Sample records for values regulatory monitoring
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Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices
Rowe, Laura A; Vossenaar, Marieke; Garrett, Greg S
2015-01-01
While fortification of staple foods and condiments has gained enormous global traction, poor performance persists throughout many aspects of implementation, most notably around the critical element of regulatory monitoring, which is essential for ensuring foods meet national fortification standards. Where coverage of fortified foods is high, limited nutritional impact of fortification programs largely exists due to regulatory monitoring that insufficiently identifies and holds producers accountable for underfortified products. Based on quality assurance data from 20 national fortification programs in 12 countries, we estimate that less than half of the samples are adequately fortified against relevant national standards. In this paper, we outline key findings from a literature review, key informant interviews with 11 fortification experts, and semi-quantitative surveys with 39 individuals from regulatory agencies and the food fortification industry in 17 countries on the perceived effectiveness of regulatory monitoring systems and barriers to compliance against national fortification standards. Findings highlight that regulatory agencies and industry disagree on the value that enforcement mechanisms have in ensuring compliance against standards. Perceived political risk of enforcement and poorly resourced inspectorate capacity appear to adversely reinforce each other within an environment of unclear legislation to create a major hurdle for improving overall compliance of fortification programs against national standards. Budget constraints affect the ability of regulatory agencies to create a well-trained inspector cadre and improve the detection and enforcement of non-compliant and underfortified products. Recommendations to improve fortification compliance include improving technical capacity; ensuring sustained leadership, accountability, and funding in both the private and the public sectors; and removing political barriers to ensure consistent detection of
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Handbook for value-impact assessments of NRC regulatory actions
International Nuclear Information System (INIS)
Mullen, M.F.; DiPalo, A.J.
1985-01-01
According to current Nuclear Regulatory Commission (NRC) procedures, value-impact (cost-benefit) assessments must be prepared for all rulemaking actions and for a broad range of other regulatory requirements and guidance. Probabilistic risk assessment (PRA) methods furnish an important part of the information base for these assessments. PRA methods are frequently the principal quantitative tool for estimating the benefits (e.g., public risk reduction) of proposed regulatory actions. In December 1983, the NRC published A Handbook for Value-Impact Assessment, NUREG/CR-3568, which provides a set of systematic procedures for performing value-impact assessments. The Handbook contains methods, data, and sources of information that can assist the regulatory analyst in conducting such assessments. The use of probabilistic risk analysis to estimate the benefits of proposed regulatory actions is described. Procedures and methods are also given for evaluating the costs and other consequences associated with regulatory actions. The Handbook has been adopted by the NRC as the recommended guideline for value impact assessments. This paper presents the background, objectives, and scope of the Handbook, describes the value-impact assessment methods (including the use of probabilistic risk assessment to estimate benefits), and discusses a selection of current and planned applications, with examples to illustrate how the methods are used
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Regulatory monitoring systems of fortified salt and wheat flour in selected ASEAN countries.
van den Wijngaart, Annoek; Bégin, France; Codling, Karen; Randall, Philip; Johnson, Quentin W
2013-06-01
Considerable efforts have been made over the past decade to address vitamin and mineral deficiencies. An increasing number of countries in the Association of Southeast Asian Nations (ASEAN) are adopting mandatory food fortification as one of the primary strategies to overcome these deficiencies. Experience shows that fortified foods can reach large parts of the population, including the poor, if the fortification is done on a mandatory rather than a voluntary basis and if the food vehicle is widely consumed. To review the importance of regulatory monitoring as an essential component of food fortification efforts in selected ASEAN countries, with special focus on the available information on regulatory monitoring systems for iodized salt and fortified wheat flour. The role of regulatory monitoring in strengthening food fortification programs was discussed during a joint regional meeting of the World Health Organization, UNICEF, the Flour Fortification Initiative, the Global Alliance for Improved Nutrition, the Micronutrient Initiative, and the World Bank on regulatory monitoring of salt and wheat flour fortification programs in Asia, which took place in Manila, Philippines, on 27-29 September 2011. This paper reviews the regulatory monitoring systems of selected ASEAN countries that participated in this meeting. Problems and challenges in regulatory monitoring systems for iodized salt and fortified wheat flour in selected ASEAN countries are identified, and a description of the role of regulatory monitoring in strengthening food fortification initiatives, particularly of salt and flour, and highlights of areas for improvement are presented. Regulatory monitoring consists of monitoring activities conducted at the production level, at customs warehouses, and at retail stores by concerned regulatory authorities, and at the production level by producers themselves, as part of quality control and assurance efforts. Unless there are appropriate enforcement and quality
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BIOSENSORS FOR ENVIRONMENTAL MONITORING: A REGULATORY PERSPECTIVE
Biosensors show the potential to complement laboratory-based analytical methods for environmental applications. Although biosensors for potential environmental-monitoring applications have been reported for a wide range of environmental pollutants, from a regulatory perspective, ...
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Development of an air-operated actuator performance monitoring system for regulatory usage
International Nuclear Information System (INIS)
Sung, K. Y.; Kwon, S. J.
2004-01-01
The performance monitoring system of air-operated actuators for regulatory usage has been being developed. Essential elements and operating parameters affecting the actuator performance have been investigated to provide basic information for system development. The monitoring system including an air-operated actuator testing facility and analysis softwares for monitoring and evaluation are also introduced in this paper. As a result of simulated tests, it was known that the system could be a useful tool for the effective monitoring of actuator performance change and fault conditions. This system would be applied to regulatory inspection for utility's data validation and to the training of regulatory staff in future after some modification and expansion
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de Alencar Silva, P.
2013-01-01
Current value modeling ontologies are grounded on the economic premise that profit sharing is a critical condition to be assessed during the configuration of a value constellation. Such a condition ought to be reinforced through a monitoring mechanism design, since a value model expresses only
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International Nuclear Information System (INIS)
Goldammer, Wolfgang; Batandjieva, Borislava; Nasvit, Oleg; German, Olga
2009-06-01
The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation
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Energy Technology Data Exchange (ETDEWEB)
Goldammer, Wolfgang; Batandjieva, Borislava (Private Consultants (Ukraine)); Nasvit, Oleg (National Security and Defence Council of Ukraine, Kyiv (Ukraine)); German, Olga (Swedish Radiation Safety Authority, Stockholm (Sweden))
2009-06-15
The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation
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Franchise Values, Regulatory Monitoring, and Capital Requirements in Optimal Bank Regulation
DEFF Research Database (Denmark)
Andersen, Thomas Barnebeck; Harr, Thomas
2008-01-01
This paper demonstrates that financial deregulation is likely to make standard prudential regulatory instruments less effective in curbing excessive risk-taking incentives among banks. This has interesting implications for optimal bank regulation. When there is an increase in competition, the opt...
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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.
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Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin
2016-05-01
Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.
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Dynamic SPR monitoring of yeast nuclear protein binding to a cis-regulatory element
International Nuclear Information System (INIS)
Mao, Grace; Brody, James P.
2007-01-01
Gene expression is controlled by protein complexes binding to short specific sequences of DNA, called cis-regulatory elements. Expression of most eukaryotic genes is controlled by dozens of these elements. Comprehensive identification and monitoring of these elements is a major goal of genomics. In pursuit of this goal, we are developing a surface plasmon resonance (SPR) based assay to identify and monitor cis-regulatory elements. To test whether we could reliably monitor protein binding to a regulatory element, we immobilized a 16 bp region of Saccharomyces cerevisiae chromosome 5 onto a gold surface. This 16 bp region of DNA is known to bind several proteins and thought to control expression of the gene RNR1, which varies through the cell cycle. We synchronized yeast cell cultures, and then sampled these cultures at a regular interval. These samples were processed to purify nuclear lysate, which was then exposed to the sensor. We found that nuclear protein binds this particular element of DNA at a significantly higher rate (as compared to unsynchronized cells) during G1 phase. Other time points show levels of DNA-nuclear protein binding similar to the unsynchronized control. We also measured the apparent association complex of the binding to be 0.014 s -1 . We conclude that (1) SPR-based assays can monitor DNA-nuclear protein binding and that (2) for this particular cis-regulatory element, maximum DNA-nuclear protein binding occurs during G1 phase
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Regulatory requirements for groundwater monitoring networks at hazardous waste sites
International Nuclear Information System (INIS)
Keller, J.F.
1989-10-01
In the absence of an explicit national mandate to protect groundwater quality, operators of active and inactive hazardous waste sites must use a number of statutes and regulations as guidance for detecting, correcting, and preventing groundwater contamination. The objective of this paper is to provide a framework of the technical and regulatory considerations that are important to the development of groundwater monitoring programs at hazardous waste sites. The technical site-specific needs and regulatory considerations, including existing groundwater standards and classifications, will be presented. 14 refs., 2 tabs
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Effluent monitoring: Its purpose and value
International Nuclear Information System (INIS)
Schoen, A.A.
1978-01-01
The purpose of effluent monitoring is described in terms of the primary objectives, the most important of which is to verify that the facility is functioning as it was designed and that the waste treatment and effluent control systems are performing as planned and expected. The object of a monitoring programme should be periodically re-examined to ensure that the programme serves a contemporary purpose. The value of the effluent monitoring programme is determined by the extent to which users of the monitoring data, i.e. the operator, the regulating authorities and the public, accept the result as indicating that the plant is operating safely, and in an environmentally acceptable manner. The credibility of the monitoring results is therefore the most important factor determining the value of an effluent monitoring programme. (author)
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International Nuclear Information System (INIS)
Gamborg, Christian; Anker, Helle Tegner; Sandøe, Peter
2014-01-01
The article focuses on the interplay between two factors giving rise to friction in bioenergy governance: profound value disagreements (e.g. the prioritizing of carbon concerns like worries over GHG emissions savings over non-carbon related concerns) and regulatory complexity (in terms of regulatory measures and options). We present ethical and legal analyses of the current stalemate on bioenergy governance in the EU using two illustrative cases: liquid biofuels for transport and solid biomass-based bioenergy. The two cases disclose some similarities between these two factors, but the remaining differences may partly explain, or justify, contrasting forms of governance. While there seems to be no easy way in which the EU and national governments can deal with the multiple sustainability issues raised by bioenergy, it is argued that failure to deal explicitly with the underlying value disagreements, or to make apparent the regulatory complexity, clouds the issue of how to move forward with governance of bioenergy. We suggest that governance should be shaped with greater focus on the role of value disagreements and regulatory complexity. There is a need for more openness and transparency about such factors, and about the inherent trade-offs in bioenergy governance. - Highlights: • Ethical and legal challenges in governance of liquid biofuels and wood pellets. • EU sustainability criteria legal and ethical analysis—EU bioenergy policy options. • Analysis of interplay between carbon and non-carbon concerns and regulatory options. • Governance must cope with value disagreement and regulatory complexity
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Towards medicines regulatory authorities' quality performance improvement: value for public health.
Pejović, Gordana; Filipović, Jovan; Tasić, Ljiljana; Marinković, Valentina
2016-01-01
The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions. Copyright © 2014 John Wiley & Sons, Ltd.
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Value Assessment in the Regulatory Context.
Miller, Kathleen L; Woodcock, Janet
2017-02-01
Value assessments are made on new drugs before they even enter the market. Regulators at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration make a clinical benefit-risk assessment to determine whether to approve a new drug. Benefits of a drug are typically quantified directly, as an assessment of efficacy. CDER defines risk as the intersection of the severity of possible harm and the probability of that harm. For a novel drug to be approved, its benefits and risks must be well understood, and the trade-off between the two must be acceptable. To assist with these benefit-risk value assessments, CDER has two ongoing initiatives: the Patient-Focused Drug Development Initiative that aims to substantially increase the role of patient voice in the regulatory process, and a transparency initiative that focuses on creating a structured framework for benefit-risk assessment. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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Regulatory requirements and quality assurance of radiation monitoring instruments
International Nuclear Information System (INIS)
Narasimharao, K.L.; Sharma, Ranjit
2005-01-01
The successful utilisation of radiation sources in the fields of medicine and industry requires the accurate measurement of activity, exposure rate and dose. Many varieties of instruments are in use for measurement of these parameters and new ones are being developed. The criteria for the design of the radiation monitoring instrument include the type and intensity of the radiation, purpose of measurement and ruggedness of the instrument. Quality and reliability of radiation monitoring instruments ensure that individuals are adequately protected. Accuracy, response time and ruggedness are required to be as per the approved/ prescribed guidelines. Regulatory authorities outline the design and performance criteria for radiation monitoring instruments and prescribe the recommendations of international agencies such as IAEA, ICRU and ISO for radiological measurement assurance programme. National Standards Laboratories all over the world prescribe procedures for calibration of various radiation monitoring instruments. The instruments should be calibrated as per these guidelines and should be traceable to national standards. The calibration traceable to national/ international standards and documentation as well as limits stipulated by the competent authority ensures the expected performance of the instrument. (author)
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Albouza Y; d'Arripe-Longueville F; Corrion K
2017-01-01
This study examined whether athletes’ values are related to aggressiveness through self-regulatory mechanisms. Athletes (N=225) completed four questionnaires to assess their values, resistive self-regulatory efficacy, moral disengagement and aggressiveness. The results of structural equation modeling showed a good fit to the data and illustrated that: (a) The status and moral values were indirectly associated with aggressiveness through the mediating roles of resistive self-regulatory efficac...
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International Nuclear Information System (INIS)
Vajgel, Stefan
2009-03-01
The electrical power generation using nuclear power plants requires this installation being safety, reliable and available for the working periods. For this purpose, an adequate, effective and well conducted maintenance program makes an essential and useful tool to the owner of the plant. However, it is necessary to follow the regulatory requirements for this program implementation which monitories this maintenance effectiveness. There are Brazilian norms requirements which must be followed. The international regulatory guides establish these requirements in good details but it is necessary to verify if this methodology for implementing can be totally applied here in Brazil. Then, the american guide NUMARC 93-01 which details how can be implemented a program for this monitoring, shows some methods for using. In this thesis, the Delphi and Probabilistic Safety Analysis were briefly included because they were preferred for implementing this monitoring.in a Brazilian plant. The results which are being obtained show that, looking the regulatory aspects, the NUMARC 93-01 follows our regulations and gives good results for the plant management. (author)
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The regulatory system of monitoring workers in Germany for intakes of radioactivity
International Nuclear Information System (INIS)
Dalheimer, A.; Henrichs, K.
1996-01-01
In Germany, the working group 'Incorporation Monitoring' of the German-Swiss Radiation Protection Association defined a new standard for the monitoring of workers occupationally exposed to radioactive material. During the last two years this draft has been accepted by the German government in the form of three guidelines. The purpose of the approach was the installation of a consistent state-of-the-art system: defining clear criteria for the necessity of routine and special monitoring programs, giving guidelines for monitoring programs ensuring that dose assessments are as reliable as necessary with the lowest possible expenses, standardizing as far as possible the procedures of dose assessments, and guaranteeing the necessary quality standards. The scientific basis of this regulatory system are the publications 30 and 54 of lCRP. (author)
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Microfabricated fuel heating value monitoring device
Robinson, Alex L [Albuquerque, NM; Manginell, Ronald P [Albuquerque, NM; Moorman, Matthew W [Albuquerque, NM
2010-05-04
A microfabricated fuel heating value monitoring device comprises a microfabricated gas chromatography column in combination with a catalytic microcalorimeter. The microcalorimeter can comprise a reference thermal conductivity sensor to provide diagnostics and surety. Using microfabrication techniques, the device can be manufactured in production quantities at a low per-unit cost. The microfabricated fuel heating value monitoring device enables continuous calorimetric determination of the heating value of natural gas with a 1 minute analysis time and 1.5 minute cycle time using air as a carrier gas. This device has applications in remote natural gas mining stations, pipeline switching and metering stations, turbine generators, and other industrial user sites. For gas pipelines, the device can improve gas quality during transfer and blending, and provide accurate financial accounting. For industrial end users, the device can provide continuous feedback of physical gas properties to improve combustion efficiency during use.
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Site-specific parameter values for the Nuclear Regulatory Commission's food pathway dose model
International Nuclear Information System (INIS)
Hamby, D.M.
1992-01-01
Routine operations at the Savannah River Site (SRS) in Western South Carolina result in radionuclide releases to the atmosphere and to the Savannah River. The resulting radiation doses to the off-site maximum individual and the off-site population within 80 km of the SRS are estimated on a yearly basis. These estimates are currently generated using dose models prescribed for the commercial nuclear power industry by the Nuclear Regulatory Commission (NRC). The NRC provides default values for dose-model parameters for facilities without resources to develop site-specific values. A survey of land- and water-use characteristics for the Savannah River area has been conducted to determine site-specific values for water recreation, consumption, and agricultural parameters used in the NRC Regulatory Guide 1.109 (1977) dosimetric models. These site parameters include local characteristics of meat, milk, and vegetable production; recreational and commercial activities on the Savannah River; and meat, milk, vegetable, and seafood consumption rates. This paper describes how parameter data were obtained at the Savannah River Site and the impacts of such data on off-site dose. Dose estimates using site-specific parameter values are compared to estimates using the NRC default values
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Knowing your customer better: the strengths of a self-regulatory value approach
Förster, J.
2009-01-01
Regulatory engagement theory's strength over alternative accounts of consumer attitudes is highlighted. In line with the theory, it is argued that in order to predict behavior, one needs to understand the processes involved in goal pursuit, including the dynamic processes of value creation. The
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Correct fair market value calculation needed to avoid regulatory challenges.
Dietrich, M O
1997-09-01
In valuing a physician practice for acquisition, it is important for buyers and sellers to distinguish between fair market value and strategic value. Although many buyers would willingly pay for the strategic value of a practice, tax-exempt buyers are required by law to consider only the fair market value in setting a bid price. Valuators must adjust group earnings to exclude items that do not apply to any willing seller and include items that do apply to any willing seller to arrive at the fair market value of the practice. In addition, the weighted average cost of capital (WACC), which becomes the discount rate in the valuation model, is critical to the measure of value of the practice. Small medical practices are assumed to have few hard assets and little long-term debt, and the WACC is calculated on the basis of those assumptions. When a small practice has considerable debt, however, this calculated WACC may be inappropriate for valuing the practice. In every case, evidence that shows that a transaction has been negotiated "at arm's length" should stave off any regulatory challenge.
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Methodology for value/impact assessment of nuclear regulatory research programs
International Nuclear Information System (INIS)
Carlson, D.D.
1978-12-01
A methodology for conducting a value/impact assessment of research programs has been developed to provide the Nuclear Regulatory Commission (NRC) an improved capability for allocating resources for confirmatory research. This report presents a seven-step evaluation process and applies it to selected units of research. The methodology is intended to provide insight into the technical merits of the programs, one dimension of the complex problem of resource allocation for confirmatory research
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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
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Watershed monitoring and modelling and USA regulatory compliance.
Turner, B G; Boner, M C
2004-01-01
The aim of the Columbus program was to implement a comprehensive watershed monitoring-network including water chemistry, aquatic biology and alternative sensors to establish water environment health and methods for determining future restoration progress and early warning for protection of drinking water supplies. The program was implemented to comply with USA regulatory requirements including Total Maximum Daily Load (TMDL) rules of the Clean Water Act (CWA) and Source Water Assessment and Protection (SWAP) rules under the Safe Drinking Water Act (SDWA). The USEPA Office of Research and Development and the Water Environment Research Foundation provided quality assurance oversight. The results obtained demonstrated that significant wet weather data is necessary to establish relationships between land use, water chemistry, aquatic biology and sensor data. These measurements and relationships formed the basis for calibrating the US EPA BASINS Model, prioritizing watershed health and determination of compliance with water quality standards. Conclusions specify priorities of cost-effective drainage system controls that attenuate stormwater flows and capture flushed pollutants. A network of permanent long-term real-time monitoring using combination of continuous sensor measurements, water column sampling and aquatic biology surveys and a regional organization is prescribed to protect drinking water supplies and measure progress towards water quality targets.
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Global Stability of Complex-Valued Genetic Regulatory Networks with Delays on Time Scales
Directory of Open Access Journals (Sweden)
Wang Yajing
2016-01-01
Full Text Available In this paper, the global exponential stability of complex-valued genetic regulatory networks with delays is investigated. Besides presenting conditions guaranteeing the existence of a unique equilibrium pattern, its global exponential stability is discussed. Some numerical examples for different time scales.
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Environmental performance, profitability, asset utilization, debt monitoring and firm value
Bukit, R. Br; Haryanto, B.; Ginting, P.
2018-02-01
The growing issue on firm value shows that firm value is not only determined by the firm ability to increase financial profit, but also by the company's concern in maintaining the environmental condition. The industrial development produces waste that pollutes the environment that has potential to serious impact on the next life. In addition to provide financial benefits, companies are increasingly facing pressure to be socially responsible for the survival of the company. However, past findings demonstrate that the effect of environmental performance, profitability, and asset utilization to the firm’s value are still unclear. This study aims to test whether environmental performance, firm profitability and asset utilization can effectively enhance firm value in two different conditions: intensive debt monitoring and less intensive debt monitoring. Sample of companies is taken from the list of Indonesia Stock Exchange during the period of 2013 to 2015. Using multiple regression analysis, discloses that: in intensive monitoring, managers tend to have high firm value when company has high environmental performance and or high profitability and high asset utilization. Monitoring system needs to be intensified especially for companies with the above characteristics.
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Lehoux, Pascale; Miller, Fiona A.; Daudelin, Geneviève; Denis, Jean-Louis
2017-01-01
Background: New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Methods: Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec’s (Canada) publicly funded healthcare system. Results: Entrepreneurs have a direct influence over a new technology’s value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology—as a health intervention and as an economic commodity—and provide economic worth to the venture that is bringing the technology to market. Conclusion: Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy. PMID:28949463
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Institutional investor monitoring motivation and the\\ud marginal value of cash
Zeng, Yeqin; Yin, Chao; Ward, Charles
2018-01-01
This paper examines whether the motivation of institutional investors in monitoring a firm is positively related to the relative importance of the firm's stock in their portfolios. We find that greater motivated monitoring institutional ownership is associated with a higher marginal value of corporate cash holdings, which cannot be explained by other corporate governance measures and institution types. Further, we find that the economic effect of institutional monitoring on the marginal value...
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International Nuclear Information System (INIS)
2001-01-01
This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information
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Directory of Open Access Journals (Sweden)
Brendan Fong
Full Text Available PURPOSE: Dendritic cell (DC vaccines have recently emerged as an innovative therapeutic option for glioblastoma patients. To identify novel surrogates of anti-tumor immune responsiveness, we studied the dynamic expression of activation and inhibitory markers on peripheral blood lymphocyte (PBL subsets in glioblastoma patients treated with DC vaccination at UCLA. EXPERIMENTAL DESIGN: Pre-treatment and post-treatment PBL from 24 patients enrolled in two Phase I clinical trials of dendritic cell immunotherapy were stained and analyzed using flow cytometry. A univariate Cox proportional hazards model was utilized to investigate the association between continuous immune monitoring variables and survival. Finally, the immune monitoring variables were dichotomized and a recursive partitioning survival tree was built to obtain cut-off values predictive of survival. RESULTS: The change in regulatory T cell (CD3(+CD4(+CD25(+CD127(low frequency in PBL was significantly associated with survival (p = 0.0228; hazard ratio = 3.623 after DC vaccination. Furthermore, the dynamic expression of the negative co-stimulatory molecule, CTLA-4, was also significantly associated with survival on CD3(+CD4(+ T cells (p = 0.0191; hazard ratio = 2.840 and CD3(+CD8(+ T cells (p = 0.0273; hazard ratio = 2.690, while that of activation markers (CD25, CD69 was not. Finally, a recursive partitioning tree algorithm was utilized to dichotomize the post/pre fold change immune monitoring variables. The resultant cut-off values from these immune monitoring variables could effectively segregate these patients into groups with significantly different overall survival curves. CONCLUSIONS: Our results suggest that monitoring the change in regulatory T cell frequencies and dynamic expression of the negative co-stimulatory molecules on peripheral blood T cells, before and after DC vaccination, may predict survival. The cut-off point generated from these data can be utilized in future
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Energy Technology Data Exchange (ETDEWEB)
Gomaa, Hassan; Khedr, Ahmed; El-Din Talha, Kamal [Egyptian Nuclear and Radiological Regulatory Authority, Cairo (Egypt). Nuclear Safety Engineering Dept.
2015-05-15
The objective of this work is to demonstrate the regulatory requirements pertaining to calibration of monitoring instruments in research reactors. The regulatory statements concerning this subject in IAEA safety standards and the implementation of such regulations in twelve countries with different levels of nuclear programs are surveyed: Australia, Bulgaria, Canada, Egypt, Finland, Germany, Hungary, Slovenia, South Korea, Spain, United Kingdom of England and United States of America. In addition, the requirements of ISO/IEC17025 and NUPIC (Nuclear Utilities Procurement Issues Committee) are compared. Seven technical and administrate aspects are suggested as the comparison criteria and the explicit expression of the statements, the level of document (i.e.: act, requirement or guide) are the considered resources. The main differences and similarities between the different approaches are identified in order to provide an input for future development of the national regulations.
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What's the Regulatory Value of a Target Product Profile?
Breder, Christopher D; Du, Wenny; Tyndall, Adria
2017-07-01
Target product profiles (TPPs) are used as a regulatory tool for dialog on clinical development or manufacturing plans. Drugs and biologics approved by the FDA that mention TPPs are associated with more efficient regulatory review times, perhaps as a result of increased planning or because the TPP promotes well-organized regulatory dialog. Published by Elsevier Ltd.
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International Nuclear Information System (INIS)
Gallucci, Raymond H.V.
2016-01-01
Highlights: • Uncertainties for values/benefits. • Upper bound four times higher than mean. • Distributional histograms. - Abstract: NUREG/BR-0184, Regulatory Analysis Technical Evaluation (RATE) Handbook, was produced in 1997 as an update to the original NUREG/CR-3568, A Handbook for Value-Impact Assessment (1983). Both documents, especially the later RATE Handbook, have been used extensively by the USNRC and its contractors not only for regulatory analyses to support backfit considerations but also for similar applications, such as Severe Accident Management Alternative (SAMA) analyses as part of license renewals. While both provided high-level guidance on the performance of uncertainty analyses for the various value/benefit attributes, detailed quantification was not of prime interest at the times of the Handbooks’ development, defaulting only to best estimates with low and high bounds on these attributes. As the USNRC examines the possibility of updating the RATE Handbook, renewed interest in a more quantitative approach to uncertainty analyses for the attributes has surfaced. As the result of an effort to enhance the RATE Handbook to permit at least default uncertainty analyses for the value/benefit attributes, it has proven feasible to assign default uncertainties in terms of 95th %ile upper bounds (and absolute lower bounds) on the five dominant value/benefit attributes, and their sum, when performing a regulatory analysis via the RATE Handbook. Appropriate default lower bounds of zero (no value/benefit) and an upper bound (95th %ile) that is four times higher than the mean (for individual value/benefit attributes) or three times higher (for their summation) can be recommended. Distributions in the form of histograms on the summed value/benefit attributes are also provided which could be combined, after appropriate scaling and most likely via simulation, with their counterpart(s) from the impact/cost analysis to yield a final distribution on the net
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Safety system status monitoring
International Nuclear Information System (INIS)
Lewis, J.R.; Morgenstern, M.H.; Rideout, T.H.; Cowley, P.J.
1984-03-01
The Pacific Northwest Laboratory has studied the safety aspects of monitoring the preoperational status of safety systems in nuclear power plants. The goals of the study were to assess for the NRC the effectiveness of current monitoring systems and procedures, to develop near-term guidelines for reducing human errors associated with monitoring safety system status, and to recommend a regulatory position on this issue. A review of safety system status monitoring practices indicated that current systems and procedures do not adequately aid control room operators in monitoring safety system status. This is true even of some systems and procedures installed to meet existing regulatory guidelines (Regulatory Guide 1.47). In consequence, this report suggests acceptance criteria for meeting the functional requirements of an adequate system for monitoring safety system status. Also suggested are near-term guidelines that could reduce the likelihood of human errors in specific, high-priority status monitoring tasks. It is recommended that (1) Regulatory Guide 1.47 be revised to address these acceptance criteria, and (2) the revised Regulatory Guide 1.47 be applied to all plants, including those built since the issuance of the original Regulatory Guide
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Safety system status monitoring
Energy Technology Data Exchange (ETDEWEB)
Lewis, J.R.; Morgenstern, M.H.; Rideout, T.H.; Cowley, P.J.
1984-03-01
The Pacific Northwest Laboratory has studied the safety aspects of monitoring the preoperational status of safety systems in nuclear power plants. The goals of the study were to assess for the NRC the effectiveness of current monitoring systems and procedures, to develop near-term guidelines for reducing human errors associated with monitoring safety system status, and to recommend a regulatory position on this issue. A review of safety system status monitoring practices indicated that current systems and procedures do not adequately aid control room operators in monitoring safety system status. This is true even of some systems and procedures installed to meet existing regulatory guidelines (Regulatory Guide 1.47). In consequence, this report suggests acceptance criteria for meeting the functional requirements of an adequate system for monitoring safety system status. Also suggested are near-term guidelines that could reduce the likelihood of human errors in specific, high-priority status monitoring tasks. It is recommended that (1) Regulatory Guide 1.47 be revised to address these acceptance criteria, and (2) the revised Regulatory Guide 1.47 be applied to all plants, including those built since the issuance of the original Regulatory Guide.
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International Nuclear Information System (INIS)
Shandala, N.K.; Titov, A.V.; Kiselev, S.M.; Isaev, D.V.; Aladova, R.A.
2012-01-01
Full text: Radiation safety at areas affected by the natural uranium mining and milling facilities is very important for the environment protection and human health. For this purpose the close operator-regulator contact is required during remedial operations. One of the key mechanisms of the operating regulatory supervision of radiation safety at uranium legacy sites is organization of independent radiation control and monitoring in the course of reclamation and after its completion. The main stages of this strategy include: detailed radiation survey at the area and in the vicinity of the former uranium mining sites; threat assessment in order to identify the regulatory priorities; environmental radiation control and monitoring. Tailings and shallow disposal sites of the uranium mining wastes are the most critical areas in terms of potential hazard for the environment. Tailings are the source of contamination of the near-land air due to the radionuclide dust resuspension from the tailing surface; surface and ground water due to washing out from by precipitation and surface streams of toxic and radioactive elements. Frequently, contamination of surface and ground waters results in some problems, especially when using the leaching fluids for the solution mining and draining hydraulic fluids. Radiation risk for the residents of areas near not operating uranium mining and milling facilities depends on the following factors: radon exhalation from the surface of dumps and tailing; radioactive dust transfer; using radioactive material in building; contamination of surface water streams and aquifers used for drinking water supply; contamination of open ponds used for fish breeding and catching; contamination of foodstuffs grown in the nuclear legacy areas. Radiation monitoring is necessary for the up-to-date response to changing radiation situation during reclamation and arrangement of adequate countermeasures. We mean here comprehensive dynamic surveillance including long
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Regulatory requirements related to maintenance and compliance monitoring
International Nuclear Information System (INIS)
Ling, A.K.H.
1997-01-01
The maintenance related regulatory requirements are identified in the regulatory documents and licence conditions. Licensee complies with these requirements by operating the nuclear power plant within the safe operating envelope as given in the operating policies and principles and do maintenance according to approved procedures and/or work plans. Safety systems are regularly tested. AECB project officers review and check to ensure that the licensee operates the nuclear power plant in accordance with the regulatory requirements and licence conditions. (author). 6 tabs
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Information system fur the management of a regulatory programme
International Nuclear Information System (INIS)
Ortiz, P.; Mrabit, K.; Miaw, S.
1998-01-01
A Regulatory Programme to monitor safety of activities involving radiation sources, implies the existence of a Regulatory Authority empowered by legislation to issue radiation protection regulations and to monitor compliance with those regulations. The core element of the programme is a system of notification and authorization (registration and licensing), inspection and enforcement. The efficiency of this system is largely dependent on the availability of reliable information on the inventory of radiation sources and installations, the administrative status of the facilities (authorization), prompt processing of inspection reports and follow up of regulatory actions, including monitoring deadlines. Essential data relevant to safety, such as personal dosimetry for occupationally exposed individuals, inspection findings and incident reports would provide, in addition, an insight on the overall safety of the country. A simple but comprehensive Regulatory Authority Information System (RAIS) linked to the authorization and inspection process will largely facilitate regulatory decisions and actions. A readily available and reliable information from the various regulatory activities will facilitate planning, optimization of resources, monitoring safety related data, disseminating safety information, making decisions and follow up regulatory actions including monitoring dead lines. The implementation of the system in more than 50 countries will contribute to experience exchange and harmonization of regulatory activities. (author)
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Plant safety and performance indicators for regulatory use
International Nuclear Information System (INIS)
Ferjancic, M.; Nemec, T.; Cimesa, S.
2004-01-01
Slovenian Nuclear Safety Administration (SNSA) supervises nuclear and radiological safety of Krsko NPP. This SNSA supervision is performed through inspections, safety evaluations of plant modifications and event analyses as well as with the safety and performance indicators (SPI) which are a valuable data source for plant safety monitoring. In the past SNSA relied on the SPI provided by Krsko NPP and did not have a set of SPI which would be more appropriate for regulatory use. In 2003 SNSA started with preparation of a new set of SPI which would be more suitable for performing the regulatory oversight of the plant. New internal SNSA procedure which is under preparation will define use and evaluation of SPI and will include definitions for the proposed set of SPI. According to the evaluation of SPI values in comparison with the limiting values and/or trending, the procedure will define SNSA response and actions. (author)
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Towards a biological monitoring guidance value for acrylamide.
Sams, C; Jones, K; Warren, N; Cocker, J; Bell, S; Bull, P; Cain, M
2015-08-19
Acrylamide is classified as a potential human carcinogen and neurotoxicant. Biological monitoring is a useful tool for monitoring worker exposure. However, other sources of exposure to acrylamide (including cigarette smoke and diet) also need to be considered. This study has performed repeat measurements of the urinary mercapturic acids of acrylamide (AAMA) and its metabolite glycidamide (GAMA) and determined globin adducts in 20 production-plant workers at a UK acrylamide production facility. The relationship between biomarker levels and environmental monitoring data (air levels and hand washes) was investigated. Good correlations were found between all of the biomarkers (r(2)=0.86-0.91) and moderate correlations were found between the biomarkers and air levels (r(2) = 0.56-0.65). Our data show that urinary AAMA is a reliable biomarker of acrylamide exposure. Occupational hygiene data showed that acrylamide exposure at the company was well within the current UK Workplace Exposure Limit. The 90th percentile of urinary AAMA in non-smoking production-plant workers (537 μmol/mol creatinine (n = 59 samples)) is proposed as a possible biological monitoring guidance value. This 90th percentile increased to 798 μmol/mol if smokers were included (n = 72 samples). These values would be expected following an airborne exposure of less than 0.07 mg/m(3), well below the current UK workplace exposure limit of 0.3mg/m(3). Comparison of biomarker levels in non-occupationally exposed individuals suggests regional variations (between UK and Germany), possibly due to differences in diet. Crown Copyright © 2015. Published by Elsevier Ireland Ltd. All rights reserved.
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Bahri, Priya; Fogd, Julianna; Morales, Daniel; Kurz, Xavier
2017-05-02
The benefit-risk balance of vaccines is regularly debated by the public, but the utility of media monitoring for regulatory bodies is unclear. A media monitoring study was conducted at the European Medicines Agency (EMA) concerning human papillomavirus (HPV) vaccines during a European Union (EU) referral procedure assessing the potential causality of complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) reported to the authorities as suspected adverse reactions. To evaluate the utility of media monitoring in real life, prospective real-time monitoring of worldwide online news was conducted from September to December 2015 with inductive content analysis, generating 'derived questions'. The evaluation was performed through the validation of the predictive capacity of these questions against journalists' queries, review of the EMA's public statement and feedback from EU regulators. A total of 4230 news items were identified, containing personal stories, scientific and policy/process-related topics. Explicit and implicit concerns were identified, including those raised due to lack of knowledge or anticipated once more information would be published. Fifty derived questions were generated and categorised into 12 themes. The evaluation demonstrated that providing the media monitoring findings to assessors and communicators resulted in (1) confirming that public concerns regarding CRPS and POTS would be covered by the assessment; (2) meeting specific information needs proactively in the public statement; (3) predicting all queries from journalists; and (4) altering the tone of the public statement with respectful acknowledgement of the health status of patients with CRSP or POTS. The study demonstrated the potential utility of media monitoring for regulatory bodies to support communication proactivity and preparedness, intended to support trusted safe and effective vaccine use. Derived questions seem to be a familiar and effective
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Sustaining Nuclear Safety: Upholding the Core Regulatory Values
International Nuclear Information System (INIS)
Kumar, S.
2016-01-01
Nuclear Energy and management of safety therein, has a somewhat distinct streak in that from its early days it has had the privilege of being shaped and supervised by the eminent scientists and engineers, in fact it owes its very origin to them. This unique engagement has resulted in culmination of the several safety elements like defence-in-depth in the form of multiple safety layers, redundancy, diversity and physical separation of components, protection against single failures as well as common cause failures right at the beginning of designing a nuclear reactor. The fundamental principles followed by regulators across the globe have many similarities such as, creation of an organization which has a conflict-free primary responsibility of safety supervision, laying down the safety criteria and requirements for the respective industry and developing and using various tools and regulatory methodology to ensure adherence to the laid down regulatory requirements. Yet the regulatory regimes in different States have evolved differently and therefore, has certain attributes which are unique to these and confer on them their identity.
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McDonough, Ian M; Bui, Dung C; Friedman, Michael C; Castel, Alan D
2015-10-01
The perceived value of information can influence one's motivation to successfully remember that information. This study investigated how information value can affect memory search and evaluation processes (i.e., retrieval monitoring). In Experiment 1, participants studied unrelated words associated with low, medium, or high values. Subsequent memory tests required participants to selectively monitor retrieval for different values. False memory effects were smaller when searching memory for high-value than low-value words, suggesting that people more effectively monitored more important information. In Experiment 2, participants studied semantically-related words, and the need for retrieval monitoring was reduced at test by using inclusion instructions (i.e., endorsement of any word related to the studied words) compared with standard instructions. Inclusion instructions led to increases in false recognition for low-value, but not for high-value words, suggesting that under standard-instruction conditions retrieval monitoring was less likely to occur for important information. Experiment 3 showed that words retrieved with lower confidence were associated with more effective retrieval monitoring, suggesting that the quality of the retrieved memory influenced the degree and effectiveness of monitoring processes. Ironically, unless encouraged to do so, people were less likely to carefully monitor important information, even though people want to remember important memories most accurately. Copyright © 2015 Elsevier B.V. All rights reserved.
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Regulatory activities; Actividades regulatorias
Energy Technology Data Exchange (ETDEWEB)
NONE
2001-07-01
This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information.
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DEFF Research Database (Denmark)
Andresen, Morten; Thomsen, Ole Cornelius; Juhler, Marianne
2013-01-01
Object Intracranial pressure (ICP) monitoring is used extensively in clinical practice, and as such, the accuracy of registered ICP values is paramount. Clinical observations of nonphysiological changes in ICP have called into question the accuracy of registered ICP values. Subsequently, the auth......Object Intracranial pressure (ICP) monitoring is used extensively in clinical practice, and as such, the accuracy of registered ICP values is paramount. Clinical observations of nonphysiological changes in ICP have called into question the accuracy of registered ICP values. Subsequently......, the authors have tried to determine if the ICP monitors from major manufacturers were affected by electrostatic discharges (ESDs), if the changes were permanent or transient in nature, and if the changes were modified by the addition of different electrical appliances normally used in the neurointensive care....... Results Five pressure monitors from 4 manufacturers were evaluated. Three monitors containing electrical circuitry at the tip of the transducer were all affected by ESDs. Clinically significant permanent changes in the reported ICP values for 1 pressure monitor were observed, as well as temporary...
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Molzon, J A; Giaquinto, A; Lindstrom, L; Tominaga, T; Ward, M; Doerr, P; Hunt, L; Rago, L
2011-04-01
The International Conference on Harmonisation (ICH) is an unparalleled undertaking, which has brought together drug regulatory authorities and pharmaceutical trade associations from Europe, Japan, and the United States, to discuss the scientific and technical aspects of medical product registration. Launched in 1990, the value and benefits of ICH to regulators are being realized. ICH has harmonized submission requirements and created a harmonized submission format that is relieving both companies and regulatory authorities of the burdens of assembling and reviewing separate submissions for each region. As more countries embrace ICH guidelines, we anticipate additional benefits, including the promotion of good review practices and, ultimately, a common regulatory language that will facilitate further interactions among global drug regulatory authorities.
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Application of maximum radiation exposure values and monitoring of radiation exposure
International Nuclear Information System (INIS)
1996-01-01
The guide presents the principles to be applied in calculating the equivalent dose and the effective dose, instructions on application of the maximum values for radiation exposure, and instruction on monitoring of radiation exposure. In addition, the measurable quantities to be used in monitoring the radiation exposure are presented. (2 refs.)
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Regulatory environment and its impact on the market value of investor-owned electric utilities
Vishwanathan, Raman
While other regulated industries have one by one been exposed to competitive reform, electric power, for over eighty years, has remained a great monopoly. For all those years, the vertically integrated suppliers of electricity in the United States have been assigned exclusive territorial (consumer) franchises and have been closely regulated. This environment is in the process change because the electric power industry is currently undergoing some dramatic adjustments. Since 1992, a number of states have initiated regulatory reform and are moving to allow retail customers to choose their energy supplier. There has also been a considerable federal government role in encouraging competition in the generation and transmission of electricity. The objective of this research is to investigate the reaction of investors to the prevailing regulatory environment in the electric utility industry by analyzing the market-to-book value for investor-owned electric utilities in the United States as a gauge of investor concern or support for change. In this study, the variable of interest is the market valuation of utilities, as it captures investor confidence to changes in the regulatory environment. Initially a classic regression model is analyzed on the full sample (of the 96 investor-owned utilities for the years 1992 through 1996), providing a total number of 480 (96 firms over 5 years) observations. Later fixed- and random-effects models are analyzed for the same full-sample model specified in the previous analysis. Also, the analysis is carried forward to examine the impact of the size of the utility and its degree of reliability on nuclear power generation on market values. In the period of this study, 1992--1996, the financial security markets downgraded utilities that were still operating in a regulated environment or had a substantial percentage of their power generation from nuclear power plants. It was also found that the financial market was sensitive to the size of
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Monitoring control program as a tool for regulatory control
International Nuclear Information System (INIS)
Silva Peres, Sueli da; Lauria, Dejanaira C.; Martins, Nadia S.F.; Rio, Monica A.P.
2008-01-01
Full text: The Institute of Radiation Protection and Dosimetry (IRD) of the Brazilian Commission of Nuclear Energy (CNEN) is responsible for developing, establishing and carrying out an independent assessment to verify the adequacy, effectiveness and accuracy of environmental radiological control carried out by licensed and controlled facilities. This independent assessment is performed by Environmental Monitoring Control Program (MCP). The MCP is a regulatory control and its main goal is to provide public and environment with an appropriate protection level against harmful effects of ionising radiation. The main purpose of the MCP is to verify whether applicable requirements prescribed by legislation are met, the environmental radiological control of the facilities are adequate and effective and the facilities are able to generate valid measuring results. The MCP is carried out in order to evaluate the quality of environmental radiation monitoring programs (EMP) and the effectiveness of their implementation, sampling conditions in the field, changes of environmental aspects in the impact area, adequacy of and adherence to procedures established and other applicable documents, technical competence of the staff and the necessary resources to ensure the required quality of the EMP. The MCP has been performed by activities should include inspecting and auditing of several types of nuclear and radioactive facilities. The inspection programme include the joint sampling program (CCP). The aim of the CCP is to check data of environmental monitoring of operator. The MCP was implemented in 1994. Ever since several problems related to the environmental control performed by operator was identified. The most important of them include problems related to the preparation and analysis of environmental samples, training of personnel, necessary resources, adherence of procedures to the purpose of the monitoring, fulfillment of procedures established, adequacy of the EMP and EMP
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Directory of Open Access Journals (Sweden)
Zijian Li
2017-07-01
Full Text Available To control the risk of human exposure to pesticides, about 50 nations have promulgated pesticide soil regulatory guidance values (RGVs, and 104 nations have provided pesticide drinking water maximum concentration levels (MCLs. In addition, 90 nations have regulated pesticide agricultural commodity maximum residue limits (MRLs. Pesticide standard values (PSVs for one single pesticide varied in a range of six, seven, or even eight orders of magnitude. Some PSVs are too large to prevent the impact of pesticides on human health. Many nations have not provided PSVs for some commonly used pesticides until now. This research has introduced several completeness values and numerical values methods to evaluate the national jurisdiction’s performance on PSVs on a nation base. The national jurisdiction ranking system developed by these methods will be beneficial to the environmental regulation makers in the management of PSVs. Results also indicate that European countries perform better in the regulation of pesticide soil RGVs, drinking water MCLs, and agricultural commodity MRLs.
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International Nuclear Information System (INIS)
Tripathi, S.M.; Rao, Suresh; Mahant, A.K.; Sathian, V.; Ghodke, Shobha; Satam, R.A.; Singh, Yashoda; Phadnis, U.V.; Shaha, V.V.
2006-01-01
The paper describes the various experiments that are regularly carried out for each PHWR since RAPS-2. The work involves performance evaluation of start-up counters and ion chambers used in Protective and Regulatory channels and start-up counters used both in-core and out of core. In addition, Radiation Safety Systems Division (RSSD) also carries out calibration of Delayed Neutron Monitors (DNM) and Self Powered Neutron Detectors (SPND). Except SPND, all other detectors are tested not only at BARC but also at reactor sites prior to initial flushing of heavy water, using the actual circuitry and control instruments at site. The performance evaluation of SPNDs is carried out at A-1 location of APSARA reactor core. Apart from these, RSSD also carries out calibration of zonal classification monitors and health physics related radiation monitors at BARC. (author)
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Shimazawa, Rumiko; Ikeda, Masayuki
2016-03-01
Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.
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76 FR 35922 - Notice of Issuance of Regulatory Guide
2011-06-20
.... Proposed Revision 1 of Regulatory Guide (RG) 8.4, ``Personnel Monitoring Device--Direct-Reading Pocket...'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are available for... NUCLEAR REGULATORY COMMISSION [NRC-2010-0148] Notice of Issuance of Regulatory Guide AGENCY...
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Regulatory point of view of SAT application
International Nuclear Information System (INIS)
Juhasz, L.
2002-01-01
I present the regulatory system for monitoring operator training and check competency of operator personnel in Hungary and the effects of SAT to the regulatory framework/practice related to recruitment, training and authorisation of operating personnel. Also I introduce an application to manage the initial and refreshing training to regulatory bodies. (author)
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Nuclear reactor effluent monitoring
International Nuclear Information System (INIS)
Minns, J.L.; Essig, T.H.
1993-01-01
Radiological environmental monitoring and effluent monitoring at nuclear power plants is important both for normal operations, as well as in the event of an accident. During normal operations, environmental monitoring verifies the effectiveness of in-plant measures for controlling the release of radioactive materials in the plant. Following an accident, it would be an additional mechanism for estimating doses to members of the general public. This paper identifies the U.S. Nuclear Regulatory Commission (NRC) regulatory basis for requiring radiological environmental and effluent monitoring, licensee conditions for effluent and environmental monitoring, NRC independent oversight activities, and NRC's program results
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Nuclear reactor effluent monitoring
Energy Technology Data Exchange (ETDEWEB)
Minns, J.L.; Essig, T.H. [Nuclear Regulatory Commission, Washington, DC (United States)
1993-12-31
Radiological environmental monitoring and effluent monitoring at nuclear power plants is important both for normal operations, as well as in the event of an accident. During normal operations, environmental monitoring verifies the effectiveness of in-plant measures for controlling the release of radioactive materials in the plant. Following an accident, it would be an additional mechanism for estimating doses to members of the general public. This paper identifies the U.S. Nuclear Regulatory Commission (NRC) regulatory basis for requiring radiological environmental and effluent monitoring, licensee conditions for effluent and environmental monitoring, NRC independent oversight activities, and NRC`s program results.
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Mound Plant Environmental Monitoring Plan
International Nuclear Information System (INIS)
Bauer, L.R.; Tullis, M.S.; Paulick, R.P.; Roush, L.L.
1994-07-01
The purpose of this Environmental Monitoring Plan (EMP) is to describe the environmental monitoring and surveillance programs in place at Mound. The Plan is required by DOE Order 5400.1 (DOE, 1990). The programs described in the EMP are required by the DOE 5400 Order series and by the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environment Surveillance (DOE 1991a), referred to as the Regulatory Guide throughout this Plan
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DEFF Research Database (Denmark)
Thöns, Sebastian; Schneider, Ronald; Faber, Michael Havbro
2015-01-01
This paper addresses the quantification of the value of structural health monitoring (SHM) before its implementation for structural systems on the basis of its Value of Information (VoI). The value of SHM is calculated utilizing the Bayesian pre-posterior decision analysis modelling the structural...... life cycle performance, the integrity management and the structural risks. The relevance and precision of SHM information for the reduction of the structural system risks and the expected cost of the structural integrity management throughout the life cycle constitutes the value of SHM...... and is quantified with this framework. The approach is focused on fatigue deteriorating structural steel systems for which a continuous resistance deterioration formulation is introduced. In a case study, the value of SHM for load monitoring is calculated for a Daniels system subjected to fatigue deterioration...
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Annual Report 2008. Nuclear Regulatory Authority
International Nuclear Information System (INIS)
2009-01-01
The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.
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Annual Report 2007. Nuclear Regulatory Authority
International Nuclear Information System (INIS)
2008-01-01
The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.
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The Influence of Brittle Daniels System Characteristics on the Value of Load Monitoring Information
DEFF Research Database (Denmark)
Thöns, Sebastian; Schneider, Ronald
This paper addresses the influence of deteriorating brittle Daniels system characteristics on the value of structural health monitoring (SHM). The value of SHM is quantified as the difference between the life cycle benefits with and without SHM. A value of SHM analysis is performed within...
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Chen, R. S.; Levy, M. A.; de Sherbinin, A. M.; Fischer, A.
2015-12-01
The proposed Sustainable Development Goals (SDGs) represent an unprecedented international commitment to collective action and targeted interventions at global, regional, and national scales. Existing monitoring and data infrastructures are inadequate for producing the variety of environmental and socioeconomic information needed to ensure efficient and effective outcomes across the range of interlinked SDGs and targets. The scientific community needs to take a lead in developing new tools and approaches that, at reasonable cost, provide monitoring data of sufficient quality and spatial and temporal coverage to support informed decision making by diverse stakeholders. The expanded SDGs related to water offer the opportunity to explore potential new monitoring approaches and data system architectures in a key sector, building on existing water monitoring capabilities and incorporating new technologies and methods. Since additional investments in monitoring will undoubtedly be limited, it is important to assess carefully the value of information produced by different options and their associated risks and tradeoffs. We review here the existing set of water monitoring systems, known gaps and limitations, stakeholder inputs on data needs, and the potential value of information in light of alternative water sector interventions. Of particular interest are opportunities to share investments in monitoring across sectors and stakeholders (e.g., public and private entities) and to identify where incremental improvements in water monitoring could have significant benefits for other SDGs (e.g., related to health, energy, agriculture, and climate change). Value of information is also driven by the numbers of people affected by decisions or able to take advantage of improved data, which implies the need not only to collect and archive data, but also to invest in making data accessible and usable to diverse and geographically dispersed users.
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Annual Report 2009. Nuclear Regulatory Authority
International Nuclear Information System (INIS)
2010-01-01
The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.
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Value of monitoring in asset management: A social costbenefit analysis approach
Zouch, M.; Courage, W.; Nápoles, O.M.
