discuss the organizational question about the preventive work with adolescents and youth, aimed on minimization of sportive and highway risk.

  9. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... 3 The President 1 2010-01-01 2010-01-01 false Regulatory Review Presidential Documents Other Presidential Documents Memorandum of January 30, 2009 Regulatory Review Memorandum for the Heads of Executive Departments and Agencies For well over two decades, the Office of Information and Regulatory Affairs (OIRA) at...

  10. Regulatory Competition in Global Financial Markets

    DEFF Research Database (Denmark)

    Ringe, Georg

    2015-01-01

    The decades-long discussion on the merits of regulatory competition appears in a new light on the global financial market. There are a number of strategies that market participants use to avoid the reach of regulation, in particular by virtue of shifting trading abroad or else relocating activities...... competition are a reality in today’s global financial market, and the financial sector is different from their traditional fields of application: the ease of arbitrage, the fragility of banking and the risks involved are exceptional. Most importantly, regulatory arbitrage does not or only rarely occurs...... or operations of financial institutions to other jurisdictions. Where this happens, such arbitrage can trigger regulatory competition between jurisdictions that may respond to the relocation of financial services (or threats to relocate) by moderating regulatory standards. Both arbitrage and regulatory...

  11. Regulatory Competition in Global Financial Markets

    DEFF Research Database (Denmark)

    Ringe, Georg

    2015-01-01

    or operations of financial institutions to other jurisdictions. Where this happens, such arbitrage can trigger regulatory competition between jurisdictions that may respond to the relocation of financial services (or threats to relocate) by moderating regulatory standards. Both arbitrage and regulatory......The decades-long discussion on the merits of regulatory competition appears in a new light on the global financial market. There are a number of strategies that market participants use to avoid the reach of regulation, in particular by virtue of shifting trading abroad or else relocating activities...... competition are a reality in today’s global financial market, and the financial sector is different from their traditional fields of application: the ease of arbitrage, the fragility of banking and the risks involved are exceptional. Most importantly, regulatory arbitrage does not or only rarely occurs...

  12. Identification of NSAID users at risk for gastrointestinal complications: a systematic review of current guidelines and consensus agreements.

    NARCIS (Netherlands)

    Tielemans, M.M.; Eikendal, T.; Jansen, J.B.M.J.; Oijen, M.G.H. van

    2010-01-01

    NSAIDs are among the most often used drugs worldwide. Numerous NSAID users are at risk for developing gastrointestinal complications. The purpose of this review was to identify and stratify risk factors for gastrointestinal complications in NSAID users documented in guidelines and consensus

  13. 78 FR 64425 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Science.gov (United States)

    2013-10-29

    ... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Food for Animals; Public... risk-based preventive controls for animal food. This proposed rule is one of several proposed rules... system. Among other things, FSMA requires FDA to issue regulations requiring preventive controls for...

  14. 78 FR 48636 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Science.gov (United States)

    2013-08-09

    ... Preventive Controls for Human Food; Extension of Comment Periods AGENCY: Food and Drug Administration, HHS... Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,'' that appeared in... Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food...

  15. Risk of low-energy hip, wrist, and upper arm fractures among current and previous users of hormone replacement therapy

    DEFF Research Database (Denmark)

    Hundrup, Yrsa Andersen; Høidrup, Susanne; Ekholm, Ola

    2004-01-01

    To examine the effect of oestrogen alone and in combination with progestin on the risk of low-energy, hip, wrist, and upper arm fractures. Additionally, to examine to what extent previous use, duration of use as well as recency of discontinuation of hormone replacement therapy (HRT) influences...... the fracture risk....

  16. The current state of knowledge on operational sanitation measures to lower risk of Phytophthora ramorum spread and the need for further study

    Science.gov (United States)

    Yana Valachovic; Dave Rizzo; Brendan Twieg

    2013-01-01

    We are working to evaluate risks associated with human spread of the sudden oak death (SOD) pathogen, Phytophthora ramorum, to currently uninfested areas in California. Port-Orford-cedar (Chamaecyparis lawsoniana (A. Murray) Parl.) root disease (POC RD), caused by Phytophthora lateralis, has brought...

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

    Science.gov (United States)

    Grigorev, Yu G

    2014-01-01

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

  18. Is global cardiovascular risk considered in current practice? Treatment and control of hypertension, hyperlipidemia, and diabetes according to patients’ risk level

    Directory of Open Access Journals (Sweden)

    Daria Roccatagliata

    2006-12-01

    Full Text Available Daria Roccatagliata1, Fausto Avanzini1, Lara Monesi1, Vittorio Caimi2, Davide Lauri1, Paolo Longoni3, Roberto Marchioli4, Massimo Tombesi2, Gianni Tognoni1, Maria Carla Roncaglioni1, on behalf of the Collaborative Group Risk and Prevention Study*1Istituto di Ricerche Farmacologiche “Mario Negri”, Milano, Italy; 2CSeRMEG Centro Studi e Ricerca in Medicina Generale, Monza, Italy; 3CoS Consorzio Sanità, Milano, Italy; 4Consorzio Mario Negri Sud, S. Maria Imbaro, Italy *A full list of investigators is reported in the AppendixObjectives: To assess the pharmacological treatment and the control of major modifiable cardiovascular risk factors in everyday practice according to the patients’ cardiovascular risk level.Methods: In a cross-sectional study general practitioners (GPs had to identify a random sample of their patients with cardiovascular risk factors or diseases and collect essential data on the pharmacological treatment and control of hypertension, hyperlipidemia, and diabetes according to the patients’ cardiovascular risk level and history of cardiovascular disease. Participants were subjects of both sexes, aged 40–80 years, with at least one known cardiovascular risk factor or a history of cardiovascular diseases.Results: From June to December 2000, 162 Italian GPs enrolled 3120 of their patients (2470 hypertensives, 1373 hyperlipidemics, and 604 diabetics. Despite the positive association between the perceived level of global cardiovascular risk and lipid-lowering drug prescriptions in hyperlipidemic subjects (from 26% for lowest risk to 56% for highest risk p < 0.0001 or the prescription of combination therapy in hypertensives (from 41% to 70%, p < 0.0001 and diabetics (from 24% to 43%, p = 0.057, control was still inadequate in 48% of diabetics, 77% of hypertensives, and 85% of hyperlipidemics, with no increase in patients at highest risk. Trends for treatment and control were similar in patients with cardiovascular diseases

  19. Analysis of current Department of Defense risk management practices in weapon system acquisition : a case study of the Advanced Amphibious Assault Vehicle (AAAV) PDRR and SDD risk management practices

    OpenAIRE

    Bailey, Robert O.

    2003-01-01

    Approved for public release; distribution in unlimited. This thesis discusses risk in Department of Defense (DoD) weapon systems acquisition. It uses the Marine Corps' Advanced Amphibious Assault Vehicle (AAAV) as a case study in risk management strategy and techniques. The AAAV will provide the Marine Corps with a fast deploying, over-the-horizon, waterborne insertion capability. The AAAV's improvements over the currently fielded Amphibious Assault Vehicle (AAV) will provide Marines with ...

  20. US EPA - A*Star Partnership - Accelerating the Acceptance of Next-Generation Sciences and Their Application to Regulatory Risk Assessment (A*Star Symposium, Singapore)

    Science.gov (United States)

    The path for incorporating new alternative methods and technologies into quantitative chemical risk assessment poses a diverse set of scientific challenges. Some of these challenges include development of relevant and predictive test systems and computational models to integrate...

  1. The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) Program - Current Status and Future Direction

    National Research Council Canada - National Science Library

    Jasmanda Wu; Juhaeri Juhaeri

    2016-01-01

      The US Food and Drug Administration (FDA) Amendments Act of 2007 granted the FDA new authorities to enhance drug safety by requiring application holders to submit a proposed Risk Evaluation and Mitigation Strategy (REMS...

  2. Metabolic syndrome and subsequent risk of type 2 diabetes and cardiovascular disease in elderly women Challenging the current definition

    DEFF Research Database (Denmark)

    Møller, Katrine Dragsbæk; Neergaard, Jesper; Laursen, Janne Marie

    2016-01-01

    , followed 3905 Danish women since 2000 (age: 70.1±6.5) with no previous diagnosis of T2DM or CVD, holding all measurements used for MetS definition; central obesity, hypertension, hyperlipidemia, and hyperglycemia combined with register-based follow-up information. Elderly women with defined MetS presented...... a 6.3-fold increased risk of T2DM (95% confidence interval: [3.74-10.50]) and 1.7-fold increased risk of CVD (1.44-2.05) compared to women with no MetS risk factors. Subdividing the control group without defined MetS revealed that both centrally obese controls and controls holding other MetS risk...

  3. Experimental evaluation of the Continuous Risk Profile (CRP) approach to the current Caltrans methodology for high collision concentration location identification.

    Science.gov (United States)

    2012-03-01

    This report evaluates the performance of Continuous Risk Profile (CRP) compared with the : Sliding Window Method (SWM) and Peak Searching (PS) methods. These three network : screening methods all require the same inputs: traffic collision data and Sa...

  4. 77 FR 9273 - WORKSHOP Sponsored by the Nuclear Regulatory Commission and the Electric Power Research Institute...

    Science.gov (United States)

    2012-02-16

    ... workshop will address uncertainties associated with risk assessments for internal fires, seismic events.... For the Nuclear Regulatory Commission. Kevin A. Coyne, Branch Chief, Probability Probabilistic Risk...

  5. Which risk understandings can be derived from the current disharmonized regulation of complementary and alternative medicine in Europe?