2013-01-01
We present a framework to investigate new monitoring techniques for infrastructures and assess their potential value for the network management. This framework is based on a social cost benefit analysis tool that aims to (i) assist decision makers in selecting and developing cost-effective new
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Application of risk-based value-impact analysis in a nuclear regulatory environment
International Nuclear Information System (INIS)
Dinnie, Keith; Land, Ronald; Stella, Mark
1992-01-01
Value-impact analysis (VIA) is a quantitative process that examines the benefits of proposed actions and the costs of implementing those actions to determine the potential for a net beneficial result. There is a point beyond which efforts to improve nuclear plant safety by implementing design changes will be unjustifiably expensive for the societal benefits obtained. Resources that would be used to obtain marginal improvements in public safety can then be used to obtain greater benefits for society in other areas. VIA can help to identify this point. What can not be accomplished by VIA is the definition of the level of risk (or safety) above which cost-benefit considerations are not applicable. This must be established separately, by political action or through promulgation of acceptable risk levels and safety goals by regulatory agencies. 18 refs
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International Nuclear Information System (INIS)
1986-09-01
Natural uranium compounds, which enter the oxide fuel cycle offer physico-chemical characteristics dependent on their structure and their production process. These characteristics govern their biological behaviour and the degree of their radioactive and chemical toxicity. The monitoring of workers occupationnally exposed to these compounds is carried out by bioassays; in order to get the best interpretation, the resulting data must be compared to reference values. These values must be closely related to the type of contaminant and the real exposure conditions. In this report, the occupational medicine services working group has examined the possibilities of obtaining such reference values and suggests recommendations and operational values covering most situations found in routine monitoring [fr
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White paper on radiological monitoring of workers exposures
International Nuclear Information System (INIS)
Shettle, Jennifer
2016-01-01
This article comments the content of a white paper which aimed at proposing new regulatory bases to update the French Code of Labour and other legal texts related to the radiation protection of workers. The author briefly comments the objectives of this white paper (to put the initial regulatory basis into question again), briefly describes the adopted approach, the new definition of risk related to ionizing radiations within the frame of a global approach to the prevention of occupational risks. She notices and comments the removal of a reference to an exposure limit for the public as input criterion in the system of radiological monitoring of workers exposures. She also comments the introduction of some concepts: the concept of a worker submitted to a risk related to ionizing radiation, and the concept of exposure value entailing a strengthened preventive action. She indicates the different modalities adopted for exposure monitoring (radiological monitoring and dose follow-up), addresses the issue of communication of dosimetry data and the access to all dosimetry information for the person in charge of radiation protection, and finally briefly evokes the idea of publishing guides for each specific sectors
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Vilkė, Alina; Bilskienė, Diana; Šaferis, Viktoras; Gedminas, Martynas; Bieliauskaitė, Dalia; Tamašauskas, Arimantas; Macas, Andrius
2014-01-01
Traumatic brain injury (TBI) is the leading cause of death and disability in young adults. Study aimed to define the predictive value of early near-infrared spectroscopy (NIRS) monitoring of TBI patients in a Lithuanian clinical setting. Data of 61 patients was analyzed. Predictive value of early NIRS monitoring, computed tomography data and regular intensive care unit (ICU) parameters was investigated. Twenty-six patients expressed clinically severe TBI; 14 patients deceased. Patients who survived expressed higher NIRS values at the periods of admission to operative room (75.4%±9.8% vs. 71.0%±20.5%; P=0.013) and 1h after admission to ICU (74.7%±1.5% vs. 61.9%±19.4%; P=0.029). The NIRS values discriminated hospital mortality groups more accurately than admission GCS score, blood sugar or hemoglobin levels. Admission INR value and NIRS value at 1h after admission to ICU were selected by discriminant analysis into the optimal set of features when classifying hospital mortality groups. Average efficiency of classification using this method was 88.9%. When rsO2 values at 1h after admission to ICU did not exceed 68.0% in the left hemisphere and 68.3% in the right hemisphere, the hazard ratio for death increased by 17.7 times (Pbrain saturation monitoring provides accurate predictive data, which can improve the allocation of scarce medical resources, set the treatment goals and alleviate the early communication with patients' relatives. Copyright © 2014 Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.
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Passive in-home health and wellness monitoring: overview, value and examples.
Alwan, Majd
2009-01-01
Modern sensor and communication technology, coupled with advances in data analysis and artificial intelligence techniques, is causing a paradigm shift in remote management and monitoring of chronic disease. In-home monitoring technology brings the added benefit of measuring individualized health status and reporting it to the care provider and caregivers alike, allowing timely and targeted preventive interventions, even in home and community based settings. This paper presents a paradigm for geriatric care based on monitoring older adults passively in their own living settings through placing sensors in their living environments or the objects they use. Activity and physiological data can be analyzed, archived and mined to detect indicators of early disease onset or changes in health conditions at various levels. Examples of monitoring systems are discussed and results from field evaluation pilot studies are summarized. The approach has shown great promise for a significant value proposition to all the stakeholders involved in caring for older adults. The paradigm would allow care providers to extend their services into the communities they serve.
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75 FR 18241 - Draft Regulatory Guide: Issuance, Availability
2010-04-09
... Guide, DG-8036, ``Personnel Monitoring Device--Direct-Reading Pocket Dosimeters.'' FOR FURTHER.... The draft regulatory guide (DG), entitled, ``Personnel Monitoring Device--Direct-Reading Pocket... this guide included guidance on indirect-reading pocket dosimeters, this guide excludes such dosimeters...
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Regulatory perspectives of concept assessment
International Nuclear Information System (INIS)
Flavelle, Peter A.
1987-09-01
The Atomic Energy Control Board is the head agency for the regulatory review of the Assessment of the Canadian Concept for Nuclear Fuel Waste Disposal being done by Atomic Energy of Canada Limited and Ontario Hydro. This paper describes the regulatory perspective of how the Concept Assessment could demonstrate the feasibility of a disposal conforming to regulatory requirements. The long-term aspects of Concept Assessment encourage the use of various predictive techniques for different time scales. Each technique will have a different potential for establishing confidence in the predictions. The predicted performance of a facility during operation should have a very high confidence, as it can be based on standard engineering calculations and the predictions can be validated later by monitoring during operation. The predictions of the transient period following closure of the facility should achieve a medium level of confidence, since they can be based on extrapolations of predictions of operational performance, using models that can be calibrated with monitoring data and with averaged input data derived from natural analog studies. Predictions based on fundamental processes will have a medium level of confidence when made to intermediate times after closure. Long-term predictions using generic or typical input data or Monte Carlo calculations of simplified models will have the least confidence and yet they can still contribute to the confidence that the disposal concept will conform to regulatory requirements
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Energy Technology Data Exchange (ETDEWEB)
Vajgel, Stefan
2009-03-15
The electrical power generation using nuclear power plants requires this installation being safety, reliable and available for the working periods. For this purpose, an adequate, effective and well conducted maintenance program makes an essential and useful tool to the owner of the plant. However, it is necessary to follow the regulatory requirements for this program implementation which monitories this maintenance effectiveness. There are Brazilian norms requirements which must be followed. The international regulatory guides establish these requirements in good details but it is necessary to verify if this methodology for implementing can be totally applied here in Brazil. Then, the american guide NUMARC 93-01 which details how can be implemented a program for this monitoring, shows some methods for using. In this thesis, the Delphi and Probabilistic Safety Analysis were briefly included because they were preferred for implementing this monitoring.in a Brazilian plant. The results which are being obtained show that, looking the regulatory aspects, the NUMARC 93-01 follows our regulations and gives good results for the plant management. (author)
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Application of maximum radiation exposure values and monitoring of radiation exposure
International Nuclear Information System (INIS)
1993-01-01
According to the Section 32 of the Radiation Act (592/91) the Finnish Centre for Radiation and Nuclear Safety gives instructions concerning the monitoring of the radiation exposure and the application of the dose limits in Finland. The principles to be applied to calculating the equivalent and the effective doses are presented in the guide. Also the detailed instructions on the application of the maximum exposure values for the radiation work and for the natural radiation as well as the instructions on the monitoring of the exposures are given. Quantities and units for assessing radiation exposure are presented in the appendix of the guide
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Esser, B. K.; Beller, H. R.; Carroll, S.; Cherry, J. A.; Jackson, R. B.; Jordan, P. D.; Madrid, V.; Morris, J.; Parker, B. L.; Stringfellow, W. T.; Varadharajan, C.; Vengosh, A.
2015-12-01
California recently passed legislation mandating dedicated groundwater quality monitoring for new well stimulation operations. The authors provided the State with expert advice on the design of such monitoring networks. Factors that must be considered in designing a new and unique groundwater monitoring program include: Program design: The design of a monitoring program is contingent on its purpose, which can range from detection of individual well leakage to demonstration of regional impact. The regulatory goals for permit-required monitoring conducted by operators on a well-by-well basis will differ from the scientific goals of a regional monitoring program conducted by the State. Vulnerability assessment: Identifying factors that increase the probability of transport of fluids from the hydrocarbon target zone to a protected groundwater zone enables the intensity of permit-required monitoring to be tiered by risk and also enables prioritization of regional monitoring of groundwater basins based on vulnerability. Risk factors include well integrity; proximity to existing wellbores and geologic features; wastewater disposal; vertical separation between the hydrocarbon and groundwater zones; and site-specific hydrogeology. Analyte choice: The choice of chemical analytes in a regulatory monitoring program is guided by the goals of detecting impact, assuring public safety, preventing resource degradation, and minimizing cost. Balancing these goals may be best served by tiered approach in which targeted analysis of specific chemical additives is triggered by significant changes in relevant but more easily analyzed constituents. Such an approach requires characterization of baseline conditions, especially in areas with long histories of oil and gas development. Monitoring technology: Monitoring a deep subsurface process or a long wellbore is more challenging than monitoring a surface industrial source. The requirement for monitoring multiple groundwater aquifers across
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Building the case for independent monitoring of food advertising on Australian television.
King, Lesley; Hebden, Lana; Grunseit, Anne; Kelly, Bridget; Chapman, Kathy
2013-12-01
To provide an independent monitoring report examining the ongoing impact of Australian self-regulatory pledges on food and drink advertising to children on commercial television. Analysis of food advertisements across comparable sample time periods in April/May 2006, 2007, 2009, 2010 and 2011. The main outcome measure comprised change in the mean rate of non-core food advertisements from 2006 to 2011. Sydney free-to-air television channels. Televised food advertisements. In 2011 the rate of non-core food advertisements was not significantly different from that in 2006 or 2010 (3·2/h v. 4·1/h and 3·1/h), although there were variations across the intervening years. The rate of fast-food advertising in 2010 was significantly higher than in 2006 (1·8/h v. 1·1/h, P advertising on Sydney television has remained essentially unchanged between 2006 and 2011, despite the implementation of two industry self-regulatory pledges. The current study illustrates the value of independent monitoring as a basic requirement of any responsive regulatory approach.
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International Nuclear Information System (INIS)
1993-07-01
The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter. The rules on which final action has been taken since March 31, 1993 are: Repeal of NRC standards of conduct; Fitness-for-duty requirements for licensees who possess, use, or transport Category I material; Training and qualification of nuclear power plant personnel; Monitoring the effectiveness of maintenance at nuclear power plants; Licensing requirements for land disposal of radioactive wastes; and Licensees' announcements of safeguards inspections
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Grignolo, Alberto; Mingping, Zhang
2018-01-01
Sweeping reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign pharmaceutical companies. Japan, South Korea, and China are leading the charge, establishing mechanisms and infrastructure that both reflect and help drive international regulatory convergence and accelerate delivery of needed, innovative products to patients. In this rapidly evolving regulatory and commercial environment, drug developers can benefit from reforms and proliferating accelerated pathway (AP) frameworks, but only with regulatory and evidence-generation strategies tailored to the region. Otherwise, they will confront significant pricing and reimbursement headwinds. Although APAC economies are at different stages of development, they share a common imperative: to balance pharmaceutical innovation with affordability. Despite the complexity of meeting these sometimes conflicting demands, companies that focus on demonstrating and delivering value for money, and that price new treatments reasonably and sustainably, can succeed both for their shareholders and the region's patient population.
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Annual Report 2013. Nuclear Regulatory Authority
International Nuclear Information System (INIS)
2010-01-01
The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across seven parts and eight annexes the activities developed by the organism during 2013. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication has annexes with the following content: regulatory documents; inspections to medical; presentations of publications from ARN staff; measurement and evaluation of the drinking water of Ezeiza; international expert report on the implementation of international standards on radiation protection in the Ezeiza Atomic Center; Code of Ethics of the Nuclear Regulatory Authority.
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Short-term biological variation of clinical chemical values in dumeril's monitors (Varanus dumerili)
DEFF Research Database (Denmark)
Bertelsen, Mads Frost; Kjelgaard-Hansen, Mads Jens; Howell, Jennifer R.
2007-01-01
Plasma biochemical values are routinely used in the medical management of ill reptiles, and for monitoring the health of clinically normal animals. Laboratory tests, including clinical biochemical values, are subject to biological and analytical variation, the magnitude of which determines the ut...
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Uncertain added value of Global Trigger Tool for monitoring of patient safety in cancer care
DEFF Research Database (Denmark)
Lipczak, Henriette; Neckelmann, Kirsten; Steding-Jessen, Marianne
2011-01-01
Monitoring patient safety is a challenging task. The lack of a golden standard has contributed to the recommendation and introduction of several methods. In 2000 the Danish Lung Cancer Registry (DLCR) was established to monitor the clinical management of lung cancer. In 2008 the Global Trigger Tool...... (GTT) was recommended in Denmark as a tool for the monitoring of patient safety. Ideally, the recommendation of a new tool should be preceded by a critical assessment of its added value....
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Integrated environmental monitoring -- prototype demonstration
International Nuclear Information System (INIS)
Bryce, R.W.; Vail, L.W.; Hostetler, D.D.; Meyer, P.D.; Carlson, T.J.; Miller, P.L.
1994-01-01
Groundwater monitoring is an important activity at US Department of Energy (DOE) sites. Monitoring programs at DOE facilities have evolved in response to operational needs at the facilities, public outcries for information, regulatory requirements, DOE orders, and improvements in monitoring technology. Decisions regarding sampling location, sampling frequency, analyses performed, and other aspects of monitoring network design can have major implications for detecting releases and for making subsequent higher level decisions about facility operation and remediation. The Integrated Environmental Monitoring (IEM) concept is a set of analytical procedures and software tools that can be used to improve monitoring network design decisions. Such decisions include the choice of monitoring locations, sampling frequencies, sensor technologies, and monitored constituents. IEM provides a set of monitoring alternatives that balance the tradeoffs between competing monitoring objectives such as the minimization of cost and the minimization of uncertainty. The alternatives provided are the best available with respect to the monitoring objectives, consistent with the physical and chemical characteristics of the site, and consist with applicable regulatory requirements. The selection of the best monitoring alternative to implement is made by the stakeholders after reviewing the alternatives and tradeoffs produced by the IEM process
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Khader, A.; McKee, M.
2010-12-01
Value of information (VOI) analysis evaluates the benefit of collecting additional information to reduce or eliminate uncertainty in a specific decision-making context. It makes explicit any expected potential losses from errors in decision making due to uncertainty and identifies the “best” information collection strategy as one that leads to the greatest expected net benefit to the decision-maker. This study investigates the willingness to pay for groundwater quality monitoring in the Eocene Aquifer, Palestine, which is an unconfined aquifer located in the northern part of the West Bank. The aquifer is being used by 128,000 Palestinians to fulfill domestic and agricultural demands. The study takes into account the consequences of pollution and the options the decision maker might face. Since nitrate is the major pollutant in the aquifer, the consequences of nitrate pollution were analyzed, which mainly consists of the possibility of methemoglobinemia (blue baby syndrome). In this case, the value of monitoring was compared to the costs of treating for methemoglobinemia or the costs of other options like water treatment, using bottled water or importing water from outside the aquifer. And finally, an optimal monitoring network that takes into account the uncertainties in recharge (climate), aquifer properties (hydraulic conductivity), pollutant chemical reaction (decay factor), and the value of monitoring is designed by utilizing a sparse Bayesian modeling algorithm called a relevance vector machine.
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Reference values for anxiety questionnaires: the Leiden Routine Outcome Monitoring Study.
Schulte-van Maaren, Yvonne W M; Giltay, Erik J; van Hemert, Albert M; Zitman, Frans G; de Waal, Margot W M; Carlier, Ingrid V E
2013-09-25
The monitoring of patients with an anxiety disorder can benefit from Routine Outcome Monitoring (ROM). As anxiety disorders differ in phenomenology, several anxiety questionnaires are included in ROM: Brief Scale for Anxiety (BSA), PADUA Inventory Revised (PI-R), Panic Appraisal Inventory (PAI), Penn State Worry Questionnaire (PSWQ), Worry Domains Questionnaire (WDQ), Social Interaction, Anxiety Scale (SIAS), Social Phobia Scale (SPS), and the Impact of Event Scale-Revised (IES-R). We aimed to generate reference values for both 'healthy' and 'clinically anxious' populations for these anxiety questionnaires. We included 1295 subjects from the general population (ROM reference-group) and 5066 psychiatric outpatients diagnosed with a specific anxiety disorder (ROM patient-group). The MINI was used as diagnostic device in both the ROM reference group and the ROM patient group. To define limits for one-sided reference intervals (95th percentile; P95) the outermost 5% of observations were used. Receiver Operating Characteristics (ROC) analyses were used to yield alternative cut-off values for the anxiety questionnaires. For the ROM reference-group the mean age was 40.3 years (SD=12.6), and for the ROM patient-group it was 36.5 years (SD=11.9). Females constituted 62.8% of the reference-group and 64.4% of the patient-group. P95 ROM reference group cut-off values for reference versus clinically anxious populations were 11 for the BSA, 43 for the PI-R, 37 for the PAI Anticipated Panic, 47 for the PAI Perceived Consequences, 65 for the PAI Perceived Self-efficacy, 66 for the PSWQ, 74 for the WDQ, 32 for the SIAS, 19 for the SPS, and 36 for IES-R. ROC analyses yielded slightly lower reference values. The discriminative power of all eight anxiety questionnaires was very high. Substantial non-response and limited generalizability. For eight anxiety questionnaires a comprehensive set of reference values was provided. Reference values were generally higher in women than in men
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Khader, A. I.; Rosenberg, D. E.; McKee, M.
2013-05-01
Groundwater contaminated with nitrate poses a serious health risk to infants when this contaminated water is used for culinary purposes. To avoid this health risk, people need to know whether their culinary water is contaminated or not. Therefore, there is a need to design an effective groundwater monitoring network, acquire information on groundwater conditions, and use acquired information to inform management options. These actions require time, money, and effort. This paper presents a method to estimate the value of information (VOI) provided by a groundwater quality monitoring network located in an aquifer whose water poses a spatially heterogeneous and uncertain health risk. A decision tree model describes the structure of the decision alternatives facing the decision-maker and the expected outcomes from these alternatives. The alternatives include (i) ignore the health risk of nitrate-contaminated water, (ii) switch to alternative water sources such as bottled water, or (iii) implement a previously designed groundwater quality monitoring network that takes into account uncertainties in aquifer properties, contaminant transport processes, and climate (Khader, 2012). The VOI is estimated as the difference between the expected costs of implementing the monitoring network and the lowest-cost uninformed alternative. We illustrate the method for the Eocene Aquifer, West Bank, Palestine, where methemoglobinemia (blue baby syndrome) is the main health problem associated with the principal contaminant nitrate. The expected cost of each alternative is estimated as the weighted sum of the costs and probabilities (likelihoods) associated with the uncertain outcomes resulting from the alternative. Uncertain outcomes include actual nitrate concentrations in the aquifer, concentrations reported by the monitoring system, whether people abide by manager recommendations to use/not use aquifer water, and whether people get sick from drinking contaminated water. Outcome costs
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International Nuclear Information System (INIS)
White, J.R.
1993-01-01
Crucial to complying with environmental regulations is selecting appropriate pollution control equipment to capture or destroy regulated pollutants. But just as important is selecting a continuous emissions monitoring system (CEM). CEMs play a dual role in an overall compliance strategy. On one hand, they identify the type and quantity of emissions at a source as a first step for determining which regulatory requirements and control technologies are applicable. They also provide ongoing emissions data to demonstrate compliance with air and other environmental regulations. Facilities are required to monitor their processes with CEMs, or a comparable technology, under several titles of the Clean Air Act Amendments of 1990. CEMs meet regulatory requirements if they include a SO 2 concentration monitor, nitrogen oxides (NO x ) concentration monitor, volumetric flow monitor, opacity monitor, diluent gas monitor and data acquisition and handling system. The entire system and each subsystem has to be installed and certified before it can be used for compliance. A written quality assurance/quality control (QA/QC) plan for the CEMs must accompany the permit application. The acid rain rules also impose performance standards and frequent calibration checks to ensure the integrity of CEMs data
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International Nuclear Information System (INIS)
Holland, R.C.
1997-02-01
This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. 52 refs., 10 figs., 12 tabs
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Feng, Mengling; Loy, Liang Yu; Zhang, Feng; Zhang, Zhuo; Vellaisamy, Kuralmani; Chin, Pei Loon; Guan, Cuntai; Shen, Liang; King, Nicolas K K; Lee, Kah Keow; Ang, Beng Ti
2012-01-01
Despite the wealth of information carried, periodic brain monitoring data are often incomplete with a significant amount of missing values. Incomplete monitoring data are usually discarded to ensure purity of data. However, this approach leads to the loss of statistical power, potentially biased study and a great waste of resources. Thus, we propose to reuse incomplete brain monitoring data by imputing the missing values - a green solution! To support our proposal, we have conducted a feasibility study to investigate the reusability of incomplete brain monitoring data based on the estimated imputation error. Seventy-seven patients, who underwent invasive monitoring of ICP, MAP, PbtO (2) and brain temperature (BTemp) for more than 24 consecutive hours and were connected to a bedside computerized system, were selected for the study. In the feasibility study, the imputation error is experimentally assessed with simulated missing values and 17 state-of-the-art predictive methods. A framework is developed for neuroclinicians and neurosurgeons to determine the best re-usage strategy and predictive methods based on our feasibility study. The monitoring data of MAP and BTemp are more reliable for reuse than ICP and PbtO (2); and, for ICP and PbtO (2) data, a more cautious re-usage strategy should be employed. We also observe that, for the scenarios tested, the lazy learning method, K-STAR, and the tree-based method, M5P, are consistently 2 of the best among the 17 predictive methods investigated in this study.
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Improving regulatory oversight of maintenance programs
International Nuclear Information System (INIS)
Cook, S.
2008-01-01
Safe nuclear power plant operation requires that risks due to failure or unavailability of Structures, Systems and Components (SSCs) be minimized. Implementation of an effective maintenance program is a key means for achieving this goal. In its regulatory framework, the important relationship between maintenance and safety is acknowledged by the CNSC. A high level maintenance program requirement is included in the Class I Facilities Regulations. In addition, the operating licence contains a condition based on the principle that the design function and performance of SSCs needs to remain consistent with the plant's design and analysis documents. Nuclear power plant licensees have the primary responsibility for safe operation of their facilities and consequently for implementation of a successful maintenance program. The oversight role of the Canadian Nuclear Safety Commission (CNSC) is to ensure that the licensee carries out that responsibility. The challenge for the CNSC is how to do this consistently and efficiently. Three opportunities for improvement to regulatory maintenance oversight are being pursued. These are related to the regulatory framework, compliance verification inspection activities and monitoring of self-reporting. The regulatory framework has been improved by clarifying expectations through the issuance of S-210 'Maintenance Programs for Nuclear Power Plants'. Inspection activities have been improved by introducing new maintenance inspections into the baseline program. Monitoring is being improved by making better use of self-reported and industry produced maintenance related performance indicators. As with any type of program change, the challenge is to ensure the consistent and optimal application of regulatory activities and resources. This paper is a summary of the CNSC's approach to improving its maintenance oversight strategy. (author)
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Assessing the value of information for long-term structural health monitoring
Pozzi, Matteo; Der Kiureghian, Armen
2011-04-01
In the field of Structural Health Monitoring, tests and sensing systems are intended as tools providing diagnoses, which allow the operator of the facility to develop an efficient maintenance plan or to require extraordinary measures on a structure. The effectiveness of these systems depends directly on their capability to guide towards the most optimal decision for the prevailing circumstances, avoiding mistakes and wastes of resources. Though this is well known, most studies only address the accuracy of the information gained from sensors without discussing economic criteria. Other studies evaluate these criteria separately, with only marginal or heuristic connection with the outcomes of the monitoring system. The concept of "Value of Information" (VoI) provides a rational basis to rank measuring systems according to a utility-based metric, which fully includes the decision-making process affected by the monitoring campaign. This framework allows, for example, an explicit assessment of the economical justifiability of adopting a sensor depending on its precision. In this paper we outline the framework for assessing the VoI, as applicable to the ranking of competitive measuring systems. We present the basic concepts involved, highlight issues related to monitoring of civil structures, address the problem of non-linearity of the cost-to-utility mapping, and introduce an approximate Monte Carlo approach suitable for the implementation of time-consuming predictive models.
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From Monitored Values to the Model Creation of the Dynamic System
Directory of Open Access Journals (Sweden)
Vladena BARANOVÁ
2015-11-01
Full Text Available Current information technology allow sensing and processes data recording under severe conditions of operation with new technical means in real time, storing the measurement data, its processing and evaluation in situ or in the laboratory. An example would be the monitoring system boring machine-rock used in tunneling Branisko. The monitored variables of the boring process were downforce of disconnecting head of boring machine, torque, speed of disconnecting head, the power consumption of the aggregate and the extended position of disconnecting head depending on the drilled length. These measured values allowed the creation of models, which help to modeling various properties of boring process within the meaning of Eykhoff definition: "A model is an expression of the essential characteristics of an existing object, which describes the knowledge of this object in a usable form".
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Directory of Open Access Journals (Sweden)
Alexandra Ryan Ahmad Dina
2012-12-01
Full Text Available The objective of this research is to examine the effect of bank monitoring as an alternative of corporate governance mechanisms on the borrowers’ firm value. The strengths of bank monitoring on the borrowers are measured based on the magnitude of the bank loan, the size of the loan from banks with high monitoring quality, the length of a bank loan outstanding period, and the number of lenders. The research hypotheses were tested using multiple regression model with a sample of 230 companies listed in Indonesia Stock Exchange during 2009. The empirical results show that only the size of the loan from banks with high monitoring quality and the number of lenders significantly influences the borrowers’ firm value. These findings imply that only banks with high monitoring quality could play an important role in the corporate governance and therefore increasing the firm value by their monitoring function. Furthermore, bank monitoring is less effective if a company borrows from many banks, and therefore decreasing the firm value
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The regulatory control of radioactive sources in Argentina
International Nuclear Information System (INIS)
Rojkind, Roberto Hector
1997-01-01
Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author)
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Regulation for continuous improvements - the new regulatory strategy of SKI
International Nuclear Information System (INIS)
Hoegberg, L.; Svensson, G.; Viktorsson, C.
1998-01-01
This paper describes the new regulatory objectives and strategy of the Swedish Nuclear Power Inspectorate. Factors that have influenced the development of the regulatory strategy, including an international peer review, are discussed. In addition to general technical requirements for a defence in depth, the new strategy strongly focuses on the quality of plant safety management processes, to be monitored by process-oriented inspections. Also, quality assurance of regulatory activities is stressed. Experience gained so far shows that the regulatory approach chosen in Sweden promotes utility self assessment, quality of safety management and ownership of safety work within the utility staff. (author)
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Regulatory regime and its influence in the nuclear safety
International Nuclear Information System (INIS)
Laaksonen, J.
1999-01-01
Main elements of nuclear regulatory regime in general is presented. These elements are: national rules and safety regulations, system of nuclear facility licensing, activities of regulatory body. Regulatory body is needed to specify the national safety regulations, review and assess the safety documentation presented to support license application, make inspections to verify fulfilment of safety regulations and license conditions, monitor the quality of work processes of user organization, and to assess whether these processes provide a high safety level, promote high safety culture, promote maintenance and development of national infrastructure relevant to nuclear safety, etc
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Energy Technology Data Exchange (ETDEWEB)
Holland, R.C. [Science Applications International Corp., San Diego, CA (United States)
1993-07-01
This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. This revision to the Environmental Monitoring Plan was written to document the changes made to the Monitoring Program during 1992. Some of the data (most notably the statistical analyses of past monitoring data) has not been changed.
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International Nuclear Information System (INIS)
Holland, R.C.
1993-07-01
This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. This revision to the Environmental Monitoring Plan was written to document the changes made to the Monitoring Program during 1992. Some of the data (most notably the statistical analyses of past monitoring data) has not been changed
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Directory of Open Access Journals (Sweden)
Wen-Tien Tsai
2016-09-01
Full Text Available In the past decades, hazardous air pollutants (HAPs, so-called air toxics or toxic air pollutants, have been detected in the atmospheric air at low concentration levels, causing public concern about the adverse effect of long-term exposure to HAPs on human health. Most HAPs belong to volatile organic compounds (VOCs. More seriously, most of them are known carcinogens or probably carcinogenic to humans. The objectives of this paper were to report the regulatory aspects and environmental monitoring management of toxic VOCs designated by Japan and Korea under the Air Pollution Control Act, and the Clean Air Conservation Act, respectively. It can be found that the environmental quality standards and environmental monitoring of priority VOCs (i.e., benzene, trichloroethylene, tetrachloroethylene, and dichloromethane have been set and taken by the state and local governments of Japan since the early 2000, but not completely established in Korea. On the other hand, the significant progress in reducing the emissions of some toxic VOCs, including acrylonitrile, benzene, 1,3-butadiene, 1,2-dichloroethane, dichloromethane, chloroform, tetrachloroethylene, and trichloroethylene in Japan was also described as a case study in the brief report paper.
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Advancing Sensor Technology to Monitor Wildfires
EPA and partners are looking at ways to use miniature sensors to monitor air quality near wildfires. Data from these small sensors can complement measurements obtained from more complex regulatory-grade monitors that are stationary.
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The regulatory control of radioactive sources in Argentina
International Nuclear Information System (INIS)
Rojkind, R.H.
1998-01-01
Argentina has been conducting nuclear activities for more than forty years, and had established a Regulatory Authority as early as in 1956. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations were in force in Argentina before the accident in Goiania. The conclusions drawn from the Goiania accident encouraged the Argentine authorities to improve some regulatory procedures and helped to enhance the quality of the regulatory process. As a result, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain have improved. Lessons learned in Argentina from the accident in Goiania are presented as well as the main characteristics of an effective enforcement programme to prevent radiological accidents when radioactive sources are used for industrial, medical, research and teaching purposes. (author)
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Environmental Monitoring Plan, Revision 6
Energy Technology Data Exchange (ETDEWEB)
Gallegos, G M; Bertoldo, N A; Blake, R G; Campbell, C G; Grayson, A R; Nelson, J C; Revelli, M A; Rosene, C A; Wegrecki, T; Williams, R A; Wilson, K R; Jones, H E
2012-03-02
The purpose of environmental monitoring is to promote the early identification of, and response to, potential adverse environmental impacts associated with Lawrence Livermore National Laboratory (LLNL) operations. Environmental monitoring supports the Integrated Safety Management System (ISMS), International Organization for Standardization (ISO) 14001 Environmental Management Systems standard, and U. S. Department of Energy (DOE) Order 458.1, Radiation Protection of the Public and the Environment. Specifically, environmental monitoring enables LLNL to detect, characterize, and respond to releases from LLNL activities; assess impacts; estimate dispersal patterns in the environment; characterize the pathways of exposure to members of the public; characterize the exposures and doses to individuals and to the population; and to evaluate the potential impacts to the biota in the vicinity of LLNL. Environmental monitoring is also a major component of compliance demonstration for permits and other regulatory requirements. The Environmental Monitoring Plan (EMP) addresses the sample collection and analytical work supporting environmental monitoring to ensure the following: (1) A consistent system for collecting, assessing, and documenting environmental data of known and documented quality; (2) A validated and consistent approach for sampling and analysis of samples to ensure laboratory data meets program-specific needs and requirements within the framework of a performance-based approach for analytical laboratory work; and (3) An integrated sampling approach to avoid duplicative data collection. LLNL prepares the EMP because it provides an organizational framework for ensuring that environmental monitoring work, which is integral to the implementation of LLNL's Environmental Management System, is conducted appropriately. Furthermore, the Environmental Monitoring Plan helps LLNL ensure compliance with DOE Order 231.1 Change 2, Environment, Safety and Health Reporting
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Assessing the value of structural health monitoring
DEFF Research Database (Denmark)
Thöns, S.; Faber, Michael Havbro
2013-01-01
Structural Health Monitoring (SHM) systems are designed for assisting owners and operators with information and forecasts concerning the fitness for purpose of structures and building systems. The benefit associated with the implementation of SHM may in some cases be intuitively anticipated...... as their responses and performances over their life-cycle. In addition, the quality of monitoring and the performance of possible remedial actions triggered by monitoring results are modeled probabilistically.The consequences accounted for, in principle include all consequences associated with the performance...
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10 CFR 26.406 - Fitness monitoring.
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Fitness monitoring. 26.406 Section 26.406 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.406 Fitness monitoring. (a...) Licensees and other entities shall implement a fitness monitoring program to deter substance abuse and...
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Identification of technical guidance related to ground water monitoring
Energy Technology Data Exchange (ETDEWEB)
Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.
1987-05-01
Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act.
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Identification of technical guidance related to ground water monitoring
International Nuclear Information System (INIS)
Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.
1987-05-01
Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act
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77 FR 30030 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants
2012-05-21
... Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance. SUMMARY... (RG) 1.160, ``Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.'' This guide... Monitoring the Effectiveness of Maintenance at Nuclear Power Plants,'' which provides methods that are...
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On the Value of Monitoring Information for the Structural Integrity and Risk Management
DEFF Research Database (Denmark)
Thöns, Sebastian
2018-01-01
facilitates the assessment of the value of information associated with SHM. The principal approach for the quantification of the value of SHM is formulated by modeling the fundamental decision of performing SHM or not in conjunction with their expected utilities. The expected utilities are calculated....... The calculation of the expected utilities necessitates a comprehensive and rigorous modeling, which is introduced close to the original formulations and for which analysis characteristics and simplifications are described and derived. The framework provides the basis for the optimization of the structural risk......This article introduces an approach and framework for the quantification of the value of structural health monitoring (SHM) in the context of the structural risk and integrity management for systems.The quantification of the value of SHM builds upon the Bayesian decision and utility theory, which...
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International Nuclear Information System (INIS)
Tsuji, Masashi; Shimazu, Yoichiro; Michishita, Hiroshi
2005-01-01
A new method for evaluating the decay ratios in a boiling water reactor (BWR) using the singular value decomposition (SVD) method had been proposed. In this method, a signal component closely related to the BWR stability can be extracted from independent components of the neutron noise signal decomposed by the SVD method. However, real-time stability monitoring by the SVD method requires an efficient procedure for screening such components. For efficient screening, an artificial neural network (ANN) with three layers was adopted. The trained ANN was actually applied to decomposed components of local power range monitor (LPRM) signals that were measured in stability experiments conducted in the Ringhals-1 BWR. In each LPRM signal, multiple candidates were screened from the decomposed components. However, decay ratios could be estimated by introducing appropriate criterions for selecting the most suitable component among the candidates. The estimated decay ratios are almost identical to those evaluated by visual screening in a previous study. The selected components commonly have the largest singular value, the largest decay ratio and the least squared fitting error among the candidates. By virtue of excellent screening performance of the trained ANN, the real-time stability monitoring by the SVD method can be applied in practice. (author)
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Vasconcelos, Maydla Dos Santos; Passos, Wilson Espíndola; Lescanos, Caroline Honaiser; Pires de Oliveira, Ivan; Trindade, Magno Aparecido Gonçalves; Caires, Anderson Rodrigues Lima; Muzzi, Rozanna Marques
2018-01-01
The techniques used to monitor the quality of the biodiesel are intensely discussed in the literature, partly because of the different oil sources and their intrinsic physicochemical characteristics. This study aimed to monitor the thermal degradation of the fatty acid methyl esters of Sesamum indicum L. and Raphanus sativus L. biodiesels (SILB and RSLB, resp.). The results showed that both biodiesels present a high content of unsaturated fatty acids, ∼84% (SILB) and ∼90% (RSLB). The SILB had a high content of polyunsaturated linoleic fatty acid (18 : 2), about 49%, and the oleic monounsaturated (18 : 1), ∼34%. On the other hand, RSLB presented a considerable content of linolenic fatty acid (18 : 3), ∼11%. The biodiesel samples were thermal degraded at 110°C for 48 hours, and acid value, UV absorption, and fluorescence spectroscopy analysis were carried out. The results revealed that both absorption and fluorescence presented a correlation with acid value as a function of degradation time by monitoring absorptions at 232 and 270 nm as well as the emission at 424 nm. Although the obtained correlation is not completely linear, a direct correlation was observed in both cases, revealing that both properties can be potentially used for monitoring the biodiesel degradation.
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Directory of Open Access Journals (Sweden)
Maydla dos Santos Vasconcelos
2018-01-01
Full Text Available The techniques used to monitor the quality of the biodiesel are intensely discussed in the literature, partly because of the different oil sources and their intrinsic physicochemical characteristics. This study aimed to monitor the thermal degradation of the fatty acid methyl esters of Sesamum indicum L. and Raphanus sativus L. biodiesels (SILB and RSLB, resp.. The results showed that both biodiesels present a high content of unsaturated fatty acids, ∼84% (SILB and ∼90% (RSLB. The SILB had a high content of polyunsaturated linoleic fatty acid (18 : 2, about 49%, and the oleic monounsaturated (18 : 1, ∼34%. On the other hand, RSLB presented a considerable content of linolenic fatty acid (18 : 3, ∼11%. The biodiesel samples were thermal degraded at 110°C for 48 hours, and acid value, UV absorption, and fluorescence spectroscopy analysis were carried out. The results revealed that both absorption and fluorescence presented a correlation with acid value as a function of degradation time by monitoring absorptions at 232 and 270 nm as well as the emission at 424 nm. Although the obtained correlation is not completely linear, a direct correlation was observed in both cases, revealing that both properties can be potentially used for monitoring the biodiesel degradation.
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The regulatory control of radioactive sources in Argentina
Energy Technology Data Exchange (ETDEWEB)
Rojkind, Roberto Hector [Autoridade Regulatoria Nuclear, Buenos Aires (Argentina)
1997-12-31
Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author) 9 refs; e-mail: rrojkind at sede.arn.gov.br
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Regulatory agencies and regulatory risk
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...
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Energy Technology Data Exchange (ETDEWEB)
Peterson, Mark [Oak Ridge National Laboratory, Oak Ridge, Tennessee 37831 (United States)
2012-07-01
The Biological Monitoring and Abatement Program (BMAP) is a long-running program that was designed to evaluate biological conditions and trends in waters downstream of Department of Energy (DOE) facilities in Oak Ridge, Tennessee. BMAP monitoring has focused on aquatic pathways from sources to biota, which is consistent with the sites' clean water regulatory focus and the overall cleanup strategy which divided remediation areas into watershed administrative units. Specific programmatic goals include evaluating operational and legacy impacts to nearby streams and the effectiveness of implemented remediation strategies at the sites. The program is characterized by consistent, long-term sampling and analysis methods in a multidisciplinary and quantitative framework. Quantitative sampling has shown conclusively that at most Oak Ridge stream sites, fish and aquatic macro-invertebrate communities have improved considerably since the 1980s. Monitoring of mercury and PCBs in fish has shown that remedial and abatement actions have also improved stream conditions, although in some cases biological monitoring suggests further actions are needed. Follow-up investigations have been implemented by BMAP to identify sources or causes, consistent with an adaptive management approach. Biological monitoring results to date have not only been used to assess regulatory compliance, but have provided additional benefits in helping address other components of the DOE's mission, including facility operations, natural resource, and scientific goals. As a result the program has become a key measure of long-term trends in environmental conditions and of high value to the Oak Ridge environmental management community, regulators, and the public. Some of the BMAP lessons learned may be of value in the design, implementation, and application of other long-term monitoring and stewardship programs, and assist environmental managers in the assessment and prediction of the effectiveness of
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Regulatory Forum Opinion Piece*: The Value of Publishing Negative Scientific Study Data.
Boorman, Gary A; Foster, John R; Laast, Victoria A; Francke, Sabine
2015-10-01
Historically it has been easier to publish positive scientific results than negative data not supporting the research hypothesis. This appears to be increasing, with fewer negative studies appearing in the literature across many disciplines. Failure to recognize the value of negative results has important implications for the toxicology community. Implications include perpetuating scientific fields based upon selective or occasionally erroneous, positive results. One example is decreased vaccination rates and increased measles infections that can lead to childhood mortality following one erroneous positive study linking vaccination to adverse effects despite multiple negative studies. Publication of negative data that challenges existing paradigms enhances progress by stopping further investment in scientifically barren topics, decreases the use of animals, and focuses research in more fruitful areas. The National Toxicology Program (NTP) publishes both positive and negative rodent data. Retrospective analysis of the NTP database has provided insights on the carcinogenic process and in the gradual acceptance of using fewer animals in safety studies. This article proposes that careful publication of both positive and negative data can enhance product safety assessment, add robustness to safety determinations in the regulatory decision-making process, and should be actively encouraged by those determining journal editorial policy. © 2015 by The Author(s).
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Risk perception, safety goals and regulatory decision-making
International Nuclear Information System (INIS)
Hoegberg, Lars
1998-01-01
Deciding on 'how safe is safe enough?' includes value judgements with implications of an ethical and political nature. As regulators are accountable to governments, parliaments and the general public, regulatory decision-making should be characterized by transparency with respect to how such value judgements are reflected in risk assessments and regulatory decisions. Some approaches in this respect are discussed in the paper, based on more than fifteen years of experience in nuclear regulatory decision-making. Issues discussed include: (1) risk profiles and safety goals associated with severe reactor accidents--individual health risks, societal risks and risk of losing investments; (2) risk profile-based licensing of the Swedish SFR final disposal facility for low and intermediate level radioactive waste
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Compliance Groundwater Monitoring of Nonpoint Sources - Emerging Approaches
Harter, T.
2008-12-01
Groundwater monitoring networks are typically designed for regulatory compliance of discharges from industrial sites. There, the quality of first encountered (shallow-most) groundwater is of key importance. Network design criteria have been developed for purposes of determining whether an actual or potential, permitted or incidental waste discharge has had or will have a degrading effect on groundwater quality. The fundamental underlying paradigm is that such discharge (if it occurs) will form a distinct contamination plume. Networks that guide (post-contamination) mitigation efforts are designed to capture the shape and dynamics of existing, finite-scale plumes. In general, these networks extend over areas less than one to ten hectare. In recent years, regulatory programs such as the EU Nitrate Directive and the U.S. Clean Water Act have forced regulatory agencies to also control groundwater contamination from non-incidental, recharging, non-point sources, particularly agricultural sources (fertilizer, pesticides, animal waste application, biosolids application). Sources and contamination from these sources can stretch over several tens, hundreds, or even thousands of square kilometers with no distinct plumes. A key question in implementing monitoring programs at the local, regional, and national level is, whether groundwater monitoring can be effectively used as a landowner compliance tool, as is currently done at point-source sites. We compare the efficiency of such traditional site-specific compliance networks in nonpoint source regulation with various designs of regional nonpoint source monitoring networks that could be used for compliance monitoring. We discuss advantages and disadvantages of the site vs. regional monitoring approaches with respect to effectively protecting groundwater resources impacted by nonpoint sources: Site-networks provide a tool to enforce compliance by an individual landowner. But the nonpoint source character of the contamination
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Handbook for value-impact assessment
International Nuclear Information System (INIS)
Heaberlin, S.W.; Burnham, J.B.; Gallucci, R.H.V.
1983-12-01
The basic purpose of this handbook is to document a set of systematic procedures for providing information that can be used in performing value-impact assessments of Nuclear Regulatory Commission (NRC) regulatory actions. The handbook describes a structured but flexible process for performing the assessment. Chapter 1 is an introduction to the value-impact assessment process. Chapter 2 describes the attributes most frequently affected by proposed NRC actions, provides guidance concerningthe appropriate level of effort to be devoted to the assessment, suggests a standard format for documenting the assessment, and discusses the treatment of uncertainty. Chapter 3 contains detailed methods for evaluating each of the attributes affected by a regulatory action. The handbook has five appendixes containing background information, technical data, and example applications of the value-impact assessment procedures. This edition of the handbook focuses primarily on assessing nuclear power reactor safety issues
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Voss, S C; Varamenti, E; Elzain Elgingo, M; Bourdon, P C
2014-04-01
Hematological and biochemical parameters of 160 Middle Eastern adolescent male athletes (aged from 12-18 years) were tested in order to investigate their iron status and to establish reference values for this population. A focus of this study was also the investigation of Reticulocyte hemoglobin (RetHe) and soluble transferrin receptor (sTfR). Complete blood count, reticulocyte and sera parameters were analyzed at the beginning of the training season for these adolescent athletes. As the diagnosis of iron deficiency in adolescents is extremely difficult subjects were subdivided in three age groups (12-13, 14-15, 16-18). For most of the parameters our results confirmed the existing reference values reported in young athletes. Exceptions were however found with lower Mean Cell Volumes (79.9±4.3 fl) in this group when compared to other age matched data. RetHe, ferritin and sTfR levels were monitored for the interpretation of the iron status in this population and reference values for these parameters were also established. Information to help evidence based decision making about the need for supplementation or further investigations is provided to physicians and nutritionists. RetHe with a proposed threshold value of 25 pg expands the list of parameters which can be used to monitor athletes.
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76 FR 55137 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants
2011-09-06
... the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/ . Regulatory guides are not... Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; request for... comment draft regulatory guide (DG) DG-1278, ``Monitoring the Effectiveness of Maintenance at Nuclear...
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Post-accident radiation monitors
International Nuclear Information System (INIS)
Laughlin, G.J.; Kathren, R.L.
1982-01-01
Under contract to the Nuclear Safety Analysis Center of the Electric Power Research Institute, technical information and specifications were obtained for commercially available radiological monitoring instrumentation designed for use as post-accident monitors. The information was collated and published in the NSAC Handbook of Postaccident Instrumentation (Kathren and Laughlin 1981), and included such data as range, accuracy, precision, sensitivity, and energy dependence of the detector, environmental and seismic limitations of the equipment, the testing program performed to evaluate the equipment, a list of references where the instrumentation is currently installed, and a list of features and accessories available with the monitoring systems. The information presented in this section reveals that, even though a number of vendors claim to be able to meet the guidance of Regulatory Guide 1.97 (USNRC 1980), few have actually conducted tests to verify that their equipment does indeed satisfy the guidance of this Regulatory Guide, and that some of the guidance may in fact be unrealistic
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Regulatory aspects for nuclear and radiation applications
International Nuclear Information System (INIS)
Duraisamy, S.
2014-01-01
The Atomic Energy Regulatory Board (AERB) is the national authority for ensuring that the use of ionizing radiation and nuclear energy does not cause any undue risk to the health of workers, members of the public and to the environment. AERB was constituted on November 15, 1983 and derives its regulatory power from the rules and notifications promulgated under the Atomic Energy Act, 1962 and the Environment (Protection) Act, 1986. AERB is provided with the necessary powers and mandate to frame safety policies, lay down safety standards and requirements for monitoring and enforcing the safety provisions. AERB follows multi-tier system for its review and assessment, safety monitoring, surveillance and enforcement. While regulating various nuclear and radiation facilities, AERB adopts a graded approach taking into account the hazard potential associated with the facilities being regulated. The regulatory process has been continuous evolving to cater to the new developments in reactor and radiation technologies. The regulatory effectiveness and efficiency of AERB have grown over the last three decades to make it into a robust organization. The radiation protection infrastructure in the country is on a sound footing and is constantly being strengthened based on experience and continued research and development. As one of its mandates AERB prescribes radiation dose limits for the occupational workers and the public, in line with the IAEA Safety Standard and ICRP recommendations. The current dose limits and the radiation safety requirements are more stringent than past. To meet the current safety standards, it is important for the facilities to have state of art radiation monitoring system and programme in place. While recognizing the current system in place, this presentation also highlights certain key radiation protection challenges associated with the implementation of radiation protection standards in the nuclear and radiation facilities especially in the areas of
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International Nuclear Information System (INIS)
Memarzadeh, Milad; Pozzi, Matteo
2016-01-01
We illustrate how to assess the Value of Information (VoI) in sequential decision making problems modeled by Partially Observable Markov Decision Processes (POMDPs). POMDPs provide a general framework for modeling the management of infrastructure components, including operation and maintenance, when only partial or noisy observations are available; VoI is a key concept for selecting explorative actions, with application to component inspection and monitoring. Furthermore, component-level VoI can serve as an effective heuristic for assigning priorities to system-level inspection scheduling. We introduce two alternative models for the availability of information, and derive the VoI in each of those settings: the Stochastic Allocation (SA) model assumes that observations are collected with a given probability, while the Fee-based Allocation model (FA) assumes that they are available at a given cost. After presenting these models at component-level, we investigate how they perform for system-level inspection scheduling. - Highlights: • On the Value of Information in POMDPs, for optimal exploration of systems. • A method for assessing the Value of Information of permanent monitoring. • A method for allocating inspections in systems made up by parallel POMDPs.
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Annual Report 2007. Nuclear Regulatory Authority; Informe Anual 2007. Autoridad Regulatoria Nuclear
Energy Technology Data Exchange (ETDEWEB)
NONE
2008-07-01
The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.
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Annual Report 2008. Nuclear Regulatory Authority; Informe Anual 2008. Autoridad Regulatoria Nuclear
Energy Technology Data Exchange (ETDEWEB)
NONE
2009-07-01
The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.
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Development of regulatory techniques for operational performance evaluation of nuclear power plants
International Nuclear Information System (INIS)
Sung, K. Y.; Lee, C. J.; Choi, J. S.; Lee, S. Y.; Kim, M. C.
2003-04-01
In order to provide the technical rationale for future risk-informed regulatory applications, four essential regulatory areas, i.e., PSA regulatory audit model, quality certification procedure on PSA, risk-informed performance indicator, and risk monitoring were surveyed, and the corresponding state-of- technology for each area was summarized. Actually, this study was performed by way of the analysis and in-depth survey on the previous experience done by any individual organizations like USNRC or US NEI, as well as the international organizations like IAEA or OECD/NEA. Through the survey results, we might look for the regulatory positions on national development
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10 CFR 36.55 - Personnel monitoring.
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 36.55 Section 36.55 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Operation of Irradiators § 36.55 Personnel monitoring. (a) Irradiator operators shall wear a personnel dosimeter that is...
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10 CFR 34.47 - Personnel monitoring.
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...
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Evaluation of NORM in facility Venezuelan oil industry to establish regulatory criteria
International Nuclear Information System (INIS)
Acevedo Lozada, D. J.; Rivas, I.; Davila, L.; Flores, Y.
2013-01-01
The present work shows the need to identify, in the Venezuelan oil industry, the existence of exposure to natural sources of radiation should be considered as occupational. As Regulatory Authority in the area of ionizing radiation the need for regulatory processes and ensure radiation protection of personnel involved in these practices arises, as well as personal and environmental monitoring. NORM identifying an installation of the Venezuelan oil industry to establish regulatory processes and take steps to ensure occupational radiation protection. (Author)
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A High-Level Petri Net Framework for Genetic Regulatory Networks
Directory of Open Access Journals (Sweden)
Banks Richard
2007-12-01
Full Text Available To understand the function of genetic regulatory networks in the development of cellular systems, we must not only realise the individual network entities, but also the manner by which they interact. Multi-valued networks are a promising qualitative approach for modelling such genetic regulatory networks, however, at present they have limited formal analysis techniques and tools. We present a flexible formal framework for modelling and analysing multi-valued genetic regulatory networks using high-level Petri nets and logic minimization techniques. We demonstrate our approach with a detailed case study in which part of the genetic regulatory network responsible for the carbon starvation stress response in Escherichia coli is modelled and analysed. We then compare and contrast this multivalued model to a corresponding Boolean model and consider their formal relationship.
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10 CFR 39.65 - Personnel monitoring.
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...
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Annual Report 2009. Nuclear Regulatory Authority; Informe Anual 2009. Autoridad Regulatoria Nuclear
Energy Technology Data Exchange (ETDEWEB)
NONE
2010-07-01
The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.
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Escher, Beate I; Neale, Peta A; Leusch, Frederic D L
2015-09-15
Cell-based bioassays are becoming increasingly popular in water quality assessment. The new generations of reporter-gene assays are very sensitive and effects are often detected in very clean water types such as drinking water and recycled water. For monitoring applications it is therefore imperative to derive trigger values that differentiate between acceptable and unacceptable effect levels. In this proof-of-concept paper, we propose a statistical method to read directly across from chemical guideline values to trigger values without the need to perform in vitro to in vivo extrapolations. The derivation is based on matching effect concentrations with existing chemical guideline values and filtering out appropriate chemicals that are responsive in the given bioassays at concentrations in the range of the guideline values. To account for the mixture effects of many chemicals acting together in a complex water sample, we propose bioanalytical equivalents that integrate the effects of groups of chemicals with the same mode of action that act in a concentration-additive manner. Statistical distribution methods are proposed to derive a specific effect-based trigger bioanalytical equivalent concentration (EBT-BEQ) for each bioassay of environmental interest that targets receptor-mediated toxicity. Even bioassays that are indicative of the same mode of action have slightly different numeric trigger values due to differences in their inherent sensitivity. The algorithm was applied to 18 cell-based bioassays and 11 provisional effect-based trigger bioanalytical equivalents were derived as an illustrative example using the 349 chemical guideline values protective for human health of the Australian Guidelines for Water Recycling. We illustrate the applicability using the example of a diverse set of water samples including recycled water. Most recycled water samples were compliant with the proposed triggers while wastewater effluent would not have been compliant with a few
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REMIT5.1, Radiation exposure monitoring and information transmittal system
International Nuclear Information System (INIS)
2007-01-01
1 - Description of program or function - The Radiation Exposure Monitoring and Information Transmittal (REMIT) is a PC-based menu driven system that facilitates the manipulation of data base files to record and report radiation exposure information. REMIT is designed to be user-friendly and contains the full text of Regulatory Guide 8.7, Rev.1, on-line as well as context-sensitive help throughout the program. The user can enter data directly from NRC Forms 4 or 5. REMIT allows the user to view the individual's exposure in relation to regulatory or administrative limits and will alert the user to exposures in excess of these limits. The system also provides for the calculation and summation of dose from intakes and the determination of the dose to the maximally exposed extremity for the monitoring year. REMIT can produce NRC Forms 4 and 5 in paper and electronic format and can import/export data from ASCII and data base files. Additional information is available from the web page www.reirs.com. REMIT system is designed to assist U.S. Nuclear Regulatory Commission (NRC) licensees in meeting the reporting requirements of the Revised 10 CFR Parts 20.1001 through 20.2401 as outlined in Regulatory Guide 8.7, Rev.1, Instructions for Recording and Reporting Occupational Exposure Data. 2 - Methods - REMIT makes use of the dose conversion factors from EPA Report 11 Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submission, and Ingestion, to calculate the Committed Dose Equivalent to the maximally exposed organ and the Committed Effective Dose Equivalent from intakes measured in microcuries. REMIT also estimates the amount (in micrograms) of uranium intake from the activity entered in microcuries. This calculation is based on the specific activities of the uranium isotopes. 3 - Restrictions on the complexity of the problem - None noted
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Prognostic value of regulatory T cells in newly diagnosed chronic myeloid leukemia patients.
Zahran, Asmaa M; Badrawy, Hosny; Ibrahim, Abeer
2014-08-01
Chronic myeloid leukemia (CML) is a clonal disease, characterized by a reciprocal t(9, 22) that results in a chimeric BCR/ABL fusion gene. Regulatory T cells (Tregs) constitute the main cell population that enables cancer cells to evade immune surveillance. The purpose of our study was to investigate the level of Tregs in newly diagnosed CML patients and to correlate it with the patients' clinical, laboratory and molecular data. We also aimed to assess the effect of treatment using tyrosine kinase inhibitor (TKI) on Treg levels. Tregs were characterized and quantified by flow cytometry in 63 newly diagnosed CML patients and 40 healthy controls. TKI was used in 45 patients with chronic phase CML, and the response to therapy was correlated with baseline Treg levels. The percentages of Tregs were significantly increased in CML patients compared to the controls. Treg numbers were significantly lower in patients with chronic phase CML versus the accelerated and blast phases, and were significantly lower in patients with complete molecular remission (CMR) compared to those patients without CMR. Tregs may play a role in the maintenance of CML. Moreover, the decrease of their levels in patients with CMR suggests that Tregs might have a clinical value in evaluating the effects of therapy.
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Digiacomo, Gregory; Chen, Peggy P.
2016-01-01
We investigated the effects of a self-regulatory intervention strategy designed to improve middle-school students' calibration accuracy, self-regulatory skills, and math achievement. Focusing on self-monitoring and self-reflection as the two key processes of this intervention in relation to improving students' math achievement and overall…
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The clinical and pathogenetic value of Foxp3+ T regulatory cells in rheumatoid arthritis
Directory of Open Access Journals (Sweden)
A. S. Avdeeva
2016-01-01
Full Text Available T regulatory cells (Tregs play a key role in the immune system due to the suppression of a hyperimmune response to autoantigens and opportunistic enteric microorganisms. In recent years, there has been evidence that Tregs can suppress various immunoinflammatory responses to a wide range of physiological and pathological stimuli, including microorganisms, tumor cells, allogeneic grafts, and fetal cells.Tregs express a broad spectrum of membrane molecules that determine their functional activity and make it possible to identify these cells; however, none has discovered a universal surface marker that would distinguish this cell subpopulation from a pool of T lymphocytes. The most specific intracellular marker for Tregs is the nuclear transcription factor Foxp3 that is of fundamental importance in the development of Tregs and their inhibitory function.The results of the vast majority of studies indicate that there are increased numbers of Tregs in the synovial fluid of patients with rheumatoid arthritis (RA; however, the data on the level of this cell population in their peripheral blood are very contradictory. The majority of investigators have observed a decrease in the percentage of circulating Tregs while other studies have revealed its increase or no differences from the corresponding value of healthy donors or patients with osteoarthritis. It is believed that a quantitative defect in CD4+CD25+Foxp3+CD127 regulatory cells is especially characteristic of early RA and associated with the risk of the latter in asymptomatic patients positive for anti-cyclic citrullinated peptide antibodies. The use of disease-modifying antirheumatic drugs and biologic agents is accompanied by a certain change in the level and functional activity of Tregs, which is responsible for the therapeutic effect of the medicaments.Thus, an important part is assigned to Tregs in the pathogenesis of autoimmune rheumatic diseases, RA in particular. The decrease in the level
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Monitoring of radiation exposure
Energy Technology Data Exchange (ETDEWEB)
NONE
2000-02-01
The guide specifies the requirements for the monitoring of radiation exposure in instances where radiation is used. In addition to workers, the guide covers students, apprentices and visitors. The guide shall also apply to exposure from natural radiation. However, the monitoring of radiation exposure in nuclear power plants is dealt with in YVL Guide 7.10 and 7.11. The guide defines the concepts relevant to the monitoring of radiation exposure and provides guidelines for determining the necessity of monitoring and subsequently arranging such in different operations. In addition, the guide specifies the criteria for the approval and regulatory control of the dosimetric service.
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Monitoring of radiation exposure
International Nuclear Information System (INIS)
2000-02-01
The guide specifies the requirements for the monitoring of radiation exposure in instances where radiation is used. In addition to workers, the guide covers students, apprentices and visitors. The guide shall also apply to exposure from natural radiation. However, the monitoring of radiation exposure in nuclear power plants is dealt with in YVL Guide 7.10 and 7.11. The guide defines the concepts relevant to the monitoring of radiation exposure and provides guidelines for determining the necessity of monitoring and subsequently arranging such in different operations. In addition, the guide specifies the criteria for the approval and regulatory control of the dosimetric service
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Continuous auditing & continuous monitoring : Continuous value?
van Hillo, Rutger; Weigand, Hans; Espana, S; Ralyte, J; Souveyet, C
2016-01-01
Advancements in information technology, new laws and regulations and rapidly changing business conditions have led to a need for more timely and ongoing assurance with effectively working controls. Continuous Auditing (CA) and Continuous Monitoring (CM) technologies have made this possible by
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Regulatory approaches for addressing dissolved oxygen concerns at hydropower facilities
Energy Technology Data Exchange (ETDEWEB)
Peterson, Mark J. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Cada, Glenn F. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Sale, Michael J. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Eddlemon, Gerald K. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)
2003-03-01
Low dissolved oxygen (DO) concentrations are a common water quality problem downstream of hydropower facilities. At some facilities, structural improvements (e.g. installation of weir dams or aerating turbines) or operational changes (e.g., spilling water over the dam) can be made to improve DO levels. In other cases, structural and operational approaches are too costly for the project to implement or are likely to be of limited effectiveness. Despite improvements in overall water quality below dams in recent years, many hydropower projects are unable to meet state water quality standards for DO. Regulatory agencies in the U.S. are considering or implementing dramatic changes in their approach to protecting the quality of the Nation’s waters. New policies and initiatives have emphasized flexibility, increased collaboration and shared responsibility among all parties, and market-based, economic incentives. The use of new regulatory approaches may now be a viable option for addressing the DO problem at some hydropower facilities. This report summarizes some of the regulatory-related options available to hydropower projects, including negotiation of site-specific water quality criteria, use of biological monitoring, watershed-based strategies for the management of water quality, and watershed-based trading. Key decision points center on the health of the local biological communities and whether there are contributing impacts (i.e., other sources of low DO effluents) in the watershed. If the biological communities downstream of the hydropower project are healthy, negotiation for site-specific water quality standards or biocriteria (discharge performance criteria based on characteristics of the aquatic biota) might be pursued. If there are other effluent dischargers in the watershed that contribute to low DO problems, watershed-scale strategies and effluent trading may be effective. This report examines the value of regulatory approaches by reviewing their use in
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Experience with neutron flux monitoring systems qualified for post-accident monitoring
International Nuclear Information System (INIS)
Shugars, H.G.; Miller, J.F.
1995-01-01
In this paper we discuss the environmental requirements for excore neutron flux monitors that are qualified for use during and after postulated accidents in Pressurized Water Reactors (PWRs). We emphasize PWRs designed in the United States, which are similar to those used also in parts of Western Europe and Eastern Asia. We then discuss design features of the flux monitoring systems necessary to address the environmental, functional, and regulatory requirements, and the experience with these systems. (author). 9 refs, 2 figs
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Ormerod, R.; Scholl, M.
2017-12-01
Rapid evolution is occurring in the monitoring and assessment of air emissions and their impacts. The development of next generation lower cost sensor technologies creates the potential for much more intensive and far-reaching monitoring networks that provide spatially rich data. While much attention at present is being directed at the types and performance characteristics of sensor technologies, it is important also that the full potential of rich data sources be realized. Parallel to sensor developments, software platforms to display and manage data in real time are increasingly common adjuncts to sensor networks. However, the full value of data can be realized by extending platform capabilities to include complex scientific functions that are integrated into an action-oriented management framework. Depending on the purpose and nature of a monitoring network, there will be a variety of potential uses of the data or its derivatives, for example: statistical analysis for policy development, event analysis, real-time issue management including emergency response and complaints, and predictive management. Moving these functions into an on-demand, optionally mobile, environment greatly increases the value and accessibility of the data. Increased interplay between monitoring data and decision-making in an operational environment is optimised by a system that is designed with equal weight on technical robustness and user experience. A system now being used by several regulatory agencies and a larger number of industries in the US, Latin America, Europe, Australia and Asia has been developed to provide a wide range of on-demand decision-support in addition to the basic data collection, display and management that most platforms offer. With stable multi-year operation, the platform, known as Envirosuite, is assisting organisations to both reduce operating costs and improve environmental performance. Some current examples of its application across a range of applications
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Environmental Monitoring Plan, Sandia National Laboratories, Livermore
International Nuclear Information System (INIS)
Holland, R.C.
1992-06-01
This Environmental Monitoring Plan was written to fulfill the requirements of DOE Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories, Livermore. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. 61 refs
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On-line monitoring for calibration reduction
International Nuclear Information System (INIS)
Hoffmann, Mario; Gran, Frauke Schmitt; Thunem, Harald P-J.
2004-04-01
On-Line Monitoring (OLM) of a channel's calibration state evaluates instrument channel performance by assessing its consistency with other plant indications. Industry and experience at several plants has shown this overall approach to be very effective in identifying instrument channels that are exhibiting degrading or inconsistent performance characteristics. The Halden Reactor Project has developed the signal validation system PEANO, which can be used to assist with the tasks of OLM. To further enhance the PEANO System for use as a calibration reduction tool, the following two additional modules have been developed; HRP Prox, which performs pre-processing and statistical analysis of signal data, Batch Monitoring Module (BMM), which is an off-line batch monitoring and reporting suite. The purpose and functionality of the HRP Prox and BMM modules are discussed in this report, as well as the improvements made to the PEANO Server to support these new modules. The Halden Reactor Project has established a Halden On-Line Monitoring User Group (HOLMUG), devoted to the discussion and implementation of on-line monitoring techniques in power plants. It is formed by utilities, vendors, regulatory bodies and research institutes that meet regularly to discuss implementation aspects of on-line monitoring, technical specification changes, cost-benefit analysis and regulatory issues. (Author)
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Prediction of regulatory gene pairs using dynamic time warping and gene ontology.
Yang, Andy C; Hsu, Hui-Huang; Lu, Ming-Da; Tseng, Vincent S; Shih, Timothy K
2014-01-01
Selecting informative genes is the most important task for data analysis on microarray gene expression data. In this work, we aim at identifying regulatory gene pairs from microarray gene expression data. However, microarray data often contain multiple missing expression values. Missing value imputation is thus needed before further processing for regulatory gene pairs becomes possible. We develop a novel approach to first impute missing values in microarray time series data by combining k-Nearest Neighbour (KNN), Dynamic Time Warping (DTW) and Gene Ontology (GO). After missing values are imputed, we then perform gene regulation prediction based on our proposed DTW-GO distance measurement of gene pairs. Experimental results show that our approach is more accurate when compared with existing missing value imputation methods on real microarray data sets. Furthermore, our approach can also discover more regulatory gene pairs that are known in the literature than other methods.
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2013-12-06
...-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify the Risk Monitoring Functionality Offered by the Exchange December 2, 2013....19b-4(f)(6)(iii). I. Self-Regulatory Organization's Statement of the Terms of Substance of the...
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An automated, self-verifying system for monitoring uranium in effluent streams
International Nuclear Information System (INIS)
Reda, R.J.; Pickett, J.L.
1992-01-01
In nuclear facilities such as nuclear fuel fabrication plants, a constant vigil is required to ensure that the concentrations of uranium in process or waste streams do not exceed required specifications. The specifications may be dictated by the process owner, a regulatory agency such as the US Nuclear Regulatory Agency or Environmental Protection Agency, or by criticality safety engineering criteria. Traditionally, uranium monitoring in effluent streams has been accomplished by taking periodic samples of the liquid stream and determining the concentration by chemical analysis. Despite its accuracy, chemical sampling is not timely enough for practical use in continuously flowing systems because of the possibility that a significant quantity of uranium may be discharged between sampling intervals. To completely satisfy regulatory standards, the liquid waste stream must be monitored for uranium on a 100% basis. To this end, an automated, radioisotopic liquid-waste monitoring system was developed by GE Nuclear Energy as an integral part of the uranium conversion and waste recovery operations. The system utilizes passive gamma-ray spectroscopy and is thus a robust, on-line, and nondestructive assay for uranium. The system provides uranium concentration data for process monitoring and assures regulatory compliance for criticality safety. A summary of the principles of system operation, calibration, and verification is presented in this paper
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Environmental Monitoring Plan, Revision 5
Energy Technology Data Exchange (ETDEWEB)
Gallegos, G M; Blake, R G; Bertoldo, N A; Campbell, C G; Coty, J; Folks, K; Grayson, A R; Jones, H E; Nelson, J C; Revelli, M A; Wegrecki, T; Williams, R A; Wilson, K
2010-01-27
The purpose of environmental monitoring is to promote the early identification of, and response to, potential adverse environmental impacts associated with Lawrence Livermore National Laboratory (LLNL) operations. Environmental monitoring supports the Integrated Safety Management System (ISMS), International Organization for Standardization (ISO) 14001 Environmental Management Systems standard, and U. S. Department of Energy (DOE) Order 450.1A, Environmental Protection Program. Specifically, in conformance with DOE Order 450.1A, Attachment 1, paragraph 1(b)(5), environmental monitoring enables LLNL to detect, characterize, and respond to releases from LLNL activities; assess impacts; estimate dispersal patterns in the environment; characterize the pathways of exposure to members of the public; characterize the exposures and doses to individuals and to the population; and to evaluate the potential impacts to the biota in the vicinity of LLNL. Environmental monitoring also serves to demonstrate compliance with permits and other regulatory requirements. The Environmental Monitoring Plan (EMP) addresses the sample collection and analytical work supporting environmental monitoring to ensure the following: (1) A consistent system for collecting, assessing, and documenting environmental data of known and documented quality. (2) A validated and consistent approach for sampling and analysis of samples to ensure laboratory data meets program-specific needs and requirements within the framework of a performance-based approach for analytical laboratory work. (3) An integrated sampling approach to avoid duplicative data collection. Until its cancellation in January 2003, DOE Order 5400.1 required the preparation of an environmental monitoring plan. Neither DOE Order 450.1A nor the ISO 14001 standard are as prescriptive as DOE Order 5400.1, in that neither expressly requires an EMP. However, LLNL continues to prepare the EMP because it provides an organizational framework for
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Analytical Chemistry in the Regulatory Science of Medical Devices.
Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott
2018-06-12
In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.
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Development of safety performance indicators of regulatory interest (SAFPER) in Pakistan
International Nuclear Information System (INIS)
Khatoon, Abida
2002-01-01
Safety performance indicators provide a very useful tool for monitoring operational safety of a nuclear power plant. Utilities in many countries have developed plant specific indicators for the assessment of their performance and safety. Regulators can make use of some of these indicators for their regulatory assessment. In addition to these regulatory bodies in some countries have also developed programs for the formulation of safety performance indicators which are used in monitoring operational safety and regulatory decision making. Realizing its usefulness Directorate of Nuclear Safety and Radiation Protection (DNSRP-the regulatory body in Pakistan) has also initiated a country specific program for the development of Safety Performance Indicators (SAFPER) based on data provided by the utility and that collected during the course of regulatory inspections. Selected areas of NPP operation to be monitored are: - Significant events; - Safety systems performance; - Barriers integrity; - Environment protection; - Workers radiation safety; and - Emergency Preparedness. One of the objectives of this program is also to monitor the effectiveness of DNSRP regulatory activities. IAEA framework is taken as one of the bases for our program. Safety performance will be assessed on the basis of Performance Indicators and inspection findings. DNSRP program as shown in Appendix includes the indicators in use and under development. It is felt that the term Safety Performance Indicators may be termed as 'SAFPER Indicators' to be used by the Regulators, as it is clear from this presentation that utility safety performance indicators together with the regulatory effectiveness indicators constitute the measure for the adequate safety to the public and the environment. Additional research is still necessary for: - indicator definition for the proposed and under developed indicators; - data collection systems; - thresholds; - trend analysis; - goal setting (benefit from the trend can be
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Deschamps, Ann E; De Geest, Sabina; Vandamme, Anne-Mieke; Bobbaers, Herman; Peetermans, Willy E; Van Wijngaerden, Eric
2008-09-01
Nonadherence to antiretroviral therapy is a substantial problem in HIV and jeopardizes the success of treatment. Accurate measurement of nonadherence is therefore imperative for good clinical management but no gold standard has been agreed on yet. In a single-center prospective study nonadherence was assessed by electronic monitoring: percentage of doses missed and drug holidays and by three self reports: (1) a visual analogue scale (VAS): percentage of overall doses taken; (2) the Swiss HIV Cohort Study Adherence Questionnaire (SHCS-AQ): percentage of overall doses missed and drug holidays and (3) the European HIV Treatment Questionnaire (EHTQ): percentage of doses missed and drug holidays for each antiretroviral drug separately. Virologic failure prospectively assessed during 1 year, and electronic monitoring were used as reference standards. Using virologic failure as reference standard, the best results were for (1) the SHCS-AQ after electronic monitoring (sensitivity, 87.5%; specificity, 78.6%); (2) electronic monitoring (sensitivity, 75%; specificity, 85.6%), and (3) the VAS combined with the SHCS-AQ before electronic monitoring (sensitivity, 87.5%; specificity, 58.6%). The sensitivity of the complex EHTQ was less than 50%. Asking simple questions about doses taken or missed is more sensitive than complex questioning about each drug separately. Combining the VAS with the SHCS-AQ seems a feasible nonadherence measure for daily clinical practice. Self-reports perform better after electronic monitoring: their diagnostic value could be lower when given independently.
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Development of Checklist for Self-Assessment of Regulatory Capture in Nuclear Safety Regulation
International Nuclear Information System (INIS)
Choi, K. S.; Lee, Y. E.; Chang, H. S.; Jung, S. J.
2011-01-01
Regulatory body performs its mission on behalf of the general public. As for nuclear industries, the public delegates the authority to the regulatory body for monitoring the safety in nuclear facilities and for ensuring that it is maintained in the socially and globally acceptable level. However, when the situation that a regulatory body behaves in the interests of industries happens, not working primarily for protecting public health and safety on behalf of the public, it is charged that regulatory body acts as an encouragement for industries which produce negative externalities such as radiation risk or radiation hazards. In this case, the regulatory body is called as 'Captured' or it is called that 'Regulatory Capture' happened. Regulatory capture is important as it may cause regulatory failure, one form of government failure, which is very serious phenomenon: severe nuclear accident at Fukushima nuclear power plants recently occurred in March, 2011. This paper aims to introduce the concept of regulatory capture into nuclear industry field through the literature survey, and suggest the sample checklist developed for self-assessment on the degree of regulatory capture within regulatory body
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1988 Monitoring Activities Review (MAR) of the environmental monitoring program
International Nuclear Information System (INIS)
1989-03-01
The EGandG Idaho Environmental Monitoring (EM) Unit is responsible for coordinating and conducting environmental measurements of radioactive and hazardous contaminants around facilities operated by EGandG Idaho. The EM Unit has several broad program objectives, which include complying with regulatory standards and developing a basis for estimating future impacts of operations at EGandG Idaho facilities. To improve program planning and to provide bases for technical improvement of the monitoring program, the EGandG Environmental Monitoring organization has regularly used the Monitoring Activities Review (MAR) process since 1982. Each MAR is conducted by a committee of individuals selected for their experience in the various types of monitoring performed by the EM organization. Previous MAR studies have focused on procedures for all currently monitored media except biota. Biotic monitoring was initiated following the last MAR. This report focuses on all currently monitored media, and includes the first review of biotic monitoring. The review of biotic monitoring has been conducted at a level of detail consistent with initial MAR reports for other parts of the Waste Management Program Facilities Environmental Monitoring Program. The review of the biotic monitoring activities is presented in Section 5.5 of this report. 21 refs., 7 figs., 4 tabs
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Value of information: A roadmap to quantifying the benefit of structural health monitoring
DEFF Research Database (Denmark)
Straub, D.; Chatzi, E.; Bismut, E.
2017-01-01
The concept of value of information (VoI) enables quantification of the benefits provided by structural health monitoring (SHM) systems – in principle. Its implementation is challenging, as it requires an explicit modelling of the structural system’s life cycle, in particular of the decisions...... that are taken based on the SHM information. In this paper, we approach the VoI analysis through an influence diagram (ID), which supports the modelling process. We provide a simple example for illustration and discuss challenges associated with real-life implementation....
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Johnson, Ted; Capel, Jim; Ollison, Will
2014-03-01
During August and September of 2012, researchers conducted a microenvironmental (ME) monitoring study in Durham, North Carolina, using two 2B Technologies O3 monitors: a dual-beam model 205 Federal Equivalent Method (FEM) 254 nm photometer and a newly developed model 211 interference-free dual-beam photometer. The two monitors were mounted in a wheeled, fan-cooled suitcase together with a battery, a disposable N2O cartridge for the model 211 monitor and filtered sample lines. A scripted technician made paired O3 measurements in a variety of MEs within 2 miles of a fixed-site FEM O3 photometer at the Durham National GuardArmory. The ratio of the 211 to Armory O3 concentrations tended to be lowest (0.8) for 104 outdoor MEs. The mean values of the ratio for in-vehicle MEs tended to fall between 0.2 and 0.7--the mean for all 27 in-car tests was 0.3. The ratio values for indoor MEs tended to be higher when the enclosure was well ventilated. The outdoor ratios tended to be lower when the measurement was made downwind of nearby roadways, likely due to exhaust NO. The in-vehicle ratios tended to be larger with windows open than closed; the smallest occurred with closed windows, active air conditioning, and vent recirculation. The 205 - 211 measurement differences were generally small, with 94% of the 176 sample differences below 5 ppb. Five differences were above 10 ppb with the largest values (173.9 and 63.6 ppb) occurring inside a violin repair shop. Roadway proximity tended to increase the differences for outdoor locations. The largest in-vehicle difference (6 ppb) occurred at a convenience store service station. As addressed in regulatory models, such differences may reduce estimated population O3 exposure by 30-50% in indoor and in-vehicle MEs where individuals spend more than 80% of their time. Computer models used to estimate exposures of human populations-such as the Air Pollution Exposure Model (APEX) developed by the U.S. Environmental Protection Agency-can be
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FORECAST: Regulatory effects cost analysis software manual -- Version 4.1. Revision 1
International Nuclear Information System (INIS)
Lopez, B.; Sciacca, F.W.
1996-07-01
The FORECAST program was developed to facilitate the preparation of the value-impact portion of NRC regulatory analyses. This PC program integrates the major cost and benefit considerations that may result from a proposed regulatory change. FORECAST automates much of the calculations typically needed in a regulatory analysis and thus reduces the time and labor required to perform these analyses. More importantly, its integrated and consistent treatment of the different value-impact considerations should help assure comprehensiveness, uniformity, and accuracy in the preparation of NRC regulatory analyses. The Current FORECAST Version 4.1 has been upgraded from the previous version and now includes an uncertainty package, an automatic cost escalation package, and other improvements. In addition, it now explicitly addresses public health impacts, occupational health impacts, onsite property damage, and government costs. Thus, FORECAST Version 4.1 can treat all attributes normally quantified in a regulatory analysis
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Monitoring compliance with requirements during site characterization
International Nuclear Information System (INIS)
Herrington, C.C.; Jennetta, A.R.; Dobson, D.C.
1991-01-01
The question of when a program of Regulatory Compliance should be applied and what it should be applied to, when the subject of compliance is a High Level Radioactive Waste Repository, defies resolution by merely relating to past practices of licensees of the US Nuclear Regulatory Commission (NRC). NRC regulations governing the disposal of High Level Waste include interactions with the potential applicant (US DOE) during the pre-license application phase of the program when the basis for regulatory compliance is not well defined. To offset this shortcoming, the DOE will establish an expanded basis for regulatory compliance, keeping the NRC apprised of the basis as it develops. As a result, the preapplication activities of DOE will assume the added benefit of qualification to a suitable Regulatory Compliance monitoring and maintenance plan
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Regulatory aspects of NPP safety
International Nuclear Information System (INIS)
Kastchiev, G.
1999-01-01
Extensive review of the NPP Safety is presented including tasks of Ministry of Health, Ministry of Internal Affairs, Ministry of Environment and Waters, Ministry of Defense in the field of national system for monitoring the nuclear power. In the frame of national nuclear safety legislation Bulgaria is in the process of approximation of the national legislation to that of EC. Detailed analysis of the status of regulatory body, its functions, organisation structure, responsibilities and future tasks is included. Basis for establishing the system of regulatory inspections and safety enforcement as well as intensification of inspections is described. Assessment of safety modifications is concerned with complex program for reconstruction of Units 1-4 of Kozloduy NPP, as well as for modernisation of Units 5 and 6. Qualification and licensing of the NPP personnel, Year 2000 problem, priorities and the need of international assistance are mentioned
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Prud'homme, Genevieve; Dobbin, Nina A.; Sun, Liu; Burnett, Richard T.; Martin, Randall V.; Davidson, Andrew; Cakmak, Sabit; Villeneuve, Paul J.; Lamsal, Lok N.; van Donkelaar, Aaron; Peters, Paul A.; Johnson, Markey
2013-12-01
Satellite remote sensing (RS) has emerged as a cutting edge approach for estimating ground level ambient air pollution. Previous studies have reported a high correlation between ground level PM2.5 and NO2 estimated by RS and measurements collected at regulatory monitoring sites. The current study examined associations between air pollution and adverse respiratory and allergic health outcomes using multi-year averages of NO2 and PM2.5 from RS and from regulatory monitoring. RS estimates were derived using satellite measurements from OMI, MODIS, and MISR instruments. Regulatory monitoring data were obtained from Canada's National Air Pollution Surveillance Network. Self-reported prevalence of doctor-diagnosed asthma, current asthma, allergies, and chronic bronchitis were obtained from the Canadian Community Health Survey (a national sample of individuals 12 years of age and older). Multi-year ambient pollutant averages were assigned to each study participant based on their six digit postal code at the time of health survey, and were used as a marker for long-term exposure to air pollution. RS derived estimates of NO2 and PM2.5 were associated with 6-10% increases in respiratory and allergic health outcomes per interquartile range (3.97 μg m-3 for PM2.5 and 1.03 ppb for NO2) among adults (aged 20-64) in the national study population. Risk estimates for air pollution and respiratory/allergic health outcomes based on RS were similar to risk estimates based on regulatory monitoring for areas where regulatory monitoring data were available (within 40 km of a regulatory monitoring station). RS derived estimates of air pollution were also associated with adverse health outcomes among participants residing outside the catchment area of the regulatory monitoring network (p health among participants living outside the catchment area for regulatory monitoring suggest that RS can provide useful estimates of long-term ambient air pollution in epidemiologic studies. This is
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Regulatory issues for nuclear power plant life management
International Nuclear Information System (INIS)
Roe, J.
2000-01-01
The workshop of 26-27 june 2000, on nuclear power Plant LIfe Management (PLIM), also included working groups in which major issues facing PLIM activities for nuclear power plants were identified and discussed. The second group was on Regulation. The Regulatory Working Group will attempt to identify some of the more pertinent issues affecting nuclear plant regulation in a changing PLIM environment, to identify some possible actions to be taken to address these issues, and to identify some of the parties responsible for taking these actions. Some preliminary regulatory issues are noted below. This is not intended to be a comprehensive list of such issues but rather is intended to stimulate discussion among the experts attending this Workshop. One of the concerns in the regulatory arena is how the structural integrity of the plants can be assured for an extended lifetime. Technological advances directed toward the following are likely to be important factors in the regulatory process of life extension. - Preventive and corrective maintenance (e.g., water chemistry control, pressure vessel annealing, and replacement of core internals). - Ageing and degradation mechanisms and evaluation (e.g., embrittlement, wear, corrosion/erosion, fatigue, and stress corrosion). - Monitoring, surveillance, and inspection (e.g., fatigue monitoring and non-destructive testing). - Optimisation of maintenance (e.g., using risk-based analysis). On the business side, there is concern about technical support by manufacturers, fuel companies, and construction companies. Maintaining a strong technical base and skilled workers in a potentially declining environment is another concern in the regulatory community. Waste management and decommissioning remain significant issue regarding PLIM. These issues affect all three areas of concern - technology, business, and regulation. It is against this background, that the issues put forth in this paper are presented. The objective of presenting these
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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
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de Bruin, Marijn; Sheeran, Paschal; Kok, Gerjo; Hiemstra, Anneke; Prins, Jan M; Hospers, Harm J; van Breukelen, Gerard J P
2012-11-01
Understanding the gap between people's intentions and actual health behavior is an important issue in health psychology. Our aim in this study was to investigate whether self-regulatory processes (monitoring goal progress and responding to discrepancies) mediate the intention-behavior relation in relation to HIV medication adherence (Study 1) and intensive exercise behavior (Study 2). In Study 1, questionnaire and electronically monitored adherence data were collected at baseline and 3 months later from patients in the control arm of an HIV-adherence intervention study. In Study 2, questionnaire data was collected at 3 time points 6-weeks apart in a cohort study of physical activity. Complete data at all time points were obtained from 51 HIV-infected patients and 499 intensive exercise participants. Intentions were good predictors of behavior and explained 25 to 30% of the variance. Self-regulatory processes explained an additional 11% (Study 1) and 6% (Study 2) of variance in behavior on top of intentions. Regression and bootstrap analyses revealed at least partial, and possibly full, mediation of the intention-behavior relation by self-regulatory processes. The present studies indicate that self-regulatory processes may explain how intentions drive behavior. Future tests, using different health behaviors and experimental designs, could firmly establish whether self-regulatory processes complement current health behavior theories and should become routine targets for intervention. (PsycINFO Database Record (c) 2012 APA, all rights reserved).
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Thirumala, Parthasarathy D; Mohanraj, Santhosh Kumar; Habeych, Miguel; Wichman, Kelley; Chang, Yue-Fang; Gardner, Paul; Snyderman, Carl; Crammond, Donald J; Balzer, Jeffrey
2013-06-01
Objective To evaluate the value of free-run electromyography (f-EMG) monitoring of extraocular cranial nerves (EOCN) III, IV, and VI during expanded endonasal surgery (EES) of the skull base in reducing iatrogenic cranial nerve (CN) deficits. Design We retrospectively identified 200 patients out of 990 who had at least one EOCN monitored during EES. We further separated patients into groups according to the specific CN monitored. In each CN group, we classified patients who had significant (SG) f-EMG activity as Group I and those who did not as Group II. Results A total of 696 EOCNs were monitored. The number of muscles supplied by EOCNs that had SG f-EMG activity was 88, including CN III = 46, CN IV = 21, and CN VI = 21. There were two deficits involving CN VI in patients who had SG f-EMG activity during surgery. There were 14 deficits observed, including CN III = 3, CN IV = 2, and CN VI = 9 in patients who did not have SG f-EMG activity during surgery. Conclusions f-EMG monitoring of EOCN during EES can be useful in identifying the location of the nerve. It seems to have limited value in predicting postoperative neurological deficits. Future studies to evaluate the EMG of EOCN during EES need to be done with both f-EMG and triggered EMG.
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As to achieve regulatory action, regulatory approaches
International Nuclear Information System (INIS)
Cid, R.; Encinas, D.
2014-01-01
The achievement of the effectiveness in the performance of a nuclear regulatory body has been a permanent challenge in the recent history of nuclear regulation. In the post-Fukushima era this challenge is even more important. This article addresses the subject from two complementary points of view: the characteristics of an effective regulatory body and the regulatory approaches. This work is based on the most recent studies carried out by the Committee on Nuclear Regulatory Activities, CNRA (OECD/NEA), as well as on the experience of the Consejo de Seguridad Nuclear, CSN, the Spanish regulatory body. Rafael Cid is the representative of CSN in these project: Diego Encinas has participated in the study on regulatory approaches. (Author)
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Determination of contamination operational value by routine monitoring in research laboratories
International Nuclear Information System (INIS)
Salomao, Edeilson; Medeiros, Regina Bitelli; Mattos, Maria Fernanda S.S.; Daros, Kellen Adriana Curci
2008-01-01
The radioisotopes have a large spectrum of applicability in many areas of science, as in medicine, agriculture and industry in general. In the biological area, the radioisotopes have brought many benefits to study physiological processes in living organisms and in vitro. The most radioisotopes used in biological research are emitters of radiation of low energy, mainly β, and are used as unsealed sources. The manipulation of these radioisotopes generates radioactive wastes and eventually can cause contamination in the areas of handling or even occasionally in areas to which access is not controlled. According to CNEN-NE-3.02 standard is necessary and mandatory the exposure and contamination levels control in the areas of handling of unsealed sources. The goal of the work is to establish how often the monitoring should be done through the survey of the contamination and exposure levels, in areas designed to manipulate 32 P and how this monitoring can contribute to the improvement the conditions of radiological protection. From the twenty eight research laboratories registered by 'Nucleo de Protecao Radiologica' (NPR) were selected four where the activities are not restrict to 32 P biological assays. The levels of contamination and exposure were evaluated using monitors GM and the layout of laboratories containing the points to be tracker defined based on the researchers' routine. At each point three values were obtained to measure the rate of contamination on the surface and exposure rate. The measures were made twice a week before and after the radioisotope manipulation. Based on these data was possible to establish the range from 0,306 to 0,678 Bq.cm -2 as operational average level to the superficial contamination. The average exposure rate measured was 5.16 n C/Kg.h. The results were important to demonstrating to researchers how they can contribute to the improvement of radiological protection conditions. (author)
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International Nuclear Information System (INIS)
Bordy, J.M.
2016-01-01
As the lens of the eye are a radio-sensitive tissue which can be affected by ionizing radiations, and as epidemiological studies lead to the proposition of a revision of their exposure limit, this sheet first recalls regulatory limits and quantities to be measured. It proposes an overview of industrial and medical situations associated with an exposure risk for lens of the eye. It presents the conditions for bearing a specific individual dosimeter, and the design of dosimeters aimed at a direct measurement. It discusses the characteristics and performance of individual protection equipment, and the criterion for the choice between a direct measurement and an indirect assessment of a characteristic value of exposure for photons and for electrons. It addresses the issues of classification and monitoring for a professional medical follow-up: description of the pathological risk, elements for a medical follow-up (examinations), classification and dose monitoring
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Comparative Analysis of Monitoring Devices for Particulate Content in Exhaust Gases
Directory of Open Access Journals (Sweden)
Beatrice Castellani
2014-07-01
Full Text Available The installation and operation of continuous particulate emission monitors in industrial processes has become well developed and common practice in industrial stacks and ducts over the past 30 years, reflecting regulatory monitoring requirements. Continuous emissions monitoring equipment is installed not only for regulatory compliance, but also for the monitoring of plant performance, calculation of emissions inventories and compilation of environmental impact assessments. Particulate matter (PM entrained in flue gases is produced by the combustion of fuels or wastes. The size and quantity of particles released depends on the type of fuel and the design of the plant. The present work provides an overview of the main industrial emission sources, a description of the main types of monitoring systems offered by manufacturers and a comparative analysis of the currently available technologies for measuring dust releases to atmosphere.
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Environmental effects monitoring for exploration drilling
International Nuclear Information System (INIS)
Buchanan, R.A.; Cook, J.A.; Mathieu, A.
2003-01-01
Strategies for monitoring the environmental effects of single exploratory offshore wells on the east coast of Canada were evaluated. The report was compiled from consultations with scientists, regulators and stakeholders as well as a review of regulatory regimes and toxicity results. The aim of the report was to develop a decision tree for determining when to conduct environmental effects monitoring (EEM). Respondents evinced lower levels of concern for single exploratory wells than for production developments. A number of scientists argued for full statistical treatment of all data, and many people argued that more assurance was needed that the marine environment was not being unduly harmed. Respondents also considered that biological effects should be a primary focus, rather than the occurrence of trace chemical signals, and that seabirds and mammals should be monitored. Concern was expressed over the value of data collected from monitoring the effects of exploratory drilling activities. It was suggested that local and site-specific issues should be considered in the design of EEM programs. Respondents expressed strong concern about potential cumulative effects with other industrial activities, and suggested that test cases should be established and monitored to develop a scientific rationale for the inclusion or exclusion of specific variables in future EEM programs. A decision tree was developed based on 3 scenarios: (1) compliance monitoring only in well known areas with no sensitive issues; opportunistic EEM surveys of sediments, benthos, seabirds and marine mammals in shallow or deep areas with no known sensitive issues; and (3) custom EEM surveys for sensitive areas. Currently, there are EEM requirements for drilling exploratory wells offshore Canada's east coast. 58 refs., 2 tabs., 7 figs
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NRC TLD Direct Radiation Monitoring Network
International Nuclear Information System (INIS)
Struckmeyer, R.; McNamara, N.
1991-04-01
This report presents the results of the NRC [Nuclear Regulatory Commission] Direct Radiation Monitoring Network for the fourth quarter of 1990. It provides the ambient radiation levels measured in the vicinity of 75 sites throughout the United States. In addition, it describes the equipment used, monitoring station selection criteria, characterization of the dosimeter response, calibration procedures, statistical methods, intercomparison, and quality assurance program. 3 figs., 4 tabs
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Regulatory approach to risk informed decision making in India
International Nuclear Information System (INIS)
Chande, S.K.; Koley, J.
2001-01-01
Atomic Energy Regulatory Board (AERB), the authority for licensing and monitoring safety in Indian Nuclear Power Plants (NPPs), makes use of insights gained from PSA together with the results of the other deterministic analyses in taking decisions regarding the acceptability of the safety of the NPPs. PSA provides an estimation of risks; it also gives information on a balanced design by revealing interaction between engineered features and weak areas in a design. For regulatory use, PSA needs to be carried out using standardized methodology and state of the art technology. PSA helps regulators in taking faster and consistent decisions. Keeping in mind the limitations associated with PSA study, AERB has decided to adopt risk-informed decision making in regulatory licensing process. This paper describes the AERB policy regarding PSA and gives an overview of the experience in this area. (author)
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Regulatory Fit and Equal Opportunity/Diversity: Implications for DEOMI
2013-01-01
sustains regulatory fit (Lee & Aaker , 2004), and greater psychological value is ascribed to expected outcomes when outcomes are pursued in a manner...groups and women. In the military, policy also delineates bona fide occupational qualifications (BFOQs) that specify the personal characteristics...that fails to create regulatory fit (Cesario, Grant, & Higgins, 2004; Cesario, Higgins, & Scholer, 2008; Lee & Aaker , 2004). Training EOA
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Routine Radiological Environmental Monitoring Plan
International Nuclear Information System (INIS)
Bechtel Nevada
1998-01-01
The U.S. Department of Energy manages the Nevada Test Site in a manner that meets evolving DOE Missions and responds to the concerns of affected and interested individuals and agencies. This Routine Radiological Monitoring Plan addressess complicance with DOE Orders 5400.1 and 5400.5 and other drivers requiring routine effluent monitoring and environmental surveillance on the Nevada Test Site. This monitoring plan, prepared in 1998, addresses the activities conducted onsite NTS under the Final Environmental Impact Statement and Record of Decision. This radiological monitoring plan, prepared on behalf of the Nevada Test Site Landlord, brings together sitewide environmental surveillance; site-specific effluent monitoring; and operational monitoring conducted by various missions, programs, and projects on the NTS. The plan provides an approach to identifying and conducting routine radiological monitoring at the NTS, based on integrated technical, scientific, and regulatory complicance data needs
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Regulatory oversight of maintenance activities at nuclear power plants
International Nuclear Information System (INIS)
Pape, M.
1997-01-01
Regulation of nuclear safety in the UK is based on monitoring of compliance with licence conditions. This paper discusses legislation aspects, license conditions, license requirements for maintenance and maintenance activities in the UK. It also addresses the regulator utility interaction, the regulatory inspection of maintenance and the trends in maintenance. (author)
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Value of a radioimmunological monitoring in cancer patients treated with interferon alpha
Energy Technology Data Exchange (ETDEWEB)
Bernier, J.; Franchimont, P. (University of Liege, Institute of Pathology (Belgium)); Reuter, A.; Vrindts-Gevaert, Y. (National Institute of Radioelements, Fleurus (Belgium)); Pouillart, P.; Bretaudeau, B.; Falcoff, E.; Magdelenat, H. (Institut Curie, 75 - Paris (France))
1984-01-01
Using a radioimmunoassy for human leukocyte interferon (IFN..cap alpha..), pharmacokinetic studies were carried out in twelve cancer patients given sequential intramuscular injections of Hu IFN..cap alpha../sub 2/. Even though individual monitoring of serum IFN titers emphasized for a given dose, marked quantitative variations of the observed maximum concentrations, their mean values were found to be dose-dependent (358+-167 U/ml at 30.10/sup 6/ U and 1044+-599 U/ml at 100.10/sup 6/ U doses). Comparison with bioassay results showed that IFN activities measured in sera were of the same order of magnitude as those calculated from radioimmunoassay standard curves. Data obtained from this series on observed peak time, half-life value and serum concentrations were consistent with those reported by the other groups using recombinant leukocyte interferon in clinical trial. Therefore, radioimmunoassay is an useful method for routinely assaying IFN..cap alpha.. used either as antitumour or antivirus agent because of its high sensitivity (4 U/ml) and its simplicity.
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Gene-environment interaction and biological monitoring of occupational exposures
International Nuclear Information System (INIS)
Hirvonen, Ari
2005-01-01
Biological monitoring methods and biological limit values applied in occupational and environmental medicine have been traditionally developed on the assumption that individuals do not differ significantly in their biotransformation capacities. It has become clear, however, that this is not the case, but wide inter-individual differences exist in the metabolism of chemicals. Integration of the data on individual metabolic capacity in biological monitoring studies is therefore anticipated to represent a significant refinement of the currently used methods. We have recently conducted several biological monitoring studies on occupationally exposed subjects, which have included the determination of the workers' genotypes for the metabolic genes of potential importance for a given chemical exposure. The exposure levels have been measured by urine metabolites, adducts in blood macromolecules, and cytogenetic alterations in lymphocytes. Our studies indicate that genetic polymorphisms in metabolic genes may indeed be important modifiers of individual biological monitoring results of, e.g., carbon disulphide and styrene. The information is anticipated to be useful in insuring that the workplace is safe for everyone, including the most sensitive individuals. This knowledge could also be useful to occupational physicians, industrial hygienists, and regulatory bodies in charge of defining acceptable exposure limits for environmental and/or occupational pollutants
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Monitoring and dose recording for the individual
International Nuclear Information System (INIS)
1988-01-01
This document specifies the conditions under which monitoring of individuals is required. For workers identified as Atomic Radiation Workers, determination of dose or exposure must be made. In circumstances where personal monitoring techniques are impractical, doses and exposures may be estimated by non-personal monitoring techniques. For workers not identified as Atomic Radiation Workers, licensees must be able to demonstrate that there is no reasonable potential for accumulating radiation doses or exposures in excess of regulatory limits. (L.L.)
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On the Value of Structural Health Monitoring Information for the Operation of Wind Parks
DEFF Research Database (Denmark)
Thöns, Sebastian; Faber, Michael H.; Val, Dimitri V.
2017-01-01
wind turbine systems and its components is developed accounting for the wind park functionality, i.e. power production, its operation and its cascading damage and failure scenarios. This system model facilitates to quantify the expected benefits and risks throughout the service life accounting......In the present paper, an approach for the quantification of the Value of Structural Health Monitoring (SHM) Information building upon a framework for infrastructure system utility and decision analysis is developed and applied to the operation of wind parks. The quantification of the value of SHM...... facilitates a benefit and risk informed assessment and optimization of SHM strategies and encompasses models for the infrastructure functionality, the structural constituent and system risks and its management as well as the performance of SHM strategies. A wind park system model incorporating the structural...
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Directory of Open Access Journals (Sweden)
Schulte-van Maaren Yvonne WM
2012-11-01
Full Text Available Abstract Introduction The Brief Symptom Inventory (BSI, Mood & Anxiety Symptom Questionnaire −30 (MASQ-D30, Short Form Health Survey 36 (SF-36, and Dimensional Assessment of Personality Pathology-Short Form (DAPP-SF are generic instruments that can be used in Routine Outcome Monitoring (ROM of patients with common mental disorders. We aimed to generate reference values usually encountered in 'healthy' and ‘psychiatrically ill’ populations to facilitate correct interpretation of ROM results. Methods We included the following specific reference populations: 1294 subjects from the general population (ROM reference group recruited through general practitioners, and 5269 psychiatric outpatients diagnosed with mood, anxiety, or somatoform (MAS disorders (ROM patient group. The outermost 5% of observations were used to define limits for one-sided reference intervals (95th percentiles for BSI, MASQ-D30 and DAPP-SF, and 5th percentiles for SF-36 subscales. Internal consistency and Receiver Operating Characteristics (ROC analyses were performed. Results Mean age for the ROM reference group was 40.3 years (SD=12.6 and 37.7 years (SD=12.0 for the ROM patient group. The proportion of females was 62.8% and 64.6%, respectively. The mean for cut-off values of healthy individuals was 0.82 for the BSI subscales, 23 for the three MASQ-D30 subscales, 45 for the SF-36 subscales, and 3.1 for the DAPP-SF subscales. Discriminative power of the BSI, MASQ-D30 and SF-36 was good, but it was poor for the DAPP-SF. For all instruments, the internal consistency of the subscales ranged from adequate to excellent. Discussion and conclusion Reference values for the clinical interpretation were provided for the BSI, MASQ-D30, SF-36, and DAPP-SF. Clinical information aided by ROM data may represent the best means to appraise the clinical state of psychiatric outpatients.
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Regulatory requirements of the integrated technology demonstration program, Savannah River Site (U)
International Nuclear Information System (INIS)
Bergren, C.L.
1992-01-01
The integrated demonstration program at the Savannah River Site (SRS) involves demonstration, testing and evaluation of new characterization, monitoring, drilling and remediation technologies for soils and groundwater impacted by organic solvent contamination. The regulatory success of the demonstration program has developed as a result of open communications between the regulators and the technical teams involved. This open dialogue is an attempt to allow timely completion of applied environmental restoration demonstrations while meeting all applicable regulatory requirements. Simultaneous processing of multiple regulatory documents (satisfying RCRA, CERCLA, NEPA and various state regulations) has streamlined the overall permitting process. Public involvement is achieved as various regulatory documents are advertised for public comment consistent with the site's community relations plan. The SRS integrated demonstration has been permitted and endorsed by regulatory agencies, including the Environmental Protection Agency (EPA) and the South Carolina Department of Health and Environmental Control. EPA headquarters and regional offices are involved in DOE's integrated Demonstration Program. This relationship allows for rapid regulatory acceptance while reducing federal funding and time requirements. (author)
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Brookhaven National Laboratory environmental monitoring plan for Calendar Year 1996
Energy Technology Data Exchange (ETDEWEB)
Naidu, J.R.; Paquette, D.; Lee, R. [and others
1996-10-01
As required by DOE Order 5400.1, each U.S. Department of Energy (DOE) site, facility, or activity that uses, generates, releases, or manages significant quantities of hazardous materials shall provide a written Environmental Monitoring Plan (EMP) covering effluent monitoring and environmental surveillance. DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance, provides specific guidance regarding environmental monitoring activities.
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Brookhaven National Laboratory environmental monitoring plan for Calendar Year 1996
International Nuclear Information System (INIS)
Naidu, J.R.; Paquette, D.; Lee, R.
1996-01-01
As required by DOE Order 5400.1, each U.S. Department of Energy (DOE) site, facility, or activity that uses, generates, releases, or manages significant quantities of hazardous materials shall provide a written Environmental Monitoring Plan (EMP) covering effluent monitoring and environmental surveillance. DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance, provides specific guidance regarding environmental monitoring activities
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Monitoring the effectiveness evaluation of investment projects
Directory of Open Access Journals (Sweden)
Skopin Alex O.
2012-02-01
Full Text Available The article raised the question of monitoring regulatory evaluation of the effectiveness of regional investment projects. This is justified by the fact that the current regulatory framework defined indicators for measuring the effectiveness of regional investment projects, but these figures are usually used only at the design stage of the project, an interim assessment of the effectiveness of a sufficiently simplified and based on the level of exploration investment.
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International Nuclear Information System (INIS)
Noble, Bram; Birk, Jasmine
2011-01-01
Negotiated environmental agreements are becoming common practice in the mining industry. In principle, negotiated environmental agreements are said to respond to many of the shortcomings of environmental impact assessment by providing for improved follow-up of project impacts through, among other things, data provision, engaging stakeholders in the monitoring and management of project impacts, and building capacity at the local level to deal with project-induced environmental change. In practice, however, little is known about the efficacy of follow-up under negotiated environmental agreements between proponents and communities and the demonstrated value added to project impact management. This paper examines follow-up practice under negotiated environmental agreements with a view to understanding whether and how community-based monitoring under privatized agreements actually contributes to improved follow-up and impact management. Based on lessons emerging from recent experiences with environmental agreements in Canada's uranium industry, we show that follow-up under negotiated agreements may be described as 'comfort monitoring'. While such monitoring does improve community-industry relations and enhance corporate image, it does little to support effects-based management. If follow-up under negotiated agreements is to be credible over the long term, there is a need to ensure that monitoring results are useful for, and integrated with, regulatory-based monitoring and project impact management practices.
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Monitoring Quality of Biotherapeutic Products Using Multivariate Data Analysis.
Rathore, Anurag S; Pathak, Mili; Jain, Renu; Jadaun, Gaurav Pratap Singh
2016-07-01
Monitoring the quality of pharmaceutical products is a global challenge, heightened by the implications of letting subquality drugs come to the market on public safety. Regulatory agencies do their due diligence at the time of approval as per their prescribed regulations. However, product quality needs to be monitored post-approval as well to ensure patient safety throughout the product life cycle. This is particularly complicated for biotechnology-based therapeutics where seemingly minor changes in process and/or raw material attributes have been shown to have a significant effect on clinical safety and efficacy of the product. This article provides a perspective on the topic of monitoring the quality of biotech therapeutics. In the backdrop of challenges faced by the regulatory agencies, the potential use of multivariate data analysis as a tool for effective monitoring has been proposed. Case studies using data from several insulin biosimilars have been used to illustrate the key concepts.
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Prud'homme, Genevieve; Dobbin, Nina A.; Sun, Liu; Burnet, Richard T.; Martin, Randall V.; Davidson, Andrew; Cakmak, Sabit; Villeneuve, Paul J.; Lamsal, Lok N.; vanDonkelaar, Aaron;
2013-01-01
Satellite remote sensing (RS) has emerged as a cutting edge approach for estimating ground level ambient air pollution. Previous studies have reported a high correlation between ground level PM2.5 and NO2 estimated by RS and measurements collected at regulatory monitoring sites. The current study examined associations between air pollution and adverse respiratory and allergic health outcomes using multi-year averages of NO2 and PM2.5 from RS and from regulatory monitoring. RS estimates were derived using satellite measurements from OMI, MODIS, and MISR instruments. Regulatory monitoring data were obtained from Canada's National Air Pollution Surveillance Network. Self-reported prevalence of doctor-diagnosed asthma, current asthma, allergies, and chronic bronchitis were obtained from the Canadian Community Health Survey (a national sample of individuals 12 years of age and older). Multi-year ambient pollutant averages were assigned to each study participant based on their six digit postal code at the time of health survey, and were used as a marker for long-term exposure to air pollution. RS derived estimates of NO2 and PM2.5 were associated with 6e10% increases in respiratory and allergic health outcomes per interquartile range (3.97 mg m3 for PM2.5 and 1.03 ppb for NO2) among adults (aged 20e64) in the national study population. Risk estimates for air pollution and respiratory/ allergic health outcomes based on RS were similar to risk estimates based on regulatory monitoring for areas where regulatory monitoring data were available (within 40 km of a regulatory monitoring station). RS derived estimates of air pollution were also associated with adverse health outcomes among participants residing outside the catchment area of the regulatory monitoring network (p < 0.05).
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Regulatory analyses for severe accident issues: an example
International Nuclear Information System (INIS)
Burke, R.P.; Strip, D.R.; Aldrich, D.C.