    Science.gov (United States)

    Wiesener, Solveig; Salamonsen, Anita; Fønnebø, Vinjar

    2018-01-10

    Many European citizens are seeking complementary and alternative medicine (CAM). These treatments are regulated very differently in the EU/EFTA countries. This may demonstrate differences in how risk associated with the use of CAM is perceived. Since most CAM treatments are practiced fairly similarly across Europe, differing risk understandings may influence patient safety for European CAM users. The overall aim of this article is thus to contribute to an overview and awareness of possible differing risk understandings in the field of CAM at a policymaking/structural level in Europe. The study is a re-analysis of data collected in the CAMbrella EU FP7 document and interview study on the regulation of CAM in 39 European countries. The 12 CAM modalities included in the CAMbrella study were ranked with regard to assumed risk potential depending on the number of countries limiting its practice to regulated professions. The 39 countries were ranked according to how many of the included CAM modalities they limit to be practiced by regulated professions. Twelve of 39 countries generally understand the included CAM treatments to represent "high risk", 20 countries "low risk", while the remaining 7 countries understand CAM treatments as carrying "very little or no risk". The CAM modalities seen as carrying a risk high enough to warrant professional regulation in the highest number of countries are chiropractic, acupuncture, massage, homeopathy and osteopathy. The countries understanding most of the CAM modalities in the study as potentially high-risk treatments are with two exceptions (Portugal and Belgium) all concentrated in the southeastern region of Europe. The variation in regulation of CAM may represent a substantial lack of common risk understandings between health policymakers in Europe. We think the discrepancies in regulation are to a considerable degree also based on factors unrelated to patient risk. We argue that it is important for patient safety that policy

  6. Comparative Analysis of Potential Risk Factors for at-Risk Gambling, Problem Gambling and Gambling Disorder among Current Gamblers—Results of the Austrian Representative Survey 2015

    Directory of Open Access Journals (Sweden)

    Sven Buth

    2017-12-01

    Full Text Available Background: The risk of developing a problem gambling behavior is distributed unequally among the population. For example, individuals who report stressful life events, show impairments of mental health or belong to a socio-economically deprived group are affected more frequently by gambling problems. The aim of our study is to investigate whether these risk factors are equally relevant for all gambling groups (social = 0 DSM-5 criteria, at risk = 1 DSM-5 criterion, problem = 2–3 DSM-5 criteria, disordered = 4–9 DSM-5 criteria.Methods: Of a total of 10,000 participants in the representative gambling survey in Austria in 2015, 4,082 individuals reported gambling during the last 12 months and were allocated to the four gambling groups according to DSM-5. With social gamblers as the reference group, relevant risk factors for the other three groups were identified by means of bi- and multivariate multinomial logistic regression.Results: Significant risk factors for gambling disorder are at-risk alcohol use (OR = 4.9, poor mental health (OR = 5.9, young age (≤26 years, OR = 2.1, a low level of formal education (OR = 2.4, having grown up with a single parent (OR = 2.5, parents with addiction problems (OR = 2.3 and belonging to the working class (OR = 2.9. Risk factors for problem gambling are parents with addiction problems (OR = 3.8, poor mental health (OR = 2.6 and a young age (OR = 2.2. With regard to at-risk gambling, only growing up with a single parent was relevant (OR = 2.4.Conclusion: Overall, the results of this study suggest, that the number and the influence of the included risk factors differ between gambling problem groups. Apparently, the development of severe gambling problems is to a lesser extent facilitated by specific risk factors than by their cumulative presence. Therefore, future prevention and treatment measures should place a particular focus on individuals who have experienced growing up in a difficult family situation

  7. Best Clinical Practice: Current Controversies in the Evaluation of Low-Risk Chest Pain with Risk Stratification Aids. Part 2.

    Science.gov (United States)

    Long, Brit; Koyfman, Alex

    2017-01-01

    Chest pain accounts for 10% of emergency department (ED) visits annually, and many of these patients are admitted because of potentially life-threatening conditions. A substantial percentage of patients with chest pain are at low risk for a major cardiac adverse event (MACE). We investigated controversies in the evaluation of patients with low-risk chest pain, including clinical scores, decision pathways, and shared decision-making. ED patients with chest pain who have negative biomarker results and nonischemic electrocardiograms are at low risk for MACE. With the large number of chest pain patients evaluated in the ED, several risk scores and pathways are in use based on history, electrocardiographic results, and biomarker results. The Thrombolysis in Myocardial Infarction and Global Registry of Acute Coronary Events scores are older rules with validation; however, they do not have adequate sensitivity or are not easy to use in the ED. The Vancouver chest pain and North American chest pain rules may be used for patients with undifferentiated chest pain in the ED. The Manchester Acute Coronary Syndromes rule uses eight factors, several of which are not available in the United States. The history, electrocardiography, age, risk factors, and troponin (HEART) score and pathway are easy to use, have high sensitivity and negative predictive values, and have better discriminatory capability for categorization. The use of pathways with shared decision-making involves the patient in management, shortens the duration of stay, and decreases risk to both the patient and the provider. Risk stratification of ED patients with chest pain has evolved, and there are many tools available. The HEART pathway, designed for ED use, has several attributes that provide safe and efficient care for patients with chest pain. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Statement on the suitability of the BEEHAVE model for its potential use in a regulatory context and for the risk assessment of multiple stressors in honeybees at the landscape level

    DEFF Research Database (Denmark)

    EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues); Topping, Christopher John

    2015-01-01

    The Panel has interpreted the Terms of Reference by carrying out a stepwise evaluation of the BEEHAVE simulation model with a view to assessing its suitability for use in a regulatory context and for risk assessment of multiple stressors at the landscape level. The EFSA opinion on good modelling...... practice was used to evaluate the model and its documentation systematically. The overall conclusion is that BEEHAVE performs well in modelling honeybee colony dynamics, and the supporting documentation is generally good but does not fully meet the criteria of the good modelling opinion. BEEHAVE is not yet...... that BEEHAVE should be adopted as the basis for modelling the impact on honeybee colonies of pesticides and other stressors, but that further development should use a standard, object-oriented language rather than NetLogo....

  9. Scoring the Current Risk Stratification Guidelines in Follow-up Evaluation of Patients After Metal-on-Metal Hip Arthroplasty: A Proposal for a Metal-on-Metal Risk Score Supporting Clinical Decision-Making.

    Science.gov (United States)

    Hussey, Daniel K; Madanat, Rami; Donahue, Gabrielle S; Rolfson, Ola; Bragdon, Charles R; Muratoglu, Orhun K; Malchau, Henrik

    2016-11-16

    In the follow-up evaluation of patients with metal-on-metal (MoM) hip replacements, current evidence suggests that orthopaedic surgeons should avoid reliance on any single investigative tool. Current risk stratification guidelines can be difficult to interpret because they do not provide guidance when there are several risk factors in different groups (high and low risk). To improve the clinical utility of risk stratification guidelines, we designed a scoring system to assess the risk of revision. The study population consisted of 1,709 patients (1,912 hips) enrolled in a multicenter follow-up study of a recalled MoM hip replacement. Eleven scoring criteria were determined on the basis of existing follow-up algorithm recommendations and consisted of patient-related factors, symptoms, clinical status, implant type, metal ion levels, and radiographic imaging results. Forward stepwise logistic regression was conducted to determine the minimum set of predictive variables for the risk of revision and to assign variable weights. The MoM risk score for each hip was then created by averaging the weighted values of each predictive variable. Receiver operating characteristic curve analysis yielded good discrimination between all revised and unrevised hips, with an area under the curve of 0.82 (p clinical decision-making process. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

  10. Current and recent drug use intensifies sexual and structural HIV risk outcomes among female sex workers in the Russian Federation.

    Science.gov (United States)

    Wirtz, Andrea L; Peryshkina, Alena; Mogilniy, Vladimir; Beyrer, Chris; Decker, Michele R

    2015-08-01

    Female sex workers (FSW) and people who inject drugs (PWID) are at high risk for HIV infection, with FSW-PWID at even greater risk. HIV-related research often focuses on the primary mode of transmission - sexual or parenteral transmission for FSW and PWID, respectively - with less known on how sex work and injection drug use (IDU) are collectively associated with the risk environment experienced by sex workers. We investigated this relationship among FSW in three Russian cities. In 2011, FSWs (N=754) in Tomsk, Krasnoyarsk, and Kazan were recruited via respondent-driven sampling and completed a survey and rapid HIV screening. Multivariable models evaluated the role of injection history (classified as active: last 6 months, former: prior to last 6 months, and never) with a set of sexual and structural HIV risk outcomes. IDU was common: 11% actively injected drugs and 11% were former injectors. HIV infection was most prevalent among active injectors (AOR: 6.7; 95% CI: 2.4-18.9) and former injectors (AOR:4.5; 95%CI: 1.7-11.6), compared to non-injectors. Some 6-8% of non-injecting FSWs reported recent physical or sexual client violence and 23% police extortion. Compared to these non-injectors, active injecting was associated with unprotected anal sex (AOR: 2.8, 95%CI: 1.2-6.4), client violence (AOR: 7.3, 95%CI: 2.1-24.7), and police extortion (AOR: 3.0 95%CI: 1.5-5.9%). Self-reported sexual and structural risk outcomes were also more prevalent among active compared to former injectors; however, few differences existed between former and non-injectors. FSW experience sexual, structural, and HIV risk outcomes and these risks are amplified for actively injecting FSWs. FSW who stopped injecting drugs demonstrated risk profiles closer to those of sex workers who had no history of injection. HIV prevention programs and outreach can provide opportunities to include harm reduction interventions and linkage to treatment for FSW to move FSWs towards lower risk environments

  11. Baseline study and risk analysis of landfill leachate - Current state-of-the-science of computer aided approaches.

    Science.gov (United States)

    Butt, T E; Alam, A; Gouda, H M; Paul, P; Mair, N

    2017-02-15

    For the successful completion of a risk analysis process, its foundation (i.e. a baseline study) has to be well established. For this purpose, a baseline study needs to be more integrated than ever, particularly when environmental legislation is increasingly becoming stringent and integrated. This research investigates and concludes that no clear evidence of computer models for baseline study has been found in a whole-system and integrated format, which risk assessors could readily and effectively use to underpin risk analyses holistically and yet specifically for landfill leachate. This is established on the basis of investigation of software packages that are particularly closely related to landfills. Holistic baseline study is also defined along with its implications and in the context of risk assessment of landfill leachate. The study also indicates a number of factors and features that need to be added to baseline study in order to render it more integrated thereby enhancing risk analyses for landfill leachate. Copyright © 2016 Elsevier B.V. All rights reserved.

  12. Relationship between reported prior condom use and current self-perceived risk of acquiring HIV among mobile female sex workers in southern India

    Directory of Open Access Journals (Sweden)

    Jain Anrudh K

    2011-12-01

    Full Text Available Abstract Background With the evolution of Health Belief Model, risk perception has been identified as one of several core components of public health interventions. While female sex workers (FSWs in India continue to be at most risk of acquiring and transmitting HIV, little is known about their perception towards risk of acquiring HIV and how this perception depends upon their history of consistent condom use behavior with different type of partners. The objective of this study is to fill this gap in the literature by examining this relationship among mobile FSWs in southern India. Methods We analyzed data for 5,413 mobile FSWs from a cross-sectional behavioral survey conducted in 22 districts from four states in southern India. This survey assessed participants’ demographics, condom use in sex with different types of partners, continuation of sex while experiencing STI symptoms, alcohol use before having sex, and self-perceived risk of acquiring HIV. Descriptive analyses and multilevel logistic regression models were used to examine the associations between risky sexual behaviors and self-perceived risk of acquiring HIV; and to understand the geographical differences in HIV risk perception. Results Of the total mobile FSWs, only two-fifths (40% perceived themselves to be at high risk of acquiring HIV; more so in the state of Andhra Pradesh (56% and less in Maharashtra (17%. FSWs seem to assess their current risk of acquiring HIV primarily on the basis of their past condom use behavior with occasional clients and less on the basis of their past condom use behaviors with regular clients and non-paying partners. Prior inconsistent condom use with occasional clients was independently associated with current perception of high HIV risk (adjusted odds ratio [aOR] = 2.1, 95% confidence interval [CI]: 1.7-2.6. In contrast, prior inconsistent condom use with non-paying partners was associated with current perception of low HIV risk (aOR= 0.7, 95% CI

  13. Dietary Magnesium and Genetic Interactions in Diabetes and Related Risk Factors: A Brief Overview of Current Knowledge

    Science.gov (United States)