1984-09-01
This report presents the results of an effort to develop a regulatory analysis methodology and presentation format to provide information for regulatory decision-making related to severe accident issues. Insights and conclusions gained from an example analysis are presented. The example analysis draws upon information generated in several previous and current NRC research programs (the Severe Accident Risk Reduction Program (SARRP), Accident Sequence Evaluation Program (ASEP), Value-Impact Handbook, Economic Risk Analyses, and studies of Vented Containment Systems and Alternative Decay Heat Removal Systems) to perform preliminary value-impact analyses on the installation of either a vented containment system or an alternative decay heat removal system at the Peach Bottom No. 2 plant. The results presented in this report are first-cut estimates, and are presented only for illustrative purposes in the context of this document. This study should serve to focus discussion on issues relating to the type of information, the appropriate level of detail, and the presentation format which would make a regulatory analysis most useful in the decisionmaking process
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Value of monitoring in road network management
Zouch, M.; Courage, W.; Napoles-Morales, O.
2014-01-01
We present a framework for road network management to assist road authorities in maintenance budget estimations and long-term maintenance strategies definition. Information about road conditions is obtained from monitoring. Available data are used to estimate and update prediction of degradation
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International Nuclear Information System (INIS)
Sneve, M.K.
2013-01-01
The availability of up to date regulatory norms and standards for nuclear and radiation safety, relevant to the management of nuclear legacy situations, combined with effective and efficient regulatory procedures for licensing and monitoring compliance, are considered to be extremely important. Accordingly the NRPA has set up regulatory cooperation programs with corresponding authorities in the Russian Federation. Cooperation began with the civilian regulatory authorities and was more recently extended to include the military authority and this joint cooperation supposed to develop the regulatory documents to improve supervision over nuclear and radiation safety while managing the nuclear military legacy facilities in Northwest Russia and other regions of the country. (Author)
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Energy Technology Data Exchange (ETDEWEB)
Sneve, M.K.
2013-03-01
The availability of up to date regulatory norms and standards for nuclear and radiation safety, relevant to the management of nuclear legacy situations, combined with effective and efficient regulatory procedures for licensing and monitoring compliance, are considered to be extremely important. Accordingly the NRPA has set up regulatory cooperation programs with corresponding authorities in the Russian Federation. Cooperation began with the civilian regulatory authorities and was more recently extended to include the military authority and this joint cooperation supposed to develop the regulatory documents to improve supervision over nuclear and radiation safety while managing the nuclear military legacy facilities in Northwest Russia and other regions of the country. (Author)
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Establishing exemption and clearance criteria by the regulatory authority
International Nuclear Information System (INIS)
Salih, A.E.A.
2012-04-01
This Project work discusses the relationship between the concepts of exemption and clearance, and their practical use in the overall scheme of regulatory control of practices. It also discusses how exemptions and clearance is established and the scope of its applications for regulatory control. The concept of general clearance levels for any type of material and any possible pathway of disposal is also introduced in this work. Guidance of the Group of Experts establishing scenarios for general clearance, parameter values, and a nuclide-specific list of calculated clearance levels is also presented. Regulatory authorities are required to develop guidance on exemption and clearance levels to assist licensees and registrants to know which practices and sources within practices are exempted from regulatory control and those to be cleared from further controls. Exemption and clearance levels are tools for assisting the Regulatory Authority to optimize the use of resources. (author)
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2013-10-22
...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule Change To Assume... Authority and Supervision September 30, 2013. On July 31, 2013, The NASDAQ Stock Market LLC (``NASDAQ'' or...) Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...
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Value of self-monitoring blood glucose pattern analysis in improving diabetes outcomes.
Parkin, Christopher G; Davidson, Jaime A
2009-05-01
Self-monitoring of blood glucose (SMBG) is an important adjunct to hemoglobin A1c (HbA1c) testing. This action can distinguish between fasting, preprandial, and postprandial hyperglycemia; detect glycemic excursions; identify and monitor resolution of hypoglycemia; and provide immediate feedback to patients about the effect of food choices, activity, and medication on glycemic control. Pattern analysis is a systematic approach to identifying glycemic patterns within SMBG data and then taking appropriate action based upon those results. The use of pattern analysis involves: (1) establishing pre- and postprandial glucose targets; (2) obtaining data on glucose levels, carbohydrate intake, medication administration (type, dosages, timing), activity levels and physical/emotional stress; (3) analyzing data to identify patterns of glycemic excursions, assessing any influential factors, and implementing appropriate action(s); and (4) performing ongoing SMBG to assess the impact of any therapeutic changes made. Computer-based and paper-based data collection and management tools can be developed to perform pattern analysis for identifying patterns in SMBG data. This approach to interpreting SMBG data facilitates rational therapeutic adjustments in response to this information. Pattern analysis of SMBG data can be of equal or greater value than measurement of HbA1c levels. 2009 Diabetes Technology Society.
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USING CONDITION MONITORING TO PREDICT REMAINING LIFE OF ELECTRIC CABLES
International Nuclear Information System (INIS)
LOFARO, R.; SOO, P.; VILLARAN, M.; GROVE, E.
2001-01-01
Electric cables are passive components used extensively throughout nuclear power stations to perform numerous safety and non-safety functions. It is known that the polymers commonly used to insulate the conductors on these cables can degrade with time; the rate of degradation being dependent on the severity of the conditions in which the cables operate. Cables do not receive routine maintenance and, since it can be very costly, they are not replaced on a regular basis. Therefore, to ensure their continued functional performance, it would be beneficial if condition monitoring techniques could be used to estimate the remaining useful life of these components. A great deal of research has been performed on various condition monitoring techniques for use on electric cables. In a research program sponsored by the U.S. Nuclear Regulatory Commission, several promising techniques were evaluated and found to provide trendable information on the condition of low-voltage electric cables. These techniques may be useful for predicting remaining life if well defined limiting values for the aging properties being measured can be determined. However, each technique has advantages and limitations that must be addressed in order to use it effectively, and the necessary limiting values are not always easy to obtain. This paper discusses how condition monitoring measurements can be used to predict the remaining useful life of electric cables. The attributes of an appropriate condition monitoring technique are presented, and the process to be used in estimating the remaining useful life of a cable is discussed along with the difficulties that must be addressed
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Regulatory measures for occupational health monitoring in BARC facilities
International Nuclear Information System (INIS)
Rajdeep; Chattopadhyay, S.
2017-01-01
Bhabha Atomic Research Centre (BARC) is the premier organization actively engaged in the research and developmental activities related to nuclear science and technology for the benefit of society and the nation. BARC has various facilities like nuclear fuel fabrication facilities, research reactors, spent fuel storage facilities, nuclear fuel re-cycling facilities, radioactive waste management facilities, machining workshops and various Physics, Chemistry and Biological laboratories. In BARC, aspects related to Occupational Safety and Health (OSH) are given paramount importance. The issues related OSH are subjected to multi-tier review process. BARC Safety Council (BSC) is the apex committee in the three-tier safety and security review framework of BARC. BSC functions as regulatory body for BARC facilities. BSC is responsible for occupational safety and health of employees in BARC facilities
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Farrer, David; Counter, Marina; Hillwig, Rebecca; Cude, Curtis
2015-01-01
Human health risks from cyanobacterial blooms are primarily related to cyanotoxins that some cyanobacteria produce. Not all species of cyanobacteria can produce toxins. Those that do often do not produce toxins at levels harmful to human health. Monitoring programs that use identification of cyanobacteria genus and species and enumeration of cyanobacterial cells as a surrogate for cyanotoxin presence can overestimate risk and lead to unnecessary health advisories. In the absence of federal criteria for cyanotoxins in recreational water, the Oregon Health Authority (OHA) developed guideline values for the four most common cyanotoxins in Oregon’s fresh waters (anatoxin-a, cylindrospermopsin, microcystins, and saxitoxins). OHA developed three guideline values for each of the cyanotoxins found in Oregon. Each of the guideline values is for a specific use of cyanobacteria-affected water: drinking water, human recreational exposure and dog recreational exposure. Having cyanotoxin guidelines allows OHA to promote toxin-based monitoring (TBM) programs, which reduce the number of health advisories and focus advisories on times and places where actual, rather than potential, risks to health exist. TBM allows OHA to more efficiently protect public health while reducing burdens on local economies that depend on water recreation-related tourism. PMID:25664510
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An Overview of Process Monitoring Related to the Production of Uranium Ore Concentrate
Energy Technology Data Exchange (ETDEWEB)
McGinnis, Brent [Innovative Solutions Unlimited, LLC
2014-04-01
Uranium ore concentrate (UOC) in various chemical forms, is a high-value commodity in the commercial nuclear market, is a potential target for illicit acquisition, by both State and non-State actors. With the global expansion of uranium production capacity, control of UOC is emerging as a potentially weak link in the nuclear supply chain. Its protection, control and management thus pose a key challenge for the international community, including States, regulatory authorities and industry. This report evaluates current process monitoring practice and makes recommendations for utilization of existing or new techniques for managing the inventory and tracking this material.
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Scientific underpinnings of biotechnology regulatory frameworks.
Gleim, Savannah; Smyth, Stuart J
2018-05-25
Part of what is presently missing at domestic regulatory levels (and that is important at the international level as well) is a detailed understanding of what the rules of, and for, regulation should be, who the actors, stakeholders and major decision makers are and finally, how to get agreement about the rules. Greater insights into the system of rules that underpin regulatory frameworks for agri-food and biotechnology products in genetically modified (GM) crop- adopting nations will provide value by clarifying the evidence used to commercialize these technologies. This article examines the public documents available from Canada, the United States, the European Union and the Organisation for Economic Cooperation and Development regarding the development of regulatory risk assessment frameworks for products of biotechnology to determine what science grounds these frameworks. The documentation used to provide the initial structure to the existing regulatory frameworks identifies the linkages, connections and relationships that exist between science, risk assessment and regulatory policy. The relationship between risk and regulation has never been more critical to the commercialization of innovative agricultural products. Documenting the role of science-based risk assessment in regulations and how this has changed over the 20 years of experience in regulating GM crops will identify changes in the risk/regulation relationship. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.
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Regulatory Capital: Why Is It Different?
Schoenmaker, D.
2015-01-01
The global financial crisis has highlighted that deviations between the accounting and regulatory concepts of equity capital have gone too far. Accounting standards have been going too far in the application of fair value accounting. If there are no markets during times of crises, it does not make
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Integrated Monitoring Plan for the Hanford Groundwater Monitoring Project
International Nuclear Information System (INIS)
Newcomer, D.R.; Thornton, E.C.; Hartman, M.J.; Dresel, P.E.
1999-01-01
Groundwater is monitored at the Hanford Site to fulfill a variety of state and federal regulations, including the Atomic Energy Act of 1954 the Resource Conservation and Recovery Act of 1976 the Comprehensive Environmental Response, Compensation, and Liability Act of 1980; and Washington Administrative Code. Separate monitoring plans are prepared for various requirements, but sampling is coordinated and data are shared among users to avoid duplication of effort. The US Department of Energy manages these activities through the Hanford Groundwater Monitoring Project. This document is an integrated monitoring plan for the groundwater project. It documents well and constituent lists for monitoring required by the Atomic Energy Act of 1954 and its implementing orders; includes other, established monitoring plans by reference; and appends a master well/constituent/frequency matrix for the entire site. The objectives of monitoring fall into three general categories plume and trend tracking, treatment/storage/disposal unit monitoring, and remediation performance monitoring. Criteria for selecting Atomic Energy Act of 1954 monitoring networks include locations of wells in relation to known plumes or contaminant sources, well depth and construction, historical data, proximity to the Columbia River, water supplies, or other areas of special interest, and well use for other programs. Constituent lists were chosen based on known plumes and waste histories, historical groundwater data, and, in some cases, statistical modeling. Sampling frequencies were based on regulatory requirements, variability of historical data, and proximity to key areas. For sitewide plumes, most wells are sampled every 3 years. Wells monitoring specific waste sites or in areas of high variability will be sampled more frequently
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Regulatory controls and slurry fracture injection
International Nuclear Information System (INIS)
Dusseault, M. B.; Bilak, R. A.
1997-01-01
The technological and regulatory framework necessary for the safe operation of solid waste disposal using slurry fracture injection (SFI) in Saskatchewan and Alberta was studied. Seven current SFI sites were used as the source of experience. Regular audits of volumes, continuous pressure recording, careful deformation monitoring and analysis, and repeated evaluation of reservoir properties were considered to be the essential features. In the case of toxic wastes, microseismic monitoring and regular well interference or tracer tests might be additional measures used to increase confidence in the containment method. Given the recent introduction of SFI technology, guarding against over-regulation was recommended to allow SFI to operate under the most effective operating conditions, and to preserve its attractiveness as an environmentally attractive and safe waste disposal alternative. 5 refs., 3 tabs., 4 figs
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Meeting regulatory standards with BeO ceramic TLD
International Nuclear Information System (INIS)
Gammage, R.B.; Christian, D.J.
1978-01-01
Measurements of exposures below 1 mR are possible with BeO ceramic TLD by signal recording that discriminates against an interfering pyroelectric incandescence. Performance under environmental monitoring conditions is considered in light of current regulatory criteria. Factors such as reproducibility and batch uniformity are satisfactory. An anomalous energy dependence causes an over-response that will probably require use of an energy compensation shield
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Assessment of regulatory effectiveness. Peer discussions on regulatory practices
International Nuclear Information System (INIS)
1999-09-01
This report arises from the seventh series of peer discussions on regulatory practices entitled 'Assessment of Regulatory Effectiveness'. The term 'regulatory effectiveness' covers the quality of the work and level of performance of a regulatory body. In this sense, regulatory effectiveness applies to regulatory body activities aimed at preventing safety degradation and ensuring that an acceptable level of safety is being maintained by the regulated operating organizations. In addition, regulatory effectiveness encompasses the promotion of safety improvements, the timely and cost effective performance of regulatory functions in a manner which ensures the confidence of the operating organizations, the general public and the government, and striving for continuous improvements to performance. Senior regulators from 22 Member States participated in two peer group discussions during March and May 1999. The discussions were focused on the elements of an effective regulatory body, possible indicators of regulatory effectiveness and its assessment. This report presents the outcome of these meetings and recommendations of good practices identified by senior regulators, which do not necessarily reflect those of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. In order to protect people and the environment from hazards associated with nuclear facilities, the main objective of a nuclear regulatory body is to ensure that a high level of safety in the nuclear activities under its jurisdiction is achieved, maintained and within the control of operating organizations. Even if it is possible to directly judge objective safety levels at nuclear facilities, such safety levels would not provide an exclusive indicator of regulatory effectiveness. The way the regulatory body ensures the safety of workers and the public and the way it discharges its responsibilities also determine its effectiveness. Hence the
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Religiosity and basic values of Russians (based on the European Social Survey and Orthodox Monitor
Directory of Open Access Journals (Sweden)
Elena Prutskova
2017-12-01
Full Text Available The article examines the relationship between religiosity and basic values in Russia. Basic values are measured by the Schwartz's Portrait Value Questionnaire. The analysis is based on the data of the European Social Survey conducted in 2012 and the Orthodox Monitor survey conducted in 2012 as well, which is a representative survey of churched Russian Orthodox Christians. Usually based on the results of mass surveys, the connection of basic values with religiosity in Russia is very weak. One possible reason is the use of inappopriate indicators to measure the degree of religiosity. One of the most important characteristics that distinguish churched Orthodox Christians is regular Communion, which presupposes quite serious preparation, fasting and Confession. People make an attempt to rethink their views, values, and change their behavior. If this happens with a certain regularity, then it can lead to a gradual change in basic values, conditioned by religiosity. Such working out the best of oneself may not occur if a person just attends religious services, but does not receive Communion. Churched Orthodox are much more committed to the values of Conservation and Self-Transcendence, and less to the values of Openness to change and Self-Enhancement. One of the unexpected results was the discovery of significant differences in the values of Universalism, in which the churched Orthodox Christians are noticeably ahead of the average Russians, while in most previous studies the relationship of religiosity to the values of Universalism was either negative or absent, and only rarely was weak positive. Also, despite the general low commitment to the values of Openness to change, the differences are due to the great rejection of the values of Hedonism and Stimulation, while the values of Self Direction differ from the average Russians only slightly.
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20 years of long-term atrazine monitoring in a shallow aquifer in western Germany.
Vonberg, David; Vanderborght, Jan; Cremer, Nils; Pütz, Thomas; Herbst, Michael; Vereecken, Harry
2014-03-01
Atrazine was banned in Germany in 1991 due to findings of atrazine concentrations in ground- and drinking waters exceeding threshold values. Monitoring of atrazine concentrations in the groundwater since then provides information about the resilience of the groundwater quality to changing agricultural practices. In this study, we present results of a monitoring campaign of atrazine concentrations in the Zwischenscholle aquifer. This phreatic aquifer is exposed to intensive agricultural land use and susceptible to contaminants due to a shallow water table. In total 60 observation wells (OWs) have been monitored since 1991, of which 15 are sampled monthly today. Descriptive statistics of monitoring data were derived using the "regression on order statistics" (ROS) data censoring approach, estimating values for nondetects. The monitoring data shows that even 20 years after the ban of atrazine, the groundwater concentrations of sampled OWs remain on a level close to the threshold value of 0.1 μg l(-1) without any considerable decrease. The spatial distribution of atrazine concentrations is highly heterogeneous with OWs exhibiting permanently concentrations above the regulatory threshold on the one hand and OWs were concentrations are mostly below the limit of quantification (LOQ) on the other hand. A deethylatrazine-to-atrazine ratio (DAR) was used to distinguish between diffuse - and point-source contamination, with a global mean value of 0.84 indicating mainly diffuse contamination. Principle Component Analysis (PCA) of the monitoring dataset demonstrated relationships between the metabolite desisopropylatrazine, which was found to be exclusively associated with the parent compound simazine but not with atrazine, and between deethylatrazine, atrazine, nitrate, and the specific electrical conductivity. These parameters indicate agricultural impacts on groundwater quality. The findings presented in this study point at the difficulty to estimate mean concentrations
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On the value of structural health monitoring
DEFF Research Database (Denmark)
Faber, Michael Havbro; Thöns, Sebastian
2014-01-01
in the fields of SHM and the quantification of value of information as well as the identification of typical situations in structural engineering in which SHM has the potential to provide value beyond its costs. Subsequently, the theoretical framework which allows for the quantification of the value...... of information collected through SHM systems is developed and elaborated. It is shown how the value of information can be quantified to support the assessment and optimization of decisions on whether and how to implement SHM. To illustrate the use of the developed theoretical framework for evaluating the benefit...
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Steering healthcare service delivery: a regulatory perspective.
Prakash, Gyan
2015-01-01
The purpose of this paper is to explore regulation in India's healthcare sector and makes recommendations needed for enhancing the healthcare service. The literature was reviewed to understand healthcare's regulatory context. To understand the current healthcare system, qualitative data were collected from state-level officials, public and private hospital staff. A patient survey was performed to assess service quality (QoS). Regulation plays a central role in driving healthcare QoS. India needs to strengthen market and institutional co-production based approaches for steering its healthcare in which delivery processes are complex and pose different challenges. This study assesses current healthcare regulation in an Indian state and presents a framework for studying and strengthening regulation. Agile regulation should be based on service delivery issues (pull approach) rather than monitoring and sanctions based regulatory environment (push approach). Healthcare pitfalls across the world seem to follow similar follies. India's complexity and experience is useful for emerging and developed economies. The author reviewed around 70 publications and synthesised them in healthcare regulatory contexts. Patient's perception of private providers could be a key input towards steering regulation. Identifying gaps across QoS dimensions would be useful in taking corrective measures.
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2011-11-21
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65744; File No. SR-C2-2011-034] Self-Regulatory... Change Related to the Quote Risk Monitor Mechanism November 14, 2011. Pursuant to Section 19(b)(1) of the...\\ 15 U.S.C. 78s(b)(3)(A)(iii). \\4\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory Organization's Statement...
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2011-11-28
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65800; File No. SR-C2-2011-035] Self-Regulatory... Rule Change Related to a Temporary Quote Risk Monitor Mechanism Rule November 21, 2011. Pursuant to...). \\2\\ 17 CFR 240.19b-4. \\3\\ 15 U.S.C. 78s(b)(3)(A)(iii). \\4\\ 17 CFR 240.19b-4(f)(6). I. Self-Regulatory...
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Equipment abnormality monitoring method and device therefor
International Nuclear Information System (INIS)
Yamada, Izumi; Asakura, Yamato; Uemura, Hiroshi; Uchida, Shunsuke; Oyamada, Osamu; Oyobe, Koji.
1994-01-01
In the present invention, it is judged whether the operation state of equipments used in a plant are normal or not by using learning performances. That is, a plurality of monitoring parameters are measured for an equipment. Previously determined monitoring parameters are extracted. A leaning mode or a monitoring mode is selected. In the leaning mode, based on the values of previously determined monitoring parameters, values of other monitoring parameters during normal states are learned. In the monitoring mode, based on the values of the previously determined monitoring parameters, typical values of other leaned monitoring parameters are outputted. The typical values of other normal monitoring parameters after learning and the values of other parameters at the present time are compared. If the values of the other parameters at the present time are out of normal range, it is judged as abnormal, and the result is alarmed and displayed. (I.S.)
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DEFF Research Database (Denmark)
Thöns, Sebastian; Limongelli, Maria Pina; Ivankovic, Ana Mandic
2017-01-01
This paper summarizes the development of Value of Structural Health Monitoring (SHM) Information analyses and introduces the development, objectives and approaches of the COST Action TU1402 on this topic. SHM research and engineering has been focused on the extraction of loading, degradation...... for its quantification. This challenge can be met with Value of SHM Information analyses facilitating that the SHM contribution to substantial benefits for life safety, economy and beyond can be may be quantified, demonstrated and utilized. However, Value of SHM Information analyses involve complex models...... encompassing the infrastructure and the SHM systems, their functionality and thus require the interaction of several research disciplines. For progressing on these points, a scientific networking and dissemination project namely the COST Action TU1402 has been initiated....
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Conformity check of JMTR to new regulatory standards
International Nuclear Information System (INIS)
Watahiki, Shunsuke; Ide, Hiroshi; Hanakawa, Hiroki; Yamaura, Takayuki; Kaminaga, Masanori
2015-01-01
With the lesson learned from the accident of TEPCO Fukushima Daiichi Nuclear Power Station, also based on the international standards, the 'New regulatory standards for nuclear facilities for research! was enforced by the Nuclear Regulatory Authority in December 2013. The main requirements of the new standards are as follows: (1) measures for earthquake, tsunami, and damage from the outside, (2) severity classification, (3) fire protection, (4) flood protection, (5) communication and contacting, (6) measures for the loss of external power supply, (7) monitoring equipment, and (8) expansion prevention of accident that releases a large amounts of radioactive materials. Under the new regulatory standards, it is demanded that the constructions, systems, and equipment with safety functions of the current nuclear facilities should maintain the safety functions in accordance with their importance against the basic ground motions and possible natural phenomena. For the buildings, equipment, and machineries of JMTR nuclear facilities, the severity classification was performed on each of safety function and seismic resistance. Based on the classification results, seismic evaluation and safety analysis were carried out. (A.O.)
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Self-Monitoring of Self-Regulation during Math Homework Behaviour Using Standardized Diaries
Schmitz, Bernhard; Perels, Franziska
2011-01-01
This study aims at enhancing math learning and general self-regulation by supporting daily self-regulated learning during math homework. The authors use standardized diaries as a self-monitoring tool to support self-regulatory behaviour. Following the theory of self-monitoring, frequent self-monitoring of self-regulation will lead to an…
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Bioaccumulation in aquatic systems: methodological approaches, monitoring and assessment
DEFF Research Database (Denmark)
Schäfer, Sabine; Buchmeier, Georgia; Claus, Evelyn
2015-01-01
, various scientific and regulatory aspects of bioaccumulation in aquatic systems and the relevant critical issues are discussed. Monitoring chemical concentrations in biota can be used for compliance checking with regulatory directives, for identification of chemical sources or event-related environmental...... temporal and geographical range. Bioaccumulation is also assessed for regulation of chemicals of environmental concern whereby mainly data from laboratory studies on fish bioaccumulation are used. Field data can, however, provide additional important information for regulators. Strategies...... for bioaccumulation assessment still need to be harmonised for different regulations and groups of chemicals. To create awareness for critical issues and to mutually benefit from technical expertise and scientific findings, communication between risk assessment and monitoring communities needs to be improved...
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The changing regulatory environment
International Nuclear Information System (INIS)
Caron, G.
1999-01-01
The role and value of regulation in the energy sector was discussed, demonstrating how, despite common perception, regulation is an essential part of Canada's strategy to find and develop new opportunities. The future vision of regulation for industry participants was presented with particular focus on issues related to streamlining the regulatory process. As far as pipelines are concerned, regulatory actions are necessary to facilitate capacity increases and to ensure the line's integrity, safety and environmental record. Furthermore, regulation provides economic solutions where market forces cannot provide them, as for example where business has elements of monopoly. It arbitrates interests of landowners, business, consumers, and environmental groups. It looks for ways to ensure conditions under which competition can flourish. It acts as the guardian of citizens' rights in a democratic society by providing citizens with an opportunity to be heard on the building or expansion of pipelines and associated facilities. As citizens become more and more concerned about their property and the land that surrounds them, citizen involvement in decision making about how industry activity affects their quality of life will become correspondingly more important. Regulatory agencies are committed to facilitate this engagement by flexible hearing procedures and by making use of evolving communication and information technology
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Deliberations on nuclear safety regulatory system in a changing industrial environment
International Nuclear Information System (INIS)
Kim, H.J.
2001-01-01
Nuclear safety concern, which may accompany such external environmental factors as privatization and restructuring of the electric power industry, is emerging as an international issue. In order to cope with the concern about nuclear safety, it is important to feedback valuable experiences of advanced countries that restructured their electric power industries earlier and further to reflect the current safety issues, which are raised internationally, fully into the nuclear safety regulatory system. This paper is to review the safety issues that might take place in the process of increasing competition in the nuclear power industry, and further to present a basic direction and effective measures for ensuring nuclear safety in response thereto from the viewpoint of safety regulation. It includes a political direction for a regulatory body's efforts to rationalize and enforce efficiently its regulation. It proposes to ensure that regulatory specialty and regulatory cost are stably secured. Also, this paper proposes maintaining a sound nuclear safety regulatory system to monitor thoroughly the safety management activities of the industry, which might be neglected as a result of focusing on reduction of the cost for producing electric power. (author)
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Demonstrating the viability and value of community-based monitoring schemes in catchment science
Starkey, Eleanor; Parkin, Geoff; Quinn, Paul; Large, Andy
2016-04-01
for the purpose of assessing the quality of citizen science observations. It has been found that citizen science observations are essential for capturing localised convective storms. Citizen scientists want their observations to be used to gain meaningful information and tackle local issues. Data has therefore been utilised to build, calibrate and validate hydrological models and support a range of catchment management applications. This has further demonstrated the value of citizen science, along with the social benefits it has to offer. Other communities are also beginning to source funding and implement their own monitoring schemes, indicating that they are both capable and self-motivated. Citizen science makes use of evolving and more readily available technology, providing catchment stakeholders with vital information. Although these types of observations present various challenges, it is argued that a citizen science approach is not intending to replace traditional techniques, rather they can be used to complement them, fill the gaps and/or provide an indication of catchment behaviour across space and through time.
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International Nuclear Information System (INIS)
Struckmeyer, R.; McNamara, N.
1990-03-01
This report presents the results of the NRC Direct Radiation Monitoring Network for the fourth quarter of 1989. It provides the ambient radiation levels measured in the vicinity of 75 sites throughout the United States. In addition, it describes the equipment used, monitoring station selection criteria, characterization of the dosimeter response, calibration procedures, statistical methods, intercomparison, and quality assurance program
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Monitoring programmes for unrestricted release related to decommissioning of nuclear facilities
International Nuclear Information System (INIS)
1992-01-01
Decommissioning of nuclear facilities usually results in a large volume of radioactive and non-radioactive materials. All these materials will have to be segregated as radioactive, non-radioactive and exempt from regulatory control, and then disposed of, reused or recycled. As more and more facilities approach decommissioning, controlling these wastes and setting release criteria and limits for these materials will represent a major task for the regulatory body and the licensee. Efforts are, therefore, under way at the IAEA to help achieve international consensus on the release criteria for decommissioning and a monitoring programme to verify compliance with these criteria. Within the above context, the present report was conceived as a technical document to provide an overview of all the factors to be considered in the development, planning and implementation of a monitoring programme to assure regulatory compliance with criteria for unrestricted release of materials, buildings and sites from decommissioning. The report is intended as a planning document for the owners, operators and regulatory bodies involved in decommissioning. 41 refs, 4 figs, 2 tabs
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DEFF Research Database (Denmark)
Petersen, Per Hyltoft; Sandberg, Sverre; Iglesias, Natàlia
2007-01-01
and odds used for diagnostic test evaluations is applied to monitoring by substituting measured concentrations with measured differences. Thus, two frequency distributions of differences are assumed, one for a stable, steady-state, situation and one for a certain change. Values exceeding a measured...
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Integrated Monitoring Plan for the Hanford Groundwater Monitoring Project
International Nuclear Information System (INIS)
Hartman, Mary J.; Dresel, P. Evan; Lindberg, Jon W.; Newcomer, Darrell R.; Thornton, Edward C.
2000-01-01
Groundwater is monitored at the Hanford Site to fulfill a variety of state and federal regulations, including the Atomic Energy Act of 1954; the Resource Conservation and Recovery Act of 1976; the Comprehensive Environmental Response, Compensation, and Liability Act of 1980; and Washington Administrative Code. Separate monitoring plans are prepared for various requirements, but sampling is coordinated and data are shared among users to avoid duplication of effort. The U.S. Department of Energy manages these activities through the Hanford Groundwater Monitoring Project. This document is an integrated monitoring plan for the groundwater project. It documents well and constituent lists for monitoring required by the Atomic Energy Act of 1954 and its implementing orders; includes other, established monitoring plans by reference; and appends a master well/constituent/ frequency matrix for the entire site. The objectives of monitoring fall into three general categories: plume and trend tracking, treatment/ storage/disposal unit monitoring, and remediation performance monitoring. Criteria for selecting Atomic Energy Act of 1954 monitoring networks include locations of wells in relation to known plumes or contaminant sources, well depth and construction, historical data, proximity to the Columbia River, water supplies, or other areas of special interest, and well use for other programs. Constituent lists were chosen based on known plumes and waste histories, historical groundwater data, and, in some cases, statistical modeling. Sampling frequencies were based on regulatory requirements, variability of historical data, and proximity to key areas. For sitewide plumes, most wells are sampled every 3 years. Wells monitoring specific waste sites or in areas of high variability will be sampled more frequently
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Thirumala, Parthasarathy D; Mohanraj, Santhosh Kumar; Habeych, Miguel; Wichman, Kelley; Chang, Yue-Fang; Gardner, Paul; Snyderman, Carl; Crammond, Donald J; Balzer, Jeffrey
2012-08-01
Objective The main objective of this study was to evaluate the value of free-run electromyography (f-EMG) monitoring of cranial nerves (CNs) VII, IX, X, XI, and XII in skull base surgeries performed using endoscopic endonasal approach (EEA) to reduce iatrogenic CN deficits. Design We retrospectively identified 73 patients out of 990 patients who had EEA in our institution who had at least one CN monitored. In each CN group, we classified patients who had significant (SG) f-EMG activity as group I and those who did not as group II. Results We monitored a total of 342 CNs. A total of 62 nerves had SG f-EMG activity including CN VII = 18, CN IX = 16, CN X = 13, CN XI = 5, and CN XII = 10. No nerve deficit was found in the nerves that had significant activity during procedure. A total of five nerve deficits including (CN IX = 1, CN X = 2, CN XII = 2) were observed in the group that did not display SG f-EMG activity during surgery. Conclusions f-EMG seems highly sensitive to surgical manipulations and in locating CNs. It seems to have limited value in predicting postoperative neurological deficits. Future studies to evaluate the EMG of lower CNs during EEA procedures need to be done with both f-EMG and triggered EMG.
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Using Inequality Measures to Incorporate Environmental Justice into Regulatory Analyses
Harper, Sam; Ruder, Eric; Roman, Henry A.; Geggel, Amelia; Nweke, Onyemaechi; Payne-Sturges, Devon; Levy, Jonathan I.
2013-01-01
Formally evaluating how specific policy measures influence environmental justice is challenging, especially in the context of regulatory analyses in which quantitative comparisons are the norm. However, there is a large literature on developing and applying quantitative measures of health inequality in other settings, and these measures may be applicable to environmental regulatory analyses. In this paper, we provide information to assist policy decision makers in determining the viability of using measures of health inequality in the context of environmental regulatory analyses. We conclude that quantification of the distribution of inequalities in health outcomes across social groups of concern, considering both within-group and between-group comparisons, would be consistent with both the structure of regulatory analysis and the core definition of environmental justice. Appropriate application of inequality indicators requires thorough characterization of the baseline distribution of exposures and risks, leveraging data generally available within regulatory analyses. Multiple inequality indicators may be applicable to regulatory analyses, and the choice among indicators should be based on explicit value judgments regarding the dimensions of environmental justice of greatest interest. PMID:23999551
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2002 WIPP Environmental Monitoring Plan
Energy Technology Data Exchange (ETDEWEB)
Washington TRU Solutions LLC
2002-09-30
DOE Order 5400.1, General Environmental Protection Program, requires each DOE | facility to prepare an environmental management plan (EMP). This document is | prepared for WIPP in accordance with the guidance contained in DOE Order 5400.1; DOE Order 5400.5, Radiation Protection of the Public and Environment; applicable sections of Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T; DOE, 1991); and the Title 10 Code of Federal Regulations (CFR) Part 834, ''Radiation Protection of the Public and Environment'' (draft). Many sections of DOE Order 5400.1 have been replaced by DOE Order 231.1, which is the driver for the annual Site Environmental Report (SER) and the guidance source for preparing many environmental program documents. The WIPP Project is operated by Westinghouse TRU Solutions (WTS) for the DOE. This plan defines the extent and scope of WIPP's effluent and environmental | monitoring programs during the facility's operational life and also discusses WIPP's quality assurance/quality control (QA/QC) program as it relates to environmental monitoring. In addition, this plan provides a comprehensive description of environmental activities at WIPP including: A summary of environmental programs, including the status of environmental monitoring activities A description of the WIPP Project and its mission A description of the local environment, including demographics An overview of the methodology used to assess radiological consequences to the public, including brief discussions of potential exposure pathways, routine and accidental releases, and their consequences Responses to the requirements described in the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance.
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2013-08-16
...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of a Proposed Rule Change to Assume... NASDAQ Stock Market LLC (``NASDAQ'' or the ``Exchange'') filed with the Securities and Exchange...: Manipulation patterns that monitor solely NASDAQ activity, including patterns that monitor the Exchange's...
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Methods for ensuring compliance with regulatory requirements: regulators and operators
International Nuclear Information System (INIS)
Fleischmann, A.W.
1989-01-01
Some of the methods of ensuring compliance with regulatory requirements contained in various radiation protection documents such as Regulations, ICRP Recommendations etc. are considered. These include radiation safety officers and radiation safety committees, personnel monitoring services, dissemination of information, inspection services and legislative power of enforcement. Difficulties in ensuring compliance include outmoded legislation, financial and personnel constraints
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Maymandi, Nahal; Kerachian, Reza; Nikoo, Mohammad Reza
2018-03-01
This paper presents a new methodology for optimizing Water Quality Monitoring (WQM) networks of reservoirs and lakes using the concept of the value of information (VOI) and utilizing results of a calibrated numerical water quality simulation model. With reference to the value of information theory, water quality of every checkpoint with a specific prior probability differs in time. After analyzing water quality samples taken from potential monitoring points, the posterior probabilities are updated using the Baye's theorem, and VOI of the samples is calculated. In the next step, the stations with maximum VOI is selected as optimal stations. This process is repeated for each sampling interval to obtain optimal monitoring network locations for each interval. The results of the proposed VOI-based methodology is compared with those obtained using an entropy theoretic approach. As the results of the two methodologies would be partially different, in the next step, the results are combined using a weighting method. Finally, the optimal sampling interval and location of WQM stations are chosen using the Evidential Reasoning (ER) decision making method. The efficiency and applicability of the methodology are evaluated using available water quantity and quality data of the Karkheh Reservoir in the southwestern part of Iran.
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Fair value accounting for financial instruments: some implications for bank regulation
Wayne Landsman
2006-01-01
I identify issues that bank regulators need to consider if fair value accounting is used for determining bank regulatory capital and when making regulatory decisions. In financial reporting, US and international accounting standard setters have issued several disclosure and measurement and recognition standards for financial instruments and all indications are that both standard setters will mandate recognition of all financial instruments at fair value. To help identify important issues for ...
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Acoustic emission/flaw relationships for inservice monitoring of LWRs
International Nuclear Information System (INIS)
Hutton, P.H.; Kurtz, R.J.; Friesel, M.A.; Skorpik, J.R.; Dawson, J.F.
1991-10-01
The program concerning Acoustic Emission/Flaw Relationships for Inservice Monitoring of LWRs was initiated in FY76 with the objective of validating the application of acoustic emission (AE) to monitor nuclear reactor pressure-containing components during operation to detect cracking. The program has been supported by the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research. Research and development has been performed by Pacific Northwest Laboratory, operated for the Department of Energy by Battelle Memorial Institute. The program has shown the feasibility of continuous, on-line AE monitoring to detect crack growth and produced validated methods for applying the technology. Included are relationships for estimating flaw severity from AE data and field applications at Watts Bar Unit 1 Reactor, Limerick Unit 1 Reactor, and the High Flux Isotope Reactor. This report discusses the program scope and organization, the three program phases and the results obtained, standard and code activities, and instrumentation and software developed under this program
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The dynamics of the transnational food chain regulatory governance
DEFF Research Database (Denmark)
Chatzopoulou, Sevasti
2015-01-01
dynamics of the interactions among public and private actors operate within the transnational food standards setting process. The study identifies the groups of interdependent actors (public and private) that interact within the transnational food chain regulatory process and develop public...... in detail how these interactions operate empirically on specific regulations. Practical implications – The paper offers an integrative thorough understanding of the food chain regulatory standard setting process, relevant for academics, policy makers, the industry, and society. Originality/value – The paper...
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[Regulatory Program for Medical Devices in Cuba: experiences and current challenges].
Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado
2016-05-01
Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.
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Bruin, de M.; Sheeran, P.; Kok, G.; Hiemstra, A.; Prins, J.M.; Hospers, H.J.; Breukelen, G.J.P.
2012-01-01
Objectives: Understanding the gap between people's intentions and actual health behavior is an important issue in health psychology. Our aim in this study was to investigate whether self-regulatory processes (monitoring goal progress and responding to discrepancies) mediate the intention-behavior
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Routine Radiological Environmental Monitoring Plan. Volume 1
Energy Technology Data Exchange (ETDEWEB)
Bechtel Nevada
1999-12-31
The U.S. Department of Energy manages the Nevada Test Site in a manner that meets evolving DOE Missions and responds to the concerns of affected and interested individuals and agencies. This Routine Radiological Monitoring Plan addressess complicance with DOE Orders 5400.1 and 5400.5 and other drivers requiring routine effluent monitoring and environmental surveillance on the Nevada Test Site. This monitoring plan, prepared in 1998, addresses the activities conducted onsite NTS under the Final Environmental Impact Statement and Record of Decision. This radiological monitoring plan, prepared on behalf of the Nevada Test Site Landlord, brings together sitewide environmental surveillance; site-specific effluent monitoring; and operational monitoring conducted by various missions, programs, and projects on the NTS. The plan provides an approach to identifying and conducting routine radiological monitoring at the NTS, based on integrated technical, scientific, and regulatory complicance data needs.
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On the method of estimating the event of unusually high values in the radiation monitoring data
International Nuclear Information System (INIS)
Kumazawa, Shigeru; Matsui, Hiroshi
1980-01-01
The method was discussed for estimating a comparatively rare occurrence of monitoring data much greater than the average in the field of radiation protection. The features of and the mutual relationships among four types of probability distributions, i.e., normal, log-normal, double-exponential and log-double-exponential, were presented, and their application to various monitoring data of radiation protection was shown. For graphical analysis of empirical distributions the followings were concluded: 1. The upper probabilities are considerably affected by the method of calculating the quantiles and the method of logarithmic transformation of a stochastic variable after a fixed value being added to or subtracted from it to obtain the better straight-line fit on the probability paper. 2. A double-exponential distribution provided a good fit to the annual dose maxima, while a log-double-exponential distribution did to the radioactive contamination maxima in a fixed period of time or in a fixed region of space. 3. The monitoring data arranged in the order of their magnitude were expressed by an exponential function of the order for dose data and by a power function of the order for radioactive contamination data. (author)
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Long-term monitoring for closed special sites
International Nuclear Information System (INIS)
Golchert, N.W.; Sedlet, J.
1987-01-01
A methodology is presented for planning and implementing a long-term environmental monitoring program for closed special radioactive waste disposal sites. The steps in the method involve collection of the available background information on the site history, site and area characteristics, waste inventory, pathway analysis, prior monitoring programs, applicable standards, and the legal/regulatory requirements. This information is coupled with factors such as experience, half-life, radionuclide migration rates, and potential hazard to develop a monitoring program. As an example, a site-specific long-term monitoring program is described for the AMAX site using the available information. Sampling techniques and practices for the monitoring program are discussed and techniques and practices expected to be available in the future are considered. 7 references, 2 tables
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International Nuclear Information System (INIS)
Petersen, T.A.; Hilsmeier, T.A.; Kapinus, D.M.
1994-01-01
As availabilities of electric power generating stations systems and components become more and more important from a financial, personnel safety, and regulatory requirements standpoint, it is evident that a comprehensive, yet simple and user-friendly program for system and component tracking and monitoring is needed to assist in effectively managing the large volume of systems and components with their large numbers of associated maintenance/availability records. A user-friendly computer software program for system and component availability monitoring has been developed that calculates, displays and monitors selected component and system availabilities. This is a Windows trademark based (Graphical User Interface) program that utilizes a system flow diagram for the data input screen which also provides a visual representation of availability values and limits for the individual components and associated systems. This program can be customized to the user's plant-specific system and component selections and configurations. As will be discussed herein, this software program is well suited for availability monitoring and ultimately providing valuable information for improving plant performance and reducing operating costs
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Mutual information and the fidelity of response of gene regulatory models
International Nuclear Information System (INIS)
Tabbaa, Omar P; Jayaprakash, C
2014-01-01
We investigate cellular response to extracellular signals by using information theory techniques motivated by recent experiments. We present results for the steady state of the following gene regulatory models found in both prokaryotic and eukaryotic cells: a linear transcription-translation model and a positive or negative auto-regulatory model. We calculate both the information capacity and the mutual information exactly for simple models and approximately for the full model. We find that (1) small changes in mutual information can lead to potentially important changes in cellular response and (2) there are diminishing returns in the fidelity of response as the mutual information increases. We calculate the information capacity using Gillespie simulations of a model for the TNF-α-NF-κ B network and find good agreement with the measured value for an experimental realization of this network. Our results provide a quantitative understanding of the differences in cellular response when comparing experimentally measured mutual information values of different gene regulatory models. Our calculations demonstrate that Gillespie simulations can be used to compute the mutual information of more complex gene regulatory models, providing a potentially useful tool in synthetic biology. (paper)
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International Nuclear Information System (INIS)
Bossio, M.C.; Muniz, C.C.
2009-01-01
This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document 'Safety Reports Series Nr 44' of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (author)
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International Nuclear Information System (INIS)
Bossio, M.C.; Muniz, C.C.
2010-01-01
This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on the one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document Safety Reports Series 44 of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (authors) [es
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Regulatory control and management of radioactive materials in the Philippines
International Nuclear Information System (INIS)
Borras, A.M.; Parami, V.K.; Domondon, D.B.
2001-01-01
The Philippine Nuclear Research Institute (PNRI) by virtue of Republic Act 2067, as amended, Republic Act 5207 and Executive Order 128 (1987), was mandated to promote, advance and regulate the safe and peaceful applications of nuclear science and technology in the Philippines. The PNRI was formerly the Philippine Atomic Energy Commission, established in 1958. This report aims to share the information and experience of PNRI as a regulatory authority on the administrative, technical and managerial aspects to ensure the safety and security of radioactive material in the country. It describes the country's regulatory framework, operational experiences, international co-operation including reporting system and database, and radiological safety assessment and compliance monitoring. It also briefly discusses the current development of the country's radiological emergency response plan and the radiation protection services offered by the PNRI. In the discussion and recommendations, some of the results of the regulatory information conferences conducted with the end-users are enumerated. (author)
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Prognostic value of monitoring tumour markers CA 15-3 and CEA during fulvestrant treatment
Directory of Open Access Journals (Sweden)
Locker Gottfried J
2006-03-01
Full Text Available Abstract Background At many centres tumour markers are used to detect disease recurrence and to monitor response to therapy in patients with advanced disease, although the real value of serial observation of marker levels remains disputed. In this study, we evaluated the prognostic value of tumour markers for predicting response (partial response [PR], stable disease [SD] ≥ 6 months, de novo disease progression (PD and secondary PD in patients receiving fulvestrant ('Faslodex' 250 mg/month for the treatment of metastatic breast cancer (MBC. Methods Changes in cancer antigen 15–3 (CA 15-3 and carcinoembryonic antigen (CEA were prospectively monitored (monthly and were also evaluated for the 3 months preceding secondary PD. Data from 67 patients with previously treated MBC participating in a Compassionate Use Programme were analysed. Results In patients with a PR (n = 7 [10.4%], a non-significant increase in CA 15-3 occurred during the first 6 months of treatment; CEA was significantly reduced (P = 0.0165. In patients with SD ≥ 6 months (n = 28 [41.8%], both CA 15-3 (P P = 0.0399 levels increased significantly after 6 months treatment. In those experiencing de novo PD (n = 32 [47.8%], CA 15-3 increased significantly (P P = 0.0002 during the same time period. Both CA 15-3 (P P Conclusion CA 15-3 increases in patients progressing on fulvestrant but may also increase in those experiencing clinical benefit; this should not be taken as a sign of PD without verification. Overall, both CA 15-3 and CEA appear to be poor prognostic markers for determining progression in patients receiving fulvestrant.
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Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M
2017-03-15
Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.
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Use of new scientific developments in regulatory risk assessments: challenges and opportunities.
Tarazona, Jose V
2013-07-01
Since the 1990s, science based ecological risk assessments constitute an essential tool for supporting decision making in the regulatory context. Using the European REACH Regulation as example, this article presents the challenges and opportunities for new scientific developments within the area of chemical control and environmental protection. These challenges can be sorted out in 3 main related topics (sets). In the short term, the challenges are directly associated with the regulatory requirements, required for facilitating a scientifically sound implementation of the different obligations for industry and authorities. It is important to mention that although the actual tools are different due to the regulatory requirements, the basic needs are still the same as those addressed in the early 1990s: understanding the ecological relevance of the predicted effects, including the uncertainty, and facilitating the link with the socio-economic assessment. The second set of challenges covers the opportunities for getting an added value from the regulatory efforts. The information compiled through REACH registration and notification processes is analyzed as source for new integrative developments for assessing the combined chemical risk at the regional level. Finally, the article discusses the challenge of inverting the process and developing risk assessment methods focusing on the receptor, the individual or ecosystem, instead of on the stressor or source. These approaches were limited in the past due to the lack of information, but the identification and dissemination of standard information, including uses, manufacturing sites, physical-chemical, environmental, ecotoxicological, and toxicological properties as well as operational conditions and risk management measures for thousands of chemicals, combined by the knowledge gathered through large scale monitoring programs and spatial information systems is generating new opportunities. The challenge is liking
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Technical Status Report of the Regulatory Assistance Project: October 2001-February 2003
Energy Technology Data Exchange (ETDEWEB)
2003-08-01
This report details the work undertaken from October 2001 to February 2003 by the Regulatory Assistance Project under subcontract to the National Renewable Energy Laboratory. The objectives of this work were to develop regulatory policy options that would reduce the institutional and infrastructure barriers to full-value deployment of distributed power systems. Specific tasks included leading technical workshops on removing or overcoming regulatory barriers to distributed resources for state utility regulators and developing a draft model rule on emission performance standards for distributed generation.
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Environmental Monitoring Plan - February 2016
Energy Technology Data Exchange (ETDEWEB)
Gallegos, G. M. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Bertoldo, N. A. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Blake, R. G. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Fish, C. B. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Grayson, A. R. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Griffin, D. M. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Jones, H. E. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Patterson, L. E. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Revelli, M. A. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Rosene, C. A. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Wegrecki, T M; Williams, R A; Wilson, K R
2016-02-08
The purpose of environmental monitoring is to promote the early identification of, and response to, potential adverse environmental impacts associated with Lawrence Livermore National Laboratory (LLNL) operations. Environmental monitoring supports the Integrated Safety Management System (ISMS), International Organization for Standardization (ISO) 14001 Environmental Management Systems standard, and U. S. Department of Energy (DOE) Order 458.1, Radiation Protection oft/ic Pubile and the Environment. Specifically, environmental monitoring enables LLNL to detect, characterize, and respond to releases from LLNL activities; assess impacts; estimate dispersal patterns in the environment; characterize the pathways of exposure to members of the public; characterize the exposures and doses to individuals and to the population; and to evaluate the potential impacts to the hiota in the vicinity of LLNL. Environmental monitoring is also a major component of compliance demonstration for permits and other regulatory requirements.
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Statistical significance of cis-regulatory modules
Directory of Open Access Journals (Sweden)
Smith Andrew D
2007-01-01
Full Text Available Abstract Background It is becoming increasingly important for researchers to be able to scan through large genomic regions for transcription factor binding sites or clusters of binding sites forming cis-regulatory modules. Correspondingly, there has been a push to develop algorithms for the rapid detection and assessment of cis-regulatory modules. While various algorithms for this purpose have been introduced, most are not well suited for rapid, genome scale scanning. Results We introduce methods designed for the detection and statistical evaluation of cis-regulatory modules, modeled as either clusters of individual binding sites or as combinations of sites with constrained organization. In order to determine the statistical significance of module sites, we first need a method to determine the statistical significance of single transcription factor binding site matches. We introduce a straightforward method of estimating the statistical significance of single site matches using a database of known promoters to produce data structures that can be used to estimate p-values for binding site matches. We next introduce a technique to calculate the statistical significance of the arrangement of binding sites within a module using a max-gap model. If the module scanned for has defined organizational parameters, the probability of the module is corrected to account for organizational constraints. The statistical significance of single site matches and the architecture of sites within the module can be combined to provide an overall estimation of statistical significance of cis-regulatory module sites. Conclusion The methods introduced in this paper allow for the detection and statistical evaluation of single transcription factor binding sites and cis-regulatory modules. The features described are implemented in the Search Tool for Occurrences of Regulatory Motifs (STORM and MODSTORM software.
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Directory of Open Access Journals (Sweden)
Yuniey Quiala Armenteros
2016-10-01
Full Text Available The Cuban Environmental Regulatory Activity has on the Environmental State Inspection an instrument for control and monitoring of compliance of current legal standards regarding environmental protection and rational use of natural resources. In this research, a design methodology for effective implementation of environmental regulatory activity in Cuba directed to processes is proposed; based on the life cycle assessment and the applicable environmental management standards, including new performance indicators, which form a new tool based on scientific criterions for the Center of Environmental Inspection and Control.
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A saturation screen for cis-acting regulatory DNA in the Hox genes of Ciona intestinalis
Energy Technology Data Exchange (ETDEWEB)
Keys, David N.; Lee, Byung-in; Di Gregorio, Anna; Harafuji, Naoe; Detter, Chris; Wang, Mei; Kahsai, Orsalem; Ahn, Sylvia; Arellano, Andre; Zhang, Quin; Trong, Stephan; Doyle, Sharon A.; Satoh, Noriyuki; Satou, Yutaka; Saiga, Hidetoshi; Christian, Allen; Rokhsar, Dan; Hawkins, Trevor L.; Levine, Mike; Richardson, Paul
2005-01-05
A screen for the systematic identification of cis-regulatory elements within large (>100 kb) genomic domains containing Hox genes was performed by using the basal chordate Ciona intestinalis. Randomly generated DNA fragments from bacterial artificial chromosomes containing two clusters of Hox genes were inserted into a vector upstream of a minimal promoter and lacZ reporter gene. A total of 222 resultant fusion genes were separately electroporated into fertilized eggs, and their regulatory activities were monitored in larvae. In sum, 21 separable cis-regulatory elements were found. These include eight Hox linked domains that drive expression in nested anterior-posterior domains of ectodermally derived tissues. In addition to vertebrate-like CNS regulation, the discovery of cis-regulatory domains that drive epidermal transcription suggests that C. intestinalis has arthropod-like Hox patterning in the epidermis.
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SELF-REGULATORY ABILITIES IN PROFESSIONAL ACTIVITY
Directory of Open Access Journals (Sweden)
G V Ozhiganova
2016-12-01
Full Text Available The self-regulation is considered by the author as a general ability of the person. The levels of self-regulation relating to any professional activity, and corresponding to these levels self-regulatory capacities are distinguished: 1 psychophysiological - the ability for self-regulation of emotional and psycho- physiological states; 2 socio-psychological - the ability for self-regulation in the process of social interaction; 3 psychological (the ability to regulate activities; the capacity for personal self-control;spiritual - the highest capacity for self-regulation due to the higher values and meanings of existence. Self-regulation at the highest spiritual level is considered in this research in connection with the actualization of higher self-regulatory capacities, leading to self-realization of the person including professional activity. Processes, levels, components of self-regulation, associated with different conditions of professional activities (for example, in extreme situations, as well as with different types of professions (teachers, sales managers, etc. are described. A particular attention is given to self- regulation in the teaching activities: levels, techniques of teachers’ self-regulatory skills are presented; the importance of teachers’ personal self-regulation is emphasized, because it determines self-development, self-improvement and self-fulfillment in their chosen profession, and is associated with the manifestation of higher self-regulatory capacities. It is noted that in the process of professional activities different levels and types of self-regulation are demanded. The self-regulation in professional activities is carried out due to various self-regulatory capabilities - from simple to complex, including the highest.
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The effect of default values in regulation matters
International Nuclear Information System (INIS)
Jang, Seung-cheol; Jung, Won-dea; Ha, Jae-joo; Jin, Young-ho
1998-01-01
Both performing and validating a detailed risk analysis of a complex system are costly and time-consuming undertakings. With the increased use of probabilistic risk analysis (PRA) in regulatory decision making, both PRA practitioners (usually, licensees) and regulators have generally favored the use of defaults because they can greatly facilitate the process of performing a PRA in the first place as well as the process of reviewing and verifying the PRA. The use of defaults can also ensure more uniform standards of PRA quality. However, different regulatory agencies differ in their approaches to the use of default values, and the implications of these differences are not yet widely understood. Moreover, large heterogeneity among licensees makes it difficult to set suitable defaults. This paper will focus on the effect of default values on estimates of risk. In particular, the following questions will be explored: ''How should defaults be set?''; and ''What are the implications of choosing different default values?'' Some insights on the effects of different levels of conservatism in setting defaults will be provided. This can help decision makers evaluate the levels of safety likely to result from regulatory decisions
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Politically Induced Regulatory Risk and Independent Regulatory Agencies
Strausz, Roland
2015-01-01
Uncertainty in election outcomes generates politically induced regulatory risk. Political parties' risk attitudes towards such risk depend on a fluctuation effect that hurts both parties and an output--expansion effect that benefits at least one party. Notwithstanding the parties' risk attitudes, political parties have incentives to negotiate away all regulatory risk by pre-electoral bargaining. Efficient pre-electoral bargaining outcomes fully eliminate politically induced regulatory risk. P...
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Improved cost-benefit techniques in the US Nuclear Regulatory Commission
Energy Technology Data Exchange (ETDEWEB)
Cronin, F.J.; Nesse, R.J.; Vaeth, M.; Wusterbarth, A.R.; Currie, J.W.
1983-06-01
The major objective of this report is to help the US Nuclear Regulatory Commission (NRC) in its regulatory mission, particularly with respect to improving the use of cost-benefit analysis and the economic evaluation of resources within the NRC. The objectives of this effort are: (1) to identify current and future NRC requirements (e.g., licensing) for valuing nonmarket goods; (2) to identify, highlight, and present the relevant efforts of selected federal agencies, some with over two decades of experience in valuing nonmarket goods, in this area; and (3) to review methods for valuing nonmarket impacts and to provide estimats of their magnitudes. Recently proposed legislation may result in a requirement for not only more sophisticated valuation analyses, but more extensive applications of these techniques to issues of concern to the NRC. This paper is intended to provide the NRC with information to more efficiently meet such requirements.
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77 FR 24228 - Condition Monitoring Techniques for Electric Cables Used in Nuclear Power Plants
2012-04-23
... Used in Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance... guide, (RG) 1.218, ``Condition Monitoring Techniques for Electric Cables Used in Nuclear Power Plants... of electric cables for nuclear power plants. RG 1.218 is not intended to be prescriptive, instead it...
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Calibration of radiation monitors at nuclear power plants
International Nuclear Information System (INIS)
Boudreau, L.; Miller, A.D.; Naughton, M.D.
1994-03-01
This work was performed to provide guidance to the utilities in the primary and secondary calibration of the radiation monitoring systems (RMS) installed in nuclear power plants. These systems are installed in nuclear power plants to monitor ongoing processes, identify changing radiation fields, predict and limit personnel radiation exposures and measure and control discharge of radioactive materials to the environment. RMS are checked and calibrated on a continuing basis to ensure their precision and accuracy. This report discusses various approaches towards primary and secondary calibrations of the RMS equipment in light of accepted practices at typical power plants and recent interpretations of regulatory guidance. Detailed calibration techniques and overall system responses, trends, and practices are discussed. Industry, utility, and regulatory sources were contacted to create an overall consensus of the most reasonable approaches to optimizing the performance of this equipment
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International Nuclear Information System (INIS)
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
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International Nuclear Information System (INIS)
Jovanovic, S.
2007-01-01
Nuclear regulatory competences in the Republic of Montenegro are shared between the ministries of health and of the environment. Following the independence of the country by mid 2006, Radiation Protection Commission (RPC) is established within the Ministry of Health, so as to match the regulatory role for the sources used in medicine. A similar step is expected to be made soon within the Ministry of the Environment, too. The two commissions will likely and logically merge into one, representing an interim regulatory authority to be functioning until a full capacity and effectively independent regulatory body is established by new nuclear law. Promulgation of the latter is expected to take part in the course of 2007. Let us mention here that the law in force is one from 1996 - quite obsolete and not taking into consideration the Basic Safety Standards (IAEA, 1996) and subsequent IAEA and EU documents in the field. Montenegro is a small, non-nuclear country (no nuclear installations or fuel cycle segments), the use of radiation sources being limited mostly to medical and industrial applications. Technical support to regulatory functions, in whatever basic form these were effectuated up to now, was/is given by the Centre for Eco-Toxicological Research of Montenegro (CETI), Department of Radiation Protection and Monitoring, in Podgorica. As to scientific support, it is fundamentally to be found at the University of Montenegro, Faculty of Sciences (FS), Department of Physics. While CETI is relatively well equipped, running quite a modern nuclear spectrometry laboratory (alpha, beta and gamma spectrometry, radon measurements) and having a decent dosimetry unit (TLD, field and workplace monitoring), FS is practically limited to sporadic theoretical studies, with very poor laboratory capabilities. Environmental radioactivity monitoring is performed by CETI, following the programme defined by the government. Licensing and inspections are the two regulatory functions still
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100-N pilot project: Proposed consolidated groundwater monitoring program
International Nuclear Information System (INIS)
Borghese, J.V.; Hartman, M.J.; Lutrell, S.P.; Perkins, C.J.; Zoric, J.P.; Tindall, S.C.
1996-11-01
This report presents a proposed consolidated groundwater monitoring program for the 100-N Pilot Project. This program is the result of a cooperative effort between the Hanford Site contractors who monitor the groundwater beneath the 100-N Area. The consolidation of the groundwater monitoring programs is being proposed to minimize the cost, time, and effort necessary for groundwater monitoring in the 100-N Area, and to coordinate regulatory compliance activities. The integrity of the subprograms requirements remained intact during the consolidation effort. The purpose of this report is to present the proposed consolidated groundwater monitoring program and to summarize the process by which it was determined
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McKee, Heather C; Ntoumanis, Nikos
2014-12-01
We aimed to investigate whether a self-regulatory skills intervention can improve weight loss-related outcomes. Fifty-five participants (M BMI = 32.60 ± 4.86) were randomized into self-regulation training and advice groups and received two training workshops and weekly practice tasks. The self-regulation training group was trained to use six self-regulatory skills: Delayed gratification, thought control, goal setting, self-monitoring, mindfulness, and coping. The advice group received dietary and physical activity advice for weight loss. Physical, self-regulatory, and psychological measures were taken at baseline, end of intervention (week 8) and at follow-up (week 12). Using intention-to-treat analysis, weight, waist circumference, body fat and body mass index (BMI) were significantly reduced at follow-up for both groups. There were significant increases in all six self-regulatory skills and the psychological measures of self-efficacy, self-regulatory success, and physical self-worth for both groups. Results indicate that self-regulatory skills training might be as effective as dietary and physical activity advice in terms of weight loss and related outcomes.
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Operational readiness of filtered air discharge monitoring systems
International Nuclear Information System (INIS)
Lafortune, J.F.; Jamieson, T.J.
1993-08-01
An assessment of the operational readiness of the Filtered Air Discharge (FAD) Stack Monitoring systems, installed in Canadian CANDU nuclear power plants, was performed in this project. Relevant Canadian and foreign standards and regulatory requirements have been reviewed and documentation on FAD stack monitoring system design, operation, testing and maintenance have been assessed to identify likely causes and potential failures of FAD stack monitoring systems and their components under both standby and accident conditions. Recommendations have also been provided in this report for design and performance review guidelines for CANDU stations. A case study of the FAD stack monitoring system at Pickering NGS is also documented in this report
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International Nuclear Information System (INIS)
Sharma, Ranjit; Anoj Kumar; Vikas; Singh, Rajvir; Patra, R.P.; Vikas Kumar; Pradeepkumar, K.S.
2012-01-01
The paper describes about the experience gained during the radiation monitoring of inactive scrap generated at various nuclear facilities. This type surveillance is carried out to prevent the spread of radioactivity in public domain and also as requirement by regulatory authorities. The inspection and certification of scrap material from nuclear facilities is a regulatory requirement to ensure that no radioactive material reaches public domain. This paper describes the methodology and experience in detection of radioactivity at inactive Scrap monitoring facility. Inactive scraps (metallic and non metallic) generated from various nuclear facilities of BARC, Trombay is dispatched to Trombay Village Store (TVS) for temporary storage before auction to the public. The monitoring at the facility includes visual inspection and radiation measurement before loading the scrap in the truck. An online PC based monitoring system and portable monitoring instruments in the range (nSv/h-µSv/h) are used to carry out radiation monitoring of inactive scrap loaded in a vehicle. Radioactive source of high activity with potential for serious environmental hazard has not been detected, but few cases of presence of radioactive/contaminated material (MS plate/equipments with low level of 137 Cs contamination) have been detected and identified using portable gamma spectrometer. Implementation of strict regulatory measures and radiation monitoring at nuclear facilities can minimize the probability of radioactive material reaching the public domain. The methodology followed for monitoring of inactive scrap is found to be effective even for detection of presence of radioactivity in scrap if any. (author)
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Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan.
Wang, Hui-Po; Wang, Chun-Li
2018-04-01
The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication. Copyright © 2018. Published by Elsevier B.V.
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Development of a metrics dashboard for monitoring involvement in the 340B Drug Pricing Program.
Karralli, Rusol; Tipton, Joyce; Dumitru, Doina; Scholz, Lisa; Masilamani, Santhi
2015-09-01
An electronic tool to support hospital organizations in monitoring and addressing financial and compliance challenges related to participation in the 340B Drug Pricing Program is described. In recent years there has been heightened congressional and regulatory scrutiny of the federal 340B program, which provides discounted drug prices on Medicaid-covered drugs to safety net hospitals and other 340B-eligible healthcare organizations, or "covered entities." Historically, the 340B program has lacked a metrics-driven reporting framework to help covered entities capture the value of 340B program involvement, community benefits provided to underserved populations, and costs associated with compliance with 340B eligibility requirements. As part of an initiative by a large health system to optimize its 340B program utilization and regulatory compliance efforts, a team of pharmacists led the development of an electronic dashboard tool to help monitor 340B program activities at the system's 340B-eligible facilities. After soliciting input from an array of internal and external 340B program stakeholders, the team designed the dashboard and associated data-entry tools to facilitate the capture and analysis of 340B program-related data in four domains: cost savings and revenue, program maintenance costs, community benefits, and compliance. A large health system enhanced its ability to evaluate and monitor 340B program-related activities through the use of a dashboard tool capturing key metrics on cost savings achieved, maintenance costs, and other aspects of program involvement. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.
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An extended value-impact approach for nuclear regulatory decision making
International Nuclear Information System (INIS)
Nelson, P.F.; Kastenberg, W.E.
1986-01-01
This paper presents an extended value-impact methodology with aids decision makers in ranking various alternative actions for reducing the risk associated with nuclear power reactors. It extends the state-of-the-art value-impact methodology by using the Analytic Hierarchy Process (AHP), a formalized decision making tool for ranking alternatives based on judgement. The AHP reduces some of the limitations present in current value-impact work, such as the inability to include subjective factors in a structured approach, as well as controversial questions such as the importance of onsite versus offsite accident costs averted, uncertainty, and impact of public opinion. In the paper, the method is applied to include a value-impact study of the implementation of either a vented-containment system or an alternative decay heat removal system as a means for reducing risk at the Grand Gulf nuclear power plant. The results of this analysis show that the method provides considerable insight to the solution of topics of interest in the decision making area of nuclear power risk management. (orig.)
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Effluent and environmental monitoring of Chalk River Laboratories
Energy Technology Data Exchange (ETDEWEB)
Pilgrim, T.; De Waele, C.; Gallagher, C. [Atomic Energy of Canada Limited, Chalk River, ON (Canada)
2014-07-01
Atomic Energy of Canada Limited's (AECL's) Environmental Protection Program has been gathering environmental monitoring data at its Chalk River Laboratories (CRL) for over 60 years. The comprehensive effluent and environmental monitoring program at CRL consists of more than 600 sampling locations, including the Ottawa River, with approximately 60,000 analyses performed on air and liquid effluent parameters each year. Monitoring for a variety of radiological and non-radiological parameters is regularly conducted on various media, including ambient air, foodstuff (e.g. milk, fish, garden produce, large game, and farm animals), groundwater, Ottawa River water and other surface water on and off-site. The purpose of the monitoring program is to verify that past and current radiological and non-radiological emissions derived from AECL operations and activities, such as process water effluent into the Ottawa River, are below regulatory limits and demonstrate that CRL operations do not negatively affect the quality of water on or leaving the site. In fact, ongoing program reports demonstrate that radiological emissions are well below regulatory limits and have been declining for the past five years, and that non-radiological contaminants do not negatively affect the quality of water on and off the site. Two updated Canadian Standards Association (CSA) standards for Effluent and Environmental monitoring have come into effect and have resulted in some changes to the AECL Program. This presentation will discuss effluent and surface water monitoring results, the observed trends, the changes triggered by the CSA standards, and a path forward for the future. (author)
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International Nuclear Information System (INIS)
2009-01-01
With the support of the Norwegian Ministry of Foreign Affairs, the NRPA has initiated a regional regulatory cooperation project with Kazakhstan, Kyrgyzstan and Tajikistan to improve regulations on nuclear safety, radiation protection and environmental issues, and assist the countries in re mediating radioactively contaminated sites. There is a critical lack in the regulatory basis for carrying out such remediation work, including a lack of relevant radiation and environmental safety norms and standards, licensing procedures and requirements for monitoring, as well as expertise to transform such a basis into practice. (Author)
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Development of web monitoring radiation area monitor
International Nuclear Information System (INIS)
Jung, Hoon Jin; Lee, Jun Hee; Namkoong, Phil; Lee, Dong Hoon; Lee, Su Hong; Lee, Gun Bae
2005-01-01
Recently the increasing number of radioisotope industry and nuclear facility have ever raised the possibility of radiation safety accident. As such a result, radioisotope companies and nuclear facility operators have become to be much interested in radiation area monitoring for efficient radiation protection. At present, almost of the radiation area monitors which are imported products are outdated in aspect of their functions. Diversification of the monitoring work is urgently demanding additional functions to be added. Thus we have developed new-type digital area monitor which enables remote web monitoring with image and radiation dose rate value at distant places through using internet, the latest IT technology, and radiation measurement technology
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What Is the Value of Value-Based Purchasing?
Tanenbaum, Sandra J
2016-10-01
Value-based purchasing (VBP) is a widely favored strategy for improving the US health care system. The meaning of value that predominates in VBP schemes is (1) conformance to selected process and/or outcome metrics, and sometimes (2) such conformance at the lowest possible cost. In other words, VBP schemes choose some number of "quality indicators" and financially incent providers to meet them (and not others). Process measures are usually based on clinical science that cannot determine the effects of a process on individual patients or patients with comorbidities, and do not necessarily measure effects that patients value; additionally, there is no provision for different patients valuing different things. Proximate outcome measures may or may not predict distal ones, and the more distal the outcome, the less reliably it can be attributed to health care. Outcome measures may be quite rudimentary, such as mortality rates, or highly contestable: survival or function after prostate surgery? When cost is an element of value-based purchasing, it is the cost to the value-based payer and not to other payers or patients' families. The greatest value of value-based purchasing may not be to patients or even payers, but to policy makers seeking a morally justifiable alternative to politically contested regulatory policies. Copyright © 2016 by Duke University Press.
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Using the IRRS to Strengthen Regulatory Competence in Ireland
International Nuclear Information System (INIS)
Smith, K.
2016-01-01
In 2015, Ireland underwent an IRRS (Integrated Regulatory Review Service) review mission. The purpose of the mission was to review Ireland’s radiation and nuclear safety regulatory framework and activities against the relevant IAEA safety standards, to report on the regulatory effectiveness and to exchange information and experience in the areas covered by the IRRS. The review mission was well-timed as there had been recent changes in the regulatory infrastructure with the merger of the Radiological Protection Institute of Ireland (RPII) and the Environmental Protection Agency (EPA) in 2014, as well as the upcoming implementation of the new Euratom Basic Safety Standards (BSS) Directive. The key objectives of the mission were to enhance the national legal, governmental and regulatory framework for nuclear and radiation safety, and national arrangements for emergency preparedness and response. The agreed scope of the review covered all relevant facilities and activities regulated in Ireland and also included medical exposures and public exposure to radon. In advance of the mission, Ireland completed a process of self-assessment and review. This process identified strengths and weaknesses in the national regulatory framework compared with the international standards. In addition to the value of having Ireland’s radiation protection framework peer reviewed by senior international experts, the mission helped to further strengthen links between all the national bodies (government, licensees, regulatory) with a role in the regulation of radiation safety. The findings from the IRRS review team’s objective evaluation of Ireland’s regulatory infrastructure are being used to prioritise actions for strengthening the regulatory framework, to provide input into the transposition of the Euratom BSS, and to support the revision of the national emergency plan for nuclear accidents. It is planned to have addressed the findings of the IRRS mission in advance of a follow up
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Use of process monitoring data to enhance material accounting
International Nuclear Information System (INIS)
Brouns, R.J.; Smith, B.W.
1980-01-01
A study was conducted for the Nuclear Regulatory Commission as part of a continuing program to estimate the effectiveness of using process monitoring data to enhance special nuclear material accounting in nuclear facilities. Two licensed fuel fabrication facilities with internal scrap recovery processes were examined. The loss detection sensitivity, timeliness, and localization capabilities of the process monitoring technique were evaluated for single and multiple (trickle) losses. 4 refs
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The interplay between societal concerns and the regulatory frame on GM crops in the European Union.
Devos, Yann; Reheul, Dirk; De Waele, Danny; Van Speybroeck, Linda
2006-01-01
Recapitulating how genetic modification technology and its agro-food products aroused strong societal opposition in the European Union, this paper demonstrates how this opposition contributed to shape the European regulatory frame on GM crops. More specifically, it describes how this opposition contributed to a de facto moratorium on the commercialization of new GM crop events in the end of the nineties. From this period onwards, the regulatory frame has been continuously revised in order to slow down further erosion of public and market confidence. Various scientific and technical reforms were made to meet societal concerns relating to the safety of GM crops. In this context, the precautionary principle, environmental post-market monitoring and traceability were adopted as ways to cope with scientific uncertainties. Labeling, traceability, co-existence and public information were installed in an attempt to meet the general public request for more information about GM agro-food products, and the specific demand to respect the consumers' and farmers' freedom of choice. Despite these efforts, today, the explicit role of public participation and/or ethical consultation during authorization procedures is at best minimal. Moreover, no legal room was created to progress to an integral sustainability evaluation during market procedures. It remains to be seen whether the recent policy shift towards greater transparency about value judgments, plural viewpoints and scientific uncertainties will be one step forward in integrating ethical concerns more explicitly in risk analysis. As such, the regulatory frame stands open for further interpretation, reflecting in various degrees a continued interplay with societal concerns relating to GM agro-food products. In this regard, both societal concerns and diversely interpreted regulatory criteria can be inferred as signaling a request - and even a quest - to render more explicit the broader-than-scientific dimension of the actual
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Proposed Regulatory Guideline on the PSA Quality for Risk-informed Applications
International Nuclear Information System (INIS)
Lee, Chang Ju; Choi, Jong Soo
2005-01-01
In the policy statement on nuclear safety issued by the Korean government in 1994, the introduction of risk-informed regulations in licensing and regulation of nuclear power plants was emphasized for the first time. It also describes the implementation of comprehensive safety assessment utilizing PSA (probabilistic safety assessment). Since then, because risk-informed environment and fundamentals had not been strong, several R and D on PSA and risk-informed regulation have been done even though their application has been delayed. However, today it is not the case. Since the follow-up policy statement (called Severe Accident Policy) was issued, which prescribes strong items such as PSA implementation and its periodic reassessment, reliability database, and risk monitoring program to the utility, we have a chance to easily get all kinds of risk information for improving current regulatory framework. In addition, with the overall availability of PSA results for all operating nuclear power plants, it is expected that many risk-informed applications (RIAs) will be submitted to the regulatory authority. In general, there are a lot of regulatory concerns associated with the quality assurance of licensee's submittals for RIA. It is also noted that making general requirements and touching specific check points are essential for the regulatory decision making process. This paper summarizes the structure and contents of our regulatory guideline for assuring PSA quality
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International Nuclear Information System (INIS)
Chinangwa, Getrude
2016-07-01
Malawi became an IAEA member state in 2006 and developed the Atomic Energy Act and Regulations in 2011 and 2012 respectively. However, regulatory authority and personnel monitoring services have not yet been established. As such, hospitals operating radiological services in Malawi do not have personnel monitoring programme. This study aimed at developing the personnel radiation monitoring program for three hospitals in Malawi namely; Kamuzu Central Hospital, Bwaila Hospital, and Mtengo wa Nthenga Hospital. A radiation protection questionnaire was administered to the X-ray Departments involved in the study to investigate radiation protection practices in the hospitals. Dose rate measurements in the facilities were taken using survey meters and doses to individuals were recorded using personal dosimeters. The results showed that the hospitals lack radiation protection program which covers the critical issues of quality assurance and control as well as the personnel dose monitoring. Average ambient dose rate values were 0.39 μSv/hr for Mtengo wa Nthenga Hospital, 5.03 μSv/hr for Bwaila Hospital and 4μSv/hr for Kamuzu Central Hospital. Average monthly dose for workers was 0.247 mSv. The study recommends the establishment of a regulatory authority, consistent dose assessment, quality control tests and structural shielding assessment in these and probably all the diagnostic facilities in Malawi. The personnel monitoring programme developed from this study is intended to guide diagnostic facilities and personnel monitoring service providers in Malawi in tracking and reporting exposure record for their occupationally exposed workers. (au)
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Strengthening Regulatory Competence in a Changing Nuclear Regulatory Environment
International Nuclear Information System (INIS)
Illizastigui, P.F.
2016-01-01
The paper addresses the approach followed by the Cuban National Center for Nuclear Safety for the management of current and new competences of its regulatory staff with the aim of allowing those staff to effectively fulfill their core regulatory functions. The approach is realized through an Integrated System for Competence Building, which is based on the IAEA recommendations, shown to be effective in ensuring the necessary competence in the relevant areas. In the author’s opinion, competence of the regulatory staff in the area of human and organizational factors is of paramount importance and needs to be further strengthened in order to be able to assess safety performance at the facilities and detect early signs of deteriorating safety performance. The former is defined by the author as the core regulatory function “Analysis” which covers the entire spectrum of assessment tasks carried out by the regulatory staff to: a) detect declining safety performance, b) diagnose latent weaknesses (root causes) and c) make effective safety culture interventions. The author suggests that competence associated with the fulfillment of the analysis function is distinctly identified and dealt with separately in the current system of managing regulatory competence. (author)
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DEFF Research Database (Denmark)
Pedersen, Ole Lederballe; Mancia, Giuseppe; Pickering, Thomas
2007-01-01
OBJECTIVE: The ambulatory blood pressure (ABP) monitoring substudy of the Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial was carried out in a subset of patients from USA, Italy and Denmark. ABP was measured after 1 year in the trial, with the aim of evaluating comparability...... of ABP levels on valsartan (VAL) and amlodipine (AML)-based regimens. METHODS: ABP was measured every 20 min during a 25-h period after morning administration of medicine; 659 patients were available for intention-to-treat analysis. RESULTS: Office blood pressure (BP) differences were smaller than...
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Data Acquisition for Low-Temperature Geothermal Well Tests and Long-Term Monitoring
Energy Technology Data Exchange (ETDEWEB)
Lienau, P J
1992-03-01
Groundwater monitoring is an essential part of the development of a low-temperature geothermal field for production and injection wells. State water resource and environmental departments are requiring both geothermal well testing and long-term monitoring as a part of the permitting process for geothermal developments. This report covers water-level measurement methods, instruments used for well testing, geochemical sampling, examples of data acquisition and regulatory mandates on groundwater monitoring.
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Data acquisition for low-temperature geothermal well tests and long-term monitoring
Energy Technology Data Exchange (ETDEWEB)
Lienau, P.J.
1992-09-01
Groundwater monitoring is an essential part of the development of a low-temperature geothermal field for production and injection wells. State water resource and environmental departments are requiring both geothermal well testing and long-term monitoring as a part of the permitting process for geothermal developments. This report covers water-level measurement methods, instruments used for well testing, geochemical sampling, examples of data acquisition and regulatory mandates on groundwater monitoring.
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Analysis of NRC Regulatory Guide 1.21 Revision 2
Energy Technology Data Exchange (ETDEWEB)
Kim, Sung Il; Yook, Dae Sik; Lee, Byung Soo [KINS, Daejeon (Korea, Republic of)
2015-05-15
It is essential to have a degree of uniformity in the methods used for measuring, evaluating, recording, and reporting data on radioactive material in effluents and solid wastes. For this purpose, the U.S. Nuclear Regulatory Commission (NRC) released a revised version of the Regulatory Guide 1.21 'Measuring, evaluating, and reporting radioactive material in liquid and gaseous effluents and solid waste' (revision 2) in 2009, updating the revision 1 version released in 1974. This study compares the previous revision 1 (1974) version with the revision 2 (2009) version to elaborate on the application of the guidelines to Korea. This study consists of an analysis of the 2009 Revision 2 version of the U.S. NRC Regulatory Guidelines 1.21 and an exposition of methods for its application in the domestic environment. Major revisions were made to allow for the adoption of a risk informed approach. Radionuclides with lower than 1% contribution to emission or radiation levels can be selected as principal radionuclides. Requirements for analysis of leaks and spills have been reinforced, with additional groundwater monitoring and hydrological data analysis becoming necessary.
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Environmental and Source Monitoring for Purposes of Radiation Protection. Safety Guide (Spanish ed.)
International Nuclear Information System (INIS)
2010-01-01
The purpose of this Safety Guide is to provide international guidance, coherent with contemporary radiation protection principles and IAEA safety requirements, on the strategy of monitoring in relation to: (a) control of radionuclide discharges under practice conditions, and (b) intervention, such as in cases of nuclear or radiological emergencies or past contamination of areas with long lived radionuclides. Three categories of monitoring are discussed: monitoring at the source of the discharge (source monitoring), monitoring in the environment (environmental monitoring) and monitoring of individual exposure in emergencies (individual monitoring). The Safety Guide also provides general guidance on assessment of the doses to critical groups of the population due to the presence of radioactive materials or radiation fields in the environment both from routine operation of nuclear and other related facilities (practice) and from nuclear or radiological emergencies and past contamination of areas with long lived radionuclides (intervention). The dose assessments are based on the results of source monitoring, environmental monitoring, individual monitoring or their combinations. This Safety Guide is primarily intended for use by national regulatory bodies and other agencies involved in national systems of radiation monitoring, as well as by operators of nuclear installations and other facilities where natural or human made radionuclides are treated and monitored. Contents: 1. Introduction; 2. Meeting regulatory requirements for monitoring in practices and interventions; 3. Responsibilities for monitoring; 4. Generic aspects of monitoring programmes; 5. Programmes for monitoring in practices and interventions; 6. Technical conditions for monitoring procedures; 7. Considerations in dose assessment; 8. Interpretation of monitoring results; 9. Quality assurance; 10. Recording of results; 11. Education and training; Glossary.
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Regulatory networks, legal federalism, and multi-level regulatory systems
Kerber, Wolfgang; Wendel, Julia
2016-01-01
Transnational regulatory networks play important roles in multi-level regulatory regimes, as e.g, the European Union. In this paper we analyze the role of regulatory networks from the perspective of the economic theory of legal federalism. Often sophisticated intermediate institutional solutions between pure centralisation and pure decentralisation can help to solve complex tradeoff problems between the benefits and problems of centralised and decentralised solutions. Drawing upon the insight...
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Olsen, Rasmus; Bihlet, Asger Reinstrup; Kalakou, Faidra; Andersen, Jeppe Ragnar
2016-04-01
Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety data, data integrity, and monitoring cost. The literature search was performed by keyword searches in MEDLINE and hand search of key journals. All publications were reviewed for details on how a monitoring approach impacted subject safety data, data integrity, or monitoring costs. Twenty-two publications were identified. Three publications showed that SDV has some value for detection of not initially reported adverse events and centralized statistical monitoring (CSM) captures atypical trends. Fourteen publications showed little objective evidence of improved data integrity with traditional monitoring such as 100 % SDV and sponsor queries as compared to reduced SDV, CSM, and remote monitoring. Eight publications proposed a potential for significant cost reductions of monitoring by reducing SDV without compromising the validity of the trial results. One hundred percent SDV is not a rational method of ensuring data integrity and subject safety based on the high cost, and this literature review indicates that reduced SDV is a viable monitoring method. Alternative methods of monitoring such as centralized monitoring utilizing statistical tests are promising alternatives but have limitations as stand-alone tools. Reduced SDV combined with a centralized, risk-based approach may be the ideal solution to reduce monitoring costs while improving essential data quality.
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Kim, Dong Wook; Sunwoo, Jun-Sang; Lee, Sang Kun
2016-10-01
Vertigo and dizziness are common neurological complaints that have long been associated with epilepsy. However, studies of patients with epileptic vertigo or dizziness with concurrent EEG monitoring are scarce. We performed the present study to investigate the incidence and localizing value of vertigo and dizziness in patients with epilepsy who had confirmation of EEG changes via video-EEG monitoring. Data of aura and clinical seizure episodes of 831 consecutive patients who underwent video-EEG monitoring were analyzed retrospectively. Out of 831 patients, 40 patients (4.8%) experienced vertigo or dizziness as aura (mean age, 32.8±11.8years), all of whom had partial seizures. Eight had mesial temporal, 20 had lateral temporal, four had frontal, one had parietal, and seven had occipital lobe onset seizures. An intracranial EEG with cortical stimulation study was performed in seven patients, and the area of stimulation-induced vertigo or dizziness coincided with the ictal onset area in only one patient. Our study showed that vertigo or dizziness is a common aura in patients with epilepsy, and that the temporal lobe is the most frequent ictal onset area in these patients. However, it can be suggested that the symptomatogenic area in patients with epileptic vertigo and dizziness may not coincide with the ictal onset area. Copyright © 2016 Elsevier B.V. All rights reserved.
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Directory of Open Access Journals (Sweden)
Yi JIN
2016-06-01
Full Text Available Objective To compare the diagnostic value of using 24-hour combined esophageal multichannel intraluminal impedance and pH monitoring (MII-pH in the diagnosis of gastro-esophageal reflux (GER and pH monitoring alone in critically ill patients. Methods A prospective observational study was performed including 116 critically ill adult patients admitted to ICU of Peking Haidian Hospital from Jul. 2013 to Dec. 2014. All the patients underwent 24-hour combined MⅡ-pH monitoring. GER episodes were recorded and its pH was recorded (acidic, weakly acidic and weakly alkaline and its composition was recorded (liquid, mixed and gas reflux. The results of the MⅡ-pH and the pH were monitored and compared. The demographic characteristics and clinical information were recorded. Results MⅡ-pH was monitored for 5024 episodes of GER in 115 of 116(99.1% patients, with a mean of 43.28±3.96 episodes per patient (median, 34 episodes; range, 0-196 episodes. The pH monitoring detected 1868 episodes (100% acid in only 54 of 116(46.6% patients, with a mean of 7.66±1.65 episodes per patient (median, 0 episodes; range, 0-81 episodes. The number of episode of all reflux and liquid reflux diagnosed by pH monitoring alone was less than those diagnosed by MⅡ-pH monitoring (P=0.000, and there was no correlation in the episodes number of all reflux and liquid reflux between the two techniques (r=0.119, 0.231. Only a moderate correlation was found in the number of episodes of acidic reflux between the two techniques (r=0.656. Conclusion MⅡ-pH monitoring is more sensitive than pH monitoring alone for establishing the diagnosis of GER. DOI: 10.11855/j.issn.0577-7402.2016.05.12
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2010-01-01
... external and internal occupational dose. Each licensee shall monitor exposures to radiation and radioactive... 10 Energy 1 2010-01-01 2010-01-01 false Conditions requiring individual monitoring of external and internal occupational dose. 20.1502 Section 20.1502 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR...
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Information system of partial monitoring system 'Radioactivity of the environment'
International Nuclear Information System (INIS)
Melicherova, T.
2007-01-01
Slovak Hydrometeorological Institute (SHMI) is operator of radiation monitoring from 1963. At present SHMI operates in its monitoring network 23 detectors GammaTracer fy Genitron, one mobile detector and one standby detector. Radiation data (dose rate in the unit nSv/h) from detectors in the automated meteorological stations are transmitted by data-logger and private institute network to National Telecommunication Centre in Bratislava. The data from MSS (message switch system) are inserted into the database. The 1 hours and 24 hours averages are computed on the server automatically. Delay between time of measurements and time of inserting data to database is only 10 min. Radiation files from SHMI network are on-line transmitted to information system of Nuclear Regulatory Authority of the Slovak Republic and to information system of Slovak Army. Transmission to to Crisis Centre of Civil Protection is under reconstruction at present. Database contains one table for radiation data and several tables for configurations, catalogues of stations and additional tables. Database works in environment client-server. On client PC runs the user front-end application. This application provides to display the data using many filters, to display tables with configurations concerning technical equipment, to display maps, graphs, etc. There is the possibility to store data into the archives, to make reports and to analyse data in the environment of professional statistical software. Precipitations values from meteorological stations were integrated do the information system of radiation monitoring for better interpretation of gamma dose rate values. SHMI cooperates in the radiation data exchange with European Commission Joint Research Centre in Ispra, Radiation Warning Centre in Vienna and Meteoservice Budapest. (author)
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Environmental radiation monitoring technology: Capabilities and needs
International Nuclear Information System (INIS)
Hofstetter, K.J.
1994-01-01
Radiation monitoring in the Savannah River Site (SRS) environment is conducted by a combination of automated, remote sampling and/or analysis systems, and manual sampling operations. This program provides early detection of radionuclide releases, minimizes the consequences, and assesses the impact on the public. Instrumentation installed at the release points monitor the atmospheric and aqueous releases from SRS operations. Ground water and air monitoring stations are strategically located throughout the site for radionuclide migration studies. The environmental radiological monitoring program at SRS includes: fixed monitoring stations for atmospheric radionuclide concentrations, aqueous monitors for surface water measurements, mobile laboratory operations for real-time, in-field measurements, aerial scanning for wide area contamination surveillance, and hand-held instruments for radionuclide-specific measurements. Rigorous environmentnal sampling surveillance coupled with laboratory analyses provide confirmatory results for all in-field measurements. Gaps in the technologies and development projects at SRS to fill these deficiencies are discussed in the context of customer needs and regulatory requirements
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REMIT, Radiation Exposure Monitoring and Information Transmittal System
International Nuclear Information System (INIS)
Cale, R.; Clark, T.; Dixson, P.; Hagemeyer, D.; Hardwick, C.; Pippen, H.
1997-01-01
1 - Description of program or function: The Radiation Exposure Monitoring and Information Transmittal (REMIT) system is designed to assist U.S. Nuclear Regulatory Commission (NRC) licensees in meeting the reporting requirements of the Revised 10 CFR Part 20 and in agreement with the guidance contained in Regulatory Guide 8.7, Rev.1, Instructions for Recording and Reporting Occupational Exposure Data. REMIT is a personal computer (PC) -based menu driven system that facilitates the manipulation of data base files to record and report radiation exposure information. REMIT is designed to be user-friendly and contains the full text of Regulatory Guide 8.7, Rev.1, on-line as well as context-sensitive help throughout the program. The user can enter data directly from NRC Form 5s or Form 4s. REMIT allows the user to view the individual's exposure in relation to regulatory or administrative limits and will alert the user to exposures in excess of these limits. The system also provides for the calculation and summation of dose from intakes and the determination of the dose to the maximally exposed extremity for the monitoring year. REMIT can produce NRC Form 5s and 4s in paper and electronic format and can import/export data from ASCII and data base files. 2 - Method of solution: REMIT makes use of the dose conversion factors from EPA Report 11 Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submission, and Ingestion, to calculate the Committed Dose Equivalent to the maximally exposed organ and the committed Effective Dose Equivalent from intakes measured in micro-curies. REMIT also estimates the amount (in micrograms) of uranium intake from the activity entered in micro-curies. This calculation is based on the specific activities of the uranium isotopes. 3 - Restrictions on the complexity of the problem: REMIT is a single- user system that only runs on IBM compatible PC systems under DOS and supports only Hewlett
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Safety culture as a matter of regulatory control and regulatory effectiveness
International Nuclear Information System (INIS)
Camargo, C.T.M.; Furieri, E.B.; Arrieta, L.A.I.; Almeida, C.U.C.
2002-01-01
More than 15 years have passed since the term 'safety culture' was introduced by the International Nuclear Safety Advisory Group (INSAG), and although the concept now is widely accepted, practical applications and characteristics have been disseminated mainly for nuclear power plant operating organizations. There is still a lack of international guidance on the use of safety culture as a regulatory matter and on the application of the concept within regulatory organizations. This work explores the meaning of safety culture in two different fields: as an element of safety management systems it shall be a matter of regulatory control; as a complementary tool for quality management it should be used to enhance regulatory effectiveness. Brazilian recent experience on regulating nuclear power reactors provide some examples on how the concept of safety culture may influence regulatory strategies and regulatory management. (author)
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International Nuclear Information System (INIS)
Cacossa, K.F.; Campbell, G.E.; Devine, K.
1995-01-01
Soil vapor extraction (SVE) is frequently used to remediate soils impacted by petroleum hydrocarbons. Four technologies have proven to be viable methods to control the off-gas emissions from SVE systems, namely, internal combustion, thermal oxidation, catalytic oxidation, and granular activated carbon adsorption. The optimal range of influent vapor concentrations for system operation differs for each of the technologies. Over the past several years the authors have worked proactively with the state regulatory community to develop general, all inclusive air pollution control permits which allow for the potential use of all four technologies over the life of the permit. Private industry has similarly worked with the state regulators to develop a less labor intensive sampling/monitoring procedure. Actual system performances, which were monitored using summa canisters and field equipment, provided the basis for the new procedure. System performance data indicated that field sampling with portable hydrocarbon analyzers, such as flame ionization detectors (FID), was preferable over the use of summa canister sampling. In addition, to reduce the costs associated with the analysis of samples, the new SVE monitoring protocol also reduced the number of system monitoring visits. These reductions equated into a cost effective, yet environmentally sound SVE system monitoring programs. Finally, the authors have worked with the regulatory community to establish permit limitations which allow operational flexibility
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International Nuclear Information System (INIS)
McConnell, Keith I.; Camper, Larry
2012-01-01
Document available in abstract form only. Full text of publication follows: The history of decommissioning activities in the United States has demonstrated the value of a mature, stable and transparent regulatory framework in facilitating the timely completion of environmental remediation. Two examples are given as case studies. The first example relates to the history of uranium concentrate (yellowcake) production in the U.S. to support the initial development of civilian nuclear power in the U.S. in the 1950's, 60's, 70's and 80's. This yellowcake production, which took place mostly in the western U.S., was undertaken before laws and regulations to prevent contamination and protect public health and safety were fully developed. Significant contamination occurred in terms of both surface and ground water contamination. Although most conventional mills producing uranium during these early years entered decommissioning in the 70's and 80's, the vast majority are still remediating their sites because of persistent contamination in ground water. Had an effective regulatory framework been in place, much of this contamination would have been prevented and remediation accomplished more effectively. In contrast to this experience, a second example is provided related to development of the regulatory framework for decommissioning of non-uranium recovery facilities in the U.S. in the late 1990's and early 2000's
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Hyle, Emily P; Jani, Ilesh V; Rosettie, Katherine L; Wood, Robin; Osher, Benjamin; Resch, Stephen; Pei, Pamela P; Maggiore, Paolo; Freedberg, Kenneth A; Peter, Trevor; Parker, Robert A; Walensky, Rochelle P
2017-09-24
To examine the clinical and economic value of point-of-care CD4 (POC-CD4) or viral load monitoring compared with current practices in Mozambique, a country representative of the diverse resource limitations encountered by HIV treatment programs in sub-Saharan Africa. We use the Cost-Effectiveness of Preventing AIDS Complications-International model to examine the clinical impact, cost (2014 US$), and incremental cost-effectiveness ratio [$/year of life saved (YLS)] of ART monitoring strategies in Mozambique. We compare: monitoring for clinical disease progression [clinical ART monitoring strategy (CLIN)] vs. annual POC-CD4 in rural settings without laboratory services and biannual laboratory CD4 (LAB-CD4), biannual POC-CD4, and annual viral load in urban settings with laboratory services. We examine the impact of a range of values in sensitivity analyses, using Mozambique's 2014 per capita gross domestic product ($620) as a benchmark cost-effectiveness threshold. In rural settings, annual POC-CD4 compared to CLIN improves life expectancy by 2.8 years, reduces time on failed ART by 0.6 years, and yields an incremental cost-effectiveness ratio of $480/YLS. In urban settings, biannual POC-CD4 is more expensive and less effective than viral load. Compared to biannual LAB-CD4, viral load improves life expectancy by 0.6 years, reduces time on failed ART by 1.0 year, and is cost-effective ($440/YLS). In rural settings, annual POC-CD4 improves clinical outcomes and is cost-effective compared to CLIN. In urban settings, viral load has the greatest clinical benefit and is cost-effective compared to biannual POC-CD4 or LAB-CD4. Tailoring ART monitoring strategies to specific settings with different available resources can improve clinical outcomes while remaining economically efficient.
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The regulatory function of self-esteem: testing the epistemic and acceptance signaling systems.
Stinson, Danu Anthony; Logel, Christine; Holmes, John G; Wood, Joanne V; Forest, Amanda L; Gaucher, Danielle; Fitzsimons, Grainné M; Kath, Jennifer
2010-12-01
The authors draw on sociometer theory (e.g., Leary, 2004) and self-verification theory (e.g., Swann, 1997) to propose an expanded model of the regulatory function of self-esteem. The model suggests that people not only possess an acceptance signaling system that indicates whether relational value is high or low but also possess an epistemic signaling system that indicates whether social feedback is consistent or inconsistent with chronic perceived relational value (i.e., global self-esteem). One correlational study and 5 experiments, with diverse operationalizations of social feedback, demonstrated that the epistemic signaling system responds to self-esteem consistent or inconsistent relational-value feedback with increases or deceases in epistemic certainty. Moreover, Studies 3-6 demonstrated that the acceptance and epistemic signaling systems respond uniquely to social feedback. Finally, Studies 5 and 6 provide evidence that the epistemic signaling system is part of a broader self-regulatory system: Self-esteem inconsistent feedback caused cognitive efforts to decrease the discrepancy between self-views and feedback and caused depleted self-regulatory capacity on a subsequent self-control task. PsycINFO Database Record (c) 2010 APA, all rights reserved.
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Application of Regulatory Focus Theory to Search Advertising
Mowle, Elyse N.; Georgia, Emily J.; Doss, Brian D.; Updegraff, John A.
2015-01-01
Purpose The purpose of this paper is to test the utility of regulatory focus theory principles in a real-world setting; specifically, Internet hosted text advertisements. Effect of compatibility of the ad text with the regulatory focus of the consumer was examined. Design/methodology/approach Advertisements were created using Google AdWords. Data were collected for the number of views and clicks each ad received. Effect of regulatory fit was measured using logistic regression. Findings Logistic regression analyses demonstrated that there was a strong main effect for keyword, such that users were almost six times as likely to click on a promotion advertisement as a prevention advertisement, as well as a main effect for compatibility, such that users were twice as likely to click on an advertisement with content that was consistent with their keyword. Finally, there was a strong interaction of these two variables, such that the effect of consistent advertisements was stronger for promotion searches than for prevention searches. Research limitations/implications The effect of ad compatibility had medium to large effect sizes, suggesting that individuals’ state may have more influence on advertising response than do individuals’ traits (e.g. personality traits). Measurement of regulatory fit was limited by the constraints of Google AdWords. Practical implications The results of this study provide a possible framework for ad creation for Internet advertisers. Originality/value This paper is the first study to demonstrate the utility of regulatory focus theory in online advertising. PMID:26430293
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Survey Guidelines and its Reading Criteria for Monitoring and Transmitting Cultural Heritage Values
De Masi, A.
2015-08-01
The paper describes reading criteria for an analysis and interpretation of material systems in relation to a built space, survey guidelines and its reading criteria for Cultural Heritage (CH) values'monitoring and transmission. In addition, integrated systems of digital technologies and 2D/3D digitization of CH are introduced for an effective and accurate reading of Venice and Milan's monuments. Specifically, the guidelines for an architectural survey allow to organize and document historic monuments information, and to identify the significant cultural/physical elements of our past in order for them to be preserved and protected for future generations. In addition, in this paper the studied projects introduce a combination of virtual technologies and historical reality with experimenting innovative solutions for CH. From the methodological point of view, this study has made use of the identification of levels of study (LS) differentiated, each of which is capable of identifying categories.
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2011-04-19
... statement therein, as follows: I. Introduction On February 4, 2011, the Financial Industry Regulatory...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a... Financial Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of the Code of Arbitration...
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Value of PET and PET-CT for monitoring tumor therapy
International Nuclear Information System (INIS)
Chen Xiang; Zhao Jinhua
2007-01-01
18 F-fluorodeoxyglucose ( 18 F-FDG) PET or PET-CT is an accurate test for differentiating residual viable tumor tissue from therapy-induced changes in tumor. Furthermore, quantitative assessment of therapy-induced changes in tumor 18 F-FDG uptake may allow the prediction of tumor response. Treatment may be adjusted according to tumor response. So it is increasingly used to monitor tumor response in patients undergoing chemotherapy and chemoradiotherapy. Here we focused on practical aspects of 18 F-FDG PET or PET-CT for treatment monitoring and on the existing advantages and challenges. (authors)
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Marquart, Hans; Warren, Nicholas D; Laitinen, Juha; van Hemmen, Joop J
2006-07-01
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 information on possible determinants of exposure. These data and information, together with some non-RISKOFDERM data were used to derive default values for potential dermal exposure of the hands for so-called 'TGD exposure scenarios'. TGD exposure scenarios have similar values for some very important determinant(s) of dermal exposure, such as amount of substance used. They form narrower bands within the so-called 'RISKOFDERM scenarios', which cluster exposure situations according to the same purpose of use of the products. The RISKOFDERM scenarios in turn are narrower bands within the so-called Dermal Exposure Operation units (DEO units) that were defined in the RISKOFDERM project to cluster situations with similar exposure processes and exposure routes. Default values for both reasonable worst case situations and typical situations were derived, both for single datasets and, where possible, for combined datasets that fit the same TGD exposure scenario. The following reasonable worst case potential hand exposures were derived from combined datasets: (i) loading and filling of large containers (or mixers) with large amounts (many litres) of liquids: 11,500 mg per scenario (14 mg cm(-2) per scenario with surface of the hands assumed to be 820 cm(2)); (ii) careful mixing of small quantities (tens of grams in default values are considered useful for estimating exposure for similar substances in similar situations with low uncertainty. Several other default values based on single datasets can also be used, but lead to estimates with a higher uncertainty, due to their more limited basis. Sufficient analogy in all described parameters of the scenario, including duration, is needed
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2002 Waste Isolation Pilot Plant Environmental Monitoring Plan
International Nuclear Information System (INIS)
Washington TRU Solutions LLC
2002-01-01
DOE Order 5400.1, General Environmental Protection Program, requires each DOE | facility to prepare an environmental management plan (EMP). This document is | prepared for WIPP in accordance with the guidance contained in DOE Order 5400.1; DOE Order 5400.5, Radiation Protection of the Public and Environment; applicable sections of Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T; DOE, 1991); and the Title 10 Code of Federal Regulations (CFR) Part 834, ''Radiation Protection of the Public and Environment'' (draft). Many sections of DOE Order 5400.1 have been replaced by DOE Order 231.1, which is the driver for the annual Site Environmental Report (SER) and the guidance source for preparing many environmental program documents. The WIPP Project is operated by Westinghouse TRU Solutions (WTS) for the DOE. This plan defines the extent and scope of WIPP's effluent and environmental | monitoring programs during the facility's operational life and also discusses WIPP's quality assurance/quality control (QA/QC) program as it relates to environmental monitoring. In addition, this plan provides a comprehensive description of environmental activities at WIPP including: A summary of environmental programs, including the status of environmental monitoring activities A description of the WIPP Project and its mission A description of the local environment, including demographics An overview of the methodology used to assess radiological consequences to the public, including brief discussions of potential exposure pathways, routine and accidental releases, and their consequences Responses to the requirements described in the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance
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Regulatory inspection of nuclear facilities and enforcement by the regulatory body. Safety guide
International Nuclear Information System (INIS)
2002-01-01
The purpose of this Safety Guide is to provide recommendations for regulatory bodies on the inspection of nuclear facilities, regulatory enforcement and related matters. The objective is to provide the regulatory body with a high level of confidence that operators have the processes in place to ensure compliance and that they do comply with legal requirements, including meeting the safety objectives and requirements of the regulatory body. However, in the event of non-compliance, the regulatory body should take appropriate enforcement action. This Safety Guide covers regulatory inspection and enforcement in relation to nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power plants; other reactors such as research reactors and critical assemblies; spent fuel reprocessing plants; and facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Section 2 sets out the objectives of regulatory inspection and enforcement. Section 3 covers the management of regulatory inspections. Section 4 covers the performance of regulatory inspections, including internal guidance, planning and preparation, methods of inspection and reports of inspections. Section 5 deals with regulatory enforcement actions. Section 6 covers the assessment of regulatory inspections and enforcement activities. The Appendix provides further details on inspection areas for nuclear facilities
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Ground-water monitoring and modeling at the Hanford Site
International Nuclear Information System (INIS)
Mitchell, P.J.; Freshley, M.D.
1987-01-01
The ground-water monitoring program at the Hanford Site in southeastern Washington State is continually evolving in response to changing operations at the site, changes in the ground-water flow system, movement of the constituents in the aquifers, and regulatory requirements. Sampling and analysis of ground water, along with ground-water flow and solute transport modeling are used to evaluate the movement and resulting distributions of radionuclides and hazardous chemical constituents in the unconfined aquifer. Evaluation of monitoring results, modeling, and information on waste management practices are being combined to continually improve the network of ground-water monitoring wells at the site
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Ground-water monitoring and modeling at the Hanford Site
International Nuclear Information System (INIS)
Mitchell, P.J.; Freshley, M.D.
1987-01-01
The ground-water monitoring program at the Hanford Site in southeastern Washington State is continually evolving in response to changing operations at the site, changes in the ground-water flow system, movement of the constituents in the aquifers, and regulatory requirements. Sampling and analysis of ground water, along with ground-water flow and solute transport modeling are used ito evaluate the movement and resulting distributions of radionuclides and hazardous chemical constituents in the unconfined aquifer. Evaluation of monitoring results, modeling, and information on waste management practices are being combined to continually improve the network of ground-water monitoring wells at the site
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van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan
2015-07-15
Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.
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Directory of Open Access Journals (Sweden)
Elena Vital'evna Bykova
2011-09-01
Full Text Available This paper describes the concept of energy security and a system of indicators for its monitoring. The indicator system includes more than 40 parameters that reflect the structure and state of fuel and energy complex sectors (fuel, electricity and heat & power, as well as takes into account economic, environmental and social aspects. A brief description of the structure of the computer system to monitor and analyze energy security is given. The complex contains informational, analytical and calculation modules, provides applications for forecasting and modeling energy scenarios, modeling threats and determining levels of energy security. Its application to predict the values of the indicators and methods developed for it are described. This paper presents a method developed by conventional nonlinear mathematical programming needed to address several problems of energy and, in particular, the prediction problem of the security. An example of its use and implementation of this method in the application, "Prognosis", is also given.
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Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies
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. PMID:24244662
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Expert views on regulatory preparedness for managing the risks of nanotechnologies.
Directory of Open Access Journals (Sweden)
Christian E H Beaudrie
Full Text Available 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.
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Regulatory analysis for USI A-1, Water Hammer
International Nuclear Information System (INIS)
Serkiz, A.W.