    Hruby, Adela; McKeown, Nicola M.; Song, Yiqing; Djoussé, Luc

    2013-01-01

    Nutritional genomics has exploded in the last decade, yielding insights—both nutrigenomic and nutrigenetic—into the physiology of dietary interactions and our genes. Among these are insights into the regulation of magnesium transport and homeostasis and mechanisms underlying magnesium’s role in insulin and glucose handling. Recent observational evidence has attempted to examine some promising research avenues on interaction between genetics and dietary magnesium in relation to diabetes and diabetes risk factors. This brief review summarizes the recent evidence on dietary magnesium’s role in diabetes and related traits in the presence of underlying genetic risk, and discusses future potential research directions. PMID:24322525

  14. Regulatory compliance associated with contrast media.

    Science.gov (United States)

    Stevens, Catherine M

    2005-01-01

    A basic understanding of the role of regulatory agencies in governing the healthcare environment and their influence over contrast media use is required of radiographers and imaging administrators to meet the many standards of compliance. In addition, radiology management teams must consider cost effectiveness, departmental efficiency, workplace safety, and compliance in choosing to implement new products. Regulatory agencies may be classified into 2 groups, voluntary and involuntary. Involuntary agencies are governmental agencies mandating regulatory compliance by local, state, or federal laws. Voluntary agencies are precisely that, those agencies an institution voluntarily chooses to participate with, to demonstrate the quality of care they provide. Failure to follow involuntary regulatory guidelines or to participate in voluntary best practice standards jeopardizes patient safety and the quality of care provided, and exposes the institution and the individual to liability risks. Severe penalties may result from a failure to maintain regulatory compliance, including the possibility of large fines, criminal indictments, and loss of third-party reimbursement. Achieving regulatory compliance is never an easy venture with the number of regulatory agencies and standards needing to be addressed. Combining regulatory compliance with the effects of doing business provides quite a challenge for today's imaging departments. A solid knowledge base in regulatory standards along with continuous investigation of new standards will allow departments to evaluate their own processes involved in providing patient care. Recognition of areas of high risk/high volume, including contrast media use, will assist in directing the departments' focus appropriately. A thorough evaluation of the products used and their respective handing and administration, in regard to patient and workplace safety, and appropriate documentation of workplace injuries due to contrast media packaging, will

  15. Diabetes mellitus and the risk of aneurysmal subarachnoid haemorrhage: A systematic review and meta-analysis of current evidence.

    Science.gov (United States)

    Yao, Xi-Yang; Jiang, Cai-Qi; Jia, Gen-Lai; Chen, Gang

    2016-12-01

    Objective This systematic review aimed to define the relationship between diabetes mellitus (DM) and the risk of aneurysmal subarachnoid haemorrhage (aSAH). Methods Studies associated with DM and aSAH published until March 2016 were retrieved from Pubmed, Embase, Web of Science, and Cochrane Library databases. A random-effects model was used to calculate the relative risks (RRs) with 95% confidence intervals (CIs). Results Eighteen observational studies were retrieved. The overall RRs for DM and aSAH were RRs = 0.59 (0.44, 0.79), with moderate heterogeneity ( I(2 )= 55.7%, Pheterogeneity = 0.000). Subgroup analysis by study quality revealed a reduced association between DM and aSAH risk in high quality studies only (RRs = 0.40, 95% CI: 0.29, 0.56; I(2 )= 0.0%, Pheterogeneity = 0.549), therefore study quality may be a source of heterogeneity. Conclusion A potential decreased risk of aSAH in DM patients was found in high quality studies. Further studies are required to confirm this causal relationship and to investigate the biological mechanisms.

  16. An Overview of Literature Topics Related to Current Concepts, Methods, Tools, and Applications for Cumulative Risk Assessment (2007–2016)

    Science.gov (United States)

    Fox, Mary A.; Brewer, L. Elizabeth; Martin, Lawrence

    2017-01-01

    Cumulative risk assessments (CRAs) address combined risks from exposures to multiple chemical and nonchemical stressors and may focus on vulnerable communities or populations. Significant contributions have been made to the development of concepts, methods, and applications for CRA over the past decade. Work in both human health and ecological cumulative risk has advanced in two different contexts. The first context is the effects of chemical mixtures that share common modes of action, or that cause common adverse outcomes. In this context two primary models are used for predicting mixture effects, dose addition or response addition. The second context is evaluating the combined effects of chemical and nonchemical (e.g., radiation, biological, nutritional, economic, psychological, habitat alteration, land-use change, global climate change, and natural disasters) stressors. CRA can be adapted to address risk in many contexts, and this adaptability is reflected in the range in disciplinary perspectives in the published literature. This article presents the results of a literature search and discusses a range of selected work with the intention to give a broad overview of relevant topics and provide a starting point for researchers interested in CRA applications. PMID:28387705

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

    Science.gov (United States)

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

    2016-11-11

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

  18. The effects of waves and currents on the transport of oil-mineral aggregates (OMAs) and their potential risks to benthic organisms

    Energy Technology Data Exchange (ETDEWEB)

    Niu, H.; Li, Z.; Lee, K.; Kepkay, P. [Bedford Inst. of Oceanography, Dartmouth, NS (Canada). Centre for Offshore Oil , Gas and Energy Research; Fisheries and Oceans Canada, Dartmouth, NS (Canada); Mullin, J. [United States Dept. of the Interior, Herndon, VA (United States). Minerals Management Service

    2009-07-01

    Wave motion can break up surface oil spills on water into micron-sized oil droplets. The many suspended particles in the water column can interact with oil droplets to form oil-mineral aggregates (OMAs). This natural process stabilizes dispersed oil droplets in the water column and improves their rate of biodegradation. This reduces the probability of oil reaching shores. This paper reported on a study that investigated the transport processes of OMAs in the marine environment. It used a newly developed integrated modelling methodology that examined the transport of OMAs and evaluated the risks to the benthic organisms under a wide range of wave and current conditions. A set of 12 simulations were conducted under mean currents of 0.16, 0.33 and 0.49 m/s and significant wave heights of 0, 0.5, 2.5 and 5.0 m. The study showed that although waves can hinder the settling of OMAs, the current has little influence on the settling. Both waves and current had an appreciable affect on transport and risks. The effects of current were observed over the entire simulation period, while the effects of the waves were more pronounced at the early stages of transport. 20 refs., 7 figs.

  19. Regulatory Information By Sector

    Science.gov (United States)

    Find environmental regulatory, compliance, & enforcement information for various business, industry and government sectors, listed by NAICS code. Sectors include agriculture, automotive, petroleum manufacturing, oil & gas extraction & other manufacturing

  20. The exposure of microfinance institutions to financial risk

    Directory of Open Access Journals (Sweden)

    Thomas Gietzen

    2017-12-01

    Full Text Available This study examines the exposure of microfinance institutions to liquidity-, interest rate and foreign exchange (FX risk. Using manually collected data from microfinance institutions’ financial reporting, I find that the microfinance sector faces minimal liquidity risk, high interest rate risk and a lower than commonly assumed exposure to FX risk. Linking risk exposure to institutional characteristics, the data shows that legal status and regional affiliation are correlated with risk exposure while regulatory quality is not. Results suggest that the development community may not expect large benefits from expanding the plethora of current measures taken to mitigate liquidity or FX risk.

  1. Electromagnetic modelling of current flow in the heart from TASER devices and the risk of cardiac dysrhythmias

    Energy Technology Data Exchange (ETDEWEB)

    Holden, S J [Defence Science and Technology Laboratory, Porton Down, Salisbury, Wiltshire SP4 0JQ (United Kingdom); Sheridan, R D [Defence Science and Technology Laboratory, Porton Down, Salisbury, Wiltshire SP4 0JQ (United Kingdom); Coffey, T J [Mathshop Ltd, Porton Down Science Park, Salisbury, Wiltshire SP4 0JQ (United Kingdom); Scaramuzza, R A [Flomerics Ltd, Electromagnetic Division, TLM House, Percy Street, Nottingham NG16 3EP (United Kingdom); Diamantopoulos, P [Bio-Medical Modelling Unit, School of Engineering, University of Sussex, Falmer, Sussex BN1 9QT (United Kingdom)

    2007-12-21

    Increasing use by law enforcement agencies of the M26 and X26 TASER electrical incapacitation devices has raised concerns about the arrhythmogenic potential of these weapons. Using a numerical phantom constructed from medical images of the human body in which the material properties of the tissues are represented, computational electromagnetic modelling has been used to predict the currents arising at the heart following injection of M26 and X26 waveforms at the anterior surface of the chest (with one TASER 'barb' directly overlying the ventricles). The modelling indicated that the peak absolute current densities at the ventricles were 0.66 and 0.11 mA mm{sup -2} for the M26 and X26 waveforms, respectively. When applied during the vulnerable period to the ventricular epicardial surface of guinea-pig isolated hearts, the M26 and X26 waveforms induced ectopic beats, but only at current densities greater than 60-fold those predicted by the modelling. When applied to the ventricles in trains designed to mimic the discharge patterns of the TASER devices, neither waveform induced ventricular fibrillation at peak currents >70-fold (for the M26 waveform) and >240-fold (for the X26) higher than the modelled current densities. This study provides evidence for a lack of arrhythmogenic action of the M26 and X26 TASER devices.

  2. Electromagnetic modelling of current flow in the heart from TASER devices and the risk of cardiac dysrhythmias

    Science.gov (United States)

    Holden, S. J.; Sheridan, R. D.; Coffey, T. J.; Scaramuzza, R. A.; Diamantopoulos, P.

    2007-12-01

    Increasing use by law enforcement agencies of the M26 and X26 TASERTASER is an acronym for Thomas A. Swift's Electric Rifle from the book Tom Swift and His Electric Rifle (1911) by Victor Appleton, ISBN-10: 1594561257. electrical incapacitation devices has raised concerns about the arrhythmogenic potential of these weapons. Using a numerical phantom constructed from medical images of the human body in which the material properties of the tissues are represented, computational electromagnetic modelling has been used to predict the currents arising at the heart following injection of M26 and X26 waveforms at the anterior surface of the chest (with one TASER 'barb' directly overlying the ventricles). The modelling indicated that the peak absolute current densities at the ventricles were 0.66 and 0.11 mA mm-2 for the M26 and X26 waveforms, respectively. When applied during the vulnerable period to the ventricular epicardial surface of guinea-pig isolated hearts, the M26 and X26 waveforms induced ectopic beats, but only at current densities greater than 60-fold those predicted by the modelling. When applied to the ventricles in trains designed to mimic the discharge patterns of the TASER devices, neither waveform induced ventricular fibrillation at peak currents >70-fold (for the M26 waveform) and >240-fold (for the X26) higher than the modelled current densities. This study provides evidence for a lack of arrhythmogenic action of the M26 and X26 TASER devices.

  3. European regulatory framework for person carrier robots

    NARCIS (Netherlands)

    Fosch Villaronga, Eduard; Roig, A.