1984-03-01
This is the staff's regulatory analysis dealing with the resolution of the Unresolved Safety Issue A-1, Water Hammer. This report contains the value-impact analysis for this issue, public comments received, and staff response, or action taken, in response to those comments. The staff's technical findings regarding water hammer in nuclear power plants are contained in NUREG-0927
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Zhou, Jie; Zhang, Limin; Tian, Yang
2016-02-16
To develop in vivo monitoring meter for pH measurements is still the bottleneck for understanding the role of pH plays in the brain diseases. In this work, a selective and sensitive electrochemical pH meter was developed for real-time ratiometric monitoring of pH in different regions of rat brains upon ischemia. First, 1,2-naphthoquinone (1,2-NQ) was employed and optimized as a selective pH recognition element to establish a 2H(+)/2e(-) approach over a wide range of pH from 5.8 to 8.0. The pH meter demonstrated remarkable selectivity toward pH detection against metal ions, amino acids, reactive oxygen species, and other biological species in the brain. Meanwhile, an inner reference, 6-(ferrocenyl)hexanethiol (FcHT), was selected as a built-in correction to avoid the environmental effect through coimmobilization with 1,2-NQ. In addition, three-dimensional gold nanoleaves were electrodeposited onto the electrode surface to amplify the signal by ∼4.0-fold and the measurement was achieved down to 0.07 pH. Finally, combined with the microelectrode technique, the microelectrochemical pH meter was directly implanted into brain regions including the striatum, hippocampus, and cortex and successfully applied in real-time monitoring of pH values in these regions of brain followed by global cerebral ischemia. The results demonstrated that pH values were estimated to 7.21 ± 0.05, 7.13 ± 0.09, and 7.27 ± 0.06 in the striatum, hippocampus, and cortex in the rat brains, respectively, in normal conditions. However, pH decreased to 6.75 ± 0.07 and 6.52 ± 0.03 in the striatum and hippocampus, upon global cerebral ischemia, while a negligible pH change was obtained in the cortex.
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Extended value-impact decision making methodology for nuclear power plant modifications
International Nuclear Information System (INIS)
Nelson, P.F.; Kastenberg, W.E.
1985-01-01
Value-impact is the term used by the Nuclear Regulatory Commission (NRC) to define what is traditionally known as cost-benefit analysis; values measure the beneficial consequences of a proposed action, impacts measure the adverse consequences, i.e. costs of the proposed action. In the regulatory framework, value-impact or cost-benefit is but one input to decision making. The present study was performed in order to illustrate how decision makers can utilize a more structured method for determining nuclear regulatory policy. In order to be useful, the method must treat all dominant factors that influence a decision; including economic, as well as societal factors such as environmental, health and safety. The method must also allow decisions to be consistent with the preferences of the decision maker as well as other interested groups. Major problems in decision making are how to incorporate non-quantifiable attributes in the method and how to reach consensus between opposing viewpoints. The Analytic Hierarchy Process (AHP) can attack these issues by making it possible to structure the decision in a way that subjective input can be included. In this paper, the AHP is developed and used to rank the value/impact ratios of alternative decay heat removal systems. It is believed that use of the AHP can decrease limitations present in a current value-impact analysis
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Identification and monitoring of non-radiological carcinogens
Energy Technology Data Exchange (ETDEWEB)
Chuaqui, C A; Petkau, A; Greenstock, C L; Brown, C P [Atomic Energy of Canada Ltd., Pinawa, MB (Canada). Whiteshell Labs.
1995-09-01
This study examines the feasibility of identifying and monitoring occupational exposures to non-radiological carcinogens in the workplace at Canadian nuclear establishments (Whiteshell Laboratories, Pickering Nuclear Generating Station, Cameco Limited and Canadian General Electric Company Limited). Recent epidemiological studies recommended that potential confounding factors of a non-radiological nature be identified and analyzed, particularly non-radiological carcinogens that may be present in the workplace at nuclear facilities. The feasibility of identifying and measuring occupational exposures to non-radiological carcinogens in Canadian nuclear facilities is examined. Also, the report describes the problem of chemical carcinogens and the mechanisms involved in chemical carcinogenesis; the epidemiology related to the problem, followed by a description of the analytical aspects of detection, monitoring and analysis of carcinogens, as well as a discussion on the regulatory aspects and the regulations in place; and the findings, recommendations and concluding remarks of this study. Several problem areas became apparent as the study proceeded. For example, the classification of a chemical as a human carcinogen is a difficult problem, as is its adequate monitoring and analysis. This situation reflects, in turn, the regulatory aspects in the workplace. A list of chemical carcinogens used industrially at the four Canadian nuclear facilities has been identified. The list includes arsenic, asbestos, benzene, cadmium, beryllium, nickel, polychlorinated biphenyls, lead and trichloroethylene. Several recommendations are made in relation to the need for practical and efficient monitoring methods for chemical carcinogens, the definition of radiation and chemical dose equivalencies, and the classification of human chemical carcinogens, as well as their disposal. (author). 122 refs., 8 tabs., 6 figs.
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Identification and monitoring of non-radiological carcinogens
International Nuclear Information System (INIS)
Chuaqui, C.A.; Petkau, A.; Greenstock, C.L.; Brown, C.P.
1995-09-01
This study examines the feasibility of identifying and monitoring occupational exposures to non-radiological carcinogens in the workplace at Canadian nuclear establishments (Whiteshell Laboratories, Pickering Nuclear Generating Station, Cameco Limited and Canadian General Electric Company Limited). Recent epidemiological studies recommended that potential confounding factors of a non-radiological nature be identified and analyzed, particularly non-radiological carcinogens that may be present in the workplace at nuclear facilities. The feasibility of identifying and measuring occupational exposures to non-radiological carcinogens in Canadian nuclear facilities is examined. Also, the report describes the problem of chemical carcinogens and the mechanisms involved in chemical carcinogenesis; the epidemiology related to the problem, followed by a description of the analytical aspects of detection, monitoring and analysis of carcinogens, as well as a discussion on the regulatory aspects and the regulations in place; and the findings, recommendations and concluding remarks of this study. Several problem areas became apparent as the study proceeded. For example, the classification of a chemical as a human carcinogen is a difficult problem, as is its adequate monitoring and analysis. This situation reflects, in turn, the regulatory aspects in the workplace. A list of chemical carcinogens used industrially at the four Canadian nuclear facilities has been identified. The list includes arsenic, asbestos, benzene, cadmium, beryllium, nickel, polychlorinated biphenyls, lead and trichloroethylene. Several recommendations are made in relation to the need for practical and efficient monitoring methods for chemical carcinogens, the definition of radiation and chemical dose equivalencies, and the classification of human chemical carcinogens, as well as their disposal. (author). 122 refs., 8 tabs., 6 figs
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Exploring self-regulatory strategies for eating behaviour in Danish adolescents
DEFF Research Database (Denmark)
Nureeva, Liliya; Brunsø, Karen; Lähteenmäki, Liisa
2016-01-01
– Focusing on improving adolescents’ self-regulatory skills in the domain of eating behaviour is a promising approach in developing future interventions. Originality/value – The present article explores self-regulatory strategies for eating behaviour in adolescence and discusses their relevance.......Purpose – Healthy eating behaviour in adolescence may be negatively affected by lack of self-regulation. The purpose of this paper is to discuss strategies for regulating eating behaviour as formulated by adolescents themselves. Design/methodology/approach – Self-regulatory strategies were elicited...... with concept mapping, which is a group-based method. Three meetings were conducted with each of four school classes in Denmark. Participants in the 12-15-year age group were recruited for the study. At the first meeting, participants had to complete the phrase “Things I can do to ensure my healthy eating are...
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Integrating environmental monitoring with cumulative effects management and decision making.
Cronmiller, Joshua G; Noble, Bram F
2018-05-01
Cumulative effects (CE) monitoring is foundational to emerging regional and watershed CE management frameworks, yet monitoring is often poorly integrated with CE management and decision-making processes. The challenges are largely institutional and organizational, more so than scientific or technical. Calls for improved integration of monitoring with CE management and decision making are not new, but there has been limited research on how best to integrate environmental monitoring programs to ensure credible CE science and to deliver results that respond to the more immediate questions and needs of regulatory decision makers. This paper examines options for the integration of environmental monitoring with CE frameworks. Based on semistructured interviews with practitioners, regulators, and other experts in the Lower Athabasca, Alberta, Canada, 3 approaches to monitoring system design are presented. First, a distributed monitoring system, reflecting the current approach in the Lower Athabasca, where monitoring is delegated to different external programs and organizations; second, a 1-window system in which monitoring is undertaken by a single, in-house agency for the purpose of informing management and regulatory decision making; third, an independent system driven primarily by CE science and understanding causal relationships, with knowledge adopted for decision support where relevant to specific management questions. The strengths and limitations of each approach are presented. A hybrid approach may be optimal-an independent, nongovernment, 1-window model for CE science, monitoring, and information delivery-capitalizing on the strengths of distributed, 1-window, and independent monitoring systems while mitigating their weaknesses. If governments are committed to solving CE problems, they must invest in the long-term science needed to do so; at the same time, if science-based monitoring programs are to be sustainable over the long term, they must be responsive to
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International Nuclear Information System (INIS)
1994-05-01
The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7
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Costs of regulatory compliance: categories and estimating techniques
International Nuclear Information System (INIS)
Schulte, S.C.; McDonald, C.L.; Wood, M.T.; Cole, R.M.; Hauschulz, K.
1978-10-01
Use of the categorization scheme and cost estimating approaches presented in this report can make cost estimates of regulation required compliance activities of value to policy makers. The report describes a uniform assessment framework that when used would assure that cost studies are generated on an equivalent basis. Such normalization would make comparisons of different compliance activity cost estimates more meaningful, thus enabling the relative merits of different regulatory options to be more effectively judged. The framework establishes uniform cost reporting accounts and cost estimating approaches for use in assessing the costs of complying with regulatory actions. The framework was specifically developed for use in a current study at Pacific Northwest Laboratory. However, use of the procedures for other applications is also appropriate
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10 CFR 60.143 - Monitoring and testing waste packages.
2010-01-01
....143 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN... repository operations area, the environment of the waste packages selected for the waste package monitoring program shall be representative of the environment in which the wastes are to be emplaced. (c) The waste...
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10 CFR 63.134 - Monitoring and testing waste packages.
2010-01-01
....134 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A... geologic repository operations area, the environment of the waste packages selected for the waste package monitoring program must be representative of the environment in which the wastes are to be emplaced. (c) The...
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Directory of Open Access Journals (Sweden)
Xiao-Hui Luo
2011-05-01
Full Text Available The feasibility and the clinical value of the enzyme-multiplied immunoassay technique (EMIT monitoring of blood concentrations of cyclosporine A (CsA in patients treated with CsA were investigated after kidney transplantation. The validation method was performed to the EMIT determination of CsA blood concentration, the CsA whole blood âtrough concentrations (C0 of patients in different time periods after renal transplantation were monitored, and combined with the clinical complications, the statistical results were analyzed and compared. EMIT was precise, accurate and stable, also with a high quality control. The mean postoperative blood concentration of CsA was as follows: 12 months, (185.6 ± 28.1ng/mL. The toxic reaction rate of CsA blood concentration within the recommended therapeutic concentration was 14. 1%, significantly lower than that of the none-recommended dose group (37.2% (P < 0.05; the transplantation rejection rate was 4.4%, significantly lower than that of the none-recommended dose group (22.5% (P < 0.05. Using EMIT to monitor the blood concentration of CsA as the routine laboratory method is feasible, and is able to reduce the CsA toxicity and rejection significantly, leading to achieving the desired therapeutic effect. Keywords: enzyme-multiplied immunoassay technique, renal transplantation, cyclosporin A, blood concentration monitoring
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Radiation monitoring of uranium workers
International Nuclear Information System (INIS)
1998-12-01
In order to manage radiological hazards in the workplace, it is necessary to have reliable measurements of workplace radiation levels and estimates of exposures and doses to workers. Over the past several years there have been many changes not only to the science of monitoring and dose assessment, but also to the regulatory framework. New International Commission on Radiological Protection (ICRP) recommendations on dose in ICRP Publication 60 (1991) and the implications of the ICRP's new respiratory tract model in ICRP Publication 66 (1994) are of particular importance. In addition, triggered by the act establishing the Canadian Nuclear Safety Commission (CNSC), which will replace the Atomic Energy Control Board (AECB), there is considerable activity in the review and development of regulatory guidance. Concurrent with these activities is the introduction of innovative mining procedures in Saskatchewan in order to extract uranium ore of particularly high grade. In view of these developments, the ACRP considered that a formal review of current monitoring practices would benefit both the CNSC and its licensees. In this report, 'uranium workers' refers to workers at uranium mines and mills, and workers at natural-uranium refineries, conversion, and fuel fabrication facilities; issues relating to long-term tailings management and to the handling of enriched materials are not addressed in this document. The report will have some relevance to workers in non-uranium mines and in industries handling naturally occurring radioactive materials (NORM) since, in some circumstances, these activities can present similar workplace radiation hazards. The report outlines the radiological hazards encountered in the Canadian uranium industry, and reviews current radiological monitoring practices and options; appendices include a glossary, a more technical discussion of monitoring methods, and an examination of errors and uncertainties in measurements of radon progeny and long
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2010-03-10
... the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission March 2, 2010. The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory Commission (NRC) will hold...
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International Nuclear Information System (INIS)
Struckmeyer, R.; McNamara, N.
1989-09-01
This report provides the status and results of the NRC Thermoluminescent Dosimeter (TLD) Direct Radiation Monitoring Network. It presents the radiation levels measured in the vicinity of NRC licensed facility sites throughout the country for the second quarter of 1989
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Regulatory control of low level radiation exposure in Tanzania
International Nuclear Information System (INIS)
Nyanda, A.M.; Muhogora, W.E.
1997-01-01
In Tanzania, the radiation protection law was issued in 1983. Under this law, the National Radiation Commission is responsible for safe uses of ionizing radiation. The regulatory control of the resulting doses from the uses of radiation sources in medicine, industry, research and teaching is presented. The system of control reflects the existing interactions between the National Radiation Commission and users through the established radiation protection infrastructure. From the national dose registry data, it is found that the highest annual individual doses over 10 years ago, came from less than 5% of total monitored workers and were in the range 10 - 15 mSv y -1 . The experienced radiation levels in uncontrolled areas of potential workplaces is less than 1 μSv h -1 . The possibility for associating such low dose levels to the effectiveness of the existing regulatory dose control framework is discussed. Despite of this achievement, the need to improve further the radiation protection and safety programs is found necessary. (author)
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Monitoring substrate enables real-time regulation of a protein localization pathway.
Ito, Koreaki; Mori, Hiroyuki; Chiba, Shinobu
2018-06-01
Protein localization machinery supports cell survival and physiology, suggesting the potential importance of its expression regulation. Here, we summarize a remarkable scheme of regulation, which allows real-time feedback regulation of the machinery expression. A class of regulatory nascent polypeptides, called monitoring substrates, undergoes force-sensitive translation arrest. The resulting ribosome stalling on the mRNA then affects mRNA folding to expose the ribosome-binding site of the downstream target gene and upregulate its translation. The target gene encodes a component of the localization machinery, whose physical action against the monitoring substrate leads to arrest cancellation. Thus, this scheme of feedback loop allows the cell to adjust the amount of the machinery to correlate inversely with the effectiveness of the process at a given moment. The system appears to have emerged late in evolution, in which a narrow range of organisms selected a distinct monitoring substrate-machinery combination. Currently, regulatory systems of SecM-SecA, VemP-SecDF2 and MifM-YidC2 are known to occur in different bacterial species.
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International Nuclear Information System (INIS)
King, S.E.; Hendrickson, P.L.; Siegel, M.R.; Woodruff, M.G.; Belfiglio, J.; Elliott, R.W.
1990-03-01
The authors reviewed federal and state statutes and regulations, as well as Department of Energy (DOE) orders and other guidance material, for potential applicability to the environmental surveillance program conducted for the Hanford site by the Pacific Northwest Laboratory (PNL). There are no federal or state statutes or regulations which are directly applicable to the environmental surveillance program. However, other regulatory schemes, while not directly applicable to the environmental surveillance program, are important insofar as they are indicative of regulatory concern and direction. Because of the evolving nature of environmental regulations, this area needs to be closely monitored for future impact on environmental surveillance activities. 9 refs.,
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International Nuclear Information System (INIS)
Dobici, F.; Piermattei, S.; Susanna, A.
1996-01-01
During these last ten years there have been occasional reports of mishaps from trafficking of contaminated scraps or containing radioactive sources. Recently an increase of events indicated that the problem becomes more important as to generate possible consequences, from a radiation protection standpoint, for workers and general public. Following the detection of contaminated metal scraps in some recycling industries and in some consignments entering the Italian borders, the competent Authorities laid down rules to put the matter under control. In this paper technical and regulatory features are discussed. (author)
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Monitoring and management of tritium from the nuclear power plant effluent
Zhang, Qiaoe; Liu, Ting; Yang, Lili; Meng, De; Song, Dahu
2018-01-01
It is important to regulate tritium nuclides from the nuclear power plant effluent, the paper briefly analyzes the main source of tritium, and the regulatory requirements associated with tritium in our country and the United States. The monitoring methods of tritium from the nuclear power plant effluent are described, and the purpose to give some advice to our national nuclear power plant about the effluent of tritium monitoring and management.
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40 CFR 52.480 - Photochemical Assessment Monitoring Stations (PAMS) Program.
2010-07-01
... of Columbia's Department of Consumer and Regulatory Affairs submitted a plan for the establishment... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Photochemical Assessment Monitoring Stations (PAMS) Program. 52.480 Section 52.480 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...
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Energy Technology Data Exchange (ETDEWEB)
Krupka, Kenneth M.; Martin, Wayne J.
2001-07-23
Natural attenuation processes are commonly used for remediation of contaminated sites. A variety of natural processes occur without human intervention at all sites to varying rates and degrees of effectiveness to attenuate (decrease) the mass, toxicity, mobility, volume, or concentration of organic and inorganic contaminants in soil, groundwater, and surface water systems. The objective of this review is to identify potential technical investments to be incorporated in the Subsurface Contaminant Focus Area Strategic Plan for monitored natural attenuation. When implemented, the technical investments will help evaluate and implement monitored natural attenuation as a remediation option at DOE sites. The outcome of this review is a set of conclusions and general recommendations regarding research needs, programmatic guidance, and stakeholder issues pertaining to monitored natural attenuation for the DOE complex.
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Environmental monitoring programme
International Nuclear Information System (INIS)
1991-08-01
During 1989 there were about 1000 premises in England and Wales authorised to discharge radioactive wastes. The majority of these premises consisted of hospitals, universities and industrial, research or manufacturing centres. Discharges from these premises when made in accordance with the strict conditions specified in their authorisations will have been of little radiological significance. In the case of nuclear sites authorisations or approvals are issued jointly by the DoE and the Ministry of Agriculture, Fisheries and Food (MAFF) known collectively as the Authorising Departments. In Wales these functions are undertaken by the Welsh Office with the support of HMIP and MAFF. The Authorising Departments specify numerical limits on the amounts of radioactivity which operators may discharge to the environment. In addition operators are required to demonstrate that the best practicable means (BPM) to minimise discharges is undertaken. Operators are also required to carry out appropriate environmental monitoring to demonstrate the effectiveness of BPM. As part of their regulatory functions the Authorising Departments undertake their own environmental monitoring programmes to act as both a check on site operator's returns and to provide independent data on the exposure of the public. HM Inspectorate of Pollution has monitored levels of radioactivity in drinking water sources for many years and published results annually. MAFF undertakes two programmes to monitor radioactivity in the aquatic environment and in terrestrial foodstuffs and publishes annual reports. Environmental monitoring programmes undertaken by both nuclear site operators and government departments are summarised. (author)
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International Nuclear Information System (INIS)
Ng, Y.C.; Hoffman, F.O.
1983-01-01
A parameter value for a radioecological assessment model is not a single value but a distribution of values about a central value. The sources that contribute to the variability of transfer factors to predict foodchain transport of radionuclides are enumerated. Knowledge of these sources, judgement in interpreting the available data, consideration of collateral information, and established criteria that specify the desired level of conservatism in the resulting predictions are essential elements when selecting appropriate parameter values for radioecological assessment models and regulatory guides. 39 references, 4 figures, 5 tables
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Energy Technology Data Exchange (ETDEWEB)
Ng, Y.C.; Hoffman, F.O.
1983-01-01
A parameter value for a radioecological assessment model is not a single value but a distribution of values about a central value. The sources that contribute to the variability of transfer factors to predict foodchain transport of radionuclides are enumerated. Knowledge of these sources, judgement in interpreting the available data, consideration of collateral information, and established criteria that specify the desired level of conservatism in the resulting predictions are essential elements when selecting appropriate parameter values for radioecological assessment models and regulatory guides. 39 references, 4 figures, 5 tables.
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2010-10-18
...-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of...(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory...
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Evolution of Cis-Regulatory Elements and Regulatory Networks in Duplicated Genes of Arabidopsis.
Arsovski, Andrej A; Pradinuk, Julian; Guo, Xu Qiu; Wang, Sishuo; Adams, Keith L
2015-12-01
Plant genomes contain large numbers of duplicated genes that contribute to the evolution of new functions. Following duplication, genes can exhibit divergence in their coding sequence and their expression patterns. Changes in the cis-regulatory element landscape can result in changes in gene expression patterns. High-throughput methods developed recently can identify potential cis-regulatory elements on a genome-wide scale. Here, we use a recent comprehensive data set of DNase I sequencing-identified cis-regulatory binding sites (footprints) at single-base-pair resolution to compare binding sites and network connectivity in duplicated gene pairs in Arabidopsis (Arabidopsis thaliana). We found that duplicated gene pairs vary greatly in their cis-regulatory element architecture, resulting in changes in regulatory network connectivity. Whole-genome duplicates (WGDs) have approximately twice as many footprints in their promoters left by potential regulatory proteins than do tandem duplicates (TDs). The WGDs have a greater average number of footprint differences between paralogs than TDs. The footprints, in turn, result in more regulatory network connections between WGDs and other genes, forming denser, more complex regulatory networks than shown by TDs. When comparing regulatory connections between duplicates, WGDs had more pairs in which the two genes are either partially or fully diverged in their network connections, but fewer genes with no network connections than the TDs. There is evidence of younger TDs and WGDs having fewer unique connections compared with older duplicates. This study provides insights into cis-regulatory element evolution and network divergence in duplicated genes. © 2015 American Society of Plant Biologists. All Rights Reserved.
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Eisenlohr-Moul, Tory A; Burris, Jessica L; Evans, Daniel R
2013-12-01
A growing body of evidence suggests that chronic pain patients suffer from chronic self-regulatory fatigue: difficulty controlling thoughts, emotions, and behavior. Pain acceptance, which involves responding to pain and related experiences without attempts to control or avoid them (pain willingness), and pursuit of valued life activities regardless of pain (activity engagement) has been associated with various favorable outcomes in chronic pain patients, including better psychological functioning. The study presented here tested the hypotheses that pain acceptance is associated with less psychological distress, higher psychological well-being, and reduced self-regulatory fatigue in temporomandibular disorder (TMD) patients, particularly for those with longer pain duration. Cross-sectional data were provided by 135 TMD patients during an initial evaluation at a university-based tertiary orofacial pain clinic. Results of hierarchical linear regression models indicated that, controlling for pain severity, pain willingness is associated with less psychological distress and lower self-regulatory fatigue, and activity engagement is associated with greater psychological well-being. Furthermore, the effect of pain willingness on psychological distress was moderated by pain duration such that pain willingness was more strongly associated with less psychological distress in patients with longer pain duration; this moderating effect was fully mediated by self-regulatory fatigue. These findings suggest pain willingness may buffer against self-regulatory fatigue in those with longer pain duration, and such conservation of self-regulatory resources may protect against psychological symptoms.
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International Nuclear Information System (INIS)
Gebeyehu Wolde, G.
2003-01-01
The application of Nuclear Techniques in Ethiopia started in the early sixties in the medical field and through time has gradually expanded to other areas. Following this growth the practice of Radiation Protection in Ethiopia dates back over 15 years. Radiation Protection Legislation 79/1993 was promulgated in December 1993, which has established an Autonomous Regulatory Authority to control and supervise the introduction and conduct of any practice involving ionizing radiation. Since 1998 the National Radiation Protection Authority has made a remarkable progress in terms of building a National Radiation Protection Infrastructure and is in a full swing transformation process towards a dynamic credible and competent regulatory Authority. The regulatory activities are designed in line with the main regulatory instruments, Notification, Authorization, Inspection and Enforcement. NRPA has a national inventory system and fully implemented the Regulatory Authority Information System (RAIS), which provides a systemic integration and will be instrumental to enhance the effectiveness of the regulatory system. A substantial progress has been made in the development and provision of support and technical services in the areas of Metrology and Calibration Services, Instrument Maintenance Service, Individual Monitoring of Personnel, Environmental and Food Monitoring and Interim Storage Facility for spent sources. Development of a national system for emergency preparedness and response is the current top agenda of NRPA. Towards ensuring an effective radiation protection and regulatory programme, NRPA is also making a proactive involvement in, expanding its outreach, information dissemination, awareness promotion and development of key human resources. In the last four years Ethiopia has been actively co-operating with IAEA in the framework of the Regional Model Projects RAF/9/024, RAF/9/028 and RAF/9/029. The inputs received through the project framework coupled with the
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Regulatory challenges in using nuclear operating experience
International Nuclear Information System (INIS)
2006-01-01
There can be no doubt that the systematic evaluation of operating experience by the operator and the regulator is essential for continued safe operation of nuclear power plants. Recent concerns have been voiced that the operating experience information and insights are not being used effectively to promote safety. If these concerns foreshadow a real trend in OECD countries toward complacency in reporting and analysing operating events and taking corrective actions, then past experience suggests that similar or even more serious events will recur. This report discusses how the regulator can take actions to assure that operators have effective programmes to collect and analyse operating experience and, just as important, for taking steps to follow up with actions to prevent the events and conditions from recurring. These regulatory actions include special inspections of an operator operating experience programme and discussion with senior plant managers to emphasize the importance of having an effective operating experience programme. In addition to overseeing the operator programmes, the regulator has the broader responsibility for assuring that industry-wide trends, both national and international are monitored. To meet these responsibilities, the regulatory body must have its own operating experience programme, and this report discusses the important attributes of such regulatory programmes. It is especially important for the regulator to have the capability for assessing the full scope of operating experience issues, including those that may not be included in an operator operating experience programme, such as new research results, international operating experience, and broad industry trend information. (author)
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Status of the PSA use in the Czech regulatory process
International Nuclear Information System (INIS)
Dusek, J.
1994-01-01
A review of previous probabilistic safety assessment (PSA) activities initiated by regulatory body and preparation of the preliminary PSA study and final PSA study (released in January 1994) for the nuclear power plant Dukovany with WWER-440 type 213 reactor is described. A brief information about the NPP Temelin (with WWER-1000) PSA Study, shutdown and PSA risk monitor current activities for the NPP Dukovany, next PSA activities in 1994 and about planned PSA activities in future is attached. (author). 21 refs
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International Nuclear Information System (INIS)
Jannik, G.T.
2001-01-01
For Department of Energy (DOE) facilities, clear regulatory guidance exists for structuring radiological air emissions monitoring programs. However, there are no parallel regulations for radiological liquid effluent monitoring programs. In order to bridge this gap and to technically justify liquid effluent monitoring decisions at DOE's Savannah River Site, a graded, risk-basked approach has been established to determine the monitoring and sampling criteria to be applied at each liquid discharge point
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Facts and values in risk assessment
International Nuclear Information System (INIS)
Cross, Frank B.
1998-01-01
Risk, as commonly understood, is a complex melange of facts, values, and fears. While this complexity of public risk perception is now broadly recognized, its implications are insufficiently explored. Public risk perceptions offer p poor guide for public policymaking. Popular assessments of risk are tainted by misinformation and unreliable heuristics. While subjective considerations, often called values, play a role in public perception of risk, those 'values' are often inappropriate for government decisionmaking. Reliance on public perceptions of risk means more premature deaths. Public risk perception also is systematically skewed contrary to the interests of the disadvantaged. Strict probabilistic risk measures generally provide a superior guide for government regulatory policy
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International Nuclear Information System (INIS)
Partridge, J.W. Jr.
1993-01-01
Federal Energy Regulatory Commission (FERC) Orders 436, 500, and 636, the Clean Air Act Amendments of 1990, Public Utility Holding Company Act reform, and the 1992 Energy Policy Act all can have significant effects on an LDC's operations. Such changes in an LDC's environments must be balanced by changes within the utility, its marketplace, and its state regulatory environment. The question is where to start. For Columbia Gas Distribution Cos., based in Columbus, OH, the new operating foundation begins with each employee. Internal strength is critical in designing initiatives that meet the needs of the marketplace and are well-received by regulators. Employees must understand not only the regulatory environment in which the LDC operates, but also how their work contributes to a positive regulatory relationship. To achieve this, Columbia initiated the COntinuing Regulatory Education program, or CORE, in 1991. CORE is a regulatory-focused, information-initiative program coordinated by Columbia's Regulatory Policy, Planning, and Government Affairs Department. The CORE programs can take many forms, such as emerging issue discussions, dialogues with regulators and key parties, updates on regulatory fillings, regulatory policy meetings, and formal training classes. The speakers and discussion facilitators can range from human resource department trainers to senior officers, from regulatory department staff members to external experts, or from state commissioners to executives from other LDCs. The goals of CORE initiatives are to: Support a professional level of regulatory expertise through employee participation in well-developed regulatory programs presented by credible experts. Encourage a constructive state regulatory environment founded on communication and cooperation. CORE achieves these goals via five program levels: introductory basics, advanced learning, professional expertise, crossfunctional dialogues, and external idea exchanges
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Value-impact analysis. Final report
International Nuclear Information System (INIS)
Cohn, M.; Dracup, J.A.; Erdmann, R.C.; Hughes, E.; vonHerrmann, J.
1979-11-01
This document represents a first step in the process of developing comprehensive value-impact methodology for the nuclear industry. It describes the development of the methodology and includes a discussion of the uses of cost-benefit or value-impact by other industries. This background is provided as a guide to the development of the methodology for the specific problems confronted by the nuclear industry. The use of benefit-cost analysis, or value-impact analysis, within the nuclear power industry has grown in recent years and is relied upon by both the regulatory community and the regulated industry. This report summarizes the state of the art of value-impact analysis as it affects these users. Relevant past experience in such fields as water resource development, transportation, environmental concerns, and health and medicine is reviewed. A critique of the applicability of existing value-impact analysis methods to nuclear safety decision problems is presented
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2011-10-26
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...
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2010-04-06
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... terms. For more information about the rulebook consolidation process, see Information Notice, March 12...
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Regulation of Telecommunications: The Choice Between Market and Regulatory Failures
Directory of Open Access Journals (Sweden)
Dmitrii Trubnikov
2017-04-01
Full Text Available Purpose – The paper examines the main regulatory frameworks of the telecommunications industry through the concept of market failure and analyses how and why the policy often leads to undesirable outcomes that might be considered as regulatory failure. Methodology/approach/design – The research uses the EU regulatory framework for electronic communications as a base for the analysis of the main policy objectives through the prism of the market failure theory with an eye to the interests of the main market players in the telecommunications markets. Findings – About any aspect of regulation allows to find ways to create opportunities for some groups of the industry and stifle activity of others. Despite the theory of market failure provides reasonable justifications for regulation of telecommunications markets, it is possible to argue that many of these problems are mainly the consequence of the policy and could be better solved by market mechanisms. Originality/value – The results of the research allow to look at the problems of telecommunications development and issues of the high level of concentration of the telecommunications markets as regulatory formed problems rather than consequences of the inherited industry’s characteristics.
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Regulation E 69-14. Monitoring requirements for medical devices
International Nuclear Information System (INIS)
2015-01-01
In the 'Regulations for the State Evaluation and Registration of Medical Equipment' force (Hereinafter Rules) set forth in Chapter VII, Articles 79 and 86, the monitoring activity as one of the programs necessary for evaluating the safety and effectiveness of medical monitoring equipment. In the years 2008 and 2011 were approved and implemented by the Center for State Control of Medical Equipment (CCEEM) Regulations and -1.1 ER and ER-1 that support and regulatory requirements 'Control and monitoring of pacemakers and implantable defibrillators' and 'Assessment, recording and control after market surgical silicone implants,' which are specific to these products and have provided a useful result for the performance of the activity. Given the number and diversity of high-risk medical devices as implantable or sustain human life that are brought into our National Health System (SNS), a regulation establishing control over the behavior becomes necessary safety and effectiveness of this equipment during use, which provide inputs to risk management. The objective of this regulation is to establish the regulatory requirements for tracking medical equipment introduced in the NHS. The provisions of this Regulation is aimed at health institutions, to CECMED as manufacturers, suppliers, distributors and importers of medical equipment.
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Energy Technology Data Exchange (ETDEWEB)
NONE
1993-07-01
In 1974 the IAEA established a Nuclear Safety Standards (NUSS) programme within which 5 Codes and 55 Safety Guides have been produced in the areas of Governmental Organization, Siting, Design, Operation and Quality Assurance. The NUSS Codes and Guides are a collection of basic and derived requirements for the safety of nuclear power plants with thermal neutron reactors. They have been developed in such a manner as to ensure the broadest international consensus. This broad consensus is one of the reasons for the relatively general wording of the main principles and sometimes causes problems when these principles are applied in the design of nuclear power plants. The requirements, particularly those of the Codes, often need interpretation in specific cases. In many areas national regulations and technical standards are available, but often these leave some questions unanswered and their practical application on a case-by-case basis is necessary. To assist in the application and interpretation of the NUSS Safety Standards and Safety Guides, the preparation of a number of Safety Practices publications has been commenced. Ibis publication is intended to assist regulators and also operating organizations. It is a compilation of the reports of the 1991/92 Peer Group discussions which considered regulatory good practices relating to monitoring and assessment of the ageing of nuclear power plants. Therefore names of participated countries in this documents are those at time of 1991/92 Peer Group discussions. It identifies those common regulatory features which require continuous reinforcement and examples of good regulatory practices that were recommended by senior regulators in the Peer Group discussions. The purpose of this publication is to provide a compilation of the 1991/92 Peer Group discussions relating to operational plant. This document the covers practices in the 20 countries participating in this round of Peer Group discussions. The document is a synopsis of
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International Nuclear Information System (INIS)
1993-01-01
In 1974 the IAEA established a Nuclear Safety Standards (NUSS) programme within which 5 Codes and 55 Safety Guides have been produced in the areas of Governmental Organization, Siting, Design, Operation and Quality Assurance. The NUSS Codes and Guides are a collection of basic and derived requirements for the safety of nuclear power plants with thermal neutron reactors. They have been developed in such a manner as to ensure the broadest international consensus. This broad consensus is one of the reasons for the relatively general wording of the main principles and sometimes causes problems when these principles are applied in the design of nuclear power plants. The requirements, particularly those of the Codes, often need interpretation in specific cases. In many areas national regulations and technical standards are available, but often these leave some questions unanswered and their practical application on a case-by-case basis is necessary. To assist in the application and interpretation of the NUSS Safety Standards and Safety Guides, the preparation of a number of Safety Practices publications has been commenced. Ibis publication is intended to assist regulators and also operating organizations. It is a compilation of the reports of the 1991/92 Peer Group discussions which considered regulatory good practices relating to monitoring and assessment of the ageing of nuclear power plants. Therefore names of participated countries in this documents are those at time of 1991/92 Peer Group discussions. It identifies those common regulatory features which require continuous reinforcement and examples of good regulatory practices that were recommended by senior regulators in the Peer Group discussions. The purpose of this publication is to provide a compilation of the 1991/92 Peer Group discussions relating to operational plant. This document the covers practices in the 20 countries participating in this round of Peer Group discussions. The document is a synopsis of
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2013-10-22
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer... 5210 (Publication of Transactions and Quotations) October 4, 2013. I. Introduction On August 15, 2013, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...
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Leong Wai Yeen, James; Salek, Sam; Walker, Stuart
2014-01-01
The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.
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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.
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Regulatory natural killer cell expression in atopic childhood asthma ...
African Journals Online (AJOL)
Introduction: Different subsets of natural killer (NK) cells were found to play a role in pathogenesis of allergy. We sought to investigate the expression of regulatory NK cells (CD56+CD16+CD158+) in atopic children with bronchial asthma in order to outline the value of these cells as biomarkers of disease severity and/or ...
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2010-04-26
... to pay arbitration awards to remain in the securities industry presents regulatory risks and is...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule... Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or...
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Development of regulatory techniques for operational performance evaluation of nuclear power plants
International Nuclear Information System (INIS)
Sung, K. Y.; Lee, C. J.
2005-03-01
For the purpose of keeping up the capability for independent regulatory audit of risk information, we developed an PSA model, independent on that of the licensee. The developed regulatory PSA model, as named MPAS (Multi-purpose Probabilistic Analysis of Safety), is primarily based on the result of feasibility study about ASME PSA standard and done by the cooperation work with KAERI PSA research team. Current MPAS model is limited to the work scope on Level 1 internal full power analysis, which is finally implemented for the KSNP. The development of MPAS model consists of plenty of works establishing overall items which comprehensively implements all subjects such as detailed logic and input data for each analysis fields. In addition, relevant computational framework utilizing PSA and risk monitoring codes is also developed for users' convenience
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Occupational noise exposure and regulatory adherence in music venues in the United Kingdom
Directory of Open Access Journals (Sweden)
Christopher Barlow
2012-01-01
Full Text Available Noise in most working environments is an unwanted by-product of the process. In most countries, noise exposure for workers has been controlled by legislation for many years. In the music industry the "noise" is actually the "desired" product, and for a long time the UK entertainment industry was exempt from these regulations. From April 2008, however, it became regulated under the Noise at Work Regulations 2005, meaning that employers from orchestras to nightclubs are legally required to adhere to the same requirements (based on ISO 9612:2009 for controlling noise exposure for their staff that have been applied to other industries for many years. A key question is to what degree, 2 years after implementation, these employers are complying with their legal responsibilities to protect the staff from noise? This study assessed four public music venues where live and/or recorded music is regularly played. Thirty staff members in different roles in the venues were monitored using noise dosimetry to determine noise exposure. Questionnaires were used to determine work patterns, attitudes to noise and hearing loss, and levels of training about noise risk. Results showed that the majority of staff (70% in all venues exceeded the daily noise exposure limit value in their working shift. Use of hearing protection was rare (<30% and not enforced by most venues. The understanding of the hazard posed by noise was low, and implementation of the noise regulations was haphazard, with staff regularly exceeding regulatory limits. The implication is that the industry is failing to meet regulatory requirements.
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Yokotsuka, M; Aoyama, M; Kubota, K
2000-07-01
The Medical Dictionary for Regulatory Activities Terminology (MedDRA) version 2.1 (V2.1) was released in March 1999 accompanied by the MedDRA/J V2.1J specifically for Japanese users. In prescription-event monitoring in Japan (J-PEM), we have employed the MedDRA/J for data entry, signal generation and event listing. In J-PEM, the lowest level terms (LLTs) in the MedDRA/J are used in data entry because the richness of LLTs is judged to be advantageous. A signal is generated normally at the preferred term (PT) level, but it has been found that various reporters describe the same event using descriptions that are potentially encoded by LLTs under different PTs. In addition, some PTs are considered too specific to generate the proper signal. In the system used in J-PEM, when an LLT is selected as a candidate to encode an event, another LLT under a different PT, if any, is displayed on the computer screen so that it may be coded instead of, or in addition to, the candidate LLT. The five-level structure of the MedDRA is used when listing events but some modification is required to generate a functional event list.
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Team structure and regulatory focus: the impact of regulatory fit on team dynamic.
Dimotakis, Nikolaos; Davison, Robert B; Hollenbeck, John R
2012-03-01
We report a within-teams experiment testing the effects of fit between team structure and regulatory task demands on task performance and satisfaction through average team member positive affect and helping behaviors. We used a completely crossed repeated-observations design in which 21 teams enacted 2 tasks with different regulatory focus characteristics (prevention and promotion) in 2 organizational structures (functional and divisional), resulting in 84 observations. Results suggested that salient regulatory demands inherent in the task interacted with structure to determine objective and subjective team-level outcomes, such that functional structures were best suited to (i.e., had best fit with) tasks with a prevention regulatory focus and divisional structures were best suited to tasks with a promotion regulatory focus. This contingency finding integrates regulatory focus and structural contingency theories, and extends them to the team level with implications for models of performance, satisfaction, and team dynamics.
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Risk monitor riskangel for risk-informed applications in nuclear power plants
International Nuclear Information System (INIS)
Wang, Fang; Wang, Jiaqun; Wang, Jin; Li, Yazhou; Hu, Liqin; Wu, Yican
2016-01-01
Highlights: • A general risk monitor riskangel with high-speed cutsets generator engine. • Benchmarks of actual nuclear power plant (NPP) instantaneous risk models. • Applications in daily operation, maintenance plan and component out of service. - Abstract: This paper studied the requirements of risk monitor software and its applications as a plant specific risk monitor, which supports risk-informed configuration risk management for the two CANDU 6 units at the Third Qinshan nuclear power plant (TQNPP) in China. It also describes the regulatory prospective on risk-informed Probabilistic Safety Assessment (PSA) applications and the use of risk monitor at operating nuclear power plants, high level technical and functional requirements for the development of CANDU specific risk monitor software, and future development trends.
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2011-07-28
...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change To... change should provide NOM Participants assistance in effectively managing their quotations. \\6\\ 15 U.S.C...,\\2\\ a proposed rule change to adopt a new risk monitor mechanism. The proposed rule change was...
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International Nuclear Information System (INIS)
Scott, W.B.; Jamison, J.D.; Stoetzel, G.A.; Tabatabai, A.S.; Vo, T.V.
1987-05-01
In a study commissioned by the Nuclear Regulatory Commission (NRC), Pacific Northwest Laboratory (PNL) evaluated the costs and benefits of modifying regulatory requirements in the areas of the postaccident sampling system, turbine rotor design reviews and inspections, combustible gas control for inerted Boiling Water Reactor (BWR) containments, and impregnated charcoal filters in certain plant ventilation systems. The basic framework for the analyses was that presented in the Regulatory Analysis Guidelines (NUREG/BR-0058) and in the Handbook for Value-Impact Assessment (NUREG/CR-3568). The effects of selected modifications to regulations were evaluated in terms of such factors as public risk and costs to industry and NRC. The results indicate that potential modifications of the regulatory requirements in three of the four areas would have little impact on public risk. In the fourth area, impregnated charcoal filters in building ventilation systems do appear to limit risks to the public and plant staff. Revisions in the severe accident source term assumptions, however, may reduce the theoretical value of charcoal filters. The cost analysis indicated that substantial savings in operating costs may be realized by changing the interval of turbine rotor inspections. Small to moderate operating cost savings may be realized through postulated modifications to the postaccident sampling system requirements and to the requirements for combustible gas control in inerted BWR containments. Finally, the use of impregnated charcoal filters in ventilation systems appears to be the most cost-effective method of reducing radioiodine concentrations
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XcisClique: analysis of regulatory bicliques
Directory of Open Access Journals (Sweden)
Grene Ruth
2006-04-01
Full Text Available Abstract Background Modeling of cis-elements or regulatory motifs in promoter (upstream regions of genes is a challenging computational problem. In this work, set of regulatory motifs simultaneously present in the promoters of a set of genes is modeled as a biclique in a suitably defined bipartite graph. A biologically meaningful co-occurrence of multiple cis-elements in a gene promoter is assessed by the combined analysis of genomic and gene expression data. Greater statistical significance is associated with a set of genes that shares a common set of regulatory motifs, while simultaneously exhibiting highly correlated gene expression under given experimental conditions. Methods XcisClique, the system developed in this work, is a comprehensive infrastructure that associates annotated genome and gene expression data, models known cis-elements as regular expressions, identifies maximal bicliques in a bipartite gene-motif graph; and ranks bicliques based on their computed statistical significance. Significance is a function of the probability of occurrence of those motifs in a biclique (a hypergeometric distribution, and on the new sum of absolute values statistic (SAV that uses Spearman correlations of gene expression vectors. SAV is a statistic well-suited for this purpose as described in the discussion. Results XcisClique identifies new motif and gene combinations that might indicate as yet unidentified involvement of sets of genes in biological functions and processes. It currently supports Arabidopsis thaliana and can be adapted to other organisms, assuming the existence of annotated genomic sequences, suitable gene expression data, and identified regulatory motifs. A subset of Xcis Clique functionalities, including the motif visualization component MotifSee, source code, and supplementary material are available at https://bioinformatics.cs.vt.edu/xcisclique/.
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2010-02-01
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...
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2012-08-08
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal of Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...
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2011-04-14
... Securities April 8, 2011. I. Introduction On March 3, 2011, the Financial Industry Regulatory Authority, Inc... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64283; File No. SR-FINRA-2011-012] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer...
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Managing Regulatory Body Competence
International Nuclear Information System (INIS)
2013-01-01
In 2001, the IAEA published TECDOC 1254, which examined the way in which the recognized functions of a regulatory body for nuclear facilities results in competence needs. Using the systematic approach to training (SAT), TECDOC 1254 provided a framework for regulatory bodies for managing training and developing and their maintaining their competence. It has been successfully used by many regulators. The IAEA has also introduced a methodology and an assessment tool - Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) - which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2009, the IAEA established a steering committee (supported by a bureau) with the mission to advise the IAEA on how it could best assist Member States to develop suitable competence management systems for their regulatory bodies. The committee recommended the development of a safety report on managing staff competence as an integral part of a regulatory body's management system. This Safety Report was developed in response to this request. It supersedes TECDOC 1254, broadens its application to regulatory bodies for all facilities and activities, and builds upon the experience gained through the application of TECDOC 1254 and SARCoN and the feedback received from Member States. This Safety Report applies to the management of adequate competence as needs change, and as such is equally applicable to the needs of States 'embarking' on a nuclear power programme. It also deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an 'embarking' State's regulatory system
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Discussion on monitoring items of radionuclides in influents from nuclear power plants
International Nuclear Information System (INIS)
Zhang Yanxia; Li Jin; Liu Jiacheng; Han Shanbiao; Yu Zhengwei
2014-01-01
For the radionuclide monitoring items of effluents from nuclear power plant, this paper makes some comparisons and analysis from three aspects of the international atomic energy general requirements, the routine radionuclide measurement items of China's nuclear power plant and effluents low level radionuclide experimental research results. Finally, it summarizes the necessary items and recommended items of the radionuclide monitoring of effluents from nuclear power plant, which can provide references for the radioactivity monitoring activities of nuclear power plant effluent and the supervisions of regulatory departments. (authors)
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Croatian energy regulatory council - independent Croatian regulatory body
International Nuclear Information System (INIS)
Klepo, M.
2002-01-01
By means of approving five energy laws, the Republic of Croatia established an appropriate legislative framework for energy sector regulation. A series of sub-law acts is presently being elaborated as well as some additional documents in order to bring about transparent and non-discriminatory provisions for the establishment of electric energy, gas, oil/oil derivatives and thermal energy markets, i.e. for the introduction and management of market activities and public services. A considerable share of these activities relates to the definition of transparent regulatory mechanisms that would guarantee the implementation of regulation rules based on the law, and be carried out by the independent regulatory body - Croatian Energy Regulatory Council. The Council's rights and obligations include firm executive functions, which present obligations to every energy entity. A dissatisfied party may set in motion a settlement of dispute, if it maintains that the decisions are not based on the law or reveal a flaw in the procedure. Therefore, it is the Council's priority to always make careful and law-abiding decisions. This paper gives insight into the regulatory framework elements based on the laws including the Council's organisational structure and non-profit entities that will prepare act proposals for the Council and perform other professional activities. (author)
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CT -guided sclerotherapy for simple renal cysts: Value of ethanol concentration monitoring
Energy Technology Data Exchange (ETDEWEB)
Yu, Jin Hong; Du, Yong; Li, Yang; Yang, Han Feng; Xu, Xiao Xue; Zheng, Hou Jun [The Affiliated Hospital of North Sichuan Medical College, Nanchong (China)
2014-02-15
The aim of our study was to evaluate the differences between sclerotherapy with and without ethanol concentration monitoring for the treatment of simple renal cysts. Sixty-seven patients with 70 simple renal cysts were randomly assigned to two groups in a 12-month prospective controlled trial. One group (group A) was treated with computed tomography (CT)-guided sclerotherapy without ethanol concentration monitoring (33 patients with 35 cysts), whereas the other group (group B) had ethanol concentration monitoring (34 patients with 35 cysts) during the procedure. Treatment outcomes between the two groups were compared 12 months later with follow-up ultrasound examination. After the 12-month follow-up period, the overall success rate was 74.3% in group A and 94.3% in group B (p = 0.022). The mean cyst size before and after treatment was 8.6 ± 2.0 cm and 2.3 ± 2.9 cm, respectively, in group A, and 8.4 ± 1.7 cm and 0.8 ± 1.9 cm, respectively, in group B. The final size of the cysts in group B was significantly smaller than that in group A (p = 0.015). The likelihood of treatment with ethanol concentration monitoring being successful was approximately 16 times higher than without ethanol concentration monitoring (p = 0.026; odds ratio = 15.7; 95% confidence interval: 1.38-179.49). There were no major complications in either group. Monitoring of Hounsfield units (HU) of ethanol by CT is an effective method in the treatment of simple renal cysts with ethanol sclerotherapy. The ethanol sclerotherapy procedure can be terminated at the point of clear fluid aspiration because the HU (-190) of CT scan corresponds to it.
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Use of PRA in the nuclear regulatory field in South Africa
International Nuclear Information System (INIS)
Hill, T.F.
1994-01-01
The nuclear regulatory authority in South Africa (since 1988 the Council for Nuclear Safety (CNS)), established in 1973 nuclear safety criteria against which to assess the level of safety of any facility using radioactive material. It is a regulatory requirement in South Africa to develop and maintain a living PRA for each facility and thereby to provide the necessary information to demonstrate compliance against these criteria. All safety submissions to the CNS must include at least a risk statement based on an accepted PRA study. The function of the CNS is to regulate all activities in South Africa involving the use of radioactive material and posing a significant risk to the public or plant personnel. This includes most aspects of the nuclear fuel cycle and the Koeberg NPS (two 2775 MW(th) PWRs). A PRA study including source terms for the two Koeberg units was presented by the contractor in 1979. This included the risk due to power and shutdown states and non reactor related accidents involving spent fuel storage, fuel handling and waste treatment related activities. At least 20 PRA studies have been performed for other nuclear facilities in the country. The CNS maintains an in-house PRA capability to perform independent assessments of licensee submission, to participate in developments of PRA methodology in the regulatory field, to perform pro-active safety work and to assist in regulatory decision making. Present ongoing work includes the development of a risk monitor, a risk management system, improvement in PRA codes, models, data collection and analysis, off-site risk assessment methodology and associated regulatory policy. (author). 1 fig
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Douglas, S.C.; Meijer, A.J.
2016-01-01
This article examines to what extent transparency is a condition for the creation of public value. Transparency is usually narrowly defined as a tool for external stakeholders to monitor the internal workings of an organization, but public value management positions transparency as a broader
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Energy Technology Data Exchange (ETDEWEB)
NONE
1997-09-01
This report describes the calendar year 1996 environmental surveillance and compliance monitoring activities of the Lockheed Martin Idaho Technologies Company Environmental Monitoring Program performed at the Idaho National Engineering and Environmental Laboratory (INEEL). Results of sampling performed by the Radiological Environmental Surveillance, Site Environmental Surveillance, Drinking Water, Effluent Monitoring, Storm Water Monitoring, Groundwater Monitoring, and Special Request Monitoring Programs are included in this report. The primary purposes of the surveillance and monitoring activities are to evaluate environmental conditions, to provide and interpret data, to verify compliance with applicable regulations or standards, and to ensure protection of human health and the environment. This report compares 1996 data with program-specific regulatory guidelines and past data to evaluate trends.
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International Nuclear Information System (INIS)
1997-09-01
This report describes the calendar year 1996 environmental surveillance and compliance monitoring activities of the Lockheed Martin Idaho Technologies Company Environmental Monitoring Program performed at the Idaho National Engineering and Environmental Laboratory (INEEL). Results of sampling performed by the Radiological Environmental Surveillance, Site Environmental Surveillance, Drinking Water, Effluent Monitoring, Storm Water Monitoring, Groundwater Monitoring, and Special Request Monitoring Programs are included in this report. The primary purposes of the surveillance and monitoring activities are to evaluate environmental conditions, to provide and interpret data, to verify compliance with applicable regulations or standards, and to ensure protection of human health and the environment. This report compares 1996 data with program-specific regulatory guidelines and past data to evaluate trends
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Bollaerts, Kaatje; De Smedt, Tom; Donegan, Katherine; Titievsky, Lina; Bauchau, Vincent
2018-03-26
New vaccines are launched based on their benefit-risk (B/R) profile anticipated from clinical development. Proactive post-marketing surveillance is necessary to assess whether the vaccination uptake and the B/R profile are as expected and, ultimately, whether further public health or regulatory actions are needed. There are several, typically not integrated, facets of post-marketing vaccine surveillance: the surveillance of vaccination coverage, vaccine safety, effectiveness and impact. With this work, we aim to assess the feasibility and added value of using an interactive dashboard as a potential methodology for near real-time monitoring of vaccine coverage and pre-specified health benefits and risks of vaccines. We developed a web application with an interactive dashboard for B/R monitoring. The dashboard is demonstrated using simulated electronic healthcare record data mimicking the introduction of rotavirus vaccination in the UK. The interactive dashboard allows end users to select certain parameters, including expected vaccine effectiveness, age groups, and time periods and allows calculation of the incremental net health benefit (INHB) as well as the incremental benefit-risk ratio (IBRR) for different sets of preference weights. We assessed the potential added value of the dashboard by user testing amongst a range of stakeholders experienced in the post-marketing monitoring of vaccines. The dashboard was successfully implemented and demonstrated. The feedback from the potential end users was generally positive, although reluctance to using composite B/R measures was expressed. The use of interactive dashboards for B/R monitoring is promising and received support from various stakeholders. In future research, the use of such an interactive dashboard will be further tested with real-life data as opposed to simulated data.
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Managing "Academic Value": The 360-Degree Perspective
Wilson, Margaret R.; Corr, Philip J.
2018-01-01
The "raison d'etre" of all universities is to create and deliver "academic value", which we define as the sum total of the contributions from the 360-degree "angles" of the academic community, including all categories of staff, as well as external stakeholders (e.g. regulatory, commercial, professional and community…
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Dry Cask Storage Inspection and Monitoring. Interim Report.
Energy Technology Data Exchange (ETDEWEB)
Bakhtiari, Susan [Argonne National Lab. (ANL), Argonne, IL (United States); Elmer, Thomas W. [Argonne National Lab. (ANL), Argonne, IL (United States); Koehl, Eugene R. [Argonne National Lab. (ANL), Argonne, IL (United States); Wang, Ke [Argonne National Lab. (ANL), Argonne, IL (United States); Raptis, Apostolos C. [Argonne National Lab. (ANL), Argonne, IL (United States); Kunerth, Dennis C. [Idaho National Lab. (INL), Idaho Falls, ID (United States); Birk, Sandra M. [Idaho National Lab. (INL), Idaho Falls, ID (United States)
2014-03-04
Recently, the U.S. Nuclear Regulatory Commission (NRC) issued the guidance on the aging management of dry storage facilities that indicates the necessity to monitor the conditions of dry cask storage systems (DCSSs) over extended periods of time.1 Part of the justification of the aging management plans is the requirement for inspection and monitoring to verify whether continued monitoring, inspection or mitigation are necessary. To meet this challenge Argonne National Laboratory (ANL) in collaboration with Idaho National Laboratory (INL) is conducting scoping studies on current and emerging nondestructive evaluation/examination (NDE) and online monitoring (OLM) technologies for DCSS integrity assessments. The scope of work plan includes identification and verification of technologies for long-term online monitoring of DCSSs’ crucial physical parameters such as temperature, pressure, leakage and structural integrity in general. Modifications have been made to the current technologies to accommodate field inspections and monitoring. A summary of the scoping studies and experimental efforts conducted to date as well as plans for future activities is provided below.
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The value of 99Tcm-HSA in monitoring acute lung injury induced by lipopolysaccharide in rats
International Nuclear Information System (INIS)
Fu Zhanli; Zhang Chunli; Wang Rongfu; Zhang Shengsuo; Xue Yun
2005-01-01
To evaluate the value of 99 Tc m labeled human serum albumin ( 99 Tc m -HSA) in monitoring acute lung injury (ALI) induced by lipopolysaccharide (LPS) in rats, twenty adult Wistar rats are given 99 Tc m -HSA intravenously, and are randomly divided into four groups 30 min later. The control and LPS group are given intravenous injection of 0.9% saline and LPS 8 mg/kg respectively. The ketamine and aminoguanidine group are given intraperitoneal injection of ketamine 4 mg/kg and aminoguanidine 20 mg/kg respectively just 30 min after administration of LPS 8 mg/kg. All of the four group rats are killed by blood letting at 3 h post-injection of 99 Tc m -HSA. Pulmonary permeability index (PPI) and the ratio of lung wet weight and dry weight (W/D) is calculated. The results of PPI and W/D in control and LPS group are 95.58 ± 11.32 and 5.38 ± 0.24, 6.61 ± 0.18 and 4.19 ± 0.11, respectively. The PPI and W/D in LPS group are much higher than that in the control group (P 0.05). So 99 tc m -HSA is an effective tracer in monitoring ALI induced by LPS in rats. (authors)
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International Nuclear Information System (INIS)
Severa, R.
2016-01-01
Africa is a continent endowed in mineral resources. Among others, there are vast deposits of gold and uranium in African countries. The by-products of these minerals are in some cases radioactive and therefore exposures must be monitored. Additionally, Africa uses a lot of radioactive sources in different industries and in the health sector. Regulation of these mining activities and facilities handling these radioactive sources becomes extremely important for the protection of people, property and the environment against harmful effects of ionizing radiation. Due to the vast size of the African continent, with inequitable resources, regional cooperation becomes key to capacity building and knowledge and information sharing. In order to achieve this, African Member States resolved to form a Forum for Nuclear Regulatory Bodies in Africa (FNRBA) in 2009. The paper will present the FNRBA, its activities, achievements and challenges in the quest to bring about effective regulation of nuclear and radiation safety in the continent. (author)
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International Nuclear Information System (INIS)
Okido, Fumiyasu; Arita, Setsuo.
1994-01-01
The present invention concerns neutron monitoring for monitoring reactor power, and presents a generation state of abnormal signals by monitoring output signals from neutron sensors, judges abnormal signals at an excessively high level outputted from the sensors to a measuring operator or a reactor operator. That is, a threshold value judging means judges whether a sensor signal exceeds a predetermined threshold value or not. When it exceeds the value, recognition signals are outputted to a memory means. The memory means memorizes the times of input of the recognition signals on every period of interval signals outputted from a reference signal generation means. The memory content of the memory means and the previously inputted hysteresis of the sensor are compared and judged, to determine the extent of the degradation of the sensors and output the result of the judgement and hysteresis information to the display means. The input means accesses to the judging means and the memory means to retrieve and correct the content of the memory means and the hysteresis information inputted to the judging means. (I.S.)
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DEFF Research Database (Denmark)
Andersen, Mads Hald
2017-01-01
responses to tumours or inhibiting autoimmunity development. However, recent studies report the discovery of self-reactive pro-inflammatory T cells—termed anti-regulatory T cells (anti-Tregs)—that target immune-suppressive cells. Thus, regulatory cells can now be defined as both cells that suppress immune...... reactions as well as effector cells that counteract the effects of suppressor cells and support immune reactions. Self-reactive anti-Tregs have been described that specifically recognize human leukocyte antigen-restricted epitopes derived from proteins that are normally expressed by regulatory immune cells......Our initial understanding of immune-regulatory cells was based on the discovery of suppressor cells that assure peripheral T-cell tolerance and promote immune homeostasis. Research has particularly focused on the importance of regulatory T cells (Tregs) for immune modulation, e.g. directing host...
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Monitoring method for steam generator operation
International Nuclear Information System (INIS)
Tamaoki, Tetsuo
1991-01-01
In an LMFBR plant having an once-through steam generator, reduction of life of a heat transfer pipe caused by heat cycle fatigue is monitored by early finding for the occurrence of abnormality in the inside of the steam generator and by continuous monitoring for the position of departure from nucleate boiling (DNB), which are difficult with existent static characteristic analysis codes. That is, RMS values of fluctuations in temperature signals sent from thermocouples for measuring the fluid temperature in the vicinity of heat transfer pipe disposed along a primary channel of the once-through type steam generator. The abnormality in heat transfer performance is monitored by the distribution change of the RMS values. Subsequently, DNB point on the side of water and steam is determined by the distribution of the RMS value. Then, accumulated values of the product between the time in which the starting point stays in the DNB region and a life consumption amount per unit time given in accordance with the operation condition are monitored. Accordingly, thermal fatigue failure of the heat transfer pipe due to temperature fluctuation in the DNB region is monitored. (I.S.)
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Neutron flux monitoring device
International Nuclear Information System (INIS)
Goto, Yasushi; Mitsubori, Minehisa; Ohashi, Kazunori.
1997-01-01
The present invention provides a neutron flux monitoring device for preventing occurrence of erroneous reactor scram caused by the elevation of the indication of a start region monitor (SRM) due to a factor different from actual increase of neutron fluxes. Namely, judgement based on measured values obtained by a pulse counting method and a judgment based on measured values obtained by a Cambel method are combined. A logic of switching neutron flux measuring method to be used for monitoring, namely, switching to an intermediate region when both of the judgements are valid is adopted. Then, even if the indication value is elevated based on the Cambel method with no increase of the counter rate in a neutron source region, the switching to the intermediate region is not conducted. As a result, erroneous reactor scram such as 'shorter reactor period' can be avoided. (I.S.)
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12 CFR 562.2 - Regulatory reports.
2010-01-01
... § 562.2 Regulatory reports. (a) Definition and scope. This section applies to all regulatory reports, as... (TFR) are examples of regulatory reports. Regulatory reports are regulatory documents, not accounting... limited to, the accounting instructions provided in the TFR, guidance contained in OTS regulations...
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Decina, Daniela; Fournier-Caruana, Jacqueline; Takane, Marina; Ostad Ali Dehaghi, Razieh; Sutter, Roland
2017-07-01
Withdrawal of type 2 oral poliovirus vaccine (OPV) in OPV-using countries required regulatory approval for use of inactivated poliovirus vaccine and bivalent OPV in routine immunization. Worldwide, a variety of mechanisms were used by member states, with some differences in approach observed between inactivated poliovirus vaccine and bivalent OPV. These included acceptance for use of World Health Organization (WHO) prequalified vaccines, registration and licensure pathways, participation in WHO-convened joint reviews of licensing dossiers, as well as pragmatic application of alternatively available mechanisms, when appropriate. Simple but effective tools were used to monitor progress and to record, authenticate, and share information. Essential to achievement of regulatory targets was ongoing communication with key stakeholders, including switch-country national regulatory authorities, vaccine manufacturers, partner organizations, and relevant units within WHO. Understanding of the regulatory environment gained through the OPV switch can be helpful in supporting further stages of the polio end game and other time-sensitive vaccine introduction programs. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.
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Energy Technology Data Exchange (ETDEWEB)
Morgan, M.G.; Morris, S.C.
1977-01-01
Knowledge of the relationship between ambient air pollution levels measured at fixed monitoring stations and the actual exposure of the population is very limited. Indeed, there is rapidly growing evidence that fixed-station monitors do not provide adequate data for population exposure. This report examines available data for carbon monoxide (CO) and sulfur dioxide (SO/sub 2/) and presents a new analysis. Actual population exposure to CO appears to be consistently higher than expected from fixed-station data, while limited evidence suggests that exposures to SO/sub 2/ are lower. A reported general relationship between indoor and outdoor levels of SO/sub 2/ is not supported by the data. If air pollution represents a threat to public health, then more attention must be given to total population exposure to pollutants. A selective use of individual air pollution monitors that can be worn or carried appears to be required at some stage by any experimental design seeking to uncover the relation between air pollution exposure and health effects. Additionally, potential uses of individual monitoring in air pollution regulation are explored. Current status and research needs for individual air pollution monitors are examined and a first-order evaluation is given of the promise held by the candidate instrumentation technologies. A national program of support for the development of individual air pollution monitors is recommended.
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2010-09-29
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...
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Mohamed Salleh, Faridah Hani; Arif, Shereena Mohd; Zainudin, Suhaila; Firdaus-Raih, Mohd
2015-12-01
A gene regulatory network (GRN) is a large and complex network consisting of interacting elements that, over time, affect each other's state. The dynamics of complex gene regulatory processes are difficult to understand using intuitive approaches alone. To overcome this problem, we propose an algorithm for inferring the regulatory interactions from knock-out data using a Gaussian model combines with Pearson Correlation Coefficient (PCC). There are several problems relating to GRN construction that have been outlined in this paper. We demonstrated the ability of our proposed method to (1) predict the presence of regulatory interactions between genes, (2) their directionality and (3) their states (activation or suppression). The algorithm was applied to network sizes of 10 and 50 genes from DREAM3 datasets and network sizes of 10 from DREAM4 datasets. The predicted networks were evaluated based on AUROC and AUPR. We discovered that high false positive values were generated by our GRN prediction methods because the indirect regulations have been wrongly predicted as true relationships. We achieved satisfactory results as the majority of sub-networks achieved AUROC values above 0.5. Copyright © 2015 Elsevier Ltd. All rights reserved.
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Safety Experts Complete IAEA Nuclear Regulatory Review of the United States
International Nuclear Information System (INIS)
2010-01-01
nuclear regulators. Such missions also help to build mutual confidence between States in the field of nuclear regulation.'' The IRRS team identified several strengths in the U.S. regulatory system, including: The achievement of a mature safety regulation system that meets its clearly defined strategic goals, organizational values, and the NRC's principles of good regulation; A transparent licensing process that accepts input from public citizens and environmental reviews, and ensures that key documents are publicly available; and A high level of human resource development, due to rigorous staff training at all levels and efforts to ensure long-term knowledge management. The IRRS team also made suggestions to improve the overall performance of the U.S. regulatory system. Examples include: The NRC should consider increasing its effort to use IAEA safety standards in its own regulations; The NRC should develop a fully integrated management system that will coordinate a number of programs and processes that are currently not fully integrated; and The NRC should incorporate lessons learned by the practice of other nations using licensee-conducted periodic safety reviews as a way to improve the NRC's assessment process. IAEA Deputy Director General Denis Flory said, ''I have been impressed by the worldwide interest and international participation in the IAEA's IRRS program. I appreciate the U.S. willingness to invite this mission and demonstrate the value of this service for all nations.'' General information about the Integrated Regulatory Review Service (IRRS) and previous missions can be found on the IAEA website. (IAEA)
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The impact of measurement errors in the identification of regulatory networks
Directory of Open Access Journals (Sweden)
Sato João R
2009-12-01
Full Text Available Abstract Background There are several studies in the literature depicting measurement error in gene expression data and also, several others about regulatory network models. However, only a little fraction describes a combination of measurement error in mathematical regulatory networks and shows how to identify these networks under different rates of noise. Results This article investigates the effects of measurement error on the estimation of the parameters in regulatory networks. Simulation studies indicate that, in both time series (dependent and non-time series (independent data, the measurement error strongly affects the estimated parameters of the regulatory network models, biasing them as predicted by the theory. Moreover, when testing the parameters of the regulatory network models, p-values computed by ignoring the measurement error are not reliable, since the rate of false positives are not controlled under the null hypothesis. In order to overcome these problems, we present an improved version of the Ordinary Least Square estimator in independent (regression models and dependent (autoregressive models data when the variables are subject to noises. Moreover, measurement error estimation procedures for microarrays are also described. Simulation results also show that both corrected methods perform better than the standard ones (i.e., ignoring measurement error. The proposed methodologies are illustrated using microarray data from lung cancer patients and mouse liver time series data. Conclusions Measurement error dangerously affects the identification of regulatory network models, thus, they must be reduced or taken into account in order to avoid erroneous conclusions. This could be one of the reasons for high biological false positive rates identified in actual regulatory network models.
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Dubuc, Alexia; Waltham, Nathan; Malerba, Martino; Sheaves, Marcus
2017-11-01
Little is known about levels of dissolved oxygen fish are exposed to daily in typical urbanised tropical wetlands found along the Great Barrier Reef coastline. This study investigates diel dissolved oxygen (DO) dynamics in one of these typical urbanised wetlands, in tropical North Queensland, Australia. High frequency data loggers (DO, temperature, depth) were deployed for several days over the summer months in different tidal pools and channels that fish use as temporal or permanent refuges. DO was extremely variable over a 24 h cycle, and across the small-scale wetland. The high spatial and temporal DO variability measured was affected by time of day and tidal factors, namely water depth, tidal range and tidal direction (flood vs ebb). For the duration of the logging time, DO was mainly above the adopted threshold for hypoxia (50% saturation), however, for around 11% of the time, and on almost every logging day, DO values fell below the threshold, including a severe hypoxic event (nursery ground value. There is a substantial discontinuity between the recommended DO values in the Australian and New Zealand Guidelines for Fresh and Marine Water Quality and the values observed in this wetland, highlighting the limited value of these guidelines for management purposes. Local and regional high frequency data monitoring programs, in conjunction with local exposure risk studies are needed to underpin the development of the management that will ensure the sustainability of coastal wetlands.
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2011-04-13
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...
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2011-07-08
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... a more limited application by their terms. For more information about the rulebook consolidation...
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2010-11-22
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...
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International Nuclear Information System (INIS)
Anon
1998-01-01
The development and application of a measuring method is described for thorium incorporation monitoring by way of measuring Rn-220 (thoron) in exhaled breath. The method is intended for application to monitoring the incorporation of thorium by occupationally exposed persons in compliance with the regulatory guide on health physics monitoring for determination of whole-body dose. (orig./CB) [de
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2012-06-11
... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD06-6-000] Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory Commission (NRC) will hold a joint meeting...
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2011-09-28
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... 14, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...
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2010-07-15
... registered capacity, may work in other investment-related industries, such as financial planning, or may seek...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule..., 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...
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International Nuclear Safety Experts Conclude IAEA Peer Review of Swiss Regulatory Framework
International Nuclear Information System (INIS)
2011-01-01
Full text: A team of international nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the regulatory framework for nuclear safety in Switzerland. The Integrated Regulatory Review Service (IRRS) mission noted good practices in the Swiss system and also made recommendations for the nation's nuclear regulatory authority, the Swiss Federal Nuclear Safety Inspectorate (ENSI). ''Our team developed a good impression of the independent Swiss regulator - ENSI - and the team considered that ENSI deserves particular credit for its actions to improve Swiss safety capability following this year's nuclear accident in Japan,'' said IRRS Team Leader Jean-Christophe Niel of France. The mission's scope covered the Swiss nuclear regulatory framework for all types of nuclear-related activities regulated by ENSI. The mission was conducted from 20 November to 2 December, mainly at ENSI headquarters in Brugg. The team held extensive discussions with ENSI staff and visited many Swiss nuclear facilities. IRRS missions are peer reviews, not inspections or audits, and are conducted at the request of host nations. For the Swiss review, the IAEA assembled a team of 19 international experts from 14 countries. The experts came from Belgium, Brazil, the Czech Republic, Finland, France, Germany, Italy, the Republic of Korea, Norway, Russia, Slovakia, Sweden, the United Kingdom, and the United States. ''The findings of the IRRS mission will help us to further improve our work. That is part of our safety culture,'' said ENSI Director General Hans Wanner. ''As Switzerland argued at international nuclear safety meetings this year for a strengthening of the international monitoring of nuclear power, we will take action to fulfil the recommendations.'' The IRRS team highlighted several good practices of the Swiss regulatory system, including the following: ENSI requires Swiss nuclear operators to back-fit their facilities by continuously upgrading
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Quality management of the nuclear regulatory body. Peer discussions on regulatory practices
International Nuclear Information System (INIS)
2001-09-01
This report is the outcome of the ninth series of peer discussions on regulatory practices entitled Nuclear Regulatory Body Quality Management, held in March and May 2001, and which involved the participation of senior nuclear regulators from 23 IAEA Member States. This report conveys the essence of two peer group discussions and highlights some good practices identified by the participating senior regulators. The objective of the discussions was to share experiences of regulatory bodies in implementing QM systems in their own work so as to ensure that the regulatory control over the licensees is effective and efficient and is commensurate with the mandate assigned by their governments. The shared experiences and good practices presented in the report, however, do not necessarily reflect the views of and good practices endorsed by the governments of the nominating Member States, the organizations to which the regulators belong, or the IAEA. The report sets down the peer group's experience in developing, implementing and evaluating QM within their regulatory bodies and identifies points to bear in mind when introducing such a system. This report is structured so that it covers the subject matter under the main headings of: application of quality management to regulatory work; development and implementation of quality management; assessment and improvement of performance; and good practices
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2011-06-13
...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change To Adopt a Risk Monitor Mechanism June 7, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange Act of... NASDAQ Stock Market LLC (``NASDAQ'') filed with the Securities and Exchange Commission (``Commission...
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Future nuclear regulatory challenges
International Nuclear Information System (INIS)
Royen, J.
1998-01-01
In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)
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Development of the Level 1 PSA Model for PGSFR Regulatory
International Nuclear Information System (INIS)
Na, Hyun Ju; Lee, Yong Suk; Shin, Andong; Suh, Nam Duk
2014-01-01
SFR (sodium-cooled fast reactor) is Gen-IV nuclear energy system, which is designed for stability, sustainability and proliferation resistance. KALIMER-600 and PGSFR (Prototype Gen-IV SFR) are under development in Korea with enhanced passive safety concepts, e.g. passive reactor shutdown, passive residual heat removal, and etc. Risk analysis from a regulatory perspective is necessary for regulatory body to support the safety and licensing review of SFR. Safety issues should be identified in the early design phase in order to prevent the unexpected cost increase and the delay of PGSFR licensing schedule. In this respect, the preliminary PSA Model of KALIMER-600 had been developed for regulatory. In this study, the development of PSA Level 1 Model is presented. The important impact factors in the risk analysis for the PGSFR, such as Core Damage Frequency (CDF), have been identified and the related safety insights have been derived. The PSA level 1 model for PGSFR regulatory is developed and the risk analysis is conducted. Regarding CDF, LOISF frequency, uncertainty parameter for passive system CCF, loss of 125V DC control center bus and damper CCF are identified as the important factors. Sensitivity analyses show that the CDF would be differentiated (lowered) according to their values
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2012-02-10
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... thereunder,\\2\\ notice is hereby given that on January 30, 2012, Financial Industry Regulatory Authority, Inc.... For more information about the rulebook consolidation process, see Information Notice, March 12, 2008...
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2010-09-28
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the Proposed Rule.... I. Introduction On July 27, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k... pertinent distribution-related information from its members in a timely fashion to facilitate its Regulation...
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2011-08-16
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Increase the Position Limit for Options on the Standard and Poor's... Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...
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International Nuclear Information System (INIS)
Emelyanov, V.
1994-01-01
RESURS programme is described implementation of which will allow to work out regulatory-methodological basis providing legal and technical solution of NPP equipment lifetime management, prediction, monitoring and estimation problems
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Regulatory difficulties in a developing country
International Nuclear Information System (INIS)
Jacobs, W.R. Jr.
1978-01-01
The regulatory agency assigned the task of regulating the initial entry into the field of nuclear power generation by a developing country has a very difficult job. Based on the authors' experience during the start-up and initial operation of Ko-Ri Unit I, the first power reactor in the Republic of Korea, observations on regulatory difficulties and recommendations for improved regulatory effectiveness are offered. The problem areas can be loosely grouped into three general categories: (1) Lack of adequate technical knowledge which is the basis for all effective regulation; (2) Difficulties with understanding and utilization of the required regulatory documentation; (3) Failure to establish the proper regulatory environment. Examples are cited from actual experience during the Ko-Ri Unit I start-up to demonstrate the impact that regulatory activities can have on a plant construction and testing programme. The problems encountered are not unique to developing countries but also exist in the United States of America. Recommendations are offered which should be beneficial to either newly formed regulatory agencies or agencies wishing to improve their abilities and effectiveness. These include: (1) Additional training of regulatory inspectors in plant operations; (2) Additional experience gained by participation in regulatory activities in other countries; (3) Increased attention given to regulatory documents, especially plant technical specifications; (4) Establishment of formal lines of communication between the utility and the regulatory agency; (5) Clear definition of regulatory responsibilities to avoid areas of overlapping jurisdiction; (6) Active participation by the regulatory staff very early in the project. It is hoped that these and other recommendations offered will greatly improve regulatory effectiveness and at the same time demonstrate that when the decision is made to 'go nuclear', a strong commitment must be made to develop and support a technically
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Radiation Exposure Monitoring and Information Transmittal (REMIT) system
International Nuclear Information System (INIS)
Cale, R.; Clark, T.; Dixson, R.; Hagemeyer, D.
1993-06-01
The Radiation Exposure Monitoring and Information Transmittal (REMIT) system is designed to assist US Nuclear Regulatory Commission (NRC)licensees in meeting the reporting requirements of the revised 10 CFR 20 and in agreement with the guidance contained in R.G. 8.7, Rev. 1, ''Instructions for Recording and Reporting Occupational Exposure Data.'' REMIT is a personal computer (PC) based menu driven system that facilitates the manipulation of data base files to record and report radiation exposure information. REMIT is designed to be user-friendly and contains the full text of R. G. 8.7, Rev. 1, on-line as well as context-sensitive help throughout the program. The user can enter data directly from NRC Forms 4 or 5, REMIT allows the user to view the individual's exposure in relation to regulatory or administrative limits and alerts the user to exposures in excess of these limits. The system also provides for the calculation and summation of dose from intakes and the determination of the dose to the maximally exposed extremity for the monitoring year. REMIT can produce NRC Forms 4 and 5 in paper and electronic format and can import/export data from ASCII and data base files
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Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L
2017-11-01
Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.
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Regulatory control of nuclear power plants
International Nuclear Information System (INIS)
2002-01-01
The purpose of this book is to support IAEA training courses and workshops in the field of regulatory control of nuclear power plants as well as to support the regulatory bodies of Member States in their own training activities. The target group is the professional staff members of nuclear safety regulatory bodies supervising nuclear power plants and having duties and responsibilities in the following regulatory fields: regulatory framework; regulatory organization; regulatory guidance; licensing and licensing documents; assessment of safety; and regulatory inspection and enforcement. Important topics such as regulatory competence and quality of regulatory work as well as emergency preparedness and public communication are also covered. The book also presents the key issues of nuclear safety such as 'defence-in-depth' and safety culture and explains how these should be taken into account in regulatory work, e.g. during safety assessment and regulatory inspection. The book also reflects how nuclear safety has been developed during the years on the basis of operating experience feedback and results of safety research by giving topical examples. The examples cover development of operating procedures and accident management to cope with complicated incidents and severe accidents to stress the importance of regulatory role in nuclear safety research. The main target group is new staff members of regulatory bodies, but the book also offers good examples for more experienced inspectors to be used as comparison and discussion basis in internal workshops organized by the regulatory bodies for refreshing and continuing training. The book was originally compiled on the basis of presentations provided during the two regulatory control training courses in 1997 and 1998. The textbook was reviewed at the beginning of the years 2000 and 2002 by IAEA staff members and consistency with the latest revisions of safety standards have been ensured. The textbook was completed in the
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Radiation and environmental monitoring at the nuclear legacy sites in Russia
Energy Technology Data Exchange (ETDEWEB)
Shandala, N.; Kiselev, S.; Titov, A.; Seregin, V.; Akhromeev, S.; Aladova, R.; Isaev, D. [SRC Burnasyan Federal Medical Biophysical Center (Russian Federation); Sneve, M. [Norwegian Radiation Protection Authority - NRPA (Norway)
2014-07-01
In 1960's, in the Northwest and Far East regions of Russia the technical bases of the Navy Fleet were built to maintain nuclear submarines by performing reloading of nuclear fuel, receiving and storing radioactive waste (RW) and spent nuclear fuel (SNF). In 2000, SevRAO enterprise in the northwest of Russia and DalRAO enterprise in the Far East were set up for the purposes of environmental remediation of the nuclear legacy sites. Regulatory supervision for radiation protection and safety at the nuclear legacy sites in Russian Far east and Northwest regions is one of regulatory functions of the Federal medical biological agency (FMBA of Russia). Improvement of the normative and regulatory basis has significant impact on effectiveness and efficiency of industrial projects aimed at reduction of nuclear and radiation hazard risk at the sites for the SNF and RW temporary storage (STS).To get unbiased comprehensive information on the current radiation conditions at the STSs and provide the effective response to changing radiation situation, the environmental radiation monitoring of the SevRAO and DalRAO facilities has been carried out during 2005-2013. The nature and peculiarity of the STS area radioactive contamination on the Kola Peninsula and in the Far East are the following: 1) high levels of radioactive contamination on the industrial site; 2) non-uniformity of the contamination distribution; 3) spread of contamination in the area of health protection zone. The following environmental components are contaminated: soil, vegetation, bottom sediments and seaweeds at the offshore sea waters. The dominant radionuclides are cesium-137 and strontium-90. At the facilities under inspection for the purpose of the dynamic control of the radiation situation the radio-ecological monitoring system was arranged. It presupposes regular radiometry inspections in-situ, their analysis and assessment of the radiation situation forecast in the course of the STS remediation main
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de Jong, Kim; de Goede, Marije
2015-01-01
Objective: Despite research on its effectiveness, many therapists still have negative attitudes toward using outcome monitoring feedback. The current study aims to investigate how the perceived match between values of an individual and those of the organization (Person–Organization fit; PO fit), and
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Review of structure damping values for elastic seismic analysis of nuclear power plants
International Nuclear Information System (INIS)
Hashimoto, P.S.; Steele, L.K.; Johnson, J.J.; Mensing, R.W.
1993-03-01
Current US Nuclear Regulatory Commission guidance on structure damping values for elastic seismic design analysis of nuclear power plants are contained in Regulatory Guide 1.61 (R.G. 1.61). The objectives of the study described in this report are to investigate the adequacy of R.G1.61 structure damping values based on currently available data, and to recommend revisions to R.G. 1.61 as appropriate. Measured structure damping values, and associated structure, foundation, excitation, and input/response parameters, were collected and compiled. These data were analyzed to identify the parameters that significantly influence structure damping and to quantify structure damping in terms of these parameters. Based on this study, current R.G. 1.61 damping values for structure design are either adequate, or require only minor revision, depending on the structure material. More explicit guidance on structure damping values for seismic analysis to determine input to equipment has been prepared, along with other recommendations to improve the applicability of R.G. 1.61
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Energy Technology Data Exchange (ETDEWEB)
Hong, R. L., Hamaguchi, L., Busch, M. A., and Weigel, D.
2003-06-01
OAK-B135 In Arabidopsis thaliana, cis-regulatory sequences of the floral homeotic gene AGAMOUS (AG) are located in the second intron. This 3 kb intron contains binding sites for two direct activators of AG, LEAFY (LFY) and WUSCHEL (WUS), along with other putative regulatory elements. We have used phylogenetic footprinting and the related technique of phylogenetic shadowing to identify putative cis-regulatory elements in this intron. Among 29 Brassicaceae, several other motifs, but not the LFY and WUS binding sites previously identified, are largely invariant. Using reporter gene analyses, we tested six of these motifs and found that they are all functionally important for activity of AG regulatory sequences in A. thaliana. Although there is little obvious sequence similarity outside the Brassicaceae, the intron from cucumber AG has at least partial activity in A. thaliana. Our studies underscore the value of the comparative approach as a tool that complements gene-by-gene promoter dissection, but also highlight that sequence-based studies alone are insufficient for a complete identification of cis-regulatory sites.
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Environmental radiation exposure: Regulation, monitoring, and assessment
International Nuclear Information System (INIS)
Chen, S.Y.; Yu, C.; Hong, K.J.
1991-01-01
Radioactive releases to the environment from nuclear facilities constitute a public health concern. Protecting the public from such releases can be achieved through the establishment and enforcement of regulatory standards. In the United States, numerous standards have been promulgated to regulate release control at nuclear facilities. Most recent standards are more restrictive than those in the past and require that radioactivity levels be as low as reasonably achievable (ALARA). Environmental monitoring programs and radiological dose assessment are means of ensuring compliance with regulations. Environmental monitoring programs provide empirical information on releases, such as the concentrations of released radioactivity in environmental media, while radiological dose assessment provides the analytical means of quantifying dose exposures for demonstrating compliance
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Improving nuclear regulatory effectiveness
International Nuclear Information System (INIS)
2001-01-01
Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)
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International Nuclear Information System (INIS)
Steinhauser, Georg
2017-01-01
After the Fukushima nuclear accident, beef proved to be a problematic food item with several exceedances entering the market. The reason was contaminated rice straw that was fed to cattle. Japanese authorities responded quickly to the exceedances and made beef one of the most-monitored food items after the Fukushima accident with more than a million samples within 5 years. Activity levels dropped quickly and are now considerably below the regulatory limit. No exceedance of the regulatory limit was observed after October 2012. The monitoring campaign focuses on the pre-market to catch any exceedances before they reach the consumer. The analysis also showed that some late beef samples exhibited an unusually high "1"3"4Cs/"1"3"7Cs activity ratio. The reason for this is unknown. (author)
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International Nuclear Information System (INIS)
Tsai, S.Y.
1988-01-01
Groundwater monitoring is an important technical requirement in managing hazardous waste disposal facilities. The purpose of monitoring is to assess whether and how a disposal facility is affecting the underlying groundwater system. This paper focuses on the regulatory and technical aspects of the design, placement, and sampling of groundwater monitoring wells for hazardous waste disposal facilities. Such facilities include surface impoundments, landfills, waste piles, and land treatment facilities. 8 refs., 4 figs
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Waste Isolation Pilot Plant Environmental Monitoring Plan
International Nuclear Information System (INIS)
2008-01-01
U.S. Department of Energy (DOE) Order 450.1, Environmental Protection Program, requires each DOE site to conduct environmental monitoring. Environmental monitoring at the Waste Isolation Pilot Plant (WIPP) is conducted in order to: (a) Verify and support compliance with applicable federal, state, and local environmental laws, regulations, permits, and orders; (b) Establish baselines and characterize trends in the physical, chemical, and biological condition of effluent and environmental media; (c) Identify potential environmental problems and evaluate the need for remedial actions or measures to mitigate the problems; (d) Detect, characterize, and report unplanned releases; (e) Evaluate the effectiveness of effluent treatment and control, and pollution abatement programs; and (f) Determine compliance with commitments made in environmental impact statements, environmental assessments, safety analysis reports, or other official DOE documents. This Environmental Monitoring Plan (EMP) explains the rationale and design criteria for the environmental monitoring program, extent and frequency of monitoring and measurements, procedures for laboratory analyses, quality assurance (QA) requirements, program implementation procedures, and direction for the preparation and disposition of reports. Changes to the environmental monitoring program may be necessary to allow the use of advanced technology and new data collection techniques. This EMP will document changes in the environmental monitoring program. Guidance for preparation of EMPs is contained in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance.
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2010-05-17
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate...\\ and Rule 19b-4 thereunder,\\2\\ notice is hereby given that on April 27, 2010, the Financial Industry... restated following the formation of FINRA through the consolidation of NASD and the member regulatory...
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International Nuclear Information System (INIS)
Watson, J.G.; Chow, J.C.; Egami, R.T.; Bowen, J.L.; Frazier, C.A.
1991-06-01
The State of California monitors the concentrations of acidic gases and particles at 10 sites throughout the state. Seven sites represent urban areas (South Coast Air Basin - three sites, San Francisco Bay Area, Bakersfield, Santa Barbara, and Sacramento) and three represent forested areas (Sequoia National Park, Yosemite National Park, and Gasquet). Several sites are collocated with monitoring instruments for other air quality and forest response networks. Continuous monitors for the dry deposition network collect hourly average values for ozone, wind speed, wind direction, atmospheric stability, temperature, dew point, time of wetness, and solar radiation. A newly-designed gas/particle sampler collects daytime (6 a.m. to 6 p.m.) and nighttime (6 p.m. to 6 a.m.) samples every sixth day for sulfur dioxide, ammonia, nitrogen dioxide, and nitric acid. Particles are collected on the same day/night schedule in PM(10) and PM(2.5) size ranges, and are analyzed for mass, sulfate, nitrate, chloride, ammonium, sodium, magnesium, potassium, and calcium ions. The sampling schedule follows the regulatory schedule adopted by the EPA and ARB for suspended particulate matter. Wet deposition data are collected at or nearby the dry deposition stations. The first year of the monitoring program included installation of the network, training of technicians, acquisition and validation of data, and transfer of the sampling and analysis technology to Air Resources Board operating divisions. Data have been validated and stored for the period May, 1988 through September, 1989
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Johnson, Rachel C.; Windell, Sean; Brandes, Patricia L.; Conrad, J. Louise; Ferguson, John; Goertler, Pascale A. L.; Harvey, Brett N.; Heublein, Joseph; Isreal, Joshua A.; Kratville, Daniel W.; Kirsch, Joseph E.; Perry, Russell W.; Pisciotto, Joseph; Poytress, William R.; Reece, Kevin; Swart, Brycen G.
2017-01-01
A robust monitoring network that provides quantitative information about the status of imperiled species at key life stages and geographic locations over time is fundamental for sustainable management of fisheries resources. For anadromous species, management actions in one geographic domain can substantially affect abundance of subsequent life stages that span broad geographic regions. Quantitative metrics (e.g., abundance, movement, survival, life history diversity, and condition) at multiple life stages are needed to inform how management actions (e.g., hatcheries, harvest, hydrology, and habitat restoration) influence salmon population dynamics. The existing monitoring network for endangered Sacramento River winterrun Chinook Salmon (SRWRC, Oncorhynchus tshawytscha) in California’s Central Valley was compared to conceptual models developed for each life stage and geographic region of the life cycle to identify relevant SRWRC metrics. We concluded that the current monitoring network was insufficient to diagnose when (life stage) and where (geographic domain) chronic or episodic reductions in SRWRC cohorts occur, precluding within- and among-year comparisons. The strongest quantitative data exist in the Upper Sacramento River, where abundance estimates are generated for adult spawners and emigrating juveniles. However, once SRWRC leave the upper river, our knowledge of their identity, abundance, and condition diminishes, despite the juvenile monitoring enterprise. We identified six system-wide recommended actions to strengthen the value of data generated from the existing monitoring network to assess resource management actions: (1) incorporate genetic run identification; (2) develop juvenile abundance estimates; (3) collect data for life history diversity metrics at multiple life stages; (4) expand and enhance real-time fish survival and movement monitoring; (5) collect fish condition data; and (6) provide timely public access to monitoring data in open data
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Savannah River Site Environmental Monitoring Plan. Volume 1, Section 1000 Addendum: Revision 3
International Nuclear Information System (INIS)
Jannik, G.T.
1994-01-01
This document -- the Savannah River Site Environmental Monitoring Plan (SRS EM Plan) -- has been prepared according to guidance contained in the DOE 5400 Series orders, in 10 CFR 834, and in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and environmental Surveillance [DOE, 1991]. The SRS EM Plan's purpose is to define the criteria, regulations, and guideline requirements with which SRS will comply. These criteria and requirements are applicable to environmental monitoring activities performed in support of the SRS Environmental Monitoring Program (SRS EM Program), WSRC-3Q1-2, Volume 1, Section 1100. They are not applicable to monitoring activities utilized exclusively for process monitoring/control. The environmental monitoring program requirements documented in the SRS EM Plan incorporate all applicable should requirements of DOE/EH-0173T and expand upon them to include nonradiological environmental monitoring program requirements
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Nuclear Regulatory legislation
International Nuclear Information System (INIS)
1984-06-01
This compilation of statutes and material pertaining to nuclear regulatory legislation through the 97th Congress, 2nd Session, has been prepared by the Office of the Executive Legal Director, U.S. Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document
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Muderris, Togay; Gokcan, M Kursat; Yorulmaz, Irfan
2009-02-01
To determine the clinical value of pharyngeal pH monitoring for the diagnosis of laryngopharyngeal reflux (LPR) by using a double-probe, triple-sensor catheter in patients with symptoms of LPR. Prospective review of pH values recorded at the pharyngeal sensor, with the sensor placed in the proximal esophagus in patients with suspected LPR. Tertiary care university hospital. Thirty-three consecutive patients with symptoms of LPR. A pH test result was considered abnormal if a single reflux episode was detected in the hypopharynx and if, in the proximal esophagus, the total percentage of time the pH value was below 4 was 1.0% or higher. Data obtained from sensors were compared to determine the validity of pharyngeal sensor. Correlation between patients' reflux finding scores, reflux finding indexes, and reflux episodes were analyzed. Of 33 patients, 17 had more than 1 reflux episode detected by the pharyngeal sensor and 19 had pathological reflux detected by the proximal esophageal sensor. Four patients who had pharyngeal reflux had a normal esophageal acid exposure time, and 6 patients who had pathological reflux detected by the proximal esophageal sensor did not experienced any pharyngeal reflux episode. Four patients would have had a false-negative test result and 6 subjects would have had a false-positive test result if a hypopharyngeal pH sensor was not implemented. The adjustable, bifurcated, triple-sensor pH probe allows identifying true hypopharyngeal reflux episodes. If single-probe, double-sensor pH monitoring is to be performed, the proximal probe should be placed in the pharynx, not in the upper esophagus.
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2010-09-02
... characteristics and risks of security futures. \\6\\ 15 U.S.C. 78o-3(b)(6). B. Self-Regulatory Organization's...-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 August 27, 2010...
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Long term pipeline monitoring in geomechanically sensitive environments
Energy Technology Data Exchange (ETDEWEB)
Weir-Jones, I.; Sun, M. [Weir-Jones Engineering Consultants Ltd. (Canada)
2011-07-01
In the oil industry, monitoring pipeline structural integrity is necessary for both regulatory and environmental purposes. Weir-Jones Engineering Consultants developed an automated structural integrity monitoring (SIM) system, data on strain, displacement and temperature are continuously acquired and automatically transmitted to the monitoring personnel. The aim of this paper is to present this technology and its implementation on one of Inter Pipeline Fund's lines as well. The automated SIM equipment was installed on a new 42'' line at the crossing of the Clearwater River close to Fort McMurray. Results showed that this technology is a good way to monitor pipelines in remote locations, environmentally sensitive areas, river and embankment crossings and in locations where external forces can put the pipeline at risk; but it should not be used otherwise as that would not be cost effective. This paper described the developed automated SIM and showed that it should only be used in specific locations to be cost effective.
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The Westinghouse BEACON on-line core monitoring system
International Nuclear Information System (INIS)
Buechel, Robert J.; Boyd, William A.; Casadei, Alberto L.
1995-01-01
BEACON (Best Estimate Analysis of Core Operations - Nuclear), a core monitoring and operational support package developed by Westinghouse, has been installed at many operating PWRs worldwide. The BEACON system is a real-time monitoring system which can be used in plants with both fixed and movable incore detector systems and utilizes an on-line nodal model combined with core instrumentation data to provide continuous core power distribution monitoring. In addition, accurate core-predictive capabilities utilizing a full core nodal model updated according to plant operating history can be made to provide operational support. Core history information is kept and displayed to help operators anticipate core behavior and take pro-active control actions. The BEACON system has been licensed by the U.S. Nuclear Regulatory Commission for direct, continuous monitoring of DNBR and peak linear heat rate. This allows BEACON to be integrated into the plant technical specifications to permit significant relaxation of operating limitations defined by conventional technical specifications. (author). 4 refs, 2 figs, 1 tab
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International Nuclear Information System (INIS)
1990-01-01
The NRC Regulatory Agenda is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter
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The Value of Continuous ST-Segment Monitoring in the Emergency Department.
Bovino, Leonie Rose; Funk, Marjorie; Pelter, Michele M; Desai, Mayur M; Jefferson, Vanessa; Andrews, Laura Kierol; Forte, Kenneth
2015-01-01
Practice standards for electrocardiographic monitoring recommend continuous ST-segment monitoring (C-STM) in patients presenting to the emergency department (ED) with signs and/or symptoms of acute coronary syndrome (ACS), but few studies have evaluated its use in the ED. We compared time to diagnosis and 30-day adverse events before and after implementation of C-STM. We also evaluated the diagnostic accuracy of C-STM in detecting ischemia and infarction. We prospectively studied 163 adults (preintervention: n = 78; intervention: n = 85) in a single ED and stratified them into low (n = 51), intermediate (n = 100), or high (n = 12) risk using History, ECG, Age, Risk factors, and Troponin (HEART) scores. The principal investigator monitored participants, activating C-STM on bedside monitors in the intervention phase. We used likelihood ratios (LRs) as the measure of diagnostic accuracy. Overall, 9% of participants were diagnosed with ACS. Median time to diagnosis did not differ before and after implementation of C-STM (5.55 vs. 5.98 hr; p = 0.43). In risk-stratified analyses, no significant pre-/postdifference in time to diagnosis was found in low-, intermediate-, or high-risk participants. There was no difference in the rate of 30-day adverse events before versus after C-STM implementation (11.5% vs. 10.6%; p = 0.85). The +LR and -LR of C-STM for ischemia were 24.0 (95% confidence interval [CI]: 1.4, 412.0) and 0.3 (95% CI: 0.02, 2.9), respectively, and for infarction were 13.7 (95% CI: 1.7, 112.3) and 0.7 (95% CI: 0.3, 1.5), respectively. Use of C-STM did not provide added diagnostic benefit for patients with signs and/or symptoms of myocardial ischemia in the ED.
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2012-12-18
... classes that the Market Maker has the general obligation to attract order flow to the Exchange. MIAX will... accordance with instructions received from the applicable Primary Lead Market Maker ``PLMM'' or Lead Market... order that was routed. Regulatory Fees A. Sales Value Fee The Sales Value Fee \\7\\ is assessed by the...
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Li, Ping; Li, Yang; Zhang, Ji; Yu, Shan-Fa; Wang, Zhi-Liang; Jia, Guang
2016-10-01
The concentration of chromium in the blood (CrB) has been confirmed as a biomarker for occupational chromium exposure, but its biological exposure indices (BEIs) are still unclear, so we collected data from the years 2006 and 2008 (Shandong Province, China) to analyze the relationship between the concentration of chromium in the air (CrA) of the workplaces and CrB to establish a reference value of CrB for biological monitoring of occupational workers. The levels of the indicators for nasal injury, kidney (β2 microglobulin (β2-MG)), and genetic damages (8-hydroxy-deoxyguanosine (8-OHdG) and micronucleus (MN)) were measured in all subjects of the year 2011 (Henan Province, China) to verify the protective effect in this reference value of CrB. Compared with the control groups, the concentrations of CrA and CrB in chromium exposed groups were significantly higher (P value of CrB was recommended to 20 μg/L. The levels of nasal injury, β2-MG, 8-OhdG, and MN were not significantly different between the low chromium exposed group (CrB ≤ 20 μg/L) and the control group, while the levels of β2-MG, 8-OHdG, and MN were statistically different in the high chromium exposed group than that in the control group. This research proved that only in occupational workers, CrB could be used as a biomarker to show chromium exposure in the environment. The recommended reference value of CrB was 20 μg/L. © The Author(s) 2015.
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International Nuclear Information System (INIS)
Ballard, H.N.; Hay, S.C.; Shade, W.N. Jr.
1992-01-01
In this paper a practical overview of stationary natural gas engine exhaust emissions control technology and trends in emissions regulatory requirements is presented. Selective and non-selective catalytic reduction and lean burn technologies are compared. Particular emphasis is focussed on implications of the Clean Air Act of 1990. Recent emissions reduction conversion kit developments and a practical approach to continuous monitoring are discussed
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Beguería, S.
2017-12-01
While large efforts are devoted to developing crop status monitoring and yield forecasting systems trough the use of Earth observation data (mostly remotely sensed satellite imagery) and observational and modeled weather data, here we focus on the information value of qualitative data on crop status from direct observations made by humans. This kind of data has a high value as it reflects the expert opinion of individuals directly involved in the development of the crop. However, they have issues that prevent their direct use in crop monitoring and yield forecasting systems, such as their non-spatially explicit nature, or most importantly their qualitative nature. Indeed, while the human brain is good at categorizing the status of physical systems in terms of qualitative scales (`very good', `good', `fair', etcetera), it has difficulties in quantifying it in physical units. This has prevented the incorporation of this kind of data into systems that make extensive use of numerical information. Here we show an example of using qualitative crop condition data to estimate yields of the most important crops in the US early in the season. We use USDA weekly crop condition reports, which are based on a sample of thousands of reporters including mostly farmers and people in direct contact with them. These reporters provide subjective evaluations of crop conditions, in a scale including five levels ranging from `very poor' to `excellent'. The USDA report indicates, for each state, the proportion of reporters fort each condition level. We show how is it possible to model the underlying non-observed quantitative variable that reflects the crop status on each state, and how this model is consistent across states and years. Furthermore, we show how this information can be used to monitor the status of the crops and to produce yield forecasts early in the season. Finally, we discuss approaches for blending this information source with other, more classical earth data sources
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Regulatory Body of Egypt: Practices and Challenges
International Nuclear Information System (INIS)
El-Messiry, A.
2016-01-01
In past, Egypt issued the law No. 59 of year 1969 for regulating the use of ionizing radiations inside the country, this law assigns the responsibilities of Egypt Atomic Energy Authority EAEA to control reactors, open sources, and all nuclear and radiation facilities inside its premises, while the ministry of health was responsible for controlling x-ray machine, sealed sources and accelerators. In 1982 EAEA established within its structure a new regulatory body called national centre for Nuclear Safety and radiation Control NC-NSRC as a dependent regulatory body, science EAEA is the operator of reactors and many nuclear and radiation facilities. On 30 March 2010 Egypt issued a nuclear law No 7 of year 2010, followed by its executive regulation in October 2011, the new law replaced the old law 59 of year 1969, in addition, the prime minster issued a decree on march 5td 2012 of establishing an independent regulatory body reported directly to him, it has the name of Egypt Nuclear and Radiological Regulatory Authority ENRRA, it is responsible for regulating all nuclear and radiation facilities and activities inside the country, except X-ray machines and linear accelerators for the medical uses, that still remains under the control of ministry of health. The new nuclear law defines the responsibility of the government to establish, support and determine the authorization and the responsibilities of the independent regulatory body. ENRRA is managed by a board of directors comprises from chairman, vice chairman, head of national security, interior, exterior, customs, export & import, standards, environment, justice organizations, besides two scientific experts from ENRRA. The board of council is the supreme authority of the dominant, and the conduct of ENRRA affairs, and take decisions within the framework of the national plan of Egypt, to achieve the objectives for which the ENRRA was established. ENRRA was organized from the old NC-NSRC staff into three regulatory
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Cultural Differences in Values as Self-Guides.
Cheung, Wing-Yee; Maio, Gregory R; Rees, Kerry J; Kamble, Shanmukh; Mane, Sangeetha
2016-06-01
Three studies tested whether individualism-collectivism moderates the extent to which values are endorsed as ideal self-guides and ought self-guides, and the consequences for regulatory focus and emotion. Across Studies 1 and 2, individualists endorsed values that are relatively central to the self as stronger ideals than oughts, whereas collectivists endorsed them as ideals and oughts to a similar degree. Study 2 found that individualists justified central values using reasons that were more promotion focused than prevention focused, whereas collectivists used similar amount of prevention-focused and promotion-focused reasons. In Study 3, individualists felt more dejected after violating a central (vs. peripheral) value and more agitated after violating a peripheral (vs. central) value. Collectivists felt a similar amount of dejection regardless of values centrality and more agitation after violating central (vs. peripheral) values. Overall, culture has important implications for how we regulate values that are central or peripheral to our self-concept. © 2016 by the Society for Personality and Social Psychology, Inc.
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Directory of Open Access Journals (Sweden)
Stefano Menichetti
2017-03-01
Full Text Available The experience of the Environmental Protection Agency of Tuscany in the determination of background values start from 2009 with various substances such as metals, non-metals and inorganic, dioxins and various matrices such as soil, groundwater, inland surface waters and coastal marine sediments. The methodologies supplied in literature have been interpreted and integrated to meet the requirements of current legislation and needs for remediation, diffuse pollution and excavated earth in specific areas. The method for diffuse pollution described here focuses on the use of statistical and geostatistical tools and what we present in this paper are some early results of interest obtained from two case studies in the Florence and in the Prato area. The study has been carried out on concentrations of tetrachlorethylene in the two groundwater bodies by identifying a number of frequency classes in the distribution. Each class has been hypothesized as corresponding to a distinct process. The occurrence both in space and time of the classes has been analysed and discussed critically concluding for a background value that has been found similar between the two zones. The investigation conducted on two monitoring stations representing hot-spots, with values in excess on background value has enabled to map spatial distribution of concentrations and to separate plumes from diffuse pollution area. The two areas show some peculiarities: Florence area shows advanced dehalogenation and a clear spatial continuity, whereas in Prato area it is limited with poor spatial continuity suggesting a spreading with vertical motions from still active primary or secondary sources. Observing how the methodological structure would require, to be fully predictive, a greater number of samples, however, the present work want to constitute a first contribution for management of areas subject to diffuse pollution.
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Nuclear Regulatory Commission information digest
International Nuclear Information System (INIS)
1990-03-01
The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide
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Idaho National Laboratory Site Environmental Monitoring Plan
Energy Technology Data Exchange (ETDEWEB)
Nordstrom, Jenifer [Idaho National Lab. (INL), Idaho Falls, ID (United States)
2014-02-01
This plan provides a high-level summary of environmental monitoring performed by various organizations within and around the Idaho National Laboratory (INL) Site as required by U.S. Department of Energy (DOE) Order 435.1, Radioactive Waste Management, and DOE Order 458.1, Radiation Protection of the Public and the Environment, Guide DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance, and in accordance with 40 Code of Federal Regulations (CFR) 61, National Emission Standards for Hazardous Air Pollutants. The purpose of these orders is to 1) implement sound stewardship practices that protect the air, water, land, and other natural and cultural resources that may be impacted by DOE operations, and 2) to establish standards and requirements for the operations of DOE and DOE contractors with respect to protection of the environment and members of the public against undue risk from radiation. This plan describes the organizations responsible for conducting environmental monitoring across the INL Site, the rationale for monitoring, the types of media being monitored, where the monitoring is conducted, and where monitoring results can be obtained. Detailed monitoring procedures, program plans, or other governing documents used by contractors or agencies to implement requirements are referenced in this plan. This plan covers all planned monitoring and environmental surveillance. Non-routine activities such as special research studies and characterization of individual sites for environmental restoration are outside the scope of this plan.