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

  4. Secondhand Smoke Is an Important Modifiable Risk Factor in Sickle Cell Disease: A Review of the Current Literature and Areas for Future Research

    Directory of Open Access Journals (Sweden)

    S. Christy Sadreameli

    2016-11-01

    Full Text Available Sickle cell disease (SCD is an autosomal recessive hemoglobinopathy that causes significant morbidity and mortality related to chronic hemolytic anemia, vaso-occlusion, and resultant end-organ damage. Tobacco smoke exposure (TSE through secondhand smoke exposure in people with SCD of all ages and through primary smoking in adolescents and adults is associated with significantly increased morbidity, with increased rates of emergency department visits and hospitalizations for painful vaso-occlusive crises and acute chest syndrome (ACS. Secondhand smoke is also associated with pulmonary function abnormalities in children with SCD who are already at risk for pulmonary function abnormalities on the basis of SCD. TSE is emerging as one of the few modifiable risk factors of SCD. This review discusses the current state of the evidence with respect to TSE and SCD morbidity, discusses potential mechanisms, and highlights current gaps in the evidence and future research directions.

  5. Probabilistic-Numerical assessment of pyroclastic current hazard at Campi Flegrei and Naples city: Multi-VEI scenarios as a tool for full-scale risk management

    CERN Document Server

    Mastrolorenzo, Giuseppe; Pappalardo, Lucia; Rossano, Sergio

    2016-01-01

    The Campi Flegrei volcanic field (Italy) poses very high risk to the highly urbanized Neapolitan area. Eruptive history was dominated by explosive activity producing pyroclastic currents (PDCs; (Proclastic Density Currents) ranging in scale from localized base surges to regional flows. Here we apply probabilistic numerical simulation approaches to produce PDC hazard maps, based on a comprehensive spectrum of flow properties and vent locations. These maps and provide all probable Volcanic Explosivity Index (VEI) scenarios from different source vents in the caldera, relevant for risk management planning. For each VEI scenario, we report the conditional probability for PDCs (i.e., the probability for a given area to be affected by the passage of PDCs) and related dynamic pressure. Model results indicate that PDCs from VEI<4 events would be confined within the Campi Flegrei caldera, PDC propagation being impeded by the northern and eastern caldera walls. Conversely, PDCs from VEI 4-5 events could invade a wide...

  6. Prevention of thyroid associated-ophthalmopathy in children and adults: current views and management of preventable risk factors.

    Science.gov (United States)

    Krassas, Gerasimos E; Perros, Petros

    2007-03-01

    Primary, secondary and tertiary prevention are defined according to the timing of the preventive intervention in the natural history of a disease. Secondary prevention in Graves' ophthalmopathy (GO) is challenging in the absence of reliable specific serum markers for subclinical GO that would allow an early diagnosis. Some risk factors for occurrence or progression of GO have been identified. Cigarette smoking, thyroid dysfunction and radioactive iodine (RAI) are known preventable risk factors. The list is probably much longer, and future research should be aimed at identifying more. Smoking cessation, restoration of euthyroidism by antithyroid drugs or L-thyroxine, glucocorticoid coverage after RAI or deferring RAI until the eye disease is inactive, may prevent progression of GO. Passive smoking seems to exacerbate autoimmune thyroid disease (AITD) in general, and may have a deleterious effect on childhood GO in particular, therefore avoidance of passive smoking is likely to be beneficial.

  7. The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) Program - Current Status and Future Direction.

    Science.gov (United States)

    Wu, Jasmanda; Juhaeri, Juhaeri

    2016-12-01

    The US Food and Drug Administration (FDA) Amendments Act of 2007 granted the FDA new authorities to enhance drug safety by requiring application holders to submit a proposed Risk Evaluation and Mitigation Strategy (REMS). A REMS is a required risk management plan that uses tools beyond the package insert. REMS elements may include a medication guide and patient package insert for patients and a communication plan focused on health care professionals. Elements to assure safe use (ETASUs) are put in place to mitigate a specific known serious risk when other less restrictive elements of a REMS are not sufficient to mitigate such risk. An implementation system is required for an REMS that includes the ETASUs. With approximately eight years of experience with REMS programs, many health care settings have created systems to manage REMS and also to integrate REMS into their practice settings. At the same time, there are issues associated with the development and implementation of REMS. In 2011, FDA created the REMS Integration Initiative to develop guidance on how to apply statutory criteria to determine when a REMS is required, to improve standardization and assessment of REMS, and to improve integration of REMS into the existing healthcare system. A key component of the REMS Integration Initiative is stakeholder outreach to better understand how existing REMS programs are working and to identify opportunities for improvement. This review attempts to share our company's experience with the REMS program, and to provide updates on FDA's efforts to improve REMS communication, to standardize REMS process, to reduce REMS program burdens and to build a common REMS platform. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  8. Repeat survey of current practice regarding corticosteroid prophylaxis for patients at increased risk of adverse reaction to intravascular contrast agents

    Energy Technology Data Exchange (ETDEWEB)

    Radhakrishnan, S. [Department of Radiology, Wishaw General Hospital, Lanarkshire Acute Hospitals NHS Trust, 50, Netherton Street, Wishaw, Lanarkshire ML2 0DP (United Kingdom)]. E-mail: sureshradhakrish@hotmail.com; Manoharan, S. [Department of Radiology, Wishaw General Hospital, Lanarkshire Acute Hospitals NHS Trust, 50, Netherton Street, Wishaw, Lanarkshire ML2 0DP (United Kingdom); Fleet, M. [Department of Radiology, Wishaw General Hospital, Lanarkshire Acute Hospitals NHS Trust, 50, Netherton Street, Wishaw, Lanarkshire ML2 0DP (United Kingdom)

    2005-01-01

    AIM: To compare the findings of a survey undertaken by us in 2002 regarding steroid premedication given in radiology departments to reduce the risk of adverse reactions in patients at increased risk of intravascular contrast media reactions with a similar survey published in 1994 by R. Seymour et al. The high risk patients considered in our survey were patients with history of asthma, drug allergies, hay fever and eczema. MATERIALS AND METHODS: A total of 225 questionnaires were sent to the consultant in charge for audit for radiology departments from the list given by the Royal College of Radiologists. 175 of the 225 questionnaires were returned (response rate 77.8%) and of these 172 were analysed with respect to the type, dose and duration of steroids. RESULTS: Compared to the survey in 1994, it was found that the number of departments who use steroid cover for all category of risk factors had increased compared to previous survey (73.8% in 2002 versus 55.3% in 1994 (p=0.001). There is now almost universal use of non-ionic contrast 98.8% versus 82.4% in 1994 (p=0.001). There is no agreed policy among radiology departments for the need or the dose or duration of steroid cover. CONCLUSION: Despite the more widespread use of non-ionic contrast media, the use of steroid premedication has increased which is contrary to what is expected as the incidence of adverse reaction to non ionic media is less than ionic contrast media.

  9. Current controversies in prenatal diagnosis 1: NIPT for chromosome abnormalities should be offered to women with low a priori risk.

    Science.gov (United States)

    Van Lith, Jan M M; Faas, Brigitte H W; Bianchi, Diana W

    2015-01-01

    In its successful annual cycle of controversies and debates, the International Society of Prenatal Diagnosis and Therapy once again addressed non-invasive prenatal testing (NIPT) by following up on the 2013 controversy, 'Should non-invasive DNA testing be the standard screening test for Down syndrome in all pregnant women'? with the proposition, 'NIPT for chromosomel abnormalities should be offered to women with low a priori risk'. © 2014 John Wiley & Sons, Ltd.

  10. Elevated resting heart rate is associated with greater risk of cardiovascular and all-cause mortality in current and former smokers

    DEFF Research Database (Denmark)

    Jensen, Magnus T; Marott, Jacob L; Jensen, Gorm B

    2010-01-01

    . Current and former smokers had, irrespective of tobacco consumption, greater relative risk of elevated RHR compared to never smokers. The relative risk of all-cause mortality per 10bpm increase in RHR was (95% CI): 1.06 (1.01-1.10) in never smokers, 1.11 (1.07-1.15) in former smokers, 1.13 (1.......09-1.16) in moderate smokers, and 1.13 (1.10-1.16) in heavy smokers. There was no gender difference. The risk estimates for cardiovascular and all-cause mortality were essentially similar. In univariate analyses, the difference in survival between a RHR in the highest (>80bpm) vs lowest quartile (...

  11. Quantitative Assessment of Current Risks to Harlequin Ducks in Prince William Sound, Alaska, from the Exxon Valdez Oil Spill

    Science.gov (United States)

    Harwell, Mark A.; Gentile, John H.; Parker, Keith R.; Murphy, Stephen M.; Day, Robert H.; Bence, A. Edward; Neff, Jerry M.; Wiens, John A.

    2012-01-01

    Harlequin Ducks (Histrionicus histrionicus) were adversely affected by the Exxon Valdez oil spill (EVOS) in Prince William Sound (PWS), Alaska, and some have suggested effects continue two decades later. We present an ecological risk assessment evaluating quantitatively whether PWS seaducks continue to be at-risk from polycyclic aromatic hydrocarbons (PAHs) in residual Exxon Valdez oil. Potential pathways for PAH exposures are identified for initially oiled and never-oiled reference sites. Some potential pathways are implausible (e.g., a seaduck excavating subsurface oil residues), whereas other pathways warrant quantification. We used data on PAH concentrations in PWS prey species, sediments, and seawater collected during 2001–2008 to develop a stochastic individual-based model projecting assimilated doses to seaducks. We simulated exposures to 500,000 individuals in each of eight age/gender classes, capturing the variability within a population of seaducks living in PWS. Doses to the maximum-exposed individuals are ∼400–4,000 times lower than chronic toxicity reference values established using USEPA protocols for seaducks. These exposures are so low that no individual-level effects are plausible, even within a simulated population that is orders-of-magnitude larger than exists in PWS. We conclude that toxicological risks to PWS seaducks from residual Exxon Valdez oil two decades later are essentially non-existent. PMID:23723680

  12. The safety of intrauterine contraception initiation among women with current asymptomatic cervical infections or at increased risk of sexually transmitted infections.

    Science.gov (United States)

    Jatlaoui, Tara C; Simmons, Katharine B; Curtis, Kathryn M

    2016-12-01

    The objective was to assess risk of pelvic inflammatory disease (PID) among women with current asymptomatic undiagnosed cervical infection or who are at high risk of sexually transmitted infections (STIs), comparing those who have a copper-bearing (Cu-) or levonorgestrel (LNG-) intrauterine device (IUD) placed with women who do not. We searched PubMed and Cochrane Library for articles from January 1984 through January 2016 addressing our objective. We assessed study quality using the United States Preventive Services Task Force evidence grading system. Our search strategy yielded 2220 articles, of which 10 met inclusion criteria. Two studies provided direct evidence of PID rates in women with undiagnosed gonococcal or chlamydial (GC/CT) infection or at high risk for STIs initiating IUDs versus other contraceptive methods (level II-2, fair to poor), and neither study found a difference. Eight studies provided indirect evidence (II-2 to II-3, fair to poor). One study found no difference in PID rates between initiators of Cu- versus LNG-IUDs. Five studies compared algorithms based on patient factors with laboratory GC/CT screening to predict cervical infection. Based on likelihood ratios, none of these algorithms adequately identified women at high risk of asymptomatic cervical infection who should not undergo IUD placement. Two studies compared IUD placement on the same day as STI screening with delayed placement after screening and found no difference in PID rates. Limited evidence suggests that IUD placement does not increase the risk of PID compared with no IUD placement among women with asymptomatic undiagnosed cervical infection or at high risk of STIs. Algorithms based on patient characteristics to identify women with asymptomatic GC/CT may be overly restrictive, leading to missed opportunities for IUD initiation. Historical concerns about higher PID risk among women at risk for STIs who use IUDs may not be relevant with modern devices and STI screening and

  13. Characterising bias in regulatory risk and decision analysis: An analysis of heuristics applied in health technology appraisal, chemicals regulation, and climate change governance.

    Science.gov (United States)

    MacGillivray, Brian H

    2017-08-01

    In many environmental and public health domains, heuristic methods of risk and decision analysis must be relied upon, either because problem structures are ambiguous, reliable data is lacking, or decisions are urgent. This introduces an additional source of uncertainty beyond model and measurement error - uncertainty stemming from relying on inexact inference rules. Here we identify and analyse heuristics used to prioritise risk objects, to discriminate between signal and noise, to weight evidence, to construct models, to extrapolate beyond datasets, and to make policy. Some of these heuristics are based on causal generalisations, yet can misfire when these relationships are presumed rather than tested (e.g. surrogates in clinical trials). Others are conventions designed to confer stability to decision analysis, yet which may introduce serious error when applied ritualistically (e.g. significance testing). Some heuristics can be traced back to formal justifications, but only subject to strong assumptions that are often violated in practical applications. Heuristic decision rules (e.g. feasibility rules) in principle act as surrogates for utility maximisation or distributional concerns, yet in practice may neglect costs and benefits, be based on arbitrary thresholds, and be prone to gaming. We highlight the problem of rule-entrenchment, where analytical choices that are in principle contestable are arbitrarily fixed in practice, masking uncertainty and potentially introducing bias. Strategies for making risk and decision analysis more rigorous include: formalising the assumptions and scope conditions under which heuristics should be applied; testing rather than presuming their underlying empirical or theoretical justifications; using sensitivity analysis, simulations, multiple bias analysis, and deductive systems of inference (e.g. directed acyclic graphs) to characterise rule uncertainty and refine heuristics; adopting "recovery schemes" to correct for known biases

  14. Behavioral Economic Laboratory Research in Tobacco Regulatory Science

    Science.gov (United States)

    Tidey, Jennifer W.; Cassidy, Rachel N.; Miller, Mollie E.; Smith, Tracy T.

    2017-01-01

    Objectives Research that can provide a scientific foundation for the United States Food and Drug Administration (FDA) tobacco policy decisions is needed to inform tobacco regulatory policy. One factor that affects the impact of a tobacco product on public health is its intensity of use, which is determined, in part, by its abuse liability or reinforcing efficacy. Behavioral economic tasks have considerable utility for assessing the reinforcing efficacy of current and emerging tobacco products. Methods This paper provides a narrative review of several behavioral economic laboratory tasks and identifies important applications to tobacco regulatory science. Results Behavioral economic laboratory assessments, including operant self-administration, choice tasks and purchase tasks, can be used generate behavioral economic data on the effect of price and other constraints on tobacco product consumption. These tasks could provide an expedited simulation of the effects of various tobacco control policies across populations of interest to the FDA. Conclusions Tobacco regulatory research questions that can be addressed with behavioral economic tasks include assessments of the impact of product characteristics on product demand, assessments of the abuse liability of novel and potential modified risk tobacco products (MRTPs), and assessments of the impact of conventional and novel products in vulnerable populations. PMID:28580378

  15. Current State and Problems of Radiation Risk Communication: Based on the Results of a 2012 Whole Village Survey.

    Science.gov (United States)

    Kuroda, Yujiro

    2017-02-24

    The entire village of Iitate was contaminated by radioactive material from the Fukushima Daiichi Nuclear Power Plant; even today, the residents remain evacuated. For the villagers, risk communication is an important element of recovery and maintaining health. This analysis focuses on the problem of radiation, presents results from a questionnaire of villagers, and examines methods for future risk communication activities. In May 2012, anonymous surveys were sent to 2914 heads of households whose addresses were registered in Iitate. Their understanding of radiation and information needs were extracted from the answers. There were 1755 valid responses (61.4%). In relation to understanding, the most frequent answer was "There are numerous opinions and I do not know which one is true" (72.2%), followed by "I definitely want opportunities to learn more about how radiation is created" (41.6%). Residents felt that they could not determine which of the available information was reliable. The 60s+ age group responded more than younger age groups that "I do not have much information and do not know much about it," "I do not know much about it, so I want to learn more," and "I definitely want opportunities to learn more about how radiation is created." Among information needs, "publications" (50.2%) and "community associations" (45.9%) received many responses; residents want study groups to be held at places and through media that give them regular opportunities to connect with each other. Residents in their 20s and 30s preferred "publications," while those in their 40s, 50s, and 60s+ were more likely to request "community associations" and "resident meetings." In addition, we found gender differences in both understanding and information needs. These results indicate that radiation and health risk communication should be addressed in a way that aligns with residents' needs by age and gender.

  16. GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations.

    Science.gov (United States)

    Van Eenennaam, Alison L

    2013-09-25

    from a GE evaluation process that currently focuses only on risk assessment and identifying ever diminishing marginal hazards, to a regulatory approach that more objectively evaluates and communicates the likely impact of approving a new GE plant or animal on agricultural production systems.

  17. Metabolic syndrome and subsequent risk of type 2 diabetes and cardiovascular disease in elderly women Challenging the current definition

    DEFF Research Database (Denmark)

    Møller, Katrine Dragsbæk; Neergaard, Jesper; Laursen, Janne Marie

    2016-01-01

    ) and cardiovascular disease (CVD) in elderly Caucasian women. We further investigated if stratification of individuals not defined with MetS would add predictive power in defining future disease prevalence of individuals with MetS. The Prospective Epidemiological Risk Factor Study, a community-based cohort study......, followed 3905 Danish women since 2000 (age: 70.1±6.5) with no previous diagnosis of T2DM or CVD, holding all measurements used for MetS definition; central obesity, hypertension, hyperlipidemia, and hyperglycemia combined with register-based follow-up information. Elderly women with defined MetS presented...

  18. Current state of cardiac rehabilitation in Germany: patient characteristics, risk factor management and control status, by education level.

    Science.gov (United States)

    Bestehorn, Kurt; Jannowitz, Christina; Horack, Martin; Karmann, Barbara; Halle, Martin; Völler, Heinz

    2011-01-01

    After the acute hospital stay, most cardiac patients in Germany are transferred for a 3-4-week period of inpatient cardiac rehabilitation. We aim to describe patient characteristics and risk factor management of cardiac rehabilitation patients with a focus on drug treatment and control status, differentiated by education level (low level, elementary school; intermediate level, secondary modern school; high level, grammar school/university). Data covering a time period between 2003 and 2008 from 68,191 hospitalized patients in cardiac rehabilitation from a large-scale registry (Transparency Registry to Objectify Guideline- Oriented Risk Factor Management) were analyzed descriptively. Further, a multivariate model was applied to assess factors associated with good control of risk factors. In the total cohort, patients with a manifestation of coronary artery disease (mean age 63.7 years, males 71.7%) were referred to cardiac rehabilitation after having received percutaneous coronary intervention (51.6%) or coronary bypass surgery (39.5%). Statin therapy increased from 76.3% at entry to 88.9% at discharge, and low density lipoprotein cholesterol education. In contrast with patients having high education, those with low education had more diabetes, hypertension, and peripheral arterial disease, had lower exercise capacity, and received less treatment with statins and guideline-orientated therapy in general. In the multivariate model, good control was significantly more likely in men (odds ratio 1.38; 95% confidence interval 1.30-1.46), less likely in patients of higher age (0.99; 0.99-0.99), with diabetes (0.90; 0.85-0.95), or peripheral arterial disease (0.88; 0.82-0.95). Compared with a low level education, a mid level education was associated with poor control (0.94; 0.89-0.99), while high education did not have a significant effect (1.08; 0.99-1.17). Patients with different levels of education treated in cardiac rehabilitation did not differ relevantly in terms of

  19. An integrative review of the current knowledge of cardiovascular disease and associated risk factors in the Old Order Amish.

    Science.gov (United States)

    Gillum, Deborah R; Staffileno, Beth A

    2011-04-01

    To review the uniqueness of the Amish culture and evaluate the published research on cardiovascular disease and associated risk factors in the Amish. A computerized database search from January 1999 to January 2009 was conducted using the search terms Amish and cardiovascular. The majority of published research is based on the Amish in Lancaster County, Pennsylvania; is genetically based; and did not make recommendations for health care practices in the Amish. Studies that focus on cardiovascular disease in the Amish outside Lancaster County, Pennsylvania, and that study cardiovascular health care practices of the Amish are needed to develop culturally specific educational interventions.

  20. Update on Head and Neck Cancer: Current Knowledge on Epidemiology, Risk Factors, Molecular Features and Novel Therapies.

    Science.gov (United States)

    Pezzuto, Francesca; Buonaguro, Luigi; Caponigro, Francesco; Ionna, Franco; Starita, Noemy; Annunziata, Clorinda; Buonaguro, Franco M; Tornesello, Maria Lina

    2015-01-01

    Tobacco use and alcohol consumption are the main risk factors associated with head and neck squamous cell carcinoma (SCC) development due to their cytotoxic and mutagenic effects on the exposed epithelia of the upper aerodigestive tract. Epstein-Barr virus (EBV) and high-risk human papillomaviruses (HPVs), both encoding viral oncoproteins able to interfere with cell cycle control, have been recognized as the etiological agents of nasopharynx carcinoma and a fraction of oropharyngeal carcinoma, respectively. Head and neck SCC is a deadly disease and despite innovative treatments represents a major challenge for patients. Recently, a number of genomic studies have highlighted the molecular heterogeneity of head and neck SCC based on methylation profiles, microRNA expression, mutated genes and new druggable pathways which may represent new targets for cancer-tailored therapies. To date, cetuximab is the only FDA-approved anti-epidermal growth factor receptor therapy for the treatment of head and neck SCC. In addition, a number of monoclonal antibodies targeting AKT, mTOR and PI3K pathways are under evaluation. Several therapeutic vaccines against HPV16 and EBV proteins are also under study. The purpose of this article is to review the epidemiology, pathogenesis and molecular features of head and neck SCC, with an emphasis on new therapies. © 2015 S. Karger AG, Basel.

  1. Multi-criteria decision-making for flood risk management: a survey of the current state of the art

    Science.gov (United States)

    Madruga de Brito, Mariana; Evers, Mariele

    2016-04-01

    This paper provides a review of multi-criteria decision-making (MCDM) applications to flood risk management, seeking to highlight trends and identify research gaps. A total of 128 peer-reviewed papers published from 1995 to June 2015 were systematically analysed. Results showed that the number of flood MCDM publications has exponentially grown during this period, with over 82 % of all papers published since 2009. A wide range of applications were identified, with most papers focusing on ranking alternatives for flood mitigation, followed by risk, hazard, and vulnerability assessment. The analytical hierarchy process (AHP) was the most popular method, followed by Technique for Order Preference by Similarity to an Ideal Solution (TOPSIS), and Simple Additive Weighting (SAW). Although there is greater interest in MCDM, uncertainty analysis remains an issue and was seldom applied in flood-related studies. In addition, participation of multiple stakeholders has been generally fragmented, focusing on particular stages of the decision-making process, especially on the definition of criteria weights. Therefore, addressing the uncertainties around stakeholders' judgments and endorsing an active participation in all steps of the decision-making process should be explored in future applications. This could help to increase the quality of decisions and the implementation of chosen measures.

  2. Validation and comparison of currently available stratification systems for patients with diabetes by risk of foot ulcer development.

    Science.gov (United States)

    Monteiro-Soares, M; Vaz-Carneiro, A; Sampaio, S; Dinis-Ribeiro, M

    2012-09-01

    There are five systems to stratify the risk for the development of a diabetic foot ulcer (DFU). This study aimed to prospectively validate all of them in the same cohort of participants to allow their direct comparison. A retrospective cohort study was conducted on all patients with diabetes but without an active DFU attending our podiatry section (n=364) from January 2008 to December 2010. Participants' characteristics and all variables composing the stratification systems were assessed at baseline. Follow-up was performed for 1 year or until DFU occurred. Participants had a mean age of 64 years; 99.7% had type 2 diabetes and 48.6% were male. Median follow-up was 12 months (1-12) during which 33 subjects (9.1%) developed a DFU. Age, diabetes duration, foot deformity, peripheral vascular disease, diabetic peripheral neuropathy, previous DFU, and previous lower extremity amputation were associated with DFU occurrence. All systems presented greater DFU occurrence frequency as the risk group was higher (χ(2), Pdiabetic foot screening and resource allocation, it would be desirable to have a single unified system, combining the available systems, prospectively validated in a multicenter context and testing the inclusion of novel predictive variables' pertinence.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2001-07-01

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

  4. Current state of cardiac rehabilitation in Germany: patient characteristics, risk factor management and control status, by education level

    Directory of Open Access Journals (Sweden)

    Bestehorn K

    2011-10-01

    Full Text Available Kurt Bestehorn1, Christina Jannowitz2, Martin Horack3, Barbara Karmann2, Martin Halle4, Heinz Völler5 1Institute for Clinical Pharmacology, Technical University, Dresden; 2Medical Department, MSD Sharp and Dohme GmbH, Haar; 3Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg, Ludwigshafen; 4Center for Prevention and Sports Medicine, Technical University, Munich; 5Klinik am See, Rehabilitation Center for Cardiovascular Diseases, Rüdersdorf, Germany Background: After the acute hospital stay, most cardiac patients in Germany are transferred for a 3–4-week period of inpatient cardiac rehabilitation. We aim to describe patient characteristics and risk factor management of cardiac rehabilitation patients with a focus on drug treatment and control status, differentiated by education level (low level, elementary school; intermediate level, secondary modern school; high level, grammar school/university. Methods: Data covering a time period between 2003 and 2008 from 68,191 hospitalized patients in cardiac rehabilitation from a large-scale registry (Transparency Registry to Objectify Guideline-Oriented Risk Factor Management were analyzed descriptively. Further, a multivariate model was applied to assess factors associated with good control of risk factors. Results: In the total cohort, patients with a manifestation of coronary artery disease (mean age 63.7 years, males 71.7% were referred to cardiac rehabilitation after having received percutaneous coronary intervention (51.6% or coronary bypass surgery (39.5%. Statin therapy increased from 76.3% at entry to 88.9% at discharge, and low density lipoprotein cholesterol <100 mg/dL rates increased from 31.1% to 69.6%. Mean fasting blood glucose decreased from 108 mg/dL to 104 mg/dL, and mean exercise capacity increased from 78 W to 95 W. Age and gender did not differ by education. In contrast with patients having high education, those with low education had more diabetes

  5. Factores y riesgos laborales psicosociales: conceptualización, historia y cambios actuales Factors and occupational psychosocial risks: concept, history and current changes

    Directory of Open Access Journals (Sweden)

    Bernardo Moreno Jiménez

    2011-01-01

    Full Text Available El trabajo ha sido históricamente un riesgo para la salud. Las condiciones laborales han supuesto habitualmente una amenaza a la salud que han ocasionado accidentes y enfermedades relacionadas con la salud de todo tipo. La imagen popular l asociada al trabajo ha sido claramente negativa. Los tiempos han cambiado de forma muy importante, pero las condiciones laborales siguen siendo preocupantes. La preocupación por los riesgos laborales se ha centrado históricamente en los riesgos físicos y ambientales, pero se ha producido una atención creciente en los riesgos psicosociales que exigen un mayor esfuerzo de definición en sus diferentes formas. En los tiempos actuales, debido a la expansión del mercado de servicios y a la globalización los riesgos psicosociales se han incrementado e intensificado. Los datos actuales muestran que sus efectos sobre la salud son amplios e importantes. Por ello, una atención integral a la salud laboral necesita cuidar de forma especial atención a los factores y riesgos psicosociales.Work has been historically a health risk. Working conditions have usually been a threat to health causing accidents and many kind of health-related diseases. The popular image associated with work has clearly been negative. Times have changed very significantly, but working conditions remain a concern. Concern about occupational risks has historically focused on environmental and physical risks, but there has been increasing attention on psychosocial risks which require a greater effort to be defined. In modern times, due to services market expansion and globalization, psychosocial risks have increased and intensified. Current data show that psychosocial risks cause important health effects. Therefore, it is important make special attention to psychosocial factors and risks.

  6. Regulatory bioinformatics for food and drug safety.

    Science.gov (United States)

    Healy, Marion J; Tong, Weida; Ostroff, Stephen; Eichler, Hans-Georg; Patak, Alex; Neuspiel, Margaret; Deluyker, Hubert; Slikker, William

    2016-10-01

    "Regulatory Bioinformatics" strives to develop and implement a standardized and transparent bioinformatic framework to support the implementation of existing and emerging technologies in regulatory decision-making. It has great potential to improve public health through the development and use of clinically important medical products and tools to manage the safety of the food supply. However, the application of regulatory bioinformatics also poses new challenges and requires new knowledge and skill sets. In the latest Global Coalition on Regulatory Science Research (GCRSR) governed conference, Global Summit on Regulatory Science (GSRS2015), regulatory bioinformatics principles were presented with respect to global trends, initiatives and case studies. The discussion revealed that datasets, analytical tools, skills and expertise are rapidly developing, in many cases via large international collaborative consortia. It also revealed that significant research is still required to realize the potential applications of regulatory bioinformatics. While there is significant excitement in the possibilities offered by precision medicine to enhance treatments of serious and/or complex diseases, there is a clear need for further development of mechanisms to securely store, curate and share data, integrate databases, and standardized quality control and data analysis procedures. A greater understanding of the biological significance of the data is also required to fully exploit vast datasets that are becoming available. The application of bioinformatics in the microbiological risk analysis paradigm is delivering clear benefits both for the investigation of food borne pathogens and for decision making on clinically important treatments. It is recognized that regulatory bioinformatics will have many beneficial applications by ensuring high quality data, validated tools and standardized processes, which will help inform the regulatory science community of the requirements

  7. Refinement and cross-validation of nickel bioavailability in PNEC-Pro, a regulatory tool for site-specific risk assessment of metals in surface water.

    Science.gov (United States)

    Verschoor, Anja J; Vijver, Martina G; Vink, Jos P M

    2017-09-01

    The European Water Framework Directive prescribes that the environmental quality standards for nickel in surface waters should be based on bioavailable concentrations. Biotic ligand models (BLMs) are powerful tools to account for site-specific bioavailability within risk assessments. Several BLMs and simplified tools are available. For nickel, most of them are based on the same toxicity dataset and chemical speciation methodology as laid down in the 2008 European Union Environmental Risk Assessment Report (RAR). Since then, further insights into the toxic effects of nickel on aquatic species have been gained, and new data and methodologies have been generated and implemented using the predicted-no-effect-concentration (PNEC)-pro tool. The aim of the present study is to provide maximum transparency on data revisions and how this affects the derived environmental quality standards. A case study with 7 different ecoregions was used to determine differences in species sensitivity distributions and in hazardous concentrations for 5% of the species (HC5) values between the original Ni-RAR BLMs and the PNEC-pro BLMs. The BLM parameters used were pH dependent, which extended the applicability domain of PNEC-pro up to a pH of 8.7 for surface waters. After inclusion of additional species and adjustment for cross-species extrapolation, the HC5s were well within the prediction range of the RAR. Based on the latest data and scientific insights, transfer functions in the user-friendly PNEC-pro tool have been updated accordingly without compromising the original considerations of the Ni-RAR. Environ Toxicol Chem 2017;36:2367-2376. © 2017 SETAC. © 2017 SETAC.

  8. A randomized trial to evaluate the risk of gastrointestinal disease due to consumption of drinking water meeting current microbiological standards.

    Science.gov (United States)

    Payment, P; Richardson, L; Siemiatycki, J; Dewar, R; Edwardes, M; Franco, E

    1991-01-01

    BACKGROUND: This project directly and empirically measured the level of gastrointestinal (GI) illness related to the consumption of tapwater prepared from sewage-contaminated surface waters and meeting current water quality criteria. METHODS: A randomized intervention trial was carried out; 299 eligible households were supplied with domestic water filters (reverse-osmosis) that eliminate microbial and chemical contaminants from their water, and 307 households were left with their usual tapwater without a filter. The GI symptomatology was evaluated by means of a family health diary maintained prospectively by all study families over a 15-month period. RESULTS: The estimated annual incidence of GI illness was 0.76 among tapwater drinkers compared with 0.50 among filtered water drinkers (p less than 0.01). These findings were consistently observed in all population subgroups. CONCLUSION: It is estimated that 35% of the reported GI illnesses among the tapwater drinkers were water-related and preventable. Our results raise questions about the adequacy of current standards of drinking water quality to prevent water-borne endemic gastrointestinal illness. PMID:2029037

  9. Risk factors and current health seeking patterns of migrants in northeastern Mexico: healthcare needs for a socially vulnerable population

    Directory of Open Access Journals (Sweden)

    Philippe eStoesslé

    2015-08-01

    Full Text Available This study identified risk factors for health and access to healthcare services of migrants during their journey across Mexico to the United States. Data were collected in shelters located in Monterrey, the largest city of northeastern Mexico, through a basic clinical examination and a survey completed by 75 migrants; 92% of them were undocumented Central Americans. During their transit, they are at a high risk of contracting, developing, and transmitting diseases. The need of working to survive affects health-seeking behavior and a constant fear of being traced keeps migrants away from public health services, which delays diagnosis and treatment of diseases. Negligent lifestyles, such as smoking, drinking (31.8% of men and 11.1% of women, and drug abuse (13% of men and 11% of women, were found. Regarding tuberculosis (TB, undocumented migrants are usually not screened, even though they come from countries with a high TB burden. Besides, they might be overexposed to TB because of their living conditions in overcrowded places with deficient hygiene, protection, and malnutrition (54.7% of the sample. Possible comorbidities like acquired immune deficiency syndrome (AIDS; 4% and diabetes (2.7%, but probably under-diagnosed were referred. Migrants have little TB knowledge, which is independent of their level of education or a previous experience of deportation. About one-third of the migrants were totally unfamiliar with TB-related symptoms, while 36% had correct knowledge of basic TB symptoms. We conclude that a shortage of information on the highly vulnerable migratory population combined with a lack of social support and health education among migrants may play a significant role in the spread of communicable diseases. We recommend that health authorities address this urgent, binational, public health concern, in order to prevent outbreaks of emerging infections.

  10. Current and future needs for developmental toxicity testing.

    Science.gov (United States)

    Makris, Susan L; Kim, James H; Ellis, Amy; Faber, Willem; Harrouk, Wafa; Lewis, Joseph M; Paule, Merle G; Seed, Jennifer; Tassinari, Melissa; Tyl, Rochelle

    2011-10-01

    A review is presented of the use of developmental toxicity testing in the United States and international regulatory assessment of human health risks associated with exposures to pharmaceuticals (human and veterinary), chemicals (agricultural, industrial, and environmental), food additives, cosmetics, and consumer products. Developmental toxicology data are used for prioritization and screening of pharmaceuticals and chemicals, for evaluating and labeling of pharmaceuticals, and for characterizing hazards and risk of exposures to industrial and environmental chemicals. The in vivo study designs utilized in hazard characterization and dose-response assessment for developmental outcomes have not changed substantially over the past 30 years and have served the process well. Now there are opportunities to incorporate new technologies and approaches to testing into the existing assessment paradigm, or to apply innovative approaches to various aspects of risk assessment. Developmental toxicology testing can be enhanced by the refinement or replacement of traditional in vivo protocols, including through the use of in vitro assays, studies conducted in alternative nonmammalian species, the application of new technologies, and the use of in silico models. Potential benefits to the current regulatory process include the ability to screen large numbers of chemicals quickly, with the commitment of fewer resources than traditional toxicology studies, and to refine the risk assessment process through an enhanced understanding of the mechanisms of developmental toxicity and their relevance to potential human risk. As the testing paradigm evolves, the ability to use developmental toxicology data to meet diverse critical regulatory needs must be retained. © 2011 Wiley Periodicals, Inc.

  11. Complexity of childhood sexual abuse: Predictors of current PTSD, mood disorders, substance use, and sexual risk behavior among adult men who have sex with men

    Science.gov (United States)

    Boroughs, Michael S.; Valentine, Sarah E.; Ironson, Gail H.; Shipherd, Jillian C.; Safren, Steven A.; Taylor, S. Wade; Dale, Sannisha K.; Baker, Joshua S.; Wilner, Julianne G.; O'Cleirigh, Conall

    2016-01-01

    Men who have sex with men (MSM) are the group most at risk for HIV and represent the majority of new infections in the United States. Rates of childhood sexual abuse (CSA) among MSM have been estimated as high as 46%. CSA is associated with increased risk of HIV and greater likelihood of HIV sexual risk behavior. The purpose of this study was to identify the relationships between CSA complexity indicators and mental health, substance use, sexually transmitted infections (STIs) and HIV sexual risk among MSM. MSM with CSA histories (n = 162) who were screened for an HIV-prevention efficacy trial completed comprehensive psychosocial assessments. Five indicators of complex CSA experiences were created: CSA by family member, CSA with penetration, CSA with physical injury, CSA with intense fear, and first CSA in adolescence. Adjusted regression models were used to identify relationships between CSA complexity and outcomes. Participants reporting CSA by family member were at 2.6 odds of current alcohol use disorder (OR: 2.64: CI 1.24 – 5.63), 2 times higher odds of substance use disorder (OR 2.1: CI 1.02 – 2.36), and 2.7 times higher odds of reporting an STI in the past year (OR 2.7: CI 1.04 – 7.1). CSA with penetration was associated with increased likelihood of current PTSD (OR 3.17: CI 1.56 – 6.43), recent HIV sexual risk behavior (OR 2.7: CI 1.16 – 6.36) and a greater number of casual sexual partners (p = .02). Both CSA with Physical Injury (OR 4.05: CI 1.9 – 8.7) and CSA with Intense Fear (OR 5.16: CI 2.5 – 10.7) were related to increased odds for current PTSD. First CSA in adolescence was related to increased odds of major depressive disorder. These findings suggest that CSA, with one or more complexities, creates patterns of vulnerabilities for MSM, including PTSD, substance use, and sexual risk taking and suggests the need for detailed assessment of CSA and the development of integrated HIV prevention programs that address mental health and substance

  12. Regulatory Myeloid Cells in Transplantation

    Science.gov (United States)

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

    2013-01-01

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

  13. Updated Regulatory Considerations for Nanomedicines.

    Science.gov (United States)

    Subin, Sankarankutty; Vijayan, Venugopal; Kumar, Jaya Raja

    2017-06-14

    Nanomedicine is a branch which deals with medicinal products, devices, non-biological complex drugs and antibody-nanoparticle conjugates and general health products that are manufactured using nanotechnology. Nanomedicine provide the same efficacies as traditional medicines owing to their improved solubility and bioavailability with reduced dosages. However, there are currently safety concerns due to the difficulties related to nanomaterial characterization; this might be the reason for unawareness of such medicines among the patients. The absence of clear regulatory guidelines further complicates matters, as it makes the path to registering them with regulatory bodies difficult. However, some products have overcome these obstacles and have been registered. While there are many international initiatives to harmonize the regulatory requirements and helps the industry to determining the most important characteristics that influence in vivo product performance. This review focuses on the various types of nanopharmaceuticals, and developments process with strategies tailored to upcoming regulations may satisfy the patients' needs. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  14. 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.

  15. Risk Factors of Young Graduates in the Competitive E.U. Labour Market at the End of the Current Economic Crisis

    Directory of Open Access Journals (Sweden)

    Kacerova Eliska

    2016-09-01

    Full Text Available Modern development trends in the labour market have been an increasingly important political and economic issue not only domestically but also on the European level. It proves the fact that in The Europe 2020 strategy, one of the main five points is the aim to increase the employment rate of the population (age: 20–64 from the current 69% to at least 75%. Various risk groups of job candidates emerge among the unemployed. The economic crisis in 2007 made the situation in the labour markets worse. The demand for labour decreased while the number of candidates increased. In recent years, fresh graduates under the age of 25 have been regarded as a high risk group sometimes nicknamed “the lost generation” or Generation Y. This generation is well accustomed to modern technologies which they use for their own benefit and they are willing and able to work from anywhere. On the contrary, those over the age of 35, who are sometimes referred to as Generation X, have different attitudes and requirements for the labour market. Despite the increasing level of education among young people, their unemployment has been worsening since the economic crisis began. The aim of this article was to ascertain how future university graduates (491 final-year students from 5 faculties at Tomas Bata University in Zlín, Czech Republic perceive individual risk factors influencing the success of today’s graduate of Generation Y in the competitive labour market. The target group, future university graduates, evaluated 13 risk areas on a five-point scale. These 13 risk areas were identified based on primary research among 1.059 employers in the Czech Republic, which is a part of a complete two-year research project IGA/FaME/2013/030. This article focuses on only two areas which closely analysed the perception of graduates as drifters, and their demands for high starting salaries. These two risk areas were mentioned by employers as the areas with the highest risk and

  16. A study on current risk assessments and guidelines on the use of food animal products derived from cloned animals.

    Science.gov (United States)

    Hur, Sun Jin

    2017-10-01

    The author widely surveyed and analyzed the food safety issues, ethical issues, permits, and approval of animal products from animals cloned by somatic cell nuclear transfer worldwide. As a result of a 2-year survey, the author found that there is no evidence that meat and milk derived from cloned animals or their progeny pose a risk to food safety in terms of genotoxicity, adverse reproductive effects, or allergic reactions. Most countries have not approved meat and milk derived from cloned animals, and their progeny are entering the food supply. To establish the guidelines, the author suggests four principles of safety assessment for meat and milk derived from cloned animals. The four main principles for safety assessment are similarities of chemical composition, adverse reproductive effects, genotoxicity, and allergic reactions under the influence of meat and milk from cloned animals and noncloned counterparts. This principle means that meat and milk derived from a cloned animal are safe if there are no differences in the four safety assessments of meat and milk between cloned animal's progeny and noncloned counterparts. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. Current status and trends in performance-based risk-sharing arrangements between healthcare payers and medical product manufacturers.

    Science.gov (United States)

    Carlson, Josh J; Gries, Katharine S; Yeung, Kai; Sullivan, Sean D; Garrison, Louis P

    2014-06-01

    Our objective was to identify and characterize publicly available cases and related trends for performance-based risk-sharing arrangements (PBRSAs). We performed a review of PBRSAs over the past 20 years (1993-2013) using available databases and reports from colleagues and healthcare experts. These were categorized according to a previously published taxonomy of scheme types and assessed in terms of the underlying product and market attributes for each scheme. Macro-level trends were identified related to the timing of scheme adoption, countries involved, types of arrangements, and product and market factors. Our search yielded 148 arrangements. From this set, 65 arrangements included a coverage with an evidence development component, 20 included a conditional treatment continuation component, 54 included a performance-linked reimbursement component, and 42 included a financial utilization component. Each type of scheme addresses fundamental uncertainties that exist when products enter the market. The pace of adoption appears to be slowing, but new countries continue to implement PBRSAs. Over this 20-year period, there has been a consistent movement toward arrangements that minimize administrative burden. In conclusion, the pace of PBRSA adoption appears to be slowing but still has traction in many health systems. These remain a viable coverage and reimbursement mechanism for a wide range of medical products. The long-term viability and growth of these arrangements will rest in the ability of the parties to develop mutually beneficial arrangements that entail minimal administrative burden in their development and implementation.

  18. Current strategies for the diagnosis and management of chronic lymphocytic leukemia (CLL, with a focus on poor-risk CLL: A review

    Directory of Open Access Journals (Sweden)

    Fabienne Mc Clanahan

    2011-06-01

    Full Text Available Despite substantial advancement in the understanding and treatment of chronic lymphocytic leukemia (CLL, a standard curative approach does not exist. The choice of treatment is generally based on the existence of biological and genetic factors associated with the prediction of prognosis, individual response to therapy, and duration of remission. About 20% of patients that require treatment have an aggressive disease course and die within a few years, despite early initiation of intensive therapy (poor-risk CLL. Poor-risk CLL can be predicted by the presence of genomic markers, and the quality and duration of response to purine-analogue-based treatment. Within this patient subgroup alternative treatment approaches such as alemtuzumab or new substances such as flavopiridol or IMiDs® should be considered. To date, the only treatment bearing curative potential is allogeneic stem cell transplantation; in contrast to conventional immunochemotherapy, it can provide long-term disease control, even in patients with del 17p or other unfavorable biological and clinical risk factors. The aim of this review was to outline the current strategies for the diagnosis and management of CLL, with a focus on high-risk CLL.

  19. Safeguards inventory and process monitoring regulatory comparison

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-06-27

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

  20. Amoeba-related health risk in drinking water systems: could monitoring of amoebae be a complementary approach to current quality control strategies?

    Science.gov (United States)

    Codony, Francesc; Pérez, Leonardo Martín; Adrados, Bárbara; Agustí, Gemma; Fittipaldi, Mariana; Morató, Jordi

    2012-01-01

    Culture-based methods for fecal indicator microorganisms are the standard protocol to assess potential health risk from drinking water systems. However, these traditional fecal indicators are inappropriate surrogates for disinfection-resistant fecal pathogens and the indigenous pathogens that grow in drinking water systems. There is now a range of molecular-based methods, such as quantitative PCR, which allow detection of a variety of pathogens and alternative indicators. Hence, in addition to targeting total Escherichia coli (i.e., dead and alive) for the detection of fecal pollution, various amoebae may be suitable to indicate the potential presence of pathogenic amoeba-resisting microorganisms, such as Legionellae. Therefore, monitoring amoeba levels by quantitative PCR could be a useful tool for directly and indirectly evaluating health risk and could also be a complementary approach to current microbial quality control strategies for drinking water systems.

  1. Waste dumping sites as a potential source of POPs and associated health risks in perspective of current waste management practices in Lahore city, Pakistan.

    Science.gov (United States)

    Hafeez, Saba; Mahmood, Adeel; Syed, Jabir Hussain; Li, Jun; Ali, Usman; Malik, Riffat Naseem; Zhang, Gan

    2016-08-15

    Persistent organic pollutants (POPs) including polychlorinated biphenyls (PCBs), polybrominated diphenyl ethers (PBDEs) and dechloran plus (DP) were analyzed in air, dust, soil and water samples from waste dump site, Lahore, Pakistan. It was revealed that PCB levels were detected higher in all matrices than PBDEs and DPs. Principal Component Analysis (PCA) showed higher usage of BDE-47, -99 and di-CBs, tri-CBs, tetra-CBs and penta-CBs. Health risk assessment of PCBs and PBDEs from soil and dust indicated low to moderate risk to the local population via different exposure pathways. It is recommended to improve current waste management practices in order to avoid emissions of contaminants and open dumping grounds should be modified into sanitary landfill. Copyright © 2016 Elsevier B.V. All rights reserved.

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

    Energy Technology Data Exchange (ETDEWEB)

    Cantor, R.

    1986-08-01

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

  3. Deferred Tax Assests and Bank Regulatory Capital

    NARCIS (Netherlands)

    Gallemore, J.

    2012-01-01

    Abstract: In this study, I examine three issues: (1) whether the probability of bank failure is increasing in the proportion of regulatory capital composed of deferred tax assets (DTA), (2) whether market participants incorporate the increased failure risk associated with the DTA component of

  4. 24 CFR 266.505 - Regulatory agreement requirements.

    Science.gov (United States)

    2010-04-01

    ... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Regulatory agreement requirements...

  5. Regulatory unbundling in telecommunications

    OpenAIRE

    Knieps, Günter

    2011-01-01

    Due to its dynamic nature, and the increasing importance of competitive sub-parts, the telecommunications sector provides particularly interesting insights for studying regulatory unbundling. Based on the theory of monopolistic bottle-necks the fallacies of overregulation by undue unbundling obligations are indicated. Neither the promotion of infrastructure competition by mandatory un-bundling of competitive subparts of telecommunications infrastructure, nor regulatory induced network fragmen...

  6. Perceived Discrimination, Psychological Distress, and Current Smoking Status: Results From the Behavioral Risk Factor Surveillance System Reactions to Race Module, 2004–2008

    Science.gov (United States)

    Peppone, Luke J.; Alcaraz, Kassandra; McQueen, Amy; Guido, Joseph J.; Carroll, Jennifer K.; Shacham, Enbal; Morrow, Gary R.

    2012-01-01

    Objectives. We examined the association between perceived discrimination and smoking status and whether psychological distress mediated this relationship in a large, multiethnic sample. Methods. We used 2004 through 2008 data from the Behavioral Risk Factor Surveillance System Reactions to Race module to conduct multivariate logistic regression analyses and tests of mediation examining associations between perceived discrimination in health care and workplace settings, psychological distress, and current smoking status. Results. Regardless of race/ethnicity, perceived discrimination was associated with increased odds of current smoking. Psychological distress was also a significant mediator of the discrimination–smoking association. Conclusions. Our results indicate that individuals who report discriminatory treatment in multiple domains may be more likely to smoke, in part, because of the psychological distress associated with such treatment. PMID:22420821

  7. Review of decision methodologies for evaluating regulatory actions affecting public health and safety. [Nuclear industry site selection

    Energy Technology Data Exchange (ETDEWEB)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels.

  8. Quantifying the Earthquake Clustering that Independent Sources with Stationary Rates (as Included in Current Risk Models) Can Produce.

    Science.gov (United States)

    Fitzenz, D. D.; Nyst, M.; Apel, E. V.; Muir-Wood, R.

    2014-12-01

    The recent Canterbury earthquake sequence (CES) renewed public and academic awareness concerning the clustered nature of seismicity. Multiple event occurrence in short time and space intervals is reminiscent of aftershock sequences, but aftershock is a statistical definition, not a label one can give an earthquake in real-time. Aftershocks are defined collectively as what creates the Omori event rate decay after a large event or are defined as what is taken away as "dependent events" using a declustering method. It is noteworthy that depending on the declustering method used on the Canterbury earthquake sequence, the number of independent events varies a lot. This lack of unambiguous definition of aftershocks leads to the need to investigate the amount of clustering inherent in "declustered" risk models. This is the task we concentrate on in this contribution. We start from a background source model for the Canterbury region, in which 1) centroids of events of given magnitude are distributed using a latin-hypercube lattice, 2) following the range of preferential orientations determined from stress maps and focal mechanism, 3) with length determined using the local scaling relationship and 4) rates from a and b values derived from the declustered pre-2010 catalog. We then proceed to create tens of thousands of realizations of 6 to 20 year periods, and we define criteria to identify which successions of events in the region would be perceived as a sequence. Note that the spatial clustering expected is a lower end compared to a fully uniform distribution of events. Then we perform the same exercise with rates and b-values determined from the catalog including the CES. If the pre-2010 catalog was long (or rich) enough, then the computed "stationary" rates calculated from it would include the CES declustered events (by construction, regardless of the physical meaning of or relationship between those events). In regions of low seismicity rate (e.g., Canterbury before

  9. Proposal for inclusion of the risk based inspection technique in Regulatory Standard NR 13; Proposta de inclusao da tecnica de inspecao baseada em risco na Norma Regulamentadora NR 13

    Energy Technology Data Exchange (ETDEWEB)

    Esteves, Vinicius Teixeira; Lima, Marco Aurelio Oliveira [Det Norske Veritas Ltda. (DNV), Rio de Janeiro, RJ (Brazil)

    2012-07-01

    In Brazil, the Regulatory Standard n. 13 (NR 13) establishes requirements for the inspection of boilers and pressure vessels which has main objective of preventing accidents with these types of equipment. Additionally, it has the Risk-Based Inspection (RBI) technique as an effective way to manage the mechanical integrity of various types of static mechanical equipment by through an inspection planning based on the risk factor. In this study, it is being proposed to include the RBI technique, in the NR 13, for the planning and definition of periods for the safety inspection of boilers and pressure vessels in order to promote an increase in the operational safety in process industries in Brazil. In this study it was carried out a critical analysis of NR 13 and RBI, and beyond that a bibliographic research of various international documents that relate the operational safety of pressurized equipment with the inspection activity, and the acceptability of RBI by governments, agencies and organizations around the world. It is considered that the inclusion and formal acceptance of RBI technique in the NR 13 must be accompanied by a rigorous control to avoid the 'trivialization' of its use and ensure the implementation rational, efficient and reliable. Finally, it was developed and suggested basic elements and minimum requirements to be inserted in the NR 13, to be attended, in order mandatory, by the companies that choose the implementation and use of the RBI technique as a tool for the planning of safety inspection of boilers and pressure vessels. It is concluded that the formal acceptance of the RBI technique in the NR 13 could aggregate much value to this standard, with regard to the prevention of accidents involving boilers or pressure vessels, and provide a technological jump to the companies that make use of RBI technique in Brazil. (author)

  10. Air temperature-related human health outcomes: current impact and estimations of future risks in Central Italy.

    Science.gov (United States)

    Morabito, Marco; Crisci, Alfonso; Moriondo, Marco; Profili, Francesco; Francesconi, Paolo; Trombi, Giacomo; Bindi, Marco; Gensini, Gian Franco; Orlandini, Simone

    2012-12-15

    The association between air temperature and human health is described in detail in a large amount of literature. However, scientific publications estimating how climate change will affect the population's health are much less extensive. In this study current evaluations and future predictions of the impact of temperature on human health in different geographical areas have been carried out. Non-accidental mortality and hospitalizations, and daily average air temperatures have been obtained for the 1999-2008 period for the ten main cities in Tuscany (Central Italy). High-resolution city-specific climatologic A1B scenarios centered on 2020 and 2040 have been assessed. Generalized additive and distributed lag models have been used to identify the relationships between temperature and health outcomes stratified by age: general adults (<65), elderly (aged 65-74) and very elderly (≥75). The cumulative impact (over a lag-period of 30 days) of the effects of cold and especially heat, was mainly significant for mortality in the very elderly, with a higher impact on coastal plain than inland cities: 1 °C decrease/increase in temperature below/above the threshold was associated with a 2.27% (95% CI: 0.17-4.93) and 15.97% (95% CI: 7.43-24.51) change in mortality respectively in the coastal plain cities. A slight unexpected increase in short-term cold-related mortality in the very elderly, with respect to the baseline period, is predicted for the following years in half of the cities considered. Most cities also showed an extensive predicted increase in short-term heat-related mortality and a general increase in the annual temperature-related elderly mortality rate. These findings should encourage efforts to implement adaptation actions conducive to policy-making decisions, especially for planning short- and long-term health intervention strategies and mitigation aimed at preventing and minimizing the consequences of climate change on human health. Copyright © 2012 Elsevier

  11. 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.

  12. Risk

    Science.gov (United States)

    Barshi, Immanuel

    2016-01-01

    Speaking up, i.e. expressing ones concerns, is a critical piece of effective communication. Yet, we see many situations in which crew members have concerns and still remain silent. Why would that be the case? And how can we assess the risks of speaking up vs. the risks of keeping silent? And once we do make up our minds to speak up, how should we go about it? Our workshop aims to answer these questions, and to provide us all with practical tools for effective risk assessment and effective speaking-up strategies..

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

    Science.gov (United States)

    Kuhlmann-Gottke, Johanna; Duchow, Karin

    2015-11-01

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

  14. The Predictive Value of PITX2 DNA Methylation for High-Risk Breast Cancer Therapy: Current Guidelines, Medical Needs, and Challenges

    Directory of Open Access Journals (Sweden)

    Michaela Aubele

    2017-01-01<