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Regulatory decision making by decision analyses
International Nuclear Information System (INIS)
Holmberg, J.; Pulkkinen, U.
1993-11-01
The Technical Research Centre of Finland (VTT) has studied with the Finnish Centre for Radiation and Nuclear Safety (STUK) the applicability of decision analytic approach to the treatment of nuclear safety related problems at the regulatory body. The role of probabilistic safety assessment (PSA) in decision making has also been discussed. In the study, inspectors from STUK exercised with a decision analytic approach by reoperationalizing two occurred and solved problems. The research scientist from VTT acted as systems analysts guiding the analysis process. The first case was related to a common cause failure phenomenon in solenoid valves controlling pneumatic valves important to safety of the plant. The problem of the regulatory body was to judge whether to allow continued operation or to require more detailed inspections and in which time chedule the inspections should be done. The latter problem was to evaluate design changes of external electrical grid connections after a fire incident had revealed weakness in the separation of electrical system. In both cases, the decision analysis was carried out several sessions in which decision makers, technical experts as well as experts of decision analysis participated. A multi-attribute value function was applied as a decision model so that attributes had to be defined to quantify the levels of achievements of the objectives. The attributes included both indicators related to the level of operational safety of the plant such as core damage frequency given by PSA, and indicators related to the safety culture, i.e., how well the chosen option fits on the regulatory policy. (24 refs., 6 figs., 9 tabs.)
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Fumigant emission reductions with TIF warrant regulatory changes
Directory of Open Access Journals (Sweden)
Husein Ajwa
2013-07-01
Full Text Available With methyl bromide's phase-out, most growers have turned to alternative fumigants, particularly 1,3-dichloropropene (1,3-D and chloropicrin. These alternatives are tightly regulated because they are classified as toxic air contaminants and volatile organic compounds; the latter combine with other substances to produce ground-level ozone (smog. Two ambient air monitoring studies were conducted to evaluate the potential of totally impermeable film (TIF to reduce emissions from shank applications of chloropicrin and 1,3-D. In 2009, a study demonstrated that TIF reduced chloropicrin and 1,3-D peak emissions by 45% and 38%, respectively, but TIF did not reduce total emissions when it was cut after 6 days. In 2011, increasing the tarp period from 5 to 10 days decreased chloropicrin and 1,3-D peak emissions by 88% and 78%, and their total emissions by 64% and 43%, respectively. Concurrent dynamic flux chamber results corroborated the ambient air monitoring data. These studies provide regulatory agencies with mitigation measures that should allow continued fumigant use at efficacious application rates.
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Energy Technology Data Exchange (ETDEWEB)
Acevedo Lozada, D. J.; Rivas, I.; Davila, L.; Flores, Y.
2013-07-01
The present work shows the need to identify, in the Venezuelan oil industry, the existence of exposure to natural sources of radiation should be considered as occupational. As Regulatory Authority in the area of ionizing radiation the need for regulatory processes and ensure radiation protection of personnel involved in these practices arises, as well as personal and environmental monitoring. NORM identifying an installation of the Venezuelan oil industry to establish regulatory processes and take steps to ensure occupational radiation protection. (Author)
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P.M. Fioretti (Paolo); R.W. Brower (Ronald); M.L. Simoons (Maarten); H.J. ten Katen (Harald); A. Beelen (Anita); T. Baardman (Taco); J. Lubsen (Jacob); P.G. Hugenholtz (Paul)
1986-01-01
textabstractThe relative value of predischarge clinical variables, bicycle ergometry, radionuclide ventriculography and 24 hour ambulatory electrocardiographic monitoring for predicting survival during the first year in 351 hospital survivors of acute myocardial infarction was assessed. Discriminant
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Regulatory Oversight of Safety Culture in Nuclear Installations
International Nuclear Information System (INIS)
2013-03-01
Experience across the international nuclear industry and in other technical fields over the past few decades has demonstrated the importance of a healthy safety culture in maintaining the safety of workers, the public and the environment. Both regulators and the nuclear industry recognize the need for licensees to develop a strong safety culture in order to support successful and sustainable nuclear safety performance. Progress over recent years can be observed in the rapid development of approaches to overseeing licensees' safety culture. This publication follows on and complements earlier publications on safety culture, from the publication Safety Culture (Safety Series No. 75-INSAG-4 (1991)), published after the Chernobyl accident, to the more recently published Safety Requirements on The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3 (2006)), which states that the management system is to be used to promote and support a strong safety culture. A number of attempts have been made at both the international and national levels to establish practical approaches to regulatory oversight of safety culture. During 2010 and 2011, two projects were conducted by the IAEA under the scope of the Safe Nuclear Energy - Regional Excellence Programme within the Norwegian Cooperation Programme with Bulgaria and Romania. These projects were implemented at the Bulgarian and Romanian regulatory bodies. They encompassed the development of a specific process to oversee licensees' safety culture, and involved 30 experts from 17 countries and 22 organizations. The IAEA continues to support Member States in the area of safety culture through its projects on safety management and capacity building. This publication addresses the basics of regulatory oversight of safety culture, describes the approaches currently implemented at several regulatory bodies around the world and, based on these examples, proposes a path to developing such a process
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Beyond clinical utility: The multiple values of DTC genetics
Directory of Open Access Journals (Sweden)
Mauro Turrini
2016-03-01
Full Text Available One point of consensus in the otherwise very controversial discussion about the benefits and dangers of DTC genetics in the health domain is the lack of substantial clinical utility. At the same time, both the empirical and conceptual literature indicate that health-related DTC tests can have value and utility outside of the clinic. We argue that a broader and multi-faceted conceptualization of utility and value would enrich the ethical and social discussion of DTC testing in several ways: First, looking at ways in which DTC testing can have personal and social value for users – in the form of entertainment, learning, or a way to relate to others – can help to explain why people still take DTC tests, and will, further down the line, foster a more nuanced understanding of secondary and tertiary uses of DTC test results (which could very well unearth new ethical and regulatory challenges. Second, considering the economic value and broader utility of DTC testing foregrounds wider social and political aspects than have been dominant in the ethical and regulatory debates surrounding DTC genetics so far. These wider political aspects include the profound power asymmetries that characterize the collection and use of personal genetic data in many contexts.
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Research and regulatory review
International Nuclear Information System (INIS)
Macleod, J.S.; Fryer, D.R.H.
1979-01-01
To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)
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Integrated photovoltaic (PV) monitoring system
Mahinder Singh, Balbir Singh; Husain, NurSyahidah; Mohamed, Norani Muti
2012-09-01
The main aim of this research work is to design an accurate and reliable monitoring system to be integrated with solar electricity generating system. The performance monitoring system is required to ensure that the PVEGS is operating at an optimum level. The PV monitoring system is able to measure all the important parameters that determine an optimum performance. The measured values are recorded continuously, as the data acquisition system is connected to a computer, and data is stored at fixed intervals. The data can be locally used and can also be transmitted via internet. The data that appears directly on the local monitoring system is displayed via graphical user interface that was created by using Visual basic and Apache software was used for data transmission The accuracy and reliability of the developed monitoring system was tested against the data that captured simultaneously by using a standard power quality analyzer device. The high correlation which is 97% values indicates the level of accuracy of the monitoring system. The aim of leveraging on a system for continuous monitoring system is achieved, both locally, and can be viewed simultaneously at a remote system.
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2011-03-07
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1..., the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange... information about the rulebook consolidation process, see Information Notice, March 12, 2008 (Rulebook...
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Current products and future plan of regulatory research for risk-informed regulation in Korea
International Nuclear Information System (INIS)
Sung, Key Yong; Lee, Chang Ju; Kim, Woong Sik; Kim, Hho Jung
2003-01-01
The first phase of a regulatory research project for risk-informed regulation (RIR) and applications (RIA) was finished in March of 2002. Various results that could be useful for preparing Korean RIR system have been developed. One of the remarkable outputs is development of reactor safety goals and acceptance criteria for RIR and RIA in Korea. The Safety Goal has a 4-tier hierarchical structure and each tier has specified goals classified for their usage. Regulatory review guides for probabilistic safety assessment (PSA) including level-1, level-2 and low power and shutdown PSA have been updated by reflecting new information obtained from not only the overseas documents but also experience and insights from regulatory review in Korea. In addition, draft regulatory guides for risk-informed in-service inspection, in-service testing, importance ranking of motor-operated valves, and AOT/STI change of Technical Specifications have been developed for preparing ongoing and future licensing work. Risk-based inspection guides with inspection items selected from a viewpoint of risk importance have been suggested for Korean standard NPPs as well. In the second phase of a research project (April of 2002 to March of 2005), two regulatory research projects on RIR were initiated. One is a study on institutionalization of risk-informed and performance-based regulation. Main topics of this project are evaluation of benefit and characteristics of RIR, development of optimized Korean RIR model, impact analysis for the change of current regulation framework, and suggestion of RIR-related laws and rules. The other is focusing on the development in the areas of a regulatory audit PSA model and regulatory guides for risk monitoring, and application techniques of risk information to the significance determination of plant performance indicators and inspection findings. It is expected that a concrete scheme and detailed regulatory techniques for embodiment of RIR system in Korea will be
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Jennings, Aaron A; Li, Zijian
2015-09-01
Surface soil contamination is a worldwide problem. Many regulatory jurisdictions attempt to control human exposures with regulatory guidance values (RGVs) that specify a soil's maximum allowable concentration. Pesticides are important soil contaminants because of their intentional toxicity and widespread surface soil application. Worldwide, at least 174 regulatory jurisdictions from 54 United Nations member states have published more than 19,400 pesticide RGVs for at least 739 chemically unique pesticides. This manuscript examines the variability of the guidance values that are applied worldwide to the original 2001 Stockholm Convention persistent organic pollutants (POP) pesticides (Aldrin, Chlordane, DDT, Dieldrin, Endrin, Heptachlor, Mirex, and Toxaphene) for which at least 1667 RGVs have been promulgated. Results indicate that the spans of the RGVs applied to each of these pesticides vary from 6.1 orders of magnitude for Toxaphene to 10.0 orders of magnitude for Mirex. The distribution of values across these value spans resembles the distribution of lognormal random variables, but also contain non-random value clusters. Approximately 40% of all the POP RGVs fall within uncertainty bounds computed from the U.S. Environmental Protection Agency (USEPA) RGV cancer risk model. Another 22% of the values fall within uncertainty bounds computed from the USEPA's non-cancer risk model, but the cancer risk calculations yield the binding (lowest) value for all POP pesticides except Endrin. The results presented emphasize the continued need to rationalize the RGVs applied worldwide to important soil contaminants. Copyright © 2015 Elsevier Ltd. All rights reserved.
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The contribution of bank regulation and fair value accounting to procyclical leverage
Amel-Zadeh; Barth, ME; Landsman, WR
2017-01-01
Our analytical description of how banks’ responses to asset price changes can result in procyclical leverage reveals that for banks with a binding regulatory leverage constraint, absent differences in regulatory risk weights across assets, procyclical leverage does not occur. For banks without a binding constraint, fair value and bank regulation both can contribute to procyclical leverage. Empirical findings based on a large sample of US commercial banks reveal that bank regulation explains p...
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International Nuclear Information System (INIS)
1991-04-01
The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter
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International Nuclear Information System (INIS)
1991-08-01
The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter
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Monitoring of MNSR operation by measuring subcritical photoneutron flux
International Nuclear Information System (INIS)
Haddad, Kh.; Alsomel, N.
2011-01-01
Passive nondestructive assay methods are used to monitor the reactor's operation. It is required for nuclear regulatory, calculation validation and safeguards purposes. So, it plays a vital role in the safety and security of the nuclear plants. The possibility of MNSR operation monitoring by measuring the subcritical state photoneutron flux were investigated in this work. The photoneutron flux is induced by the fuels hard gamma radiation in the beryllium reflector. Theoretical formulation and experimental tests were performed. The results show that within a specified cooling time range, the photoneutron flux is induced by a single dominant hard gamma emitter such as 117 Cd (activation product) and 140 Ba ( 140 La fission product). This phenomenon was utilized to monitor the cooling time and the operation neutron flux during the last campaign. Thus a passive nondestructive assay method is proposed with regard to the reactor operation's monitoring.
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Energy Technology Data Exchange (ETDEWEB)
White, G.J.; Breckenridge, R.P.
1997-01-01
Section 160 of the Clean Air Act (CAA) calls for measures be taken {open_quotes}to preserve, protect, and enhance air quality in national parks, national wilderness areas, national monuments, national seashores, and other areas of special national or regional natural, recreational, scenic, or historic value.{close_quotes} Pursuant to this, stringent requirement have been established for {open_quotes}Class I{close_quotes} areas, which include most National Parks and Wilderness Areas. Federal Land Managers (FLMs) are charged with the task of carrying out these requirements through the identification of air quality related values (AQRVs) that are potentially at risk from atmospheric pollutants. This is a complex task, the success of which is dependent on the gathering of information on a wide variety of factors that contribute to the potential for impacting resources in Class I areas. Further complicating the issue is the diversity of ecological systems found in Class I areas. There is a critical need for the development of monitoring programs to assess the status of AQRVs in Class I areas with respect to impacts caused by atmospheric pollutants. These monitoring programs must be based on the measurement of a carefully selected suite of key physical, chemical, and biological parameters that serve as indicators of the status of the ecosystems found in Class I areas. Such programs must be both scientifically-based and cost-effective, and must provide the data necessary for FLMs to make objective, defensible decisions. This document summarizes a method for developing AQRV monitoring programs in Class I areas.
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International Nuclear Information System (INIS)
Ueshima, Yoshinobu.
1995-01-01
The device of the present invention reliably conducts monitoring by radiation monitors in a nuclear power plant thereby contributing to save the number of radiation operators and reduction of radiation exposure. Namely, radiation monitors continuously measure a plurality of γ-ray levels. A branched simultaneously counting circuit receives these signals. The output of the branched simultaneously counting circuit is inputted to a differentiation means. The differentiation means calculates a variation coefficient for each of the radiation monitoring values, namely, equivalent dose rates, and records and monitors change with time of the equivalent dose rates. With such procedures, the results of the monitoring of γ-ray levels can be judged objectively corresponding to the increase of the equivalent dose rates. As a result, the number of radiation operators can be saves and radiation exposure of the radiation operators can be reduced. (I.S.)
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2010-01-19
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule... hereby given that on December 23, 2009, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). NASD Rule 2450...
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Regulatory aspects of radiation sources safety in Albania
International Nuclear Information System (INIS)
Dollani, K.; Kushe, R.
1998-01-01
In this paper are presented the regulatory aspects of the radiation sources safety in Albania, based in the new Radiological Protection Act and Regulations. The radiation protection infrastructures and procedures are described as well as their functioning for the implementation of relevant activities such as licensing and regular inspection, personal dose monitoring, emergency preparedness which are developed in the frame of the IAEA Technical Co-operation Programme. The issue of the security of radiation sources is dealt in close relation with the preparation and use of the inventory of all radiation sources in the country. A special attention is paid to the identification and location of lost sources for their finding and secure storage. (author)
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Energy Technology Data Exchange (ETDEWEB)
Kihm, Steve [Seventhwave, Madison, WI (United States); Satchwell, Andrew [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Cappers, Peter [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)
2017-07-26
This technical brief identifies conditions under which utility regulators should consider implementing policy approaches that seek to mitigate negative outcomes due to an increase in interest rates. Interest rates are a key factor in determining a utility’s cost of equity and investors find value when returns exceed the cost of equity. Through historical observations of periods of rising and falling interest rates and application of a pro forma financial tool, we identify the key drivers of utility stock valuations and estimate the degree to which those valuations might be affected by increasing interest rates.3 We also analyze the efficacy of responses by utility regulators to mitigate potential negative financial impacts. We find that regulators have several possible approaches to mitigate a decline in value in an environment of increasing interest rates, though regulators must weigh the tradeoffs of improving investor value with potential increases in customer costs. Furthermore, the range of approaches reflects today’s many different electric utility regulatory models and regulatory responses to a decline in investor value will fit within state-specific models.
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International Nuclear Information System (INIS)
Kirner, N.P.
1985-01-01
There are many regulatory hoops through which waste generators, brokers, and disposal site operators must jump to dispose of waste safely. As the proposed exclusionary date of January 1, 1986, approaches, these regulatory hoops have the distinct possibility of multiplying or at least changing shape. The state of Washington, in its role as an Agreement State with the US Nuclear Regulatory Commission, licenses and inspects the commercial operator of the Northwest Compact's low-level radioactive waste disposal site on the Hanford Reservation. Washington has received as much as 53%, or 1.4 million cubic feet per year, of the nation's total volume of waste disposed. To control such a large volume of waste, a regulatory program involving six agencies has developed over the years in Washington
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Regulatory Control of Radiation Sources. Safety Guide
International Nuclear Information System (INIS)
2009-01-01
This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.
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International Nuclear Information System (INIS)
1991-10-01
The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter
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International Nuclear Information System (INIS)
1993-04-01
The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter
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Monitoring of the radon exposure in workplaces: Regulatory approaches
International Nuclear Information System (INIS)
Ettenhuber, E.
2002-01-01
Germany has a reference level of 2 10 6 Bqh/m 3 for radon in workplaces, corresponding to an annual dose of 6 mSv and a limit of 6 10 6 Bqh/m 3 , corresponding to 10 mSv/y. If the reference level is exceeded remedial action has to be taken and a new radon measurement should be carried out. If it is not possible to reduce the radon concentration below the reference level the competent authority has to be notified and monitoring of the radon concentrations performed. Germany has performed a study to investigate the exposure by natural radionuclides in workplaces in a large number of industrial activities, with a dose assessment of the workers under normal circumstances. They made a categorization of NORM activities in dose ranges of 20 mSv/y. Most of the NORM activities fall in the category <1 mSv/y when normal occupational hygiene measures are taken
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International Nuclear Information System (INIS)
Betsill, J.D.; Gruebel, R.D.
1995-09-01
The Verification and Monitoring Options Study Project (VAMOS) was established to identify high-priority options for future vadose-zone environmental research in the areas of in-situ remediation monitoring, post-closure monitoring, and containment emplacement and verification monitoring. VAMOS examined projected needs not currently being met with applied technology in order to develop viable monitoring and verification research options. The study emphasized a compatible systems approach to reinforce the need for utilizing compatible components to provide user friendly site monitoring systems. To identify the needs and research options related to vadose-zone environmental monitoring and verification, a literature search and expert panel forums were conducted. The search included present drivers for environmental monitoring technology, technology applications, and research efforts. The forums included scientific, academic, industry, and regulatory environmental professionals as well as end users of environmental technology. The experts evaluated current and future monitoring and verification needs, methods for meeting these needs, and viable research options and directions. A variety of high-priority technology development, user facility, and technology guidance research options were developed and presented as an outcome of the literature search and expert panel forums
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International Nuclear Information System (INIS)
Sankhla, Rajesh; Singh, I.S.; Rao, D.D.; Pradeepkumar, K.S.
2015-01-01
Whole body monitoring of radiation workers at nuclear facilities is a regulatory requirement and is recommended for assessment of internal contamination due to gamma emitting radio nuclides. Additionally, nuclear accidents like Chernobyl, Fukushima and radiological accidents like Goiania have clearly highlighted the need for in-vivo monitoring of the members of the public during and/or after such accidents. To cater to these requirements, a high throughput, fast screening, standing linear geometry Quick Scan Whole Body Monitor (QS-WBM) is designed, fabricated and commissioned to measure internal contamination due to gamma emitting radio nuclides (E γ >200keV) incorporated in the human body. The system is designed to achieve sensitivity comparable with conventional WBM for 1 - 2 minutes counting time and to accommodate different body sizes of Indian occupational workers. It is calibrated using BARC reference Bottle Mannequin Absorption (BOMAB) type phantom and also using a family of BOMAB type phantoms representative of different age groups namely 1-, 5-, 10-, 15- and 20- years. The developed system will also be highly useful during emergency situations when large numbers of persons are to be monitored in short interval of time. (author)
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Czech Academy of Sciences Publication Activity Database
Bouček, Jan; Mrkvan, Tomáš; Chovanec, M.; Kuchař, M.; Betka, Jaroslav; Bouček, V.; Hladíková, M.; Betka, J.; Eckschlager, T.; Říhová, Blanka
2010-01-01
Roč. 14, 1-2 (2010), s. 426-433 ISSN 1582-1838 R&D Projects: GA MZd NR8883; GA MŠk 1M0505 Institutional research plan: CEZ:AV0Z50200510 Keywords : regulatory T cell s * head and neck squamous cell carcinoma * tumour markers Subject RIV: EC - Immunology Impact factor: 4.608, year: 2010
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Policy and Regulatory Challenges in the Tourism Collaborative Economy
DEFF Research Database (Denmark)
Dredge, Dianne
2017-01-01
The choice of policy approach and regulatory framework in dealing with the collaborative economy rests on two fundamental factors—that government decisions should be based on good sound knowledge and that this knowledge should be above politics. In the newly emerging and rapidly growing collabora......The choice of policy approach and regulatory framework in dealing with the collaborative economy rests on two fundamental factors—that government decisions should be based on good sound knowledge and that this knowledge should be above politics. In the newly emerging and rapidly growing......-sectors of the collaborative economy. However, these solutions are often based on assumptions about government sovereignty and power relations that do not necessarily apply in the slippery global world of platform capitalism. This chapter seeks to undertake a critical exploration of the factors and values that permeate...
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Regulatory Approaches for Adding Capacity to Existing Hydropower Facilities
Energy Technology Data Exchange (ETDEWEB)
Levine, Aaron L. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Curtis, Taylor L. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Kazerooni, Borna [National Renewable Energy Laboratory (NREL), Golden, CO (United States)
2017-10-24
In 2015, hydroelectric generation accounted for more than 6 percent of total net electricity generation in the United States and 46 percent of electricity generation from all renewables. The United States has considerable hydroelectric potential beyond what is already being developed. Nearly 7 GW of this potential is found by adding capacity to existing hydropower facilities. To optimize the value of hydroelectric generation, the U.S. Department of Energy's Hydropower Vision Study highlights the importance of adding capacity to existing facilities. This report provides strategic approaches and considerations for Federal Energy Regulatory Commission licensed and exempt hydropower facilities seeking to increase generation capacity, which may include increases from efficiency upgrades. The regulatory approaches reviewed for this report include capacity and non-capacity amendments, adding capacity during relicensing, and adding capacity when converting a license to a 10-MW exemption.
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'Green' preferences as regulatory policy instrument
International Nuclear Information System (INIS)
Brennan, Timothy J.
2006-01-01
We examine here the suggestion that if consumers in sufficient numbers are willing to pay the premium to have power generated using low-emission technologies, tax or permit policies become less necessary or stringent. While there are implementation difficulties with this proposal, our purpose is more fundamental: Can economics make sense of using preferences as a regulatory instrument? If 'green' preferences are exogenously given, to what extent can or should they be regarded as a substitute for other policies? Even with 'green' preferences, production and consumption of polluting goods continue to impose social costs not borne in the market. Moreover, if green preferences are regarded as a policy instrument, the 'no policy' baseline would require a problematic specification of counterfactual 'non-green' preferences. Viewing green preferences as a regulatory policy instrument is conceptually sensible if the benchmark for optimal emissions is based on value judgments apart from the preferences consumers happen to have. If so, optimal environmental protection would be defined by reference to ethical theory, or, even less favorably, by prescriptions from policy advocates who give their own preferences great weight while giving those of the public at large (and the costs they bear) very little consideration. (author)
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Nuclear regulatory decision making
International Nuclear Information System (INIS)
Wieland, Patricia; Almeida, Ivan Pedro Salati de
2011-01-01
The scientific considerations upon which the nuclear regulations are based provide objective criteria for decisions on nuclear safety matters. However, the decisions that a regulatory agency takes go far beyond granting or not an operating license based on assessment of compliance. It may involve decisions about hiring experts or research, appeals, responses to other government agencies, international agreements, etc.. In all cases, top management of the regulatory agency should hear and decide the best balance between the benefits of regulatory action and undue risks and other associated impacts that may arise, including issues of credibility and reputation. The establishment of a decision framework based on well established principles and criteria ensures performance stability and consistency, preventing individual subjectivity. This article analyzes the challenges to the decision-making by regulatory agencies to ensure coherence and consistency in decisions, even in situations where there is uncertainty, lack of reliable information and even divergence of opinions among experts. The article explores the basic elements for a framework for regulatory decision-making. (author)
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Nuclear regulatory decision making
International Nuclear Information System (INIS)
2005-01-01
The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear utilities operate their plants at all times in an acceptably safe manner. In meeting this objective, the regulatory body should strive to ensure that its regulatory decisions are technically sound, consistent from case to case, and timely. In addition, the regulator must be aware that its decisions and the circumstances surrounding those decisions can affect how its stakeholders, such as government policy makers, the industry it regulates, and the public, view it as an effective and credible regulator. In order to maintain the confidence of those stakeholders, the regulator should make sure that its decisions are transparent, have a clear basis in law and regulations, and are seen by impartial observers to be fair to all parties. Based on the work of a Nuclear Energy Agency (NEA) expert group, this report discusses some of the basic principles and criteria that a regulatory body should consider in making decisions and describes the elements of an integrated framework for regulatory decision making. (author)
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International Nuclear Information System (INIS)
Song, K. Y.; Lee, C. J.; Kim, W. S.; Jeong, D. W.; Kim, H. J.
2002-01-01
The first phase of a R and D project for risk-informed regulation (RIR) and applications (RIA) has been finished. Various results which would be useful for preparing domestic RIR system were accomplished, in areas of safety goals and general principles of RIR, which provide fundamental bases for establishment of RIR system as well as regulatory review guides, which ensure the quality for PSA. RIA guidelines for ISI, IST, MOV, Tech.-Sepc. also have been developed, implementing some pilot plant applications. As essential documents for actual RIR inspection, risk-informed inspection guides and implementation guide for maintenance effectiveness were prepared. In the second phase of R and D, two projects on RIR area will be performed. One is to study on institutionalization of RIR and performance-based regulation, another is to develop a PSA model for regulatory audit as well as regulatory technology for risk monitoring
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Lu, Jia; Zheng, Lei; Li, Runtian; Hao, Chunmin; Gao, Wenbin; Feng, Ziwei; Yin, Guangya; Wang, Yue
2017-09-25
To evaluate the diagnostic value of dynamic monitoring of C-reactive protein (CRP) in drainage fluid in predicting early anastomotic leakage after colorectal surgery. This study enrolled 172 patients, who were diagnosed as colorectal cancer before operation and underwent radical surgery, without residual tumor tissues by postoperative pathology and perioperative infection, at the Tianjin Medical University Cancer Hospital between July 2015 and January 2016. The C-reactive(CRP) protein level in drainage fluid was continuously monitored from postoperative days (POD) 1 to 5. CRP level was compared between anastomotic leakage (AL) group and non-anastomotic leakage (NAL) group. Receiver operating characteristics (ROC) curve was used to estimate the value of monitoring CRP in drainage fluid to predict anastomotic leakage after colorectal surgery. Among 172 patients, 101 cases were male and 71 cases were female, with age of (59.9±10.3) years. Anastomotic leakage occurred after colorectal surgery in 24 cases(14.0%, AL group ) and other 148 cases were defined as NAL group. Other than body mass index (BMI), differences in baseline data were not statistically significant between two groups. The CRP lever in AL group and NAL group showed rising trend from POD1 to POD4 [Day 1: (6.7±8.4) g/L vs. (8.0±10.6) g/L; Day 2: (24.8±14.6) g/L vs. (28.3±21.1) g/L, Day 3: (54.8±26.5) g/L vs. (53.8±27.6)g/L, Day 4: (62.0±32.2) g/L vs. (58.4±30.7) g/L], while the differences were not significant (all P>0.05). At POD 5, the CRP lever of AL group increased continuously, while that of NAL group decreased with significant difference [(65.3±38.9) g/L vs. (44.7±39.5) g/L, t=-2.85, P=0.005]. Further stratification analysis on AL group revealed CRP level in early AL (AL occurrence POD 10) showed rising trend from POD 1 to 4, then decreased slightly at POD 5, but whose differences were not significant (all P>0.05). ROC curve was drawn with AL condition as state variables and CRP level as
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Value added medicines: what value repurposed medicines might bring to society?
Toumi, Mondher; Rémuzat, Cécile
2017-01-01
Background & objectives : Despite the wide interest surrounding drug repurposing, no common terminology has been yet agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. The objectives of the present study were to assess from a wide perspective which value drug repurposing might bring to society, but also to identify key obstacles for adoption of these medicines and to discuss policy recommendations. Methods : A preliminary comprehensive search was conducted to assess how the concept of drug repurposing was described in the literature. Following completion of the literature review, a primary research was conducted to get perspective of various stakeholders across EU member states on drug repurposing ( healthcare professionals, regulatory authorities and Health Technology Assessment (HTA) bodies/payers, patients, and representatives of the pharmaceutical industry developing medicines in this field). Ad hoc literature review was performed to illustrate, when appropriate, statements of the various stakeholders. Results : Various nomenclatures have been used to describe the concept of drug repurposing in the literature, with more or less broad definitions either based on outcomes, processes, or being a mix of both. In this context, Medicines for Europe (http://www.medicinesforeurope.com/value-added-medicines/) established one single terminology for these medicines, known as value added medicines, defined as 'medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers'. Stakeholder interviews highlighted three main potential benefits for value added medicines: (1) to address a number of medicine-related healthcare inefficiencies related to irrational use of medicines, non-availability of appropriate treatment options, shortage of mature products, geographical inequity in medicine access
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Monitoring system specifications: retrieval of surf from a salt repository
International Nuclear Information System (INIS)
1980-01-01
The task of developing specifications for a reference monitoring system determined by repository environmental conditions, retrieval operations, and federal regulatory criteria is discussed. The monitoring system specified in this report is capable of measuring (1) package position and orientation, (2) vault deformation, (3) brine accumulation, (4) spent fuel dissolution, (5) temperature, (6) nuclear radiation, and (7) package condition with sufficient accuracy to provide data input to a general risk assessment model. In order to define a monitoring system which can provide probabilistic data on radiological risk to operating personnel and the general public for a salt mine repository, the following information is required: (1) a complete design of the salt SURF repository including inventory, density and waste package design details; (2) probalistic failure rate data on containment integrity of the SURF waste package; (3) probabilistic failure rate data on the monitoring system components
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Virginia Power's regulatory reduction program
International Nuclear Information System (INIS)
Miller, G.D.
1996-01-01
Virginia Power has two nuclear plants, North Anna and Surry Power Stations, which have two units each for a total of four nuclear units. In 1992, the Nuclear Regulatory Commission solicited comments from the nuclear industry to obtain their ideas for reducing the regulatory burden on nuclear facilities. Pursuant to the new regulatory climate, Virginia Power developed an internal program to evaluate and assess the regulatory and self-imposed requirements to which they were committed, and to pursue regulatory relief or internal changes where possible and appropriate. The criteria were that public safety must be maintained, and savings must be significant. Up to the date of the conference, over US$22 million of one-time saving had been effected, and US$2.75 million in annual savings
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75 FR 7526 - Withdrawal of Regulatory Guide
2010-02-19
...'s Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections . Regulatory guides are... NUCLEAR REGULATORY COMMISSION [NRC-2010-0052] Withdrawal of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 1.56, ``Maintenance of Water Purity in Boiling...
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KWOC [Key-Word-Out-of-Context] Index of US Nuclear Regulatory Commission Regulatory Guide Series
International Nuclear Information System (INIS)
Jennings, S.D.
1990-04-01
To meet the objectives of the program funded by the Department of Energy (DOE)-Nuclear Energy (NE) Technology Support Programs, the Performance Assurance Project Office (PAPO) administers a Performance Assurance Information Program that collects, compiles, and distributes program-related information, reports, and publications for the benefit of the DOE-NE program participants. THE ''KWOC Index of US Nuclear Regulatory Commission Regulatory Guide Series'' is prepared as an aid in searching for specific topics in the US Nuclear Regulatory Commission, Regulatory Guide Series
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Programmes and Systems for Source and Environmental Radiation Monitoring
International Nuclear Information System (INIS)
2010-01-01
The discharge of radionuclides to the atmosphere and aquatic environments is a legitimate practice in the nuclear and other industries, hospitals and research. Where appropriate, monitoring of the discharges and of relevant environmental media is an essential regulatory requirement in order to ensure appropriate radiation protection of the public. Such monitoring provides information on the actual amounts of radioactive material discharged and the radionuclide concentrations in the environment, and is needed to demonstrate compliance with authorized limits, to assess the radiation exposure of members of the public and to provide data to aid in the optimization of radiation protection. Uncontrolled releases of radionuclides to the atmosphere and aquatic environments may occur as a result of a nuclear or radiological accident. Again, monitoring at the source of the release and of the environment is necessary. In this case, monitoring is used both to assess the radiation exposure of members of the public and to determine the actions necessary for public protection, including longer term countermeasures. Source and environmental monitoring associated with the release of radionuclides to the environment is the subject of a number of IAEA Safety Standards, particularly IAEA Safety Standard RS-G-1.8 (Environmental and Source Monitoring for Purposes of Radiation Protection). This publication is intended to complement this Safety Guide and, by so doing, replaces Safety Series No. 41 (Objectives and Design of Environmental Monitoring Programmes for Radioactive Contaminants) and Safety Series No. 46 (Monitoring of Airborne and Liquid Radioactive Releases from Nuclear Facilities to the Environment). Like Safety Standard RS-G-1.8, this Safety Report deals with monitoring at the source and in the environment associated with authorized releases of radionuclides to the environment. It also deals with the general issues of emergency monitoring during and in the aftermath of an
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Professional and Regulatory Search
Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.
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Perceptions of regulatory approaches
International Nuclear Information System (INIS)
Halin, Magnus; Leinonen, Ruusaliisa
2012-01-01
Ms. Ruusaliisa Leinonen and Mr. Magnus Halin from Fortum gave a joint presentation on industry perceptions of regulatory oversight of LMfS/SC. It was concluded that an open culture of discussion exists between the regulator (STUK) and the licensee, based on the common goal of nuclear safety. An example was provided of on how regulatory interventions helped foster improvements to individual and collective dose rate trends, which had remained static. Regulatory interventions included discussions on the ALARA concept to reinforce the requirement to continuously strive for improvements in safety performance. Safety culture has also been built into regulatory inspections in recent years. Training days have also been organised by the regulatory body to help develop a shared understanding of safety culture between licensee and regulatory personnel. Fortum has also developed their own training for managers and supervisors. Training and ongoing discussion on LMfS/SC safety culture is considered particularly important because both Fortum and the regulatory body are experiencing an influx of new staff due to the demographic profile of their organisations. It was noted that further work is needed to reach a common understanding of safety culture on a practical level (e.g., for a mechanic setting to work), and in relation to the inspection criteria used by the regulator. The challenges associated with companies with a mix of energy types were also discussed. This can make it more difficult to understand responsibilities and decision making processes, including the role of the parent body organisation. It also makes communication more challenging due to increased complexity and a larger number of stakeholders
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International Nuclear Information System (INIS)
Saito, I.
2014-01-01
May 11th 2011, nuclear accidents occurred by Tohoku Region Pacific Coast Earthquake made radioisotopes overflow in reactors and spread around the environments, and it caused risk of food contamination in these areas. And May 17th 2011, Ministry of Health, Labour and Welfare Japan announced provisional regulation values of radioactive materials in food in accordance with the food sanitation act. And they had notified the municipality to corresponding foods above the provisional regulation not had to be on sale. It causes massive needs for food monitoring in Japan. For reply to these massive needs, Hitachi Aloka Medical Ltd. commercialized food monitor: CAN-OSP-NAI in cooperation with CANBERRA Industries Inc. And after this, commercialized food screening system: FSS-101 for reply more expand food monitoring in Japan. This paper introduce Hitachi Aloka Medical Ltd. products which two types of food monitor product, provisional regulation values of radioactive materials in food in accordance with the food sanitation act and with comparing with past food monitoring, needs when accident happen. I wish this is going to be good report for help to radioactive and radiation detection in the future. (author)
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The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities
Energy Technology Data Exchange (ETDEWEB)
Alves, C E G R; Azevedo, E M; Mendes, L C G; Franca, W F L; Gutterres, R F; Goncalves, M [Comissao Nacional de Energia Nuclear-CGMI/CNEN, Rua General Severiano 90, 22290-901, Rio de Janeiro (Brazil); De Sa, L V; Da Rosa, L A R [Instituto de Radioprotecao e Dosimetria-IRD/CNEN, Avenida Salvador Allende s/n, 22780-160, Rio de Janeiro (Brazil)], E-mail: telo@xexeu.org
2009-12-01
This paper aims to demonstrate the importance of the regulatory inspections carried out by the Brazilian regulatory body in the area of nuclear medicine. The main aspects observed during the inspections are presented as well as the time evolution of the non-compliances, according to their occurrence by type. We also evaluate factors concerning the working of the nuclear medicine facility responsible for solving the non-compliances. The results suggest a decrease of occurrence of non-compliances with time that can be related to the strictness of the inspections and the awareness of the personnel in the nuclear medicine facilities. An analysis of radiation dose exposure levels for the professionals involved in nuclear medicine was carried out; although dose values are below regulatory dose limits, their occurrence is not decreasing satisfactorily. Results indicate the need for staff training and commitment of the responsible nuclear medicine facility staff to the radiological protection procedures. Our results also emphasise the importance of continuous coercive actions to improve the level of radiological protection in nuclear medicine facilities in compliance with the standards established by the national regulatory authority and international recommendations.
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The future of yogurt: scientific and regulatory needs.
German, J Bruce
2014-05-01
Lactation biology, microbial selection, and human diversity are central themes that could guide investment in scientific research, industrial innovation, and regulatory policy oversight to propel yogurt into the central role for health-promoting food products. The ability of yogurt to provide the nourishing properties of milk together with the live microorganisms from fermentation provides a unique combination of food assets. Academic research must now define the various targets on which these biological assets act to improve health and develop the metrics that can quantitatively document their benefits. The food industry must reconcile that yogurt and its microorganisms cannot be expected to provide measurable benefits for all consumers, at all doses, and at all times. A supportive regulatory oversight must demand safety and yet encourage innovations that support a value proposition for yogurt in health. Health valuation in the marketplace will be driven by parallel innovations, including accurate assessment technologies, validated microbial ingredients, and health-aware consumers.
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The Romanian nuclear regulatory body as a nuclear communicator
International Nuclear Information System (INIS)
Cluculescu, Cristina
2000-01-01
controlled and monitored the physical protection, the records, preservation, and transportation of radioactive materials and specific fissionable materials as well as the management of radioactive waste. An opened communication is an important task for regulatory body to gain the public thrust and acceptance. The implication of regulatory body in emergency exercises is also an important factor for current mass-media information
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Role of in-house safety analysis and research activities in regulatory decision making
International Nuclear Information System (INIS)
Pradhan, Santosh K.; Nagrale, Dhanesh B.; Gaikwad, Avinash J.
2015-01-01
Achievement of an acceptable level of nuclear safety is an essential requirement for the peaceful utilization of nuclear energy. The success of Global Nuclear Safety Regime is built upon a foundation of research. Such research has been sponsored by Governments and industry and has led to improved designs, safer and more reliable plant operation, and improvements in operating plant efficiency. A key element of this research has been the nuclear safety research performed or sponsored by regulatory organizations. In part, it has been the safety research performed or sponsored by regulatory organizations that has contributed to improved safety and has laid the foundation for activities such as risk-informed regulation, plant life extension, improved plant performance (e.g. power uprates) and new plant designs. The regulatory research program is meant to improve the regulatory authority’s knowledge where uncertainty exists, where safety margins are not well-characterized, and where regulatory decisions need to be confirmed in existing or new designs and technologies. The regulatory body get research initiated either in-house or by the licensee or through technical support organizations (TSOs). Research and analysis carried out within the regulatory body is of immense value in this context. This could be in the form of analysis of safety significant events, analysis of severe accidents, review of operating experience, independent checks of critical designs and even review of operator responses under different situations towards arriving at modifications to training programmes and licensing procedures for operating personnel. A latent benefit of regulatory research carried out by the regulators themselves is that it improves their technical competence considerably which in turn leads to high quality safety reviews and improved regulation in general. The aim of the present paper is to provide an overview of role of regulatory research and the in-house regulatory safety
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Technical experience of the Belgian regulatory body regarding shielded cells
International Nuclear Information System (INIS)
Cortenbosch, G.; Degreef, G.; Noterman, N.; Mommaert, C.; Smidts, O.; Hasendonck, M. van; Drymael, H.; Schmitz, F.; Kennes, C.; Carlier, P.
2010-01-01
Radiation protection and nuclear safety are of paramount importance when operating shielded cells in hot labs and using remote handling tools. Therefore, various aspects should be ensured throughout the lifecycle of nuclear installations disposing of such type of equipment. The presented aspects are the results of the regulatory body experience with this kind of installations (licensing, operations, operating experience, events). This paper will deal with safety considerations such as filtration, fire protection, shielding, ventilation, waste management, separation of the product fluxes, leak tightness, introduction of equipment, interlocks, failsafe components, piloting software, monitoring and education/training. (orig.)
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2012-02-28
... 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule... FINRA and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the..., and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's...
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Learning from your mistakes: The functional value of spontaneous error monitoring in aphasia
Directory of Open Access Journals (Sweden)
Erica L. Middleton
2014-04-01
Ex. 4.\t(T = umbrella “umbelella, umbrella”: Phonological error; DetCorr We used mixed effects logistic regression to assess whether the log odds of changing from error to correct was predicted by monitoring status of the error (DetCorr vs. NoDet; DetNoCorr vs. NoDet; whether the monitoring benefit interacted with direction of change (forward, backward; and whether effects varied by error type. Figure 1 (top shows that the proportion accuracy change was higher for DetCorr, relative to NoDet, consistent with a monitoring benefit. The difference in log odds was significant for semantic errors in both directions (forward: coeff. = -1.73; z= -7.78; p < .001; backward: coeff = -0.92; z= -3.60; p < .001, and for phonological errors in both directions (forward: coeff. = -0.74; z= -2.73; p=.006; backward : coeff. = -.76; z = -2.73; p = .006. The difference between DetNoCorr and NoDet was not significant in any condition. Figure 1 (bottom shows that for Semantic errors, there was a directional asymmetry favoring the Forward condition (interaction: coeff. = .79; z = 2.32; p = .02. Phonological errors, in contrast, produced comparable effects in Forward and Backward direction. The results demonstrated a benefit for errors that were detected and corrected. This monitoring benefit was present in both the forward and backward direction, supporting the Strength hypothesis. Of greatest interest, the monitoring benefit for Semantic errors was greater in the forward than backward direction, indicating a role for learning.
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International Nuclear Information System (INIS)
Walker, Randy M.; Kopsick, Deborah A.; Gorman, Bryan L.; Ganguly, Auroop R.; Ferren, Mitch; Shankar, Mallikarjun
2009-01-01
Thousands of shipments of radioisotopes developed in the United States (U.S.) are transported domestically and internationally for medical and industrial applications, including to partner laboratories in European Union (EU) countries. Over the past five years, the Environmental Protection Agency (EPA), the Department of Energy (DOE), and Oak Ridge National Laboratory (ORNL)1 have worked with state first responder personnel, key private sector supply chain stakeholders, the Department of Homeland Security (DHS), the Department of Transportation (DOT), the Department of Defense (DoD) and the Nuclear Regulatory Commission (NRC) on Radio Frequency Identification (RFID) tracking and monitoring of medical, research and industrial radioisotopes in commerce. ORNL was the pioneer of the international radioisotope shipping and production business. Most radioisotopes made and used today were either made or discovered at ORNL. While most of the radioisotopes used in the commercial sector are now produced and sold by the private market, ORNL still leads the world in the production of exotic, high-value and/or sensitive industrial, medical and research isotopes. The ORNL-EPA-DOE Radiological Source Tracking and Monitoring (RadSTraM) project tested, evaluated, and integrated RFID technologies in laboratory settings and at multiple private-sector shipping and distribution facilities (Perkin Elmer and DHL) to track and monitor common radioisotopes used in everyday commerce. The RFID tracking capability was also tested in association with other deployed technologies including radiation detection, chemical/explosives detection, advanced imaging, lasers, and infrared scanning. At the 2007 EU-U.S. Summit, the leaders of the US Department of Commerce (DOC) and EU European Commission (EC) committed to pursue jointly directed Lighthouse Priority Projects. These projects are intended to foster cooperation and reduce regulatory burdens with respect to transatlantic commerce. The
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Monitoring product safety in the postmarketing environment.
Sharrar, Robert G; Dieck, Gretchen S
2013-10-01
The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.
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Digital communication with fetal monitors.
Bozóki, Z
1997-11-01
Fetal heart rate (FHR) values in the averaged format that are provided by commercial computed cardiotocography analysis systems may be unsuitable for special analysis purposes. I developed a communication software program to obtain any measured values of fetal monitors for individual analysis of computed cardiotocography. The software program was used to study the data continuity of beat-to-beat FHR values as an experiment for chaos theory and power spectrum analysis. The results indicated that the signal loss was recognized at a precision of 95%. The described method of digital communication with fetal monitors was found to be useful for individual purposes in the field of computed cardiotocography analysis.
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Marbach, Daniel; Roy, Sushmita; Ay, Ferhat; Meyer, Patrick E.; Candeias, Rogerio; Kahveci, Tamer; Bristow, Christopher A.; Kellis, Manolis
2012-01-01
Gaining insights on gene regulation from large-scale functional data sets is a grand challenge in systems biology. In this article, we develop and apply methods for transcriptional regulatory network inference from diverse functional genomics data sets and demonstrate their value for gene function and gene expression prediction. We formulate the network inference problem in a machine-learning framework and use both supervised and unsupervised methods to predict regulatory edges by integrating transcription factor (TF) binding, evolutionarily conserved sequence motifs, gene expression, and chromatin modification data sets as input features. Applying these methods to Drosophila melanogaster, we predict ∼300,000 regulatory edges in a network of ∼600 TFs and 12,000 target genes. We validate our predictions using known regulatory interactions, gene functional annotations, tissue-specific expression, protein–protein interactions, and three-dimensional maps of chromosome conformation. We use the inferred network to identify putative functions for hundreds of previously uncharacterized genes, including many in nervous system development, which are independently confirmed based on their tissue-specific expression patterns. Last, we use the regulatory network to predict target gene expression levels as a function of TF expression, and find significantly higher predictive power for integrative networks than for motif or ChIP-based networks. Our work reveals the complementarity between physical evidence of regulatory interactions (TF binding, motif conservation) and functional evidence (coordinated expression or chromatin patterns) and demonstrates the power of data integration for network inference and studies of gene regulation at the systems level. PMID:22456606
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Marbach, Daniel; Roy, Sushmita; Ay, Ferhat; Meyer, Patrick E; Candeias, Rogerio; Kahveci, Tamer; Bristow, Christopher A; Kellis, Manolis
2012-07-01
Gaining insights on gene regulation from large-scale functional data sets is a grand challenge in systems biology. In this article, we develop and apply methods for transcriptional regulatory network inference from diverse functional genomics data sets and demonstrate their value for gene function and gene expression prediction. We formulate the network inference problem in a machine-learning framework and use both supervised and unsupervised methods to predict regulatory edges by integrating transcription factor (TF) binding, evolutionarily conserved sequence motifs, gene expression, and chromatin modification data sets as input features. Applying these methods to Drosophila melanogaster, we predict ∼300,000 regulatory edges in a network of ∼600 TFs and 12,000 target genes. We validate our predictions using known regulatory interactions, gene functional annotations, tissue-specific expression, protein-protein interactions, and three-dimensional maps of chromosome conformation. We use the inferred network to identify putative functions for hundreds of previously uncharacterized genes, including many in nervous system development, which are independently confirmed based on their tissue-specific expression patterns. Last, we use the regulatory network to predict target gene expression levels as a function of TF expression, and find significantly higher predictive power for integrative networks than for motif or ChIP-based networks. Our work reveals the complementarity between physical evidence of regulatory interactions (TF binding, motif conservation) and functional evidence (coordinated expression or chromatin patterns) and demonstrates the power of data integration for network inference and studies of gene regulation at the systems level.
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Gap Analysis: Application to Earned Value Analysis
Langford, Gary O.; Franck, Raymond (Chip)
2008-01-01
Sponsored Report (for Acquisition Research Program) Earned Value is regarded as a useful tool to monitor commercial and defense system acquisitions. This paper applies the theoretical foundations and systematics of Gap Analysis to improve Earned Value Management. As currently implemented, Earned Value inaccurately provides a higher value for the work performed. This preliminary research indicates that Earned Value calculations can be corrected. Value Analysis, properly defined and enacted,...
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Clancy, Michael; Belli, Antonio; Davies, David; Lucas, Samuel J. E.; Su, Zhangjie; Dehghani, Hamid
2015-07-01
The subject of superficial contamination and signal origins remains a widely debated topic in the field of Near Infrared Spectroscopy (NIRS), yet the concept of using the technology to monitor an injured brain, in a clinical setting, poses additional challenges concerning the quantitative accuracy of recovered parameters. Using high density diffuse optical tomography probes, quantitatively accurate parameters from different layers (skin, bone and brain) can be recovered from subject specific reconstruction models. This study assesses the use of registered atlas models for situations where subject specific models are not available. Data simulated from subject specific models were reconstructed using the 8 registered atlas models implementing a regional (layered) parameter recovery in NIRFAST. A 3-region recovery based on the atlas model yielded recovered brain saturation values which were accurate to within 4.6% (percentage error) of the simulated values, validating the technique. The recovered saturations in the superficial regions were not quantitatively accurate. These findings highlight differences in superficial (skin and bone) layer thickness between the subject and atlas models. This layer thickness mismatch was propagated through the reconstruction process decreasing the parameter accuracy.
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2011-02-22
.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory..., and C below, of the most significant aspects of such statements. A. Self-Regulatory Organization's...
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Legal and Regulatory Barriers to Reverse Innovation.
Rowthorn, Virginia; Plum, Alexander J; Zervos, John
Reverse innovation, or the importation of new, affordable, and efficacious models to high-income countries from the developing world, has emerged as a way to improve the health care system in the United States. Reverse innovation has been identified as a key emerging trend in global health systems in part because low-resourced settings are particularly good laboratories for low-cost/high-impact innovations that are developed out of necessity. A difficult question receiving scant attention is that of legal and regulatory barriers. The objective of this paper is to understand and elucidate the legal barriers faced by innovators bringing health interventions to the United States. Semistructured qualitative interviews were conducted with 9 key informants who have directly participated in the introduction of global health care approaches to the United States health system. A purposive sampling scheme was employed to identify participants. Phone interviews were conducted over one week in July 2016 with each participant and lasted an average of 35 minutes each. Purely legal barriers included questions surrounding tort liability, standard of care, and concerns around patient-administered self-care. Regulatory burdens included issues of international medical licensure, reimbursement, and task shifting and scope of work challenges among nonprofessionals (e.g. community health workers). Finally, perceived (i.e. not realized or experienced) legal and regulatory barriers to innovative modalities served as disincentives to bringing products or services developed outside of the United States to the United States market. Conflicting interests within the health care system, safety concerns, and little value placed on low-cost interventions inhibit innovation. Legal and regulatory barriers rank among, and contribute to, an anti-innovation atmosphere in healthcare for domestic and reverse innovators alike. Reverse innovation should be fostered through the thoughtful development of
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Nuclear Regulatory Legislation
International Nuclear Information System (INIS)
1989-08-01
This compilation of statutes and material pertaining to nuclear regulatory legislation through the 100th Congress, 2nd Session, has been prepared by the Office of the General Counsel, US Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document. Persons using this document are placed on notice that it may not be used as an authoritative citation in lieu of the primary legislative sources. Furthermore, while every effort has been made to ensure the completeness and accuracy of this material, neither the United States Government, the Nuclear Regulatory Commission, nor any of their employees makes any expressed or implied warranty or assumes liability for the accuracy or completeness of the material presented in this compilation
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Power distribution monitor in a nuclear reactor
International Nuclear Information System (INIS)
Uematsu, Hitoshi
1983-01-01
Purpose: To enable accurate monitoring for the reactor power distribution within a short time in a case where abnormality occurs in in-core neutron monitors or in a case where the reactor core state changes after the calibration for the neutron monitors. Constitution: The power distribution monitor comprises a power distribution calculator adapted to be inputted counted values from a reactor core present state data instruments and calculate the neutron flux distribution in the reactor core and the power distribution based on previously incorporated physical models, an RCF calculator adapted to be inputted with the counted values from the in-core neutron monitors and the neutron flux distribution and the power distribution calculated in the power distribution calculator and compensate the counted errors included in the counted values form the in-core neutron monitors and the calculation errors included in the power distribution calculated in the power distribution calculator to thereby calculate the power distribution within the reactor core, and an input/output device for the input of the data required for said power distribution calculator and the display for the calculation result calculated in the RCF calculator. (Ikeda, J.)
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Risk-based Regulatory Evaluation Program methodology
International Nuclear Information System (INIS)
DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.
1987-01-01
The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions