State regulatory issues in acid rain compliance

International Nuclear Information System (INIS)

Solomon, B.D.; Brick, S.

1992-01-01

This article discusses the results of a US EPA workshop for state regulators and commission staff on acid rain compliance concerns. The topics of the article include the results of market-based emissions control, how emissions trading is expected to reduce emissions, public utility commissions approval of compliance plans, the purposes of the workshop, market information, accounting issues, regulatory process and utility planning, multi-state compliance planning, and relationship to other compliance issues

75 FR 27028 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

Science.gov (United States)

2010-05-13

... regulatory issues and their potential impact on investors and the securities markets. The Committee will lend... SECURITIES AND EXCHANGE COMMISSION [Release No. 33-9123; File No. 265-26] COMMODITY FUTURES TRADING COMMISSION Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Securities and...

THE SOCIAL CONTEXT OF KENTISH RAISING: ISSUES IN OLD ENGLISH SOCIOLINGUISTICS

Directory of Open Access Journals (Sweden)

Graeme Trousdale

2005-06-01

Full Text Available This article considers issues in Old English sociolinguistics, in relation to specific changes affecting the low front vowels in ninth-century Kentish, as manifest in spelling variation in charters of the time. This change is referred to as Kentish Raising (Hogg 1988. It is suggested that variationist sociolinguistics is not an appropriate framework within which to explain Kentish Raising, since the nature of the data is such that a variationist approach is untenable. A reconstruction of the social, political and cultural situation in ninth-century Kent is provided, which examines Mercian influence in the period, and suggests that a Mercian-driven change from above (Second Fronting cannot be the source of Kentish Raising. Finally, it is proposed that recent work in genetic anthropology, which seeks to discover more about the nature and extent of the continental migrations, may be useful in understanding the social context in which the varieties of Old English existed and developed.

Regulatory Issues Surrounding Merchant Interconnection

International Nuclear Information System (INIS)

Kuijlaars, Kees-Jan; Zwart, Gijsbert

2003-11-01

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

Regulatory Issues Surrounding Merchant Interconnection

Energy Technology Data Exchange (ETDEWEB)

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

2003-11-01

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

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

Regulatory issues in accreditation of toxicology laboratories.

Science.gov (United States)

Bissell, Michael G

2012-09-01

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

77 FR 40817 - Low-Level Radioactive Waste Regulatory Management Issues

Science.gov (United States)

2012-07-11

...-2011-0012] RIN-3150-AI92 Low-Level Radioactive Waste Regulatory Management Issues AGENCY: Nuclear... regulatory time of compliance for a low-level radioactive waste disposal facility, allowing licensees the... system, and revising the NRC's licensing requirements for land disposal of radioactive waste. DATES: The...

Overview of Variable Renewable Energy Regulatory Issues: A Clean Energy Regulators Initiative Report

Energy Technology Data Exchange (ETDEWEB)

Miller, M.; Cox, S.

2014-05-01

This CERI report aims to provide an introductory overview of key regulatory issues associated with the deployment of renewable energy -- particularly variable renewable energy (VRE) sources such wind and solar power. The report draws upon the research and experiences from various international contexts, and identifies key ideas that have emerged from the growing body of VRE deployment experience and regulatory knowledge. The report assumes basic familiarity with regulatory concepts, and although it is not written for a technical audience, directs the reader to further reading when available. VRE deployment generates various regulatory issues: substantive, procedural, and public interest issues, and the report aims to provide an empirical and technical grounding for all three types of questions as appropriate.

Enhancing regulatory effectiveness by improving the process for identifying and resolving generic issues

International Nuclear Information System (INIS)

Vander Molen, Harold J.

2001-01-01

The Generic Issues Program first began formally in response to a Commission directive in October of 1976. In 1983, it became one of the first programs to make successful use of probabilistic risk information to aid in regulatory decision-making. In the 16 years since the program became quantitative, 836 issues have been processed. Of these, 106 reactor safety issues were prioritized as requiring further evaluation to determine the final resolution. Approximately a dozen generic issues remain unresolved. Although there is far less reactor licensing activity than in the 1970s, new issues continue to be identified from research and operational experience. These issues often involve complex and controversial questions of safety and regulation, and an efficient and effective means of addressing these issues is essential for regulatory effectiveness. Issues that involve a significant safety question require swift, effective, enforceable, and cost-effective regulatory actions. Issues that are of little safety significance must be quickly shown to be so and dismissed in an expeditious manner so as to avoid unnecessary expenditure of limited resources and to reduce regulatory uncertainty. Additionally, in the time since the generic issue program began, probabilistic risk assessment techniques have advanced significantly while agency resources have continued to diminish. Accordingly, the paper discusses the steps that have been taken to enhance the effectiveness and efficiency of the generic issue resolution process. Additionally, four resolved issues are discussed, along with key elements of a proposed new procedure for resolving potential generic issues

Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine.

Science.gov (United States)

Gilbert, Frederic; O'Connell, Cathal D; Mladenovska, Tajanka; Dodds, Susan

2018-02-01

Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

A Process Perspective on Regulation: A Grounded Theory Study into Regulatory Practice in Newly Liberalized Network-Based Markets

NARCIS (Netherlands)

Ubacht, J.

The transition from a former monopolistic towards a more competitive market in
newly liberalized network-based markets raises regulatory issues. National Regulatory Authorities (NRA) face the challenge to deal with these issues in order to guide the transition process. Although this transition

Selected legal and institutional issues related to Ocean Thermal Energy Conversion (OTEC) development

Energy Technology Data Exchange (ETDEWEB)

Nanda, V. P.

1979-06-01

Ocean Thermal Energy Conversion (OTEC), an attractive alternative to traditional energy sources, is still in the early stages of development. To facilitate OTEC commercialization, it is essential that a legal and institutional framework be designed now so as to resolve uncertainties related to OTEC development, primarily involving jurisdictional, regulatory, and environmental issues. The jurisdictional issues raised by OTEC use are dependent upon the site of an OTEC facility and its configuration; i.e., whether the plant is a semipermanent fixture located offshore or a migrating plant ship that provides a source of energy for industry at sea. These issues primarily involve the division of authority between the Federal Government and the individual coastal states. The regulatory issues raised are largely speculative: they involve the adaptation of existing mechanisms to OTEC operation. Finally, the environmental issues raised center around compliance with the National Environmental Policy Act (NEPA) as well as international agreements. 288 references.

A study on the implement of regulatory issue problems about service business

International Nuclear Information System (INIS)

Kim, In Hwan; Shim, H. S.; Yoon, K. H.; Jun, I. Y.; Kang, W. S.; Chang, J. H.

2004-12-01

This study is intended to derive a proposal for revision of the Atomic Energy Law, with understanding of differences between regulatory requirements and current issues based on findings during safety review and regular inspection. The contents and scope of this study is as follows: - Deep review for service business in 'the rationalization of the radiation protection system related with use of radionuclide', studied by Korea Isotope Association and presentation in the Korea Association for radiation protection, - Efficient regulatory activity through pre-finding of current regulatory issues to be derived during safety review and regular inspection

Sustainable Markets Investment Briefings: the regulatory taking doctrine

Energy Technology Data Exchange (ETDEWEB)

Cotula, Lorenzo

2007-08-15

This is the third of a series of briefings which discuss the sustainable development issues raised by legal arrangements for the protection of foreign investment. The briefings are based on legal research by IIED and its partners. The goal is to provide accessible but accurate information for human rights, development and environmental organisations working on issues raised by foreign investment in low- and middle-income countries. Briefing 3 introduces one of the most controversial legal doctrines of investment law – 'regulatory taking' – and sets out its implications for sustainable development.

Regulatory issues resolved through design certification on the System 80+trademark standard plant design

International Nuclear Information System (INIS)

Ritterbusch, S.E.; Brinkman, C.B.

1996-01-01

The US Nuclear Regulatory Commission (NRC) has completed its review of the System 80+trademark Standard Plant Design, approving advanced design features and closing severe accident licensing issues. Final Design Approval was granted in July 1994. The NRC review was extensive, requiring written responses to over 4,950 questions and formal printing of over 50,000 Safety Analysis Report pages. New safety issues never before addressed in a regulatory atmosphere had to be resolved with detailed analysis and evaluation of design features. the System 80+ review demonstrated that regulatory issues can be firmly resolved only through presentation of a detailed design and completion of a comprehensive regulatory review

Regulatory challenges of robotics : Some guidelines for addressing legal and ethical issues

NARCIS (Netherlands)

Leenes, Ronald; Palmerini, Erica; Koops, Bert-Jaap; Bertolini, Andrea; Salvini, Pericle; Lucivero, Federica

2017-01-01

Robots are slowly, but certainly, entering people’s professional and private lives. They require the attention of regulators due to the challenges they present to existing legal frameworks and the new legal and ethical questions they raise. This paper discusses four major regulatory dilemmas in the

Regulatory controls for NORM contamination: Emerging issues and strategies

International Nuclear Information System (INIS)

Wennerberg, Linda

1992-01-01

Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)

Regulatory Safety Issues in the Structural Design Criteria of ASME Section III Subsection NH and for Very High Temperatures for VHTR & GEN IV

Energy Technology Data Exchange (ETDEWEB)

William J. O’Donnell; Donald S. Griffin

2007-05-07

The objective of this task is to identify issues relevant to ASME Section III, Subsection NH [1], and related Code Cases that must be resolved for licensing purposes for VHTGRs (Very High Temperature Gas Reactor concepts such as those of PBMR, Areva, and GA); and to identify the material models, design criteria, and analysis methods that need to be added to the ASME Code to cover the unresolved safety issues. Subsection NH was originally developed to provide structural design criteria and limits for elevated-temperature design of Liquid Metal Fast Breeder Reactor (LMFBR) systems and some gas-cooled systems. The U.S. Nuclear Regulatory Commission (NRC) and its Advisory Committee for Reactor Safeguards (ACRS) reviewed the design limits and procedures in the process of reviewing the Clinch River Breeder Reactor (CRBR) for a construction permit in the late 1970s and early 1980s, and identified issues that needed resolution. In the years since then, the NRC and various contractors have evaluated the applicability of the ASME Code and Code Cases to high-temperature reactor designs such as the VHTGRs, and identified issues that need to be resolved to provide a regulatory basis for licensing. This Report describes: (1) NRC and ACRS safety concerns raised during the licensing process of CRBR , (2) how some of these issues are addressed by the current Subsection NH of the ASME Code; and (3) the material models, design criteria, and analysis methods that need to be added to the ASME Code and Code Cases to cover unresolved regulatory issues for very high temperature service.

Your Genes, Your Choices: Exploring the Issues Raised by Genetic Research

Energy Technology Data Exchange (ETDEWEB)

Baker, C.

1999-05-31

Your Genes, Your Choices provides accurate information about the ethical, legal, and social implications of the Human Genome Project and genetic research in an easy-to-read style and format. Each chapter in the book begins with a brief vignette, which introduces an issue within a human story, and raises a question for the reader to think about as the basic science and information are presented in the rest of the chapter.

On-farm welfare assessment for regulatory purposes: Issues and possible solutions

DEFF Research Database (Denmark)

Sørensen, Jan Tind; Fraser, David

2010-01-01

On-farm welfare assessment has been used mainly for non-regulatory purposes such as producer education or to qualify for voluntary welfare-assurance programs. The application of on-farm assessments in regulatory programs would require four issues to be addressed: (1) selecting criteria...... solution. Issues 3 and 4 (fairness and efficiency) require scientific data on the precision, repeatability, independence, and cost-of-scoring for the various candidate criteria. A process is also needed to bring the scientific information into the deliberative process, either as formal recommendations and...

76 FR 10072 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX, Adequacy of Station...

Science.gov (United States)

2011-02-23

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0013] Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX, Adequacy of Station Electric Distribution System Voltages; Reopening of... (NRC's) Draft Regulatory Issue Summary 2011-XX, Adequacy of Station Electric Distribution System...

Key Regulatory Issues for Digital Instrumentation and Control Systems at Nuclear Power Plants

International Nuclear Information System (INIS)

Korsah, Kofi; Wood, Richard Thomas

2008-01-01

To help reduce the uncertainty associated with application of digital instrumentation and controls (I and C) technology in nuclear power plants, the Nuclear Regulatory Commission (NRC) has issued six Interim Staff Guidance (ISG) documents that address the current regulatory positions on what are considered the significant digital I and C issues. These six documents address the following topics: Cyber Security, Diversity and Defense-in-Depth, Risk Informed Digital I and C Regulation, Communication issues, Human Factors and the Digital I and C Licensing Process (currently issued as Draft). After allowing for further refinement based on additional technical insight gathered by NRC staff through near-term research and detailed review of relevant experience, it is expected that updated positions ultimately will be incorporated into regulatory guides and staff review procedures. This paper presents an overview of the guidance provided by the NRC-issued ISGs on key technology considerations (i.e., the first five documents above) for safety-related digital I and C systems.

Regulatory Safety Issues in the Structural Design Criteria of ASME Section III Subsection NH and for Very High Temperatures for VHTR and GEN IV

International Nuclear Information System (INIS)

O'Donnell, William J.; Griffin, Donald S.

2007-01-01

The objective of this task is to identify issues relevant to ASME Section III, Subsection NH [1], and related Code Cases that must be resolved for licensing purposes for VHTGRs (Very High Temperature Gas Reactor concepts such as those of PBMR, Areva, and GA); and to identify the material models, design criteria, and analysis methods that need to be added to the ASME Code to cover the unresolved safety issues. Subsection NH was originally developed to provide structural design criteria and limits for elevated-temperature design of Liquid Metal Fast Breeder Reactor (LMFBR) systems and some gas-cooled systems. The U.S. Nuclear Regulatory Commission (NRC) and its Advisory Committee for Reactor Safeguards (ACRS) reviewed the design limits and procedures in the process of reviewing the Clinch River Breeder Reactor (CRBR) for a construction permit in the late 1970s and early 1980s, and identified issues that needed resolution. In the years since then, the NRC and various contractors have evaluated the applicability of the ASME Code and Code Cases to high-temperature reactor designs such as the VHTGRs, and identified issues that need to be resolved to provide a regulatory basis for licensing. This Report describes: (1) NRC and ACRS safety concerns raised during the licensing process of CRBR , (2) how some of these issues are addressed by the current Subsection NH of the ASME Code; and (3) the material models, design criteria, and analysis methods that need to be added to the ASME Code and Code Cases to cover unresolved regulatory issues for very high temperature service.

The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

International Nuclear Information System (INIS)

Lee, Yong Suk; Jung, Dae Wook; Cho, Nam Chul

2008-01-01

The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future

The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

Energy Technology Data Exchange (ETDEWEB)

Lee, Yong Suk; Jung, Dae Wook [Future and Challenges Inc., Seoul (Korea, Republic of); Cho, Nam Chul [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2008-10-15

The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future.

Animal Health Ireland: providing national leadership and coordination of non-regulatory animal health issues in Ireland.

Science.gov (United States)

More, S J; Doherty, M L; Downey, L; McKenzie, K; Devitt, C; O'Flaherty, J

2011-12-01

Livestock production plays an important role in the Irish economy. Regulatory animal health issues are the responsibility of government, but until recently there has been no national coordination of non-regulatory animal health issues. This gap has recently been filled with the establishment of Animal Health Ireland (AHI), a not-for-profit, partnership-based organisation providing national leadership and coordination of non-regulatory animal health issues in Ireland. Animal Health Ireland provides benefits to livestock producers and processors by providing the knowledge, education and coordination required to establish effective control strategies, both on-farm and nationally. This paper presents a brief overview of the context for AHI, and of its establishment and initial activities. Non-regulatory animal health issues have been prioritised. A series of work programmes (each focusing on a high-priority issue) have been established. Partnership is critical to success, both for AHI as an organisation and for effective farm-level transfer of knowledge. This model for national leadership and coordination of non-regulatory animal health issues may be of relevance elsewhere.

Addressing issues raised by stakeholders: evolving practices at the Canadian Nuclear Safety Commission (CNSC)

International Nuclear Information System (INIS)

Flavelle, Peter

2004-01-01

the CNSC are well coordinated, effectively managed and responsive to the needs of the public, stakeholders and employees. A corporate outreach program is continually evolving to coordinate and improve the effectiveness of CNSC staff interactions with various stakeholder groups. Stakeholder consultation is also undertaken for regulatory amendments, the development of regulatory documents and proposed changes in regulatory programs. A consequence of enhanced accessibility, transparency and openness is the broaching of issues that are of concern to specific stakeholders or are in connection with a specific licensing decision. Frequently, issues that are presented in stakeholder interventions at hearings result in direction to CNSC staff by the Commission tribunal to pursue specific questions or to undertake specific actions. For example, at a recent hearing the issue of communication by a licensee was raised in an intervention by a non-government organization, resulting in the Commission recommending a follow up meeting between the local community stakeholders, CNSC staff and the licensee, leading to changes in the licensee's public information program. Improved openness has also lead to increased stakeholder requests for information on nuclear substance licenses, on the nuclear industry and on regulating the nuclear industry. These requests are received through the CNSC information e-mail account, a toll-free telephone number, and the regular mail. In addition, the CNSC also receives requests for information under Canada's Access to Information Act. The CNSC responds to these requests as efficiently as possible. Stakeholder requests for information are passed to an appropriate CNSC staff member for an electronic or oral response. Interaction with an identifiable staff member contributes to developing confidence in the CNSC as a competent, open and transparent regulator. There are several further examples of CNSC/AECB response to stakeholder issues. At the

Environmental Regulatory Update Table, May/June 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number sign}.

Environmental Regulatory Update Table, May/June 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number_sign}.

Telemental Health for Children and Adolescents: An Overview of Legal, Regulatory, and Risk Management Issues.

Science.gov (United States)

Kramer, Gregory M; Luxton, David D

2016-04-01

The use of technology to provide telemental healthcare continues to increase; however, little has been written about the legal and regulatory issues involved in providing this form of care to children and adolescents. This article reviews existing laws and regulations to summarize the risk management issues relevant to providing telemental healthcare to children and adolescents. There are several legal and regulatory areas in which telemental health clinicians need to have awareness. These areas include: 1) Licensure, 2) malpractice liability, 3) credentialing and privileging, 4) informed consent, 5) security and privacy, and 6) emergency management. Although legal and regulatory challenges remain in providing telemental healthcare to children and adolescents, it is possible to overcome these challenges with knowledge of the issues and appropriate risk management strategies. We provide general knowledge of these key legal and regulatory issues, along with some risk management recommendations.

Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape.

Science.gov (United States)

Benda, Norbert; Brandt, Andreas

2018-01-01

Recently, new draft guidelines on multiplicity issues in clinical trials have been issued by European Medicine Agency (EMA) and Food and Drug Administration (FDA), respectively. Multiplicity is an issue in clinical trials, if the probability of a false-positive decision is increased by insufficiently accounting for testing multiple hypotheses. We outline the regulatory principles related to multiplicity issues in confirmatory clinical trials intended to support a marketing authorization application in the EU, describe the reasons for an increasing complexity regarding multiple hypotheses testing and discuss the specific multiplicity issues emerging within the regulatory context and being relevant for drug approval.

Regulatory issues and assumptions associated with barriers in the vadose zone surrounding buried waste

International Nuclear Information System (INIS)

Siskind, B.; Heiser, J.

1993-02-01

One of the options for control of contaminant migration from buried waste sites is the construction of a subsurface barrier that consists of a wall of low permeability material. The barrier material should be compatible with soil and waste conditions specific to the site and have as low an effective diffusivity as is reasonably achievable to minimize or inhibit transport of moisture and contaminants. This report addresses the regulatory issues associated with the use of non-traditional organic polymer barriers as well as the use of soil-bentonite or cement-bentonite mixtures for such barriers, considering barriers constructed from these latter materials to be a regulatory baseline. The regulatory issues fall into two categories. The first category consists of issues associated with the acceptability of such barriers to the EPA as a method for achieving site or performanceimprovement. The second category encompasses those regulatory issues concerning health, safety and the environment which must be addressed regarding barrier installation and performance, especially if non-traditional materials are to be used

Major nuclear safety and regulatory issues in Korea

International Nuclear Information System (INIS)

Chang, Soon Heung

2004-01-01

Recently the value of nuclear energy is being re-considered due to the increase of oil price, the lack of energy supply, and the competition with renewable energy source. In Unites States, Europe, and East Asia, the prospects for continuous nuclear energy development or the policy for retaining nuclear energy have been announced. According to the nuclear energy promotion plan in Korea, there are 19 operating nuclear plants currently and more 7 plants will be constructed in the future. Until now, qualitative as well as quantitative growth is remarkable. Korean nuclear power plants achieved world-best level of capacity factor. However, because of the various nuclear industrial activities, we have a lot of regulatory issues for operating plants, building new plants, and other nuclear related facilities such as research reactors or radioactive waste storage facility. In this article, important regulatory issues which are emerging in Korea will be reviewed and the approaches to solve the issues including public acceptance will be presented. Especially, I will go into detail of two special case studies: The one is the thermal sleeve separation incident in Younggwang nuclear units 5 and 6 whose outage lasts about 80 days and 90 days respectively, which is not common in worldwide nuclear history. The other is about consensus meeting of Korea nuclear energy policy which was managed by a non-governmental organization. (author)

Regulatory issues in the maintenance of Argentine nuclear power plants

International Nuclear Information System (INIS)

Castro, E.; Caruso, G.

1997-01-01

The influence of maintenance activities upon nuclear safety and their relevance as means to detect and prevent aging make them play an outstanding role among the fields of interest of the Argentine nuclear regulatory body (ENREN). Such interest is reinforced by the fact that the data obtained during maintenance are used - among other - as inputs in the Probabilistic Safety Analyses required for those nuclear power plants. This paper provides a brief description of the original requirements by the regulatory body concerning maintenance, of the factors that led to review the criteria involved in such requirements and of the key items identified during the reviewing process. The latter shall be taken into account in the maintenance regulatory policy, for the consequent issue of new requirements from the utilities and for the eventual publication of a specific regulatory standard. (author)

Regulatory changes raise troubling questions for genomic testing.

Science.gov (United States)

Evans, Barbara J; Dorschner, Michael O; Burke, Wylie; Jarvik, Gail P

2014-11-01

By 6 October 2014, many laboratories in the United States must begin honoring new individual data access rights created by recent changes to federal privacy and laboratory regulations. These access rights are more expansive than has been widely understood and pose complex challenges for genomic testing laboratories. This article analyzes regulatory texts and guidances to explore which laboratories are affected. It offers the first published analysis of which parts of the vast trove of data generated during next-generation sequencing will be accessible to patients and research subjects. Persons tested at affected laboratories seemingly will have access, upon request, to uninterpreted gene variant information contained in their stored variant call format, binary alignment/map, and FASTQ files. A defect in the regulations will subject some non-CLIA-regulated research laboratories to these new access requirements unless the Department of Health and Human Services takes swift action to avert this apparently unintended consequence. More broadly, all affected laboratories face a long list of daunting operational, business, compliance, and bioethical issues as they adapt to this change and to the Food and Drug Administration's recently announced plan to publish draft guidance outlining a new oversight framework for lab-developed tests.

A study on the regulatory approach of major technical issues

Energy Technology Data Exchange (ETDEWEB)

Chang, Keun Sun; Choi, J. T.; Kim, I. J. [Sunmoon Univ., Asan (Korea, Republic of); Lee, S. H.; Baek, W. P.; Yang, S. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

1998-06-15

This project is to provide the regulatory direction of 4 major technical issues for the Korean Next Generation Reactors, which are parts of major technical issues resulted from the safety regulation R and D on the KNGR. The outstanding results are as follows : reliability of risk significant SSCs established during design stage must be maintained through the operating life of the plant, currently used classification method of plant conditions and safety requirement were reviewed, and a quantitative classification method is needed to be developed further, the basic regulatory directions are proposed for multiple failures such as SBO, TLOFW, multiple SGTR and ATWS, safety requirements are proposed for survivability/availability of severe accident mitigation design features by 5 items if basic requirements, selection of initial event, identification of available equipment and instruments, identification of environmental conditions and verification methods.

Regulatory issues of digital instrumentation and control system in Lungmen project

International Nuclear Information System (INIS)

Chuang, C.F.; Chou, H.P.

2004-01-01

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

Japan's regulatory and safety issues regarding nuclear materials transport

International Nuclear Information System (INIS)

Saito, T.; Yamanaka, T.

2004-01-01

This paper focuses on the regulatory and safety issues on nuclear materials transport which the Government of Japan (GOJ) faces and needs to well handle. Background information about the status of nuclear power plants (NPP) and nuclear fuel cycle (NFC) facilities in Japan will promote a better understanding of what this paper addresses

Assessing the role of regulatory bodies in managing health professional issues and errors in Europe.

Science.gov (United States)

Risso-Gill, Isabelle; Legido-Quigley, H; Panteli, D; Mckee, M

2014-08-01

This paper explores how medical regulatory bodies in nine European countries manage professional issues involving quality and patient safety, to build on limited existing information on procedures for regulating medical professionals in Europe. Twelve vignettes describing scenarios of concerns about standards of physicians were developed, covering clinical, criminal and administrative matters. Medical regulatory bodies in nine European countries were asked what action they would normally take in each situation. Their responses were related to their regulatory mandate. Responses varied greatly across participating countries. Regulators are always involved where patients are at risk or where a criminal offence is committed within the clinical setting. Non-criminal medical issues were generally handled by the employer, if any, at their discretion. Countries varied in the use of punitive measures, the extent to which they took an interest in issues arising outside professional activities, and whether they dealt with issues themselves or referred cases to another regulatory authority or took no action at all. There is little consistency across Europe on the regulation of medical professionals. There is considerable diversity in the range of topics that regulatory bodies oversee, with almost all covering health care quality and safety and others encompassing issues related to reputation, respect and trust. These inconsistencies have significant implications for professional mobility, patient safety and quality of care. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

Science.gov (United States)

2012-02-28

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0048] Proposed Generic Communication; Regulatory Issue... CFR) Part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants,'' to satisfy the... inservice testing programs during the initial 120-month program interval following nuclear power plant...

Reactivation of nuclear power plant construction projects. Plant status, policy issues and regulatory options

International Nuclear Information System (INIS)

Spangler, M.B.

1986-07-01

Prior to the TMI-2 accident on March 28, 1979, four nuclear power plant units that had previously been issued a construction permit were cancelled, principally because of reduced projections of regional power demand. Since that time, an additional 31 units with CPs have been cancelled and eight units deferred. On December 23, 1985 one of the deferred units (Limerick-2) was reactivated and construction resumed. The primary objective of this policy study is to identify the principal issues requiring office-level consideration in the event of reactivation of the construction of one or more of the nuclear power plants falling into two categories: (1) LWR units issued a construction permit whose construction has been cancelled, and (2) LWR units whose construction has been deferred. The study scope is limited to identifying regulatory issues or questions deserving analysis rather than providing, at this time, answers or recommended actions. Five tasks are addressed: a tabulation and discussion of the status of all cancelled and deferred LWR units; and identification of potential safety and environmental issues; an identification of regulatory or policy issues and needed information to determine the desirability of revising certain rules and policies; and identification of regulatory options and decision criteria; and an identification of decision considerations in determining staff requirements and organizational coordination of LWR reactivation policy and implementation efforts. 41 refs

Emerging regulatory challenges facing the Indian rural electrification programme

International Nuclear Information System (INIS)

Bhattacharyya, Subhes C.; Srivastava, Leena

2009-01-01

The purpose of this paper is to present and analyse the regulatory issues emerging from the newly launched programme of rural electricity access in India. We focus on two broad areas, namely regulatory issues related to the organisation/structuring of the activities and issues related to subsidy and tariffs. The paper looks into the alternative organisational arrangements being used by the programme and identifies problem areas through a responsibility mapping. The tariff principle being followed by the programme is then analysed considering the alternative organisational forms and issues related to such pricing policies are identified. Possible alternative pricing options are then suggested. The paper finds that while the franchisee model is an innovative idea, it raises issues that the regulators should be concerned with. The programme has so far relied on the simplest franchisee model because of its ease of implementation but a transition to more complex alternatives would require careful considerations

Some issues raised by the National Academy of Sciences study for MC and A

International Nuclear Information System (INIS)

Tingey, F.H.

1988-01-01

Six of several issues raised by the recent DOE commissioned National Academy of Science Study for MC and A are briefly discussed in part along with resulting recommendations for DOE consideration. The activities discussed are: 1. Evaluating System Performance; 2. Management of Inventory Differences; 3. Management of Shipper-Receiver Differences; 4. Managing the MC and A Data Base; 5. Management of Threat and Vulnerability; and 6. MSSA Content and Preparation

Selected review of regulatory standards and licensing issues for nuclear power plants

International Nuclear Information System (INIS)

Stevenson, J.D.; Thomas, F.A.

1982-11-01

This report presents a compilation and description of current foreign regulatory standards and licensing issues in the areas of interest associated with Siting, Structural Engineering, Metallurgy and Materials, and Mechanical Engineering. In addition, summary comparisons of the requirements of both the US and foreign nuclear power plant regulatory standards are provided. The selected foreign countries surveyed include Canada, France, Japan, Sweden, United Kingdom of Great Britain and Northern Ireland, and the Federal Republic of Germany

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)

Regulatory issues on using programmable logic device in nuclear power plants

International Nuclear Information System (INIS)

Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H.

2012-01-01

For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards

Regulatory issues on using programmable logic device in nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2012-10-15

For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards.

Medical Students Raising Concerns.

Science.gov (United States)

Druce, Maralyn R; Hickey, Andrea; Warrens, Anthony N; Westwood, Olwyn M R

2016-09-16

After a number of high-profile incidents and national reports, it has become clear that all health professionals and all medical students must be able to raise concerns about a colleague's behavior if this behavior puts patients, colleagues, or themselves at risk.Detailed evidence from medical students about their confidence to raise concerns is limited, together with examples of barriers, which impair their ability to do so. We describe a questionnaire survey of medical students in a single-center, examining self-reported confidence about raising concerns in a number of possible scenarios. Thematic analysis was applied to comments about barriers identified.Although 80% of respondents felt confident to report a patient safety issue, students were less confident around issues of probity, attitude, and conduct. This needs to be addressed to create clear mechanisms to raise concerns, as well as support for students during the process.

Regulatory Audit Activities on Nuclear Design of Reactor Cores

International Nuclear Information System (INIS)

Yang, Chae-Yong; Lee, Gil Soo; Lee, Jaejun; Kim, Gwan-Young; Bae, Moo-Hun

2016-01-01

Regulatory audit analyses are initiated on the purpose of deep knowledge, solving safety issues, being applied in the review of licensee's results. The current most important safety issue on nuclear design is to verify bias and uncertainty on reactor physics codes to examine the behaviors of high burnup fuel during rod ejection accident (REA) and LOCA, and now regulatory audits are concentrated on solving this issue. KINS develops regulatory audit tools on its own, and accepts ones verified from foreign countries. The independent audit tools are sometimes standardized through participating the international programs. New safety issues on nuclear design, reactor physics tests, advanced reactor core design are steadily raised, which are mainly drawn from the independent examination tools. It is some facing subjects for the regulators to find out the unidentified uncertainties in high burnup fuels and to systematically solve them. The safety margin on nuclear design might be clarified by precisely having independent tools and doing audit calculations by using them. SCALE-PARCS/COREDAX and the coupling with T-H code or fuel performance code would be certainly necessary for achieving these purposes

Regulatory Audit Activities on Nuclear Design of Reactor Cores

Energy Technology Data Exchange (ETDEWEB)

Yang, Chae-Yong; Lee, Gil Soo; Lee, Jaejun; Kim, Gwan-Young; Bae, Moo-Hun [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2016-10-15

Regulatory audit analyses are initiated on the purpose of deep knowledge, solving safety issues, being applied in the review of licensee's results. The current most important safety issue on nuclear design is to verify bias and uncertainty on reactor physics codes to examine the behaviors of high burnup fuel during rod ejection accident (REA) and LOCA, and now regulatory audits are concentrated on solving this issue. KINS develops regulatory audit tools on its own, and accepts ones verified from foreign countries. The independent audit tools are sometimes standardized through participating the international programs. New safety issues on nuclear design, reactor physics tests, advanced reactor core design are steadily raised, which are mainly drawn from the independent examination tools. It is some facing subjects for the regulators to find out the unidentified uncertainties in high burnup fuels and to systematically solve them. The safety margin on nuclear design might be clarified by precisely having independent tools and doing audit calculations by using them. SCALE-PARCS/COREDAX and the coupling with T-H code or fuel performance code would be certainly necessary for achieving these purposes.

Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

International Nuclear Information System (INIS)

Wilmot, Roger D.

2011-02-01

The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

Strategic and policy issues raised by the transition from thermal to fast nuclear systems

International Nuclear Information System (INIS)

2009-01-01

The renewed interest in nuclear energy triggered by concerns about global climate change and security of supply, which could lead to substantial growth in nuclear electricity generation, enhances the attractiveness of fast neutron reactors with closed fuel cycles. Moving from the current fleet of thermal neutron reactors to fast neutron systems will require many decades and extensive RD-D efforts. This book identifies and analyses key strategic and policy issues raised by such a transition, aiming at providing guidance to decision makers on the best approaches for implementing transition scenarios. The topics covered in this book will be of interest to government and nuclear industry policy makers as well as to specialists working on nuclear energy system analyses and advanced fuel cycle issues. (author)

Ethical and Logistical Issues Raised by the Advanced Donation Program "Pay It Forward" Scheme.

Science.gov (United States)

Ross, Lainie Friedman; Rodrigue, James R; Veatch, Robert M

2017-10-01

The advanced donation program was proposed in 2014 to allow an individual to donate a kidney in order to provide a voucher for a kidney in the future for a particular loved one. In this article, we explore the logistical and ethical issues that such a program raises. We argue that such a program is ethical in principle but there are many logistical issues that need to be addressed to ensure that the actual program is fair to both those who do and do not participate in this program. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Liability for oil spill damages: issues, methods, and examples

International Nuclear Information System (INIS)

Grigalunas, T.A.; Opaluch, J.J.; Diamantides, J.; Mazzotta, M.

1998-01-01

Liability is an important incentive-based instrument for preventing oil spills and provides a sustainable approach for restoring coastal resources injured by spills. However, the use of liability for environmental damages raises many challenges, including quantification of money measures of damages. In this article, case studies are used to illustrate the issues, methods, and challenges associated with assessing a range of damages, from those that can be measured relatively easily using market information to more 'esoteric', and much more difficult, cases involving non-market-valued losses. Also discussed are issues raised by the new national and international regulatory focus on restoration and by the simplified, compensatory formula used by some states. (author)

Raising the bar (6)

NARCIS (Netherlands)

Elhorst, Paul; Abreu, Maria; Amaral, Pedro; Bhattacharjee, Arnab; Corrado, Luisa; Doran, Justin; Fingleton, Bernard; Fuerst, Franz; Garretsen, Harry; Igliori, Danilo; Le Gallo, Julie; McCann, Philip; Monastiriotis, Vassilis; Quatraro, Francesco; Yu, Jihai

2017-01-01

Raising the bar (6). Spatial Economic Analysis. This editorial summarizes and comments on the papers published in issue 12(4) so as to raise the bar in applied spatial economic research and highlight new trends. The first paper addresses the question of whether 'jobs follow people' or 'people follow

Distracted Driving Raises Crash Risk

Science.gov (United States)

... this issue Health Capsule Distracted Driving Raises Crash Risk En español Send us your comments Video technology ... distracted driving, especially among new drivers, raises the risk for car crashes and near crashes. The study ...

Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

Energy Technology Data Exchange (ETDEWEB)

Wilmot, Roger D. (Galson Sciences Limited (United Kingdom))

2011-02-15

The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

Japan's regulatory and safety issues regarding nuclear materials transport

Energy Technology Data Exchange (ETDEWEB)

Saito, T. [Nuclear and Industrial Safety Agency, Ministry of Economy, Trade and Industry, Government of Japan, Tokyo (Japan); Yamanaka, T. [Japan Nuclear Energy Safety Organization, Government of Japan, Tokyo (Japan)

2004-07-01

This paper focuses on the regulatory and safety issues on nuclear materials transport which the Government of Japan (GOJ) faces and needs to well handle. Background information about the status of nuclear power plants (NPP) and nuclear fuel cycle (NFC) facilities in Japan will promote a better understanding of what this paper addresses.

Macroeconomic Conditions and Capital Raising

OpenAIRE

Isil Erel; Brandon Julio; Woojin Kim; Michael S. Weisbach

2011-01-01

Do macroeconomic conditions affect firms' abilities to raise capital? If so, how do they affect the manner in which the capital is raised? We address these questions using a large sample of publicly-traded debt issues, seasoned equity offers, bank loans and private placements of equity and debt. Our results suggest that a borrower's credit quality significantly affects its ability to raise capital during macroeconomic downturns. For noninvestment-grade borrowers, capital raising tends to be p...

Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues.

Science.gov (United States)

Sanders, M E; Huis in't Veld, J

1999-01-01

Properly formulated probiotic-containing foods offer consumers a low risk, low cost dietary component that has the potential to promote health in a variety of ways. Several such products are available commercially, although markets in Japan and Europe are more developed than in the USA. Once healthful attributes of a probiotic product have been identified, there remain microbiological, product, regulatory and labeling issues to be addressed prior to marketing. Microbiological and product issues include safety, effective scale-up for manufacturing, definition of probiotic activity, probiotic stability in the product over the course of product manufacture, shelf-life and consumption, definition of effective dose and target population(s), and development of quality assurance approaches. Examples of probiotic-containing foods are given. Regulatory and labeling issues are complicated because they differ for each country, but are likewise critical because they provide the means for communication of the product benefits to the consumer. The regulatory climate worldwide appears to be one of caution about overstating the benefits of such products but at the same time not preventing corporate commitment to marketing.

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study

Directory of Open Access Journals (Sweden)

Carla Pires

Full Text Available CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1 to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2 to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose. RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

Reversibility of Decisions and Retrievability of Radioactive Waste: An Overview of Regulatory Positions and Issues

International Nuclear Information System (INIS)

Ruiz-Lopez, Carmen; Pescatore, Claudio

2015-02-01

The Radioactive Waste Management Committee (RWMC) of the NEA has been at the forefront worldwide in examining the topic of Reversibility and Retrievability (R and R). As early as 2001, an NEA survey-based report entitled 'Reversibility and Retrievability in Geological Disposal of Radioactive Waste' provided an overview of R and R by an ad-hoc group of experts from 11 NEA Member countries. The 2001 report (NEA 2001) observed that national safety regulations dealt mainly with operational safety and design targets for long-term (post-closure) safety and relatively little consideration was given to retrievability/reversibility or its implications. Yet, policy frames saw benefits from retrievability. In 2007, the RWMC launched the NEA R and R project with participation from 15 countries and two international organisations. The project included, amongst its members, representatives of six organisations involved in regulation, five regulatory authorities of five countries and one technical support organisation to the safety authorities. The project aimed to improve awareness amongst the RWMC constituency of the breadth of issues and positions regarding the concepts of R and R with the goal of providing a neutral overview of relevant issues and viewpoints in OECD countries. Hence substantial attention was given to R and R regulatory issues mainly in the context of decision making for repository development. The report (NEA 2011) points out regulatory issues, including safety criteria and licensing considerations. The present document presents an overview of findings, positions, boundary conditions and issues based on the results of the R and R project of 2007-2011 (stepwise decision making and reversibility, regulatory authorisations and R and R, decision making for retrieval) and of the Reims conference of December 2010 (terminology and definitions, legal and policy context, motivations for R and R, practical aspects, stakeholders confidence aspects)

76 FR 57006 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; NRC Regulation of...

Science.gov (United States)

2011-09-15

... NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 150 [NRC-2011-0146] Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; NRC Regulation of Military Operational Radium-226... published for public comment the proposed draft RIS 2011-XX; NRC Regulation of Military Operational Radium...

A study on the regulatory approach of major technical issues

Energy Technology Data Exchange (ETDEWEB)

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

1999-02-15

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

Anatomy of a cogeneration deal : natural gas contracts and regulatory issues

International Nuclear Information System (INIS)

Brett, J.T.

1999-01-01

The special features of gas contracts for cogeneration projects were discussed. It was recommended that a gas power purchase contract should be entered early in a project development cycle to justify requests for new pipeline facilities. Issues regarding buyer's commitments, market prices, and volumes were also discussed. In the event of failure to deliver, the contract should include provisions which would make it possible to source gas elsewhere, terminate the contract or seek damages. This paper also discussed various pricing provisions in a gas commodity contract, security of supplies, gas transportation arrangements, regulatory considerations, outstanding issues, and IMO (independent market operator) requirements

Regulatory Compliance in Multi-Tier Supplier Networks

Science.gov (United States)

Goossen, Emray R.; Buster, Duke A.

2014-01-01

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

Waste management regulatory compliance issues related to D ampersand D activities at Oak Ridge National Laboratory (ORNL)

International Nuclear Information System (INIS)

Hitch, J.P.; Arnold, S.E.; Burwinkle, T.; Daugherty, D.

1994-01-01

The waste management activities at ORNL related to the decontamination and decommissioning (D ampersand D) of radioactively contaminated buildings are divided into four categories: Operational facilities, inactive or surplus facilities, future facilities planning, and D ampersand D activities. This paper only discusses regulatory issues related to inactive or surplus facilities. Additionally, rather than attempting to address all resulting waste streams and related regulations, this paper highlights only a few of the ORNL waste streams that present key regulatory issues

Policy issues raised by intervenor requests for financial assistance in NRC proceedings

International Nuclear Information System (INIS)

1975-01-01

The purpose of the report presented is to focus and develop the myriad issues raised by intervenor requests for financial assistance for the NRC's proposed rulemaking proceeding. The report analyzes and assesses the various alternatives open to the Commission, and collects relevant data and material which may be informative to those participating in and conducting the rulemaking. Three major questions are examined: (1) should the Commission, as a matter of policy choice, provide financial assistance to intervenors in NRC proceedings; (2) are there preferable alternatives to direct intervenor financial aid, such as the establishment of an office of public counsel or provision of other forms of Commission assistance; and (3) what are the legal, administrative and policy considerations involved in implementing a determination to award financial assistance to intervenors, should the Commission so decide

Regulatory analysis for resolution of USI [Unresolved Safety Issue] A-47

International Nuclear Information System (INIS)

Szukiewicz, A.J.

1989-07-01

This report presents a summary of the regulatory analysis conducted by the US Nuclear Regulatory Commission staff to evaluate the value/impact of alternatives for the resolution of Unresolved Safety Issue A-47, ''Safety Implications of Control Systems.'' The NRC staff's resolution presented herein is based on these analyses and on the technical findings and conclusions presented in NUREG-1217, the companion document to this report. The staff has concluded that certain actions should be taken to improve safety in light-water reactor plants. The staff recommended that certain plants improve their control systems to preclude reactor vessel/steam generator overfill events and to prevent steam generator dryout, modify their technical specifications to verify operability of such systems, and modify selected emergency procedures to ensure safe shutdown of the plant following a small-break loss-of-coolant accident. This report was issued as a draft for public comment on May 27, 1988. As a result of the public comments received, this report was revised. The NRC staff's responses to and resolution of the public comments are included as Appendix C to the final report, NUREG-1217

78 FR 26820 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

Science.gov (United States)

2013-05-08

... affiliate relationship between NASDAQ and NOS, its member, raises the issue of an exchange's affiliation... unfair competitive advantage and potential conflicts of interest between an exchange's self-regulatory... regarding the potential for conflicts of interest in instances where a member firm is affiliated with an...

Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission's dispositions

International Nuclear Information System (INIS)

Watanabe, Norio; Suzudo, Tomoaki

1998-09-01

Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission's (USNRC's) responses to the recommendations made by the NRC's study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC's dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

Regulatory and institutional issues for development of remedial action strategies at ORNL

International Nuclear Information System (INIS)

Kocher, D.C.

1988-01-01

This paper discusses a number of unresolved regulatory and institutional issues of fundamental importance to the development of strategies for cleanup of sites contaminated by the radioactive materials at Oak Ridge National Laboratory. These issues include the development of criteria for limiting radiation exposures of the public from remedial action sites, the time period to be assumed for active institutional controls over contaminated sites and the location at which such controls will be maintained, and the applicability of current standards for radioactivity in drinking water to surface waters and ground waters on the Oak Ridge Reservation. Proposals for resolution of these issues emphasize the need to protect public health, but in a cost-effective manner. 21 refs

Nanoparticulate materials and regulatory policy in Europe: An analysis of stakeholder perspectives

International Nuclear Information System (INIS)

Helland, Aasgeir; Kastenholz, Hans; Thidell, Aake; Arnfalk, Peter; Deppert, Knut

2006-01-01

The novel properties of nanoparticulate materials (NPM) and the rapid development of NPM based products have raised many unanswered questions and concerns by different stakeholders over its consequences for the environment and human health. These concerns have led to an increasing discussion in both the US and Europe about possible regulatory policies for NPM. In this article a comparative study of stakeholders' perceptions on regulatory policy issues with NPM in Europe is presented. It was found that industry wants to regulate this area if the scientific evidence demonstrates that NPM are harmful, but also that the regulatory bodies do not find it necessary at this point of time to regulate until scientific evidence demonstrates that NPM are harmful. This research therefore shows that there will most likely not be any regulatory interventions until there is an established and convincing scientific knowledge base demonstrating that NPM can be hazardous. It is furthermore discussed in this article the different roles and responsibilities of the stakeholders in financing the research required to establish the necessary level of fundamental scientific evidence. It was also found that the activity of the regulatory bodies on this issue differ between the European countries

International regulatory issues and approaches in the transition phase from operation to decommissioning

International Nuclear Information System (INIS)

Pyy, P.; Hrehor, M.; ); Murley, T.; Ranieri, R.; Laaksonen, J.

2005-01-01

Full text: The paper summarizes the work performed by an international group of senior nuclear safety regulators which was convened by the Committee on Nuclear Regulatory Activities (CNRA) of the OECD/Nuclear Energy Agency. The fundamental objective of this work was to identify the safety, environmental, organizational, human factors and public policy issues arising from decommissioning that will produce new challenges for the regulator. The study begins by recognizing that decommissioning is not simply an extension of operation and thus it is important for both the management of the facility and the regulator to understand the fundamental nature of the change taking place. Major regulatory policy issues discussed during this study include assurance of adequate funds, waste storage and disposal sites, material release criteria and site release criteria. Some of the important regulatory challenges relate to organizational and human factors, to safety and security requirements and to waste disposal and license termination. The importance of regular communication with both the corporate and site management and with public is recognized in the study as one of the key factors. When a nuclear facility ceases operation and enters into the decommissioning phase, both the operator and the regulator face a new set of challenges very different from those of an operating facility. The operator should have in place a strategic plan for decommissioning, prepared well in advance and reviewed by the regulatory body, to guide the facility managers and personnel through the changed circumstances. An essential part of the strategic plan should be the operator's plan for securing adequate funds to complete the decommissioning activities. In fact, the regulator should ensure that the operator sets aside funds, perhaps in a trust fund, while the facility is still operating and generating revenues. Both the operator and the regulator should expect a heightened public interest and concern

Healthier? More Efficient? Fairer? An Overview of the Main Ethical Issues Raised by the Use of Ubicomp in the Workplace

Directory of Open Access Journals (Sweden)

Céline Ehrwein NIHAN

2013-05-01

Full Text Available The development of Ambient Intelligence (AmI will radically transform our everyday life and social representations. These transformations will notably impact the working environment. The objective of this paper is to offer a first survey of the main ethical issues raised by the development of intelligent working environments (IWEs. It especially focuses on the capacity of such environments to collect and handle personal medical data. The first two sections of this paper aim to clarify the methodology (2 as well as the object (3 of the research. We then point out some of the main ethical issues raised by IWEs and their capacity to collect and handle medical data. The final section attempts to offer some elements of reflection regarding the ethical principles that should guide the development of IWEs in the future.

Development of cross border gas transmission projects raise challenging issues. Case studies: The transmed and the Maghreb/Europe pipelines

International Nuclear Information System (INIS)

Khene, D.

1997-01-01

Development of cross border gas transmission projects raise complex and interdependent issues whose successful resolution require not only technical and management strengths but also a close cooperation between the key players involved in the game. In this paper we shall attempt to explain some of the major issues encountered during the appraisal and construction of long distance gas pipeline schemes. The information used derive essentially from the experience gained during the development of the Trans-mediterranean and the Maghreb/Europe pipelines. Running through the various issues we shall also identify and then discuss a number of factors which contributed to the successful implementation of these two projects. (au)

Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission`s dispositions

Energy Technology Data Exchange (ETDEWEB)

Watanabe, Norio; Suzudo, Tomoaki [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

1998-09-01

Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission`s (USNRC`s) responses to the recommendations made by the NRC`s study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC`s dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

78 FR 26826 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing of Proposed Rule Change for...

Science.gov (United States)

2013-05-08

...\\ Accordingly, the affiliate relationship between Phlx and NOS, its member, raises the issue of an exchange's... unfair competitive advantage and potential conflicts of interest between an exchange's self-regulatory... potential for conflicts of interest in instances where a member firm is affiliated with an exchange of which...

78 FR 29795 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc ; Notice of Filing of Proposed Rule Change for...

Science.gov (United States)

2013-05-21

...\\ Accordingly, the affiliate relationship between BX and NOS, its member, raises the issue of an exchange's... unfair competitive advantage and potential conflicts of interest between an exchange's self-regulatory... potential for conflicts of interest in instances where a member firm is affiliated with an exchange of which...

Issues of Meaning and Interpretation Raised by Diagetic versus Non-diagetic Use of Music in Television and Film

DEFF Research Database (Denmark)

Grund, Cynthia M.

2008-01-01

Issues of Meaning and Interpretation Rasied by Diagetic versus Non-diagetic Use of Music in Television and Film. When music occurs in the soundtrack of a film or television show, it can either be attributed to a source within the narrative, so that the characters can hear it, or it can...... be "background" music, available to the viewer, but not to the characters. In this presentation, we will explore the complex of issues related to meaning and interpretaiton raised by diagetic v non-diagetic use of music in television and film. Matters to be addressed include: How is it of significance...

The Campus Green: Fund Raising in Higher Education. ERIC Digest.

Science.gov (United States)

Brittingham, Barbara E.; Pezzullo, Thomas R.

This digest summarizes issues raised in a research report on fund raising in higher education. The following questions are addressed: What are the changes and trends since the early days of educational fund raising? What are the implications? What is known about spending? What is known about donor behavior? What are the major ethical issues? What…

NRC [Nuclear Regulatory Commission] staff evaluation of the General Electric Company Nuclear Reactor Study (''Reed Report'')

International Nuclear Information System (INIS)

1987-07-01

In 1975, the General Electric Company (GE) published a Nuclear Reactor Study, also referred to as ''the Reed Report,'' an internal product-improvement study. GE considered the document ''proprietary'' and thus, under the regulations of the Nuclear Regulatory Commission (NRC), exempt from mandatory public disclosure. Nonetheless, members of the NRC staff reviewed the document in 1976 and determined that it did not raise any significant new safety issues. The staff also reached the same conclusion in subsequent reviews. However, in response to recent inquiries about the report, the staff reevaluated the Reed Report from a 1987 perspective. This re-evaluation, documented in this staff report, concluded that: (1) there are no issues raised in the Reed Report that support a need to curtail the operation of any GE boiling water reactor (BWR); (2) there are no new safety issues raised in the Reed Report of which the staff was unaware; and (3) although certain issues addressed by the Reed Report are still being studied by the NRC and the industry, there is no basis for suspending licensing and operation of GE BWR plants while these issues are being resolved

Key regulatory and safety issues emerging NEA activities. Lessons Learned from Fukushima Dai-ichi NPS Accident - Key Regulatory and Safety Issues

International Nuclear Information System (INIS)

Nakoski, John

2013-01-01

A presentation was provided on the key safety and regulatory issues and an update of activities undertaken by the NEA and its members in response to the accident at the Fukushima Daiichi nuclear power stations (NPS) on 11 March 2011. An overview of the accident sequence and the consequences was provided that identified the safety functions that were lost (electrical power, core cooling, and primary containment) that lead to units 1, 2, and 3 being in severe accident conditions with large off-site releases. Key areas identified for which activities of the NEA and member countries are in progress include accident management; defence-in-depth; crisis communication; initiating events; operating experience; deterministic and probabilistic assessments; regulatory infrastructure; radiological protection and public health; and decontamination and recovery. For each of these areas, a brief description of the on-going and planned NEA activities was provided within the three standing technical committees of the NEA with safety and regulatory mandates (the Committee on Nuclear Regulatory Activities - CNRA, the Committee on the Safety of Nuclear Installations - CSNI, and the Committee on Radiation Protection and Public Health - CRPPH). On-going activities of CNRA include a review of enhancement being made to the regulatory aspects for the oversight of on-site accident management strategies and processes in light of the lessons learned from the accident; providing guidance to regulators on crisis communication; and supporting the peer review of the safety assessments of risk-significant research reactor facilities in light of the accident. Within the scope of the CSNI mandate, activities are being undertaken to better understand accident progression; characteristics of new fuel designs; and a benchmarking study of fast-running software for estimating source term under severe accident conditions to support protective measure recommendations. CSNI also has ongoing work in human

Suggested technical scheme to help resolve regulatory issues

Energy Technology Data Exchange (ETDEWEB)

Harvey, T.

1978-07-01

A management-planning model envisioned as a useful tool for planning and guiding the development of a nuclear waste repository data base is described. It incorporates the technical assessment goals and objectives of the US Nuclear Regulatory Commission, and it provides a strategy for reaching them. The model strategy includes provisions for the breadth, timeliness, and defensibility of its predictions. Consideration is given to observational data, its structure, and future refinements. The structure of the data is consistent with the needs of a systems model whose structure is proposed to resolve questions about repository safety. Uncertainties are categorized as an aid in defining and resolving technical issues. The model provides a framework for ultimately exposing all the sensitive and controversial factors. Some quantitative aspects of data acquisition are presented. 12 figures.

Suggested technical scheme to help resolve regulatory issues

International Nuclear Information System (INIS)

Harvey, T.

1978-07-01

A management-planning model envisioned as a useful tool for planning and guiding the development of a nuclear waste repository data base is described. It incorporates the technical assessment goals and objectives of the US Nuclear Regulatory Commission, and it provides a strategy for reaching them. The model strategy includes provisions for the breadth, timeliness, and defensibility of its predictions. Consideration is given to observational data, its structure, and future refinements. The structure of the data is consistent with the needs of a systems model whose structure is proposed to resolve questions about repository safety. Uncertainties are categorized as an aid in defining and resolving technical issues. The model provides a framework for ultimately exposing all the sensitive and controversial factors. Some quantitative aspects of data acquisition are presented. 12 figures

Instream sand and gravel mining: Environmental issues and regulatory process in the United States

Science.gov (United States)

Meador, M.R.; Layher, A.O.

1998-01-01

Sand and gravel are widely used throughout the U.S. construction industry, but their extraction can significantly affect the physical, chemical, and biological characteristics of mined streams. Fisheries biologists often find themselves involved in the complex environmental and regulatory issues related to instream sand and gravel mining. This paper provides an overview of information presented in a symposium held at the 1997 midyear meeting of the Southern Division of the American Fisheries Society in San Antonio, Texas, to discuss environmental issues and regulatory procedures related to instream mining. Conclusions from the symposium suggest that complex physicochemical and biotic responses to disturbance such as channel incision and alteration of riparian vegetation ultimately determine the effects of instream mining. An understanding of geomorphic processes can provide insight into the effects of mining operations on stream function, and multidisciplinary empirical studies are needed to determine the relative effects of mining versus other natural and human-induced stream alterations. Mining regulations often result in a confusing regulatory process complicated, for example, by the role of the U.S. Army Corps of Engineers, which has undergone numerous changes and remains unclear. Dialogue among scientists, miners, and regulators can provide an important first step toward developing a plan that integrates biology and politics to protect aquatic resources.

Status report on roadmap headquarters issue resolution activities

International Nuclear Information System (INIS)

1993-01-01

The Roadmap Project Office (RPO), under the Office of Planning (EM-14), continues to review headquarters (HQ) issues raised by the field in their roadmap documents. Currently, twenty-nine HQ issues are in the ''resolution'' process or are being defined for resolution. The resolution process involves an Environmental Restoration and Waste Management Program (EM) HQ person, the Action Officer (AO), as the leader in the resolution process. The RPO is responsible to EM-14 for reporting on the progress of issue resolution activities and also to provide contractor support to each Action Officer: the contractor support person is identifies as the Issue Resolution Facilitator (IF). Field contacts also are identified for each issue. This document provides current information on HQ issues actively in the ''resolution'' process or being defined for resolution. The issues are primarily institutional rather than technical and mainly involve regulatory, coordination, prioritization, policy and management concerns

Regulatory issues and assumptions associated with polymers for subsurface barriers surrounding buried waste

International Nuclear Information System (INIS)

Heiser, J.; Siskind, B.

1993-01-01

One of the options for control of contaminant migration from buried waste sites is the construction of a subsurface barrier that consists of a wall of low permeability material. Subsurface barriers will improve remediation performance by removing pathways for contaminant transport due to groundwater movement, meteorological water infiltration, vapor- and gas-phase transport, transpiration, etc. Subsurface barriers may be used to open-quotes directclose quotes contaminant movement to collection sumps/lysimeters in cases of unexpected remediation failures or transport mechanisms, to contain leakage from underground storage tanks, and to restrict in-situ soil cleanup operation and chemicals. Brookhaven National Laboratory is currently investigating advanced polymer materials for subsurface barriers. This report addresses the regulatory aspects of using of non-traditional polymer materials as well as soil-bentonite or cement-bentonite mixtures for such barriers. The regulatory issues fall into two categories. The first category consists of issues associated with the acceptability of subsurface barriers to the Environmental Protection Agency (EPA) as a method for achieving waste site performance improvement. The second category encompasses those regulatory issues concerning health, safety and the environment which must be addressed regarding barrier installation and performance, especially if non-traditional materials are to be used. Since many of EPA's concerns regarding subsurface barriers focus on the chemicals used during installation of these barriers the authors discuss the results of a search of the Federal Register and the Code of Federal Regulations for references in Titles 29 and 40 pertaining to key chemicals likely to be utilized in installing non-traditional barrier materials. The use of polymeric materials in the construction industry has been accomplished with full compliance with the applicable health, safety, and environmental regulations

Regulatory policy issues and the Clean Air Act: Issues and papers from the state implementation workshops

Energy Technology Data Exchange (ETDEWEB)

Rose, K. [ed.; Burns, R.E.

1993-07-01

The National Regulatory Research Institute (NRRI), with funding from the US Environmental Protection Agency (EPA) and the US Department of Energy (DOE), conducted four regional workshops` on state public utility commission implementation of the Clean Air Act Amendments of 1990 (CAAA). The workshops had four objectives: (1) to discuss key issues and concerns on CAAA implementation, (2) to encourage a discussion among states on issues of common interests, (3) to attempt to reach consensus, where possible, on key issues, and (4) to provide the workshop participants with information and materials to assist in developing state rules, orders, and procedures. From the federal perspective, a primary goal was to ensure that workshop participants return to their states with a comprehensive background and understanding of how state commission actions may affect implementation of the CAAA and to be able to provide guidance to their jurisdictional utilities. It was hoped that this would reduce some of the uncertainty utilities face and assist in the development of an efficient allowance market. This report is divided into two main sections. In Section II, eleven principal issues are identified and discussed. These issues were chosen because they were either the most frequently discussed or they were related to the questions asked in response to the speakers` presentations. This section does not cover all the issues relevant to state implementation nor all the issues discussed at the workshops; rather, Section II is intended to provide an overview of the,planning, ratemaking, and multistate issues. Part III is a series of workshop papers presented by some of the speakers. Individual papers have been cataloged separately.

Why Banning Embedded Sales Commissions Is a Public Policy Issue

OpenAIRE

Henri-Paul Rousseau

2017-01-01

Regulatory authorities have consulted on the option of banning embedded sales commissions for Canadian financial advisors. Such an action would create more problems than it would solve. It would have serious ramifications for Canadians’ access to financial advice and raise issues of choice, industry concentration and price transparency for clients seeking advice on investments and retirement. Financial advisors have much greater knowledge of investments than their clients, who rightly expect ...

Transmission access raises unresolved economic issues

International Nuclear Information System (INIS)

Happ, H.H.

1994-01-01

The electric utility industry is in the process of gradual change from a fully regulated industry to one of partial deregulation. Instead of relying on regulation to achieve a fair and equitable price to the consumer for electric energy, the reliance is placed more and more on market forces, through competition, to provide wholesale energy at the best market price. Clearly, open transmission access is required to create a viable competitive wholesale market for new generation resources. This article describes four unresolved, or at least partially unresolved, issues associated with transmission access for wholesale wheeling. Wheeling has been defined as the use of a utility's transmission facilities to transmit power for other buyers and sellers. At least three parties are involved in a wheeling transaction: a seller, a buyer, and one or more wheeling utilities that transmit the power from the seller to the buyer. This article considers wholesale or bulk wheeling only, and does not consider retail wheeling. The four unresolved economic issues described in this article pertain to transmission access: Actual cost of providing transmission services, Methodology or methodologies used in evaluating the cost of wheeling, Contract path versus the actual power flows of the wheel, Issues associated with the formation of transmission regions

Lessons Learned and Regulatory Countermeasures of Nuclear Safety Issues Last Year

Energy Technology Data Exchange (ETDEWEB)

Lee, Y. E. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2013-05-15

Competitiveness of nuclear as the electric resource in terms of the least cost and the carbon abatement has been debated. Some institutions insist that the radioactive wastes management cost, nuclear accident cost and cheap shale gas would make the nuclear energy less competitive, while others still address the ability of nuclear energy as economical and low-carbon electric resource. This situation reminds that ensuring nuclear safety is the most important prerequisite to use of nuclear energy. Therefore, this paper will compare the different views on future nuclear competitiveness discussed right after the Fukushima accident and summarize the lessons learned and regulatory countermeasures from nuclear safety issues last year. Korea has improved the effectiveness of safety regulation up to now and still has been making efforts on further enhancing nuclear safety. The outcomes of these efforts have resulted in a high level of safety in Korean NPPs and contributing largely to the global nuclear safety through sharing and exchanging the information and knowledge of our nuclear experiences. However, now we are faced with the new challenges such as decreasing the public. Additionally, public criticism of the regulatory activities demands more clear regulatory guides and transparent process. Recently, new president announced the 'Priority to Safety and Public Trust' as the precondition to utilize the nuclear energy. We will continue to make much more efforts for the improvement of the quality of regulatory activities and effectiveness of regulatory decision making process than we have done so far. Competence through effective capacity building would be a helpful pathway to build up the public trust and ensure the acceptable level of nuclear safety. We are set to prepare the action items to be taken in the near future for improving the technical competency and transparency as the essential components of the national safety and will make efforts to implement them

Ethical and regulatory aspects of embryonic stem cell research.

Science.gov (United States)

Jain, Kewal K

2002-12-01

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

Regulatory analysis for the resolution of generic issue C---8, main steam isolation valve leakage and LCS [leakage control system] failure

International Nuclear Information System (INIS)

Graves, C.C.

1990-06-01

Generic Issue C-8 deals with staff concerns about public risk because of the incidence of leak test failures reported for main steam isolation valves (MSIVs) at boiling water reactors and the limitations of the leakage control systems (LCSs) for mitigating the consequences of leakage from these valves. If the MSIV leakage is greatly in excess of the allowable value in the technical specifications, the LCS would be unavailable because of design limitations. The issue was initiated in 1983 to assess (1) the causes of MSIV leakage failures, (2) the effectiveness of the LCS and alternative mitigation paths, and (3) the need for additional regulatory action to reduce public risk. This report presents the regulatory analysis for Generic Issue C-8 and concludes that no new regulatory requirements are warranted

Issues on raising a bilingual child in Costa Rica: a myth or a reality?

Directory of Open Access Journals (Sweden)

Allen Quesada Pacheco

2011-01-01

Full Text Available This article deals with main issues concerning bilingualism and bilingual first language acquisition (BFLA. A review of the literature is presented on how children learn languages. In addition, this paper summarizes what bilingualism is and addresses how the One-parent One-language (OPOL and the Minority Language at Home (ML@H methods work. The paper includes sample testimonies of Itzel, a three-year-old child, raised with these methods. It also illustrates samples of her code-switching and code-mixing as part of her evolution in bilingual first language acquisition. Based on this evolution, there is some evidence that a child can become bilingual under foreign language conditions. Finally, the article reflects on the decisive role that dedication, consistency and effort have as crucial components to accomplish BFLA.

Incorporation of Student-Centered, Practical Applications of Geographic Information Systems to Raise Awareness and Generate Solutions for Local Environmental Issues

Science.gov (United States)

Bilsley, N. A.; Love, C. A.; Minster, J. B. H.

2014-12-01

Geographic Information Systems (GIS) offer a plethora of applications for numerous fields, from geological sciences to urban planning. Therefore, developing a practical GIS curriculum for students from a diverse selection of majors can be challenging, especially since time constraints presented by the course term limit the number of projects that can cater to each student's academic focus. However, open ended assignments that allow students the freedom to personalize their projects present an opportunity to teach the universal functionality of GIS, as well as stimulate curiosity of students from all backgrounds by allowing them to tailor a project to their personal interests. During an introductory GIS course at the University of California, San Diego, projects prompted students to utilize ArcGIS in ways of their choice that raised awareness of local environmental issues, as well as encouraged students to incorporate environmentally sustainable practices into their lives. In view of the frequently stated interest of students to enter careers where they can use their newly learned GIS skills, the educational platform of choice is ESRI's ArcGIS, but the choice of platform remains flexible. As GIS resources become more accessible with the development of programs such as OpenGIS and OpenStreetMap, the potential for GIS to effectively communicate environmental issues to the public is growing fast. Incorporating these environmental issues into a curriculum not only allows students to personalize their education, but also raises awareness of such problems and provides students with the ability to communicate those issues using GIS.

Overview of Fukushima accident and regulatory issues for FCFS after the accident

International Nuclear Information System (INIS)

Ueda, Y.

2013-01-01

In the first part of his presentation Yoshinori Ueda (JNES, Japan) gave an overview of the Fukushima accident and an outline of the emergency safety measures and response at the NPP site. The second part was focused on the regulatory issues for FCFs after the accident. The first issue was the emergency safety measures in case of total loss of AC power (loss capabilities of decay heat removal and hydrogen accumulation prevention) and tsunami in the reprocessing facilities and associated spent fuel storages at Tokai and Rokkasho plants. The second issue was the directions to the licensees of these facilities to secure the work environment in the main control rooms in case of complete loss of AC power, to secure communication within the facility in case of such emergency, and to secure material and equipment for radiation protection, and to deploy heavy tools for rubble removal. No paper has been made available for this presentation

Raising the bar (7)

NARCIS (Netherlands)

Elhorst, Paul; Abreu, Maria; Amaral, Pedro; Bhattacharjee, Arnab; Corrado, Luisa; Doran, Justin; Fingleton, Bernard; Fuerst, Franz; Garretsen, Harry; Igliori, Danilo; Gallo, Julie Le; McCann, Philip; Monastiriotis, Vassilis; Quatraro, Francesco; Yu, Jihai

2018-01-01

This editorial summarises the papers published in issue 13.1 so as to raise the bar in applied spatial economic research and highlight new trends. The first paper adopts a scale neutral approach to investigate the spatial mechanisms that cause regional innovation and growth. The second paper claims

Raising the Bar (3)

NARCIS (Netherlands)

Elhorst, Paul; Abreu, M.; Amaral, P.; Bhattacharjee, A.; Corrado, L.; Fingleton, B.; Fuerst, F.; Garretsen, H.; Igliori, D.; Le Gallo, J.; McCann, P.; Monastiriotis, V.; Pryce, G.; Yu, J.

This editorial summarizes and comments on the papers published in issue 11(3) so as to raise the bar in applied spatial economic research and highlight new trends. The first paper proposes spatial and a-spatial indicators to describe the networks of airline companies around the world. The second

Raising venture capital in the biopharma industry.

Science.gov (United States)

Leytes, Lev J

2002-11-15

Raising venture capital (VC) is both an art and a science. Future entrepreneurs should carefully consider the various issues of VC financing that have a strong impact on the success of their business. In addition to attracting the best venture capital firms, these issues include such subtle but important points as the timing of financing (especially of the first round), external support sources, desirable qualities of a VC firm, amount to be raised, establishing a productive interface between the founders and the venture capitalists, and most importantly the effects of well-executed VC funding on hiring senior executives and scientific leaders.

Scalable human ES culture for therapeutic use: propagation, differentiation, genetic modification and regulatory issues.

Science.gov (United States)

Rao, M

2008-01-01

Embryonic stem cells unlike most adult stem cell populations can replicate indefinitely while preserving genetic, epigenetic, mitochondrial and functional profiles. ESCs are therefore an excellent candidate cell type for providing a bank of cells for allogenic therapy and for introducing targeted genetic modifications for therapeutic intervention. This ability of prolonged self-renewal of stem cells and the unique advantages that this offers for gene therapy, discovery efforts, cell replacement, personalized medicine and other more direct applications requires the resolution of several important manufacturing, gene targeting and regulatory issues. In this review, we assess some of the advance made in developing scalable culture systems, improvement in vector design and gene insertion technology and the changing regulatory landscape.

Safety Committees for Argentinean Research Reactor - Regulatory Issues

International Nuclear Information System (INIS)

Perrin, Carlos D.

2009-01-01

In the field of radiological and nuclear safety, the Nuclear Regulatory Authority (ARN) of Argentina controls three research reactors and three critical assemblies, by means of evaluations, audits and inspections, in order to ensure the fulfillment of the requirements established in the Licenses, in the Regulatory Standards and in the Mandatory Documentation in general. From the Nuclear Regulatory Authority's point of view, within the general process of research reactors safety management, the Operational Organization self verification of radiological and nuclear safety plays an outstanding role. In this aspect the ARN has established specific requirements in the Regulatory Standards, in the Operation Licenses and in the Operational Limits and Conditions. These requirements include the figure of different safety committees, which act as reviewers or advisers in diverse situations. This paper describes the main characteristics of the committees, their function, scope and the regulatory documents where the requirements are included. (author)

Ethical Issues Raised by Private Practice Physiotherapy Are More Diverse than First Meets the Eye: Recommendations from a Literature Review

Science.gov (United States)

Drolet, Marie-Josée; Williams-Jones, Bryn

2015-01-01

ABSTRACT Purpose: Physiotherapy in private practice differs from physiotherapy practised in a public setting in several ways, the most evident of which is the for-profit nature of private physiotherapy clinics; these differences can generate distinct and challenging ethical issues. The objectives of this article are to identify ethical issues encountered by physiotherapists in private practice settings and to identify potential solutions and recommendations to address these issues. Method: After a literature search of eight databases, 39 studies addressing ethical issues in a private practice context were analyzed. Results: A total of 25 ethical issues emerging from the included studies were classified into three main categories: (1) business and economic issues (e.g., conflicts of interests, inequity in a managed care context, lack of time affecting quality of care); (2) professional issues (e.g., professional autonomy, clinical judgment, treatment effectiveness, professional conduct); and (3) patients' rights and welfare issues (e.g., confidentiality, power asymmetries, paternalism vs. patient autonomy, informed consent). Recommendations as to how physiotherapists could better manage these issues were then identified and categorized. Conclusions: The physiotherapy community should reflect on the challenges raised by private practice so that professionals can be supported—through education, research, and good governance—in providing the best possible care for their patients. PMID:25931663

Ethical issues raised by private practice physiotherapy are more diverse than first meets the eye: recommendations from a literature review.

Science.gov (United States)

Hudon, Anne; Drolet, Marie-Josée; Williams-Jones, Bryn

2015-01-01

Physiotherapy in private practice differs from physiotherapy practised in a public setting in several ways, the most evident of which is the for-profit nature of private physiotherapy clinics; these differences can generate distinct and challenging ethical issues. The objectives of this article are to identify ethical issues encountered by physiotherapists in private practice settings and to identify potential solutions and recommendations to address these issues. After a literature search of eight databases, 39 studies addressing ethical issues in a private practice context were analyzed. A total of 25 ethical issues emerging from the included studies were classified into three main categories: (1) business and economic issues (e.g., conflicts of interests, inequity in a managed care context, lack of time affecting quality of care); (2) professional issues (e.g., professional autonomy, clinical judgment, treatment effectiveness, professional conduct); and (3) patients' rights and welfare issues (e.g., confidentiality, power asymmetries, paternalism vs. patient autonomy, informed consent). Recommendations as to how physiotherapists could better manage these issues were then identified and categorized. The physiotherapy community should reflect on the challenges raised by private practice so that professionals can be supported-through education, research, and good governance-in providing the best possible care for their patients.

Topics raised by the summary report of the first review meeting

International Nuclear Information System (INIS)

2001-01-01

This document presents the fulfilling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 7 of the document contains topics raised by the summary report of the first review meeting. The chapter covers status and position of the regulatory body, collective doses, effluents release trends, adoption of the ICRP 60 and basic safety standards, regulatory strategy, quality assurance, monitoring safety management, international cooperation, probabilistic safety assessment and safety improvement programmes

Addressing the ethical, legal, and social issues raised by voting by persons with dementia.

Science.gov (United States)

Karlawish, Jason H; Bonnie, Richard J; Appelbaum, Paul S; Lyketsos, Constantine; James, Bryan; Knopman, David; Patusky, Christopher; Kane, Rosalie A; Karlan, Pamela S

2004-09-15

This article addresses an emerging policy problem in the United States participation in the electoral process by citizens with dementia. At present, health care professionals, family caregivers, and long-term care staff lack adequate guidance to decide whether individuals with dementia should be precluded from or assisted in casting a ballot. Voting by persons with dementia raises a series of important questions about the autonomy of individuals with dementia, the integrity of the electoral process, and the prevention of fraud. Three subsidiary issues warrant special attention: development of a method to assess capacity to vote; identification of appropriate kinds of assistance to enable persons with cognitive impairment to vote; and formulation of uniform and workable policies for voting in long-term care settings. In some instances, extrapolation from existing policies and research permits reasonable recommendations to guide policy and practice. However, in other instances, additional research is necessary.

Regulatory analysis for the resolution of Unresolved Safety Issue A-44, Station Blackout. Draft report

International Nuclear Information System (INIS)

Rubin, A.M.

1986-01-01

''Station Blackout'' is the complete loss of alternating current (ac) electric power to the essential and nonessential buses in a nuclear power plant; it results when both offsite power and the onsite emergency ac power systems are unavailable. Because many safety systems required for reactor core decay heat removal and containment heat removal depend on ac power, the consequences of a station blackout could be severe. Because of the concern about the frequency of loss of offsite power, the number of failures of emergency diesel generators, and the potentially severe consequences of a loss of all ac power, ''Station Blackout'' was designated as Unresolved Safety Issue (USI) A-44. This report presents the regulatory analysis for USI A-44. It includes: (1) a summary of the issue, (2) the proposed technical resolution, (3) alternative resolutions considered by the Nuclear Regulatory Commission (NRC) staff, (4) an assessment of the benefits and costs of the recommended resolution, (5) the decision rationale, and (6) the relationship between USI A-44 and other NRC programs and requirements

Development of safety-related regulatory requirements for nuclear power in developing countries. Key issue paper no. 4

International Nuclear Information System (INIS)

Han, K.I.

2000-01-01

In implementing a national nuclear power program, balanced regulatory requirements are necessary to ensure nuclear safety and cost competitive nuclear power, and to help gain public acceptance. However, this is difficult due to the technology-intensive nature of the nuclear regulatory requirements, the need to reflect evolving technology and the need for cooperation among multidisciplinary technical groups. This paper suggests approaches to development of balanced nuclear regulatory requirements in developing countries related to nuclear power plant safety, radiation protection and radioactive waste management along with key technical regulatory issues. It does not deal with economic or market regulation of electric utilities using nuclear power. It suggests that national regulatory requirements be developed using IAEA safety recommendations as guidelines and safety requirements of the supplier country as a main reference after careful planning, manpower buildup and thorough study of international and supplier country's regulations. Regulation making is not recommended before experienced manpower has been accumulated. With an option that the supplier country's regulations may be used in the interim, the lack of complete national regulatory requirements should not deter introduction of nuclear power in developing countries. (author)

Ethical and legal challenges in bioenergy governance: Coping with value disagreement and regulatory complexity

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

Regulatory and legal issues

International Nuclear Information System (INIS)

Raisler, K.M.; Gregory, A.M.

1999-01-01

This chapter focuses on the legal issues relating to the derivatives market in the USA, and analyses the Commodity Futures Trading Commission's (CFTCs) information on swaps and hybrid instruments. The law and regulation in the USA is examined and the jurisdictional reach of the Securities and Exchange Commission (SEC), CFTC, and the Commodity Exchange Act (CEA) is described. The forward contract exclusion and the case of Transnor (Bermuda) Ltd. versus BP North America Petroleum, state laws, swap policy statement issues by the CFTC, the Futures Trading Practices Act of 1992, swaps exemptions, the exemption of hybrid instruments from the CEA, and energy contract exemption are discussed. Enforceability, derivatives, and issues before regulators are considered

Regulatory analysis for Generic Issue 23: Reactor coolant pump seal failure. Draft report for comment

Energy Technology Data Exchange (ETDEWEB)

Shaukat, S K; Jackson, J E; Thatcher, D F

1991-04-01

This report presents the regulatory/backfit analysis for Generic Issue 23 (GI-23), 'Reactor Coolant Pump Seal Failure'. A backfit analysis in accordance with 10 CFR 50.109 is presented in Appendix E. The proposed resolution includes quality assurance provisions for reactor coolant pump seals, instrumentation and procedures for monitoring seal performance, and provisions for seal cooling during off-normal plant conditions involving loss of all seal cooling such as station blackout. Research, technical data, and other analyses supporting the resolution of this issue are summarized in the technical findings report (NUREG/CR-4948) and cost/benefit report (NUREG/CR-5167). (author)

Topical Session on 'Addressing Issues Raised by Stakeholders: Impacts on Process, Content and Behaviour in Waste Organisations'

International Nuclear Information System (INIS)

2004-01-01

At its 5. meeting in June 2004, the FSC held a topical session aimed at reviewing how organisations are adapting to the new outreach and decision-making context. Eleven organisations from eight countries provided the relevant information, which are collected in these proceedings. Learning and adapting to societal requirements - and organising institutions accordingly - is one of the main aspects of the future programme of work of the FSC. This topical session on 'Addressing Issues Raised by Stakeholders: Impacts on Process, Content and Behaviour in Waste Organisations' provides useful material for future initiatives as well as a source of information to interested stakeholders and practitioners. It focused on how regulators and implementers responded and are restructuring to respond to stakeholders' concerns, issues and needs regarding radioactive waste management

Using Drones to Study Human Beings: Ethical and Regulatory Issues.

Science.gov (United States)

Resnik, David B; Elliott, Kevin C

2018-02-27

Researchers have used drones to track wildlife populations, monitor forest fires, map glaciers, and measure air pollution but have only begun to consider how to use these unmanned aerial vehicles to study human beings. The potential use of drones to study public gatherings or other human activities raises novel issues of privacy, confidentiality, and consent, which this article explores in depth. It argues that drone research could fall into several different categories: non-human subjects research (HSR), exempt HSR, or non-exempt HSR. In the case of non-exempt HSR, it will be difficult for institutional review boards to approve studies unless they are designed so that informed consent can be waived. Whether drone research is non-HSR, exempt HSR, or non-exempt HSR, it is important for investigators to consult communities which could be affected by the research.

Ethical and regulatory issues arising from proteomic research and technology.

Science.gov (United States)

Reymond, Marc A; Steinert, Ralf; Eder, Frank; Lippert, Hans

2003-08-01

Over the last two decades, medical research has begun to make extensive use of products of human origin in therapeutics, oncology, and most recently, in genetic diseases. This has raised many ethical issues involving patient rights, including issues of consent. Besides informed consent, researchers should address several topics when designing studies using human tissues. Reward for the patient should be kept minimal. Sample transfer should be organized along non-profit lines, at least in Europe. Sampling procedures should be at no risk for human volunteers, and at minimal risk for patients. Biosafety aspects should be addressed, in particular when international collaborations are intended or when collaboration is existing between academia and industry. Regulations on importation and exportation of human tissues should be observed. Data acquisition and storage should be addressed in accordance with national data protection regulations, in particular when using computerized databases. If follow-up information is to be taken, the authorization for such information should be requested. The right for patient's information (or for no information) on the research results should also be addressed. The issues of validation and patenting should be also solved, usually by informing the patient that he/she will have no commercial rights on potential research results. The patient should be told if the samples are transferred to another research laboratory or private company. Samples and related data should be destroyed on request at any time point during the course of the study. If possible, traceability of the donor should be ensured.

Healthier? More Efficient? Fairer? An Overview of the Main Ethical Issues Raised by the Use of Ubicomp in the Workplace

OpenAIRE

Céline Ehrwein NIHAN

2013-01-01

The development of Ambient Intelligence (AmI) will radically transform our everyday life and social representations. These transformations will notably impact the working environment. The objective of this paper is to offer a first survey of the main ethical issues raised by the development of intelligent working environments (IWEs). It especially focuses on the capacity of such environments to collect and handle personal medical data. The first two sections of this paper aim to clarify the m...

Use of importance measures in risk-informed regulatory applications

International Nuclear Information System (INIS)

Cheok, Michael C.; Parry, Gareth W.; Sherry, Richard R.

1998-01-01

The use of importance measures to analyze PRA results is discussed. Commonly used importance measures are defined. Some issues that have been identified as potentially limiting their usefulness are addressed, namely: there is no simple relationship between importance measures evaluated at the single component level and those evaluated at the level of a group of components, and, as a result, some of the commonly used importance measures are not realistic measures of the sensitivity of the overall risk to parameter value changes; and, importance measures do not typically take into account parameter uncertainties which raises the question of the robustness of conclusions drawn from importance analyses. The issues are explored in the context of both ranking and categorization of structures, systems, and components (SSCs) with respect to risk-significance and safety-significance for use in risk-informed regulatory analyses

The spectrum of ethical issues in a Learning Health Care System: a systematic qualitative review.

Science.gov (United States)

McLennan, Stuart; Kahrass, Hannes; Wieschowski, Susanne; Strech, Daniel; Langhof, Holger

2018-04-01

To determine systematically the spectrum of ethical issues that is raised for stakeholders in a 'Learning Health Care System' (LHCS). The systematic review was conducted in PubMed and Google Books between the years 2007 and 2015. The literature search retrieved 1258 publications. Each publication was independently screened by two reviewers for eligibility for inclusion. Ethical issues were defined as arising when a relevant normative principle is not adequately considered or two principles come into conflict. A total of 65 publications were included in the final analysis and were analysed using an adapted version of qualitative content analysis. A coding frame was developed inductively from the data, only the highest-level categories were generated deductively for a life-cycle perspective. A total of 67 distinct ethical issues could be categorized under different phases of the LHCS life-cycle. An overarching theme that was repeatedly raised was the conflict between the current regulatory system and learning health care. The implementation of a LHCS can help realize the ethical imperative to continuously improve the quality of health care. However, the implementation of a LHCS can also raise a number of important ethical issues itself. This review highlights the importance for health care leaders and policy makers to balance the need to protect and respect individual participants involved in learning health care activities with the social value of improving health care.

The Child Abuse Matter and the Major Role Played by the Teacher: Issues Raised by a Pilot Focus Group Sample of Primary Teachers

Science.gov (United States)

Vitalaki, Elena

2013-01-01

A great deal of attention is now being paid to issues raised by child abuse. Recent reports, enquiries and relevant agencies have all recognized the important role played by teachers in aiding the detection and prevention of child abuse, due to their close everyday contact with children. The result of the ideas presented in the present work was…

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

Science.gov (United States)

Dufield, Dawn; Neubert, Hendrik; Garofolo, Fabio; Kirkovsky, Leo; Stevenson, Lauren; Dumont, Isabelle; Kaur, Surinder; Xu, Keyang; Alley, Stephen C; Szapacs, Matthew; Arnold, Mark; Bansal, Surendra; Haidar, Sam; Welink, Jan; Le Blaye, Olivier; Wakelin-Smith, Jason; Whale, Emma; Ishii-Watabe, Akiko; Bustard, Mark; Katori, Noriko; Amaravadi, Lakshmi; Aubry, Anne-Françoise; Beaver, Chris; Bergeron, Annik; Cai, Xiao-Yan; Cojocaru, Laura; DeSilva, Binodh; Duggan, Jeff; Fluhler, Eric; Gorovits, Boris; Gupta, Swati; Hayes, Roger; Ho, Stacy; Ingelse, Benno; King, Lindsay; Lévesque, Ann; Lowes, Steve; Ma, Mark; Musuku, Adrien; Myler, Heather; Olah, Timothy; Patel, Shefali; Rose, Mark; Schultz, Gary; Smeraglia, John; Swanson, Steven; Torri, Albert; Vazvaei, Faye; Wilson, Amanda; Woolf, Eric; Xue, Li; Yang, Tong-Yuan

2014-01-01

The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input. Part 1 (Small molecules bioanalysis using LCMS) was published in the Bioanalysis issue 6(22) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the Bioanalysis issue 6(24).

Nuclear Regulatory Systems in Africa: Improving Safety and Security Culture Through Education and Training

International Nuclear Information System (INIS)

Kazadi Kabuya, F.

2016-01-01

The purpose of this paper is to address the important issue of supporting safety and security culture through an educational and training course program designed both for regulatory staff and licensees. Enhancing the safety and security of nuclear facilities may involve assessing the overall effectiveness of the organization's safety culture. Safety Culture implies steps such as identifying and targeting areas requiring attention, putting emphasis on organizational strengths and weaknesses, human attitudes and behaviours that may positively impact an organization's safety culture, resulting in improving workplace safety and developing and maintaining a high level of awareness within these facilities. Following the terrorist attacks of September 11, 2001, international efforts were made towards achieving such goals. This was realized through meetings, summits and training courses events, with main aim to enhance security at facilities whose activities, if attacked, could impact public health and safety. During regulatory oversight inspections undertaken on some licensee's premises, violations of security requirements were identified. They mostly involved inadequate management oversight of security, lack of a questioning attitude, complacency and mostly inadequate training in both security and safety issues. Using training and education approach as a support to raise awareness on safety and security issues in the framework of improving safety and security culture, a tentative training program in nuclear and radiological safety was started in 2002 with the main aim of vulgarizing the regulatory framework. Real first needs for a training course program were identified among radiographers and radiologists with established working experience but with limited knowledge in radiation safety. In the field of industrial uses of radiation the triggering events for introducing and implementing a training program were: the loss of a radioactive source in a mining

Recent environment, energy and resources cases and issues in Alberta

Energy Technology Data Exchange (ETDEWEB)

Kruhlak, R.; Naffin, D.K. [McLennan Ross LLP, Edmonton, AB (Canada)

2005-07-01

Significant environmental issues and regulatory proceedings in Alberta were discussed. The Mackenzie Valley Pipeline Project was reviewed in relation to the Deh Cho First Nation's advanced actions in the federal court to enjoin the review panel from proceeding with the review process. The Deh Cho First Nation is seeking a declaration that the plan violates their rights under the Canadian Charter of Rights and Freedoms and the Constitution Act. Various regulatory and government agencies have now developed a plan to coordinate their different regulatory processes and approvals in the Cooperation Plan for the Environmental Impact Assessment and Regulatory Review of the Northern Gas Pipeline project. The Deh Cho allege that they were not afforded the opportunity to participate in the development and implementation of the plan. A review panel plans to proceed once the environmental and social impacts are determined, and the consortiums plan to minimize harm has been submitted. Issues concerning contaminated sites were discussed with reference to Lynnview Ridge, where Imperial Oil and Devon Estates Ltd. built a residential subdivision built on the site of a decommissioned oil storage tank site. Periodic monitoring detected some general concerns, including high lead levels in soil and hydrocarbon vapors. Environmental Protection Orders (EPO) and appeals were discussed, including Imperial and Devon's appeal that the pollution problem should have been addressed through the contaminated sites provision and not the substance release EPO. Several recommendations were made, including better definition processes for liability allocation; a clarification of persons excluded from responsibility; voluntary remediation agreements that limit liability; and environmental site information systems to support due diligence. It was expected that the final set of recommendations will be of use to all jurisdictions in Canada. Regulatory issues concerning public safety were

Addressing communications between Regulatory Body and TSO: perceptions and problems

International Nuclear Information System (INIS)

Salati de Almeida, I.P.

2007-01-01

The use of TSO assistance by the Regulatory Bodies is a way of facing the complexity of the technology and issues to be dealt with in the licensing and controlling process in the nuclear area. Although both TSO and Regulatory Body are well prepared and adjusted, the nature and environment of TSO work is rather different from the regulators. Some of the TSO members act as a consultant, giving expert advice to the regulators in a specific subject, some are in charge of inspections and audits, others do the job together with the regulators. The way that a TSO member perceives the work to be done, however, often creates different perspectives for questions related to the licensing and controlling process. These perceptions are usually a source of problems between the two partners, regulators and TSO members. In this paper some of this kind of problems are raised and suggestions of how to deal with them are proposed for discussion. (author)

Fourth and Fifth Amendment issues raised by Chemical Weapons Convention inspections

Energy Technology Data Exchange (ETDEWEB)

Tanzman, E.A. [Argonne National Lab., IL (United States). Economics and Law Section

1994-10-21

The Chemical Weapons Convention (CWC) offers a unique challenge to the United States system of constitutional law. This discussion is about the Fourth and Fifth Amendment issues raised by the CWC and about how federal implementing legislation can allow verification inspections to take place in the United States under the Chemical Weapons Convention while remaining in compliance with the Constitution. By implementing legislation, the author means a federal statute that would be enacted separately from Senate approval of the Convention itself. Although implementing legislation is a relatively unusual accompaniment to a treaty, it will be necessary to the CWC, and the Administration has submitted a bill that was under consideration in the last Congress and presumably will be reintroduced early next year. The Fourth and Fifth Amendment problems posed by the CWC arise from the verification inspection scheme embodied in the treaty. The CWC depends heavily on on-site inspections to verify compliance with its key requirements. These include destroying all chemicals weapons stockpiles and bringing potential chemical weapons precursors under international control. The Convention contains four distinct kinds of inspections: systematic inspections of chemical weapons storage and destruction facilities, routine inspections of various declared facilities, challenge inspections, and a variant on challenge inspections in cases of alleged use of chemical weapons. All inspections are supposed to be only as intrusive as necessary to carry out the Convention. These inspections will be carried out by inspectors employed by the Organization for the Prohibition of Chemical Weapons (OPCW), located in The Hague, which is responsible for enforcing the Convention. Generally, the inspected State Party is permitted to assign observers to accompany the inspectors.

Decommissioning: Regulatory activities and identification of key organizational and human factors safety issues

International Nuclear Information System (INIS)

Durbin, N.E.; Melber, B.D.; Lekberg, A.

2001-12-01

In the late 1990's the Swedish government decided to shut down Unit 1 of the Barsebaeck nuclear power plant. This report documents some of the efforts made by the Swedish Nuclear Power Inspectorate (SKI) to address human factors and organizational issues in nuclear safety during decommissioning of a nuclear facility. This report gives a brief review of the background to the decommissioning of Barsebaeck 1 and points out key safety issues that can arise during decommissioning. The main regulatory activities that were undertaken were requirements that the plant provide special safety reports on decommissioning focusing on first, the operation of both units until closure of Unit 1 and second, the operation of Unit 2 when Unit 1 was closed. In addition, SKI identified areas that might be affected by decommissioning and called these areas out for special attention. With regard to these areas of special attention, SKI required that the plant provide monthly reports on changing and emerging issues as well as self-assessments of the areas to be addressed in the special safety reports. Ten key safety issues were identified and evaluated with regard to different stages of decommissioning and with regard to the actions taken by Barsebaeck. Some key conclusions from SKI's experience in regulating a decommissioning nuclear power plant conclude the report

Structural evaluation of WIPP disposal room raised to Clay Seam G

International Nuclear Information System (INIS)

Park, Byoung Yoon; Holland, John F.

2004-01-01

This report summarizes a series of structural calculations that examine effects of raising the Waste Isolation Pilot Plant repository horizon from the original design level upward 2.43 meters. These calculations allow evaluation of various features incorporated in conceptual models used for performance assessment. Material presented in this report supports the regulatory compliance re-certification, and therefore begins by replicating the calculations used in the initial compliance certification application. Calculations are then repeated for grid changes appropriate for the new horizon raised to Clay Seam G. Results are presented in three main areas: 1. Disposal room porosity, 2. Disturbed rock zone characteristics, and 3. Anhydrite marker bed failure. No change to the porosity surface for the compliance re-certification application is necessary to account for raising the repository horizon, because the new porosity surface is essentially identical. The disturbed rock zone evolution and devolution are charted in terms of a stress invariant criterion over the regulatory period. This model shows that the damage zone does not extend upward to MB 138, but does reach MB 139 below the repository. Damaged salt would be expected to heal in nominally 100 years. The anhydrite marker beds sustain states of stress that promote failure and substantial marker bed deformation into the room assures fractured anhydrite will sustain in the proximity of the disposal rooms

ENSI’s regulatory framework strategy

International Nuclear Information System (INIS)

2015-03-01

This short brochure issued by the Swiss Federal Nuclear Safety Inspectorate ENSI defines the organisation’s regulatory framework strategy. Six guiding principles are declared and discussed: Comprehensive harmonisation with relevant international requirements, basing the regulatory framework on existing, tried-and-tested regulations, issuing of its own guidelines only when it is necessary to do so, guidelines to be drawn up transparently and with the involvement of all stakeholders and basing the level of detail of its regulatory framework on hazard potential and risk

The concept of milk kinship in Islam: issues raised when offering preterm infants of Muslim families donor human milk.

Science.gov (United States)

El-Khuffash, Afif; Unger, Sharon

2012-05-01

Research has documented health benefits associated with donor human milk (DHM). Offering DHM to people of the Muslim faith raises important religious concerns for these families. Knowledge of these beliefs and an understanding of the rationale for these beliefs enable the health care team to establish rapport and build a foundation of trust with patients and their families, thereby paving the way to developing a treatment plan that is in the best interest of the patients without compromising care. This article describes the issues and a rationale for them and provides physicians caring for preterm infants of Muslim families with information to facilitate advocating DHM to those families.

Current issues and actions

Energy Technology Data Exchange (ETDEWEB)

Black, D.G.

1995-06-01

This section of the 1994 Hanford Site Environmental Report summarizes the progress that has been made toward achieving full regulatory compliance at the Hanford Site. Ongoing compliance self-assessments, implementation of the Tri-Party Agreement, and public meetings continue to identify environmental compliance issues. These issues are discussed openly with the regulatory agencies and with the public to ensure that all environmental compliance issues are addressed.

Current issues and actions

International Nuclear Information System (INIS)

Black, D.G.

1995-01-01

This section of the 1994 Hanford Site Environmental Report summarizes the progress that has been made toward achieving full regulatory compliance at the Hanford Site. Ongoing compliance self-assessments, implementation of the Tri-Party Agreement, and public meetings continue to identify environmental compliance issues. These issues are discussed openly with the regulatory agencies and with the public to ensure that all environmental compliance issues are addressed

Legal briefs in dental bias case raise issues pivotal to epidemic.

Science.gov (United States)

1998-03-20

The U.S. Supreme Court will hear oral arguments in March that could profoundly alter the way courts, employers, and the medical community deal with HIV. [Name removed] v. [Name removed] raises the issues of whom the law covers, whether health care providers have a choice in treating HIV and AIDS patients or refusing to treat them, and whether the stigma of HIV impedes an infected person's ability to participate in mainstream American life. This is the first time that the Supreme Court will interpret the Americans with Disabilities Act (ADA) and how the case is decided could affect the legal rights of people with other impairments. The case grew out of a dentist's refusal to treat an HIV-positive patient in his office because of the increased risk of contracting the disease. [Name removed] offered to treat [name removed] in a hospital, where infection control procedures are better. [Name removed] sued, relying on the ADA, and prevailed in both Federal district court and the 1st U.S. Circuit Court of Appeals. The Supreme Court asked both sides to discuss the following questions: does the ADA protect all people with HIV, including those with no symptoms, from discrimination; is reproduction a major life activity under the ADA; and should the court defer to the health-care provider's professional judgement for evaluating whether a patient poses a direct threat. [Name removed] argues that an asymptomatic person cannot be disabled under the meaning of the law and cites two celebrities as examples, Earvin "Magic" Johnson and Greg Louganis. [Name removed] argues that the definition of disability under the ADA is intentionally broad to achieve the remedial purpose of enabling Americans with disabilities to live full, independent and economically sufficient lives. The elements of the case, the key players, and the legislative history are reviewed.

Indexes to Nuclear Regulatory Commission issuance, July-December 1980. Index of Volume 12, Number 4

International Nuclear Information System (INIS)

1980-01-01

Issuances of the Atomic Safety and Licensing Board (ASLB), the Atomic Safety and Licensing Appeal Boards (ALAB), the Administrative Law Judge (ALJ), regulatory issuances of the Commission (CLI), the Directors Denial (DD), and the Denials of Petitions for Rulemaking for the period July through December 1980 appear in Nuclear Regulatory Commission Issuances, 12 NRC No. 1, Pages 1-136, through 12 NRC No. 6, Pages 607-742. Digests and indexes for these issuances are presented in this document. These digests and indexes are intended to serve as a guide to the issuances. Information elements common to the cases heard and ruled upon are: Case name (owners of facility); Name of facility, docket number; Type of hearing (for construction permit, operating licenses, etc.); Issues raised by appellants; Issuance number; Type of issuance (memorandum, order, decision, etc.); Issuance pagination; Legal citations (cases, regulations, and statutes); and Subject matter of issues and/or rulings. These information elements are displayed in one or more of five separate formats arranged as follows: Case name index; Digests and headers; Legal citation index; Subject index; and Facility index

Future nuclear regulatory challenges. A report by the NEA Committee on Nuclear Regulatory Activities

International Nuclear Information System (INIS)

1998-01-01

Future challenges are considered that may arise from technical, socio-economic and political issues; organizational, management and human aspects; and international issues. The perceived challenges have been grouped into four categories, each covered by a chapter. Technical issues are addressed that many present regulatory challenges in the future: ageing nuclear power plants. External changes to industry are considered next that have an effect on regulators, privatization, cost reduction consequences, commercialization etc. It is followed by the impacts of internal changes: organizational, managerial, human-resources, licensing, staff training etc. Finally, international issues are discussed with potential regulatory impact. (R.P.)

Debatable Issues of Regulatory Policy of Russian Nanoindustry

Directory of Open Access Journals (Sweden)

Frolov Daniil Petrovich

2015-05-01

Full Text Available The article studies the debatable issues of regulatory policy in the sphere of nanoindustry. The nanotech industry has interindustry character that is caused by interdisciplinarity of a nanoscience therefore it is necessary to recognize objectively impossible exact definition of its branch structure. As a result of terminological uncertainty, the state support and regulation of nanotech industry is a difficult process. The substantial expansionism of the term “nanotechnology” and metaphorism of the concept “nanoindustry” is reasoned. The need of creating more detailed classification (by 1-2 orders of nanotechnologies and allocation of at least three subindustries of nanotech industry is proved. The deficiency of convergent orientation of policy of regulation of the Russian hi-tech industries is revealed. The conceptual discrepancy of nanoindustrial policy of the Russian Federation combining elements of traditional policy of import substitution and new industrial policy is shown. The expediency of transition from universal policy of nanoindustry regulation to the development of a package of the segment-focused strategies of development of different types of nanotechnologies and the nanotechnological activities is proved. The special attention is paid to a safety control problem (combination of obligatory certification and voluntary marking of nanoproduction, strengthening the role of nanotech industry self-regulation and active integration of stakeholders into the system of strategic planning.

Vitrification of underground storage tanks: Technology development, regulatory issues, and cost analysis

International Nuclear Information System (INIS)

Tixier, J.S.; Corathers, L.A.; Anderson, L.D.

1992-03-01

In situ vitrification (ISV), developed by the Pacific Northwest Laboratory (PNL) for the US Department of Energy (DOE), is a thermal treatment process for the remediation of hazardous, radioactive, or mixed waste sites. The process has been broadly patented both domestically and abroad. Since the inception of ISV in 1980, developmental activities have been focused on applications to contaminated soils, and more recently the potential for application to buried wastes and underground structures (tanks). Research performed to date on the more advanced ISV applications (i.e., application to buried wastes and underground tanks) shows that significant technical and economic potential exists for using ISV to treat buried wastes and underground structures containing radionuclides and/or hazardous constituents. Present ISV applications are directed to the treatment of contaminated soils; the likelihood of using ISV to treat underground tanks depends on the resolution of significant technical and institutional issues related to this advanced application. This paper describes the ISV process and summarizes the technical progress of underground tank vitrification (UTV), discusses pertinent regulatory issues facing the use of UTV, and presents the potential cost of UTV relative to other remedial action alternatives

NRC regulatory agenda

International Nuclear Information System (INIS)

1990-01-01

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

Regulatory, administrative and financial problems raised by radioactive waste disposal

International Nuclear Information System (INIS)

Reyners, P.

1980-03-01

This paper analyses the salient aspects of the non-technical problems involved in radioactive waste disposal: the division of operational, regulatory and administrative responsibilities, the usefulness of providing a form of institutional control of the waste disposed of, and the question of the length of time for such mechanisms, both of which are closely linked to the preceding point. A description follows of the R and D financing mechanisms in the field and of the surveillance systems to be set up. Finally, mention is made of the legal and practical difficulties encountered in the application of the third party liability and insurance regime to long-term waste management and the international dimension of all these questions. (NEA) [fr

Cobalt release from inexpensive jewellery: has the use of cobalt replaced nickel following regulatory intervention?

DEFF Research Database (Denmark)

Thyssen, Jacob Pontoppidan; Jellesen, Morten S; Menné, Torkil

2010-01-01

Before the introduction of the EU Nickel Directive, concern was raised that manufacturers of jewellery might turn from the use of nickel to cobalt following the regulatory intervention on nickel exposure.......Before the introduction of the EU Nickel Directive, concern was raised that manufacturers of jewellery might turn from the use of nickel to cobalt following the regulatory intervention on nickel exposure....

Bond Issues.

Science.gov (United States)

Pollack, Rachel H.

2000-01-01

Notes trends toward increased borrowing by colleges and universities and offers guidelines for institutions that are considering issuing bonds to raise money for capital projects. Discussion covers advantages of using bond financing, how use of bonds impacts on traditional fund raising, other cautions and concerns, and some troubling aspects of…

Resolution of digital instrumentation and control and human factors technical and regulatory issues for new plants and for modernization of operating plants

International Nuclear Information System (INIS)

Naser, J.A.; Torok, R.C.; Canavan, K.T.

2008-01-01

There are several technical and regulatory issues in the areas of digital I and C, human factors, and control rooms needing generic resolution. If they are not generically resolved, they can contribute to protracted regulatory reviews for operating plant license amendments and substantial delays and increased costs for new plant COL approvals. Therefore; a coordinated, proactive program has been established to resolve key issues. Both Industry and NRC have roles in resolving these key issues and addressing them in future design efforts and regulatory reviews. The Industry initiative is led by the NEI Digital I and C and Human Factors Working Group. NRC has established Task Working Groups under the NRC Digital I and C Steering Committee to address the issues and interact with Industry. EPRI is providing technical input and resolution leadership for some of the issues being addressed in three of the task working groups. For the Highly Integrated Control Room - Human Factors Task area, EPRI has taken the lead in developing draft industry position technical reports for the following three issues: 1) Minimum inventory of human system interfaces, 2) Computerized procedures and associated topics of automation and soft controls, and 3) Methodology to determine the acceptability of manual operator actions response times for a BTP 7-19 software common cause failure. For the Diversity and Defense-in-Depth area, EPRI has taken the lead in developing two draft industry position technical papers on the following topics: 1) Integrating defensive measures and diversity attributes to protect against digital common cause failures and 2) Susceptibility of digital devices and components to common cause failures. For the Risk Informing area, EPRI has taken the lead in developing two draft industry position technical papers on the following topics: 1) Clarifying how to use current methods to model digital systems in a PRA and 2) Application of PRA to specific digital I and C issues

Communication Regulatory Science: Mapping a New Field.

Science.gov (United States)

Noar, Seth M; Cappella, Joseph N; Price, Simani

2017-12-13

Communication regulatory science is an emerging field that uses validated techniques, tools, and models to inform regulatory actions that promote optimal communication outcomes and benefit the public. In the opening article to this special issue on communication and tobacco regulatory science, we 1) describe Food and Drug Administration (FDA) regulation of tobacco products in the US; 2) introduce communication regulatory science and provide examples in the tobacco regulatory science realm; and 3) describe the special issue process and final set of articles. Communication research on tobacco regulatory science is a burgeoning area of inquiry, and this work advances communication science, informs and potentially guides the FDA, and may help to withstand legal challenges brought by the tobacco industry. This research has the potential to have a major impact on the tobacco epidemic and population health by helping implement the most effective communications to prevent tobacco initiation and increase cessation. This special issue provides an example of 10 studies that exemplify tobacco regulatory science and demonstrate how the health communication field can affect regulation and benefit public health.

Legal and Regulatory Frameworks for Decommissioning and Waste Management

International Nuclear Information System (INIS)

Leech, Jonathan

2016-01-01

Safe and efficient decommissioning and waste management requires clear structures for allocating responsibility and funding. Organisation of decommissioning and waste management activities and the regulatory environment within which those activities are undertaken should also allow the supply chain to prosper and, wherever possible, reduce barriers to international availability of resources and waste facilities. Radioactive waste treatment and disposal in particular raises both legal and political challenges to effective international co-operation, yet options for decommissioning and waste management are maximised where international barriers can be minimised. Added to this, international nuclear liabilities issues must be managed so as to avoid unnecessary deterrents to international mobility of capability within the decommissioning market. Contractual terms and insurance arrangements for international shipments of nuclear waste and materials will also need to take into account imminent changes to liabilities conventions, ensuring compliance and management of compliance costs (of both insurance and management time). This paper explores legal and commercial structures intended to support effective decommissioning and waste management and examines regulatory and commercial factors affecting the ability of facility operators to utilise internationally available capability. It focusses on: - strategic approaches developed in the UK to address decommissioning and waste management liabilities associated with the UK's first and second generation civil nuclear sites and comparison of those approaches with other jurisdictions with significant decommissioning liabilities; - liability and compliance risks associated with navigating international nuclear liabilities regimes in context of both mobility of decommissioning capability and international waste shipment; and - regulatory issues affecting international availability of waste treatment facilities, including

U.S. NRC's generic issues program

International Nuclear Information System (INIS)

Kauffman, J.V.; Foster, J.W.

2008-01-01

The United States Nuclear Regulatory Commission (NRC) has a Generic Issues Program (GIP) to address Generic Issues (GI). A GI is defined as 'a regulatory matter involving the design, construction, operation, or decommissioning of several, or a class of, NRC licensees or certificate holders that is not sufficiently addressed by existing rules, guidance, or programs'. This rather legalistic definition has several practical corollaries: First, a GI must involve safety. Second, the issue must involve at least two plants, or it would be a plant-specific issue rather than a GI. Third, the potential safety question must not be covered by existing regulations and guidance (compliance). Thus, the effect of a GI is to potentially change the body of regulations and associated guidance (e.g., regulatory guides). The GIP was started in 1976, thus it is a relatively mature program. Approximately 850 issues have been processed by the program to date. More importantly, even after 30 years, new GIs continue to be proposed. The entire set of Generic Issues (GIs) is updated annually in NUREG-0933, 'A Prioritization of Generic Safety Issues'. GIs normally involve complex questions of safety and regulation. Efficient and effective means of addressing these issues are very important for regulatory effectiveness. If an issue proves to pose a genuine, significant safety question, then swift, effective, enforceable, and cost-effective action needs to be taken. Conversely, if an issue is of little safety significance, the issue should be dismissed in an expeditious manner, avoiding unnecessary expenditure of resources and regulatory burden or uncertainty. This paper provides a summary of the 5-stage program, from identification through the regulatory assessment stage. The paper also includes a discussion of the program's seven criteria, sources of proposed GIs, recent improvements, publicly available information, historical performance, and status of current GIs. (authors)

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)

Technical findings and regulatory analysis for Generic Safety Issue II.E.4.3, ''Containment Integrity Check''

International Nuclear Information System (INIS)

Serkiz, A.W.

1988-04-01

This report contains the technical findings and regulatory analysis for Generic Safety Issue II.E.4.3, ''Containment Integrity Check.'' An evaluation of the containment isolation history from 1965 to 1983 reveals that (except for a small number of events) containment integrity has been maintained and that the majority of reported events have been events related to exceeding Technical Specification limits (or 0.6 of the allowable leakage level). In addition, more recent risk analyses have shown that allowable leakage rates even if increased by a factor of 10 would not significantly increase risk. Potential methods of continuous monitoring are identified and evaluated. Therefore, these technical findings and risk evaluations support closure of Generic Safety Issue II.E.4.3

NRC regulatory agenda

International Nuclear Information System (INIS)

1991-04-01

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

NRC Regulatory Agenda

International Nuclear Information System (INIS)

1991-08-01

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

International regulatory landscape and integration of corrective genome editing into in vitro fertilization.

Science.gov (United States)

Araki, Motoko; Ishii, Tetsuya

2014-11-24

Genome editing technology, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeat (CRISPR)/Cas, has enabled far more efficient genetic engineering even in non-human primates. This biotechnology is more likely to develop into medicine for preventing a genetic disease if corrective genome editing is integrated into assisted reproductive technology, represented by in vitro fertilization. Although rapid advances in genome editing are expected to make germline gene correction feasible in a clinical setting, there are many issues that still need to be addressed before this could occur. We herein examine current status of genome editing in mammalian embryonic stem cells and zygotes and discuss potential issues in the international regulatory landscape regarding human germline gene modification. Moreover, we address some ethical and social issues that would be raised when each country considers whether genome editing-mediated germline gene correction for preventive medicine should be permitted.

Regulatory analysis for the resolution of Generic Issue 125.II.7 ''Reevaluate Provision to Automatically Isolate Feedwater from Steam Generator During a Line Break''

International Nuclear Information System (INIS)

Basdekas, D.L.

1988-09-01

Generic Issue 125.II.7 addresses the concern related to the automatic isolation of auxiliary feedwater (AFW) to a steam generator with a broken steam or feedwater line. This regulatory analysis provides a quantitative assessment of the costs and benefits associated with the removal of the AFW automatic isolation and concludes that no new regulatory requirements are warranted. 21 refs., 7 tabs

Issues and Dilemmas in Sexual Treatment

Science.gov (United States)

Lassen, Carol L.

1976-01-01

This paper raises issues and questions which repeatedly confront the sex therapist rather than the patient. Issues raised are: conflict in values; the impotent male; masturbation; nonorgasmic females; and the philosophical approach to therapy of women therapists influenced by the women's movement. (NG)

Regulatory frameworks for mobile medical applications.

Science.gov (United States)

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

2015-05-01

A mobile application (app) is a software program that runs on mobile communication devices such as a smartphone. The concept of a mobile medical app has gained popularity and diffusion but its reference regulatory context has raised discussion and concerns. Theoretically, a mobile app can be developed and uploaded easily by any person or entity. Thus, if an app can have some effects on the health of the users, it is mandatory to identify its reference regulatory context and the applicable prescriptions.

NRC Regulatory Agenda

International Nuclear Information System (INIS)

1991-10-01

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

NRC regulatory agenda

International Nuclear Information System (INIS)

1993-04-01

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

Removal of regulatory controls for materials and sites

International Nuclear Information System (INIS)

2004-01-01

Issues with the removal of regulatory controls are very important on the agenda of the regulatory authorities dealing with radioactive waste management (RWM). These issues arise prominently in decommissioning and in site remediation, and decisions can be very wide ranging having potentially important economic impacts and reaching outside the RWM area. The RWMC Regulators Forum started to address these issues by holding a topical discussion at its meeting in March 2003. Ths present document collates the national regulatory positions in the area of removal of regulatory controls. A summary of the national positions is also provided. The document is up to date to April 2004. (authors)

Regulatory analysis for the resolution of Generic Issue 115, enhancement of the reliability of the Westinghouse Solid State Protection System

International Nuclear Information System (INIS)

Basdekas, D.L.

1989-05-01

Generic Issue 115 addresses a concern related to the reliability of the Westinghouse reactor protection system for plants using the Westinghouse Solid State Protection System (SSPS). Several options for improving the reliability of the Westinghouse reactor trip function for these plants and their effect on core damage frequency (CDF) and overall risk were evaluated. This regulatory analysis includes a quantitative assessment of the costs and benefits associated with the various options for enhancing the reliability of the Westinghouse SSPS and provides insights for consideration and industry initiatives. No new regulatory requirements are proposed. 25 refs., 11 tabs

Regulatory compliance issues related to the White Oak Creek Embayment time-critical removal action

International Nuclear Information System (INIS)

Leslie, M.; Kimmel, B.L.

1992-01-01

In September 1990, Martin Marietta Energy Systems (Energy Systems) discovered high levels of Cesium-137 present in surface sediments at the mouth of White Oak Creek (WOC) Embayment. WOC receives the majority of surface water drainage from Oak Ridge National Laboratory. Following this discovery, the Department of Energy (DOE) and Energy Systems pursued stabilizing sediment migration under provisions of the National Contingency Plan (NCP) Section 300.400 et. seq. as a time-critical removal action. However, significant uncertainty exists concerning the applicability of NCP procedural requirements designed for conducting US EPA-led, Superfund-financed response actions, because NCP Subpart K dealing with response actions at federal facilities has not been promulgated. In addition, relatively new guidance exists from DOE concerning National Environmental Policy Act documentation requirements for categorical exclusions associated with conducting removal actions at DOE facilities. A proactive approach was taken to identify issues and involve appropriate state and federal regulatory agencies. This approach required achieving consensus among all involved parties and identification of all applicable or relevant and appropriate regulatory requirements related to the removal action. As a result, this project forms a framework for conducting future time-critical removal actions at federal facilities

Using the Emanuel et al. framework to assess ethical issues raised by a biomedical research ethics committee in South Africa.

Science.gov (United States)

Tsoka-Gwegweni, Joyce M; Wassenaar, Douglas R

2014-12-01

The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC. © The Author(s) 2014.

FORUM ISSUES IN THE ENFORCEMENT OF REGULATORY ...

African Journals Online (AJOL)

in his role as father of the country. In modern times, the ... of self-regulatory organisations in most financial markets who thus far have ..... companies and their officers under the Act? There are as yet no clear an- swers to ..... 578 (High Court of Singapore) where Chief Justice Yong Pung How held that to establish a breach of ...

Regulatory issues associated with closure of the Hanford AX Tank Farm ancillary equipment

International Nuclear Information System (INIS)

Becker, D.L.

1998-01-01

Liquid mixed, high-level radioactive waste has been stored in underground single-shell tanks at the US Department of Energy's (DOE's) Hanford Site. After retrieval of the waste from the single-shell tanks, the DOE will proceed with closure of the tank farm. The 241-AX Tank Farm includes four one-million gallon single-shell tanks in addition to sluice lines, transfer lines, ventilation headers, risers, pits, cribs, catch tanks, buildings, well and associated buried piping. This equipment is classified as ancillary equipment. This document addresses the requirements for regulatory close of the ancillary equipment in the Hanford Site 241-AX Tank Farm. The options identified for physical closure of the ancillary equipment include disposal in place, disposal in place after treatment, excavation and disposal on site in an empty single-shell tank, and excavation and disposal outside the AX Tank Farm. The document addresses the background of the Hanford Site and ancillary equipment in the AX Tank Farm, regulations for decontamination and decommissioning of radioactively contaminated equipment, requirements for the cleanup and disposal of radioactive wastes, cleanup and disposal requirements governing hazardous and mixed waste, and regulatory requirements and issues associated with each of the four physical closure options. This investigation was conducted by the Sandia National Laboratories, Albuquerque, New Mexico, during Fiscal Year 1998 for the Hanford Tanks Initiative Project

A study on technical issues of materials and design bases in ASME section III subsection NH code

International Nuclear Information System (INIS)

Lee, Hyeong Yeon; Kim, Jong Bum; Yoo, Bong

2000-12-01

In this study, an analysis of evaluation report by ORNL on the technical issues of elevated temperatures design guide line, ASME Code Section III Subsection NH was conducted and a brief evaluation procedure of the creep-fatigue damage was presented. ORNL published the report in 1993 and reviewed the issue areas where code rules or regulatory guides may be lacking or inadequate to ensure safe operation over the expected life cycles for liquid metal reactor systems. From historical viewpoint of the ASME NH code development, ASME Code Case 47 was changed much in 1989 edition, which includes the stress relaxation behavior in creep damage evaluation. Afterwards the 1992 version of CC N-47 was upgraded to Subsection NH in 1995 edition, which is the same with that of CC N-47 1992 edition except few material data. This report brings up the technical and regulatory issues that can not guarantee the safe and reliable operation of the ALMR which got the conceptual design certification from NRC. Twenty three technical issues were raised and settlement methodology were proposed. Additionally, the status of items approved by ASME code subgroup of elevated temperature design committee for the revision of the most recent 1998 edition of ASME NH was described

Regulatory and licensee surveys

International Nuclear Information System (INIS)

2009-01-01

Prior to the workshop two CSNI/WGHOF surveys were distributed. One survey was directed at regulatory bodies and the other was directed at plant licensees. The surveys were: 1 - Regulatory Expectations of Licensees' Arrangements to Ensure Suitable Organisational Structure, Resources and Competencies to Manage Safety (sent to WGHOF regulatory members). The survey requested that the respondents provide a brief overview of the situation related to plant organisations in their country, their regulatory expectations and their formal requirements. The survey addressed three subjects: the demonstration and documentation of organisational structures, resources and competencies, organisational changes, issues for improvement (for both current and new plants). Responses were received from eleven regulatory bodies. 2 - Approaches to Justify Organisational Suitability (sent to selected licensees). The purpose of the survey to was to gain an understanding of how licensees ensure organisational suitability, resources and competencies. This information was used to assist in the development of the issues and subjects that were addressed at the group discussion sessions. Responses were received from over fifteen licensees from nine countries. The survey requested that the licensees provide information on how they ensure effective organisational structures at their plants. The survey grouped the questions into the following four categories: organisational safety functions, resource and competence, decision-making and communication, good examples and improvement needs. The findings from these surveys were used in conjunction with other factors to identify the key issues for the workshop discussion sessions. The responses from these two surveys are discussed briefly in Sections 4 and 5 of this report. More extensive reviews of the regulatory and licensee responses are provided in Appendix 1

Contrast media. Safety issues and ESUR guidelines. 2. rev. ed.

Energy Technology Data Exchange (ETDEWEB)

Thomsen, Henrik S. [Copenhagen University Hospital, Herlev (Denmark). Dept. of Diagnostic Radiology; Copenhagen Univ., Herlev (Denmark). Dept. of Diagnostic Sciences; Webb, Judith A.W. (eds.) [St. Bartholomew' s Hospital London Univ. (United Kingdom). Dept. of Radiology

2009-07-01

In 1994 the European Society of Urogenital Radiology (ESUR) set up a committee to consider the safety of contrast media used for diagnostic imaging. Subsequently the committee questioned members, reviewed the literature, proposed guidelines and discussed these proposals with participants at the annual symposia of the society. The end result of this work was the successful first edition of this book, published in 2006. This second edition not only updates the previous edition, but also contains some completely new chapters, for example on gadolinium-based contrast agents, meta-analyses in contrast media research and various regulatory issues. Comprehensive consideration is given to the many different safety issues relating to iodinated, MR, ultrasound and barium contrast media. The text includes chapters on both acute and delayed non-renal adverse reactions and on renal adverse reactions. All those questions frequently raised in radiological practice are addressed, and the well-known ESUR guidelines on contrast media are included. This book, presented in a handy, easy to use format, provides an invaluable, unique and unparalleled source of information on the safety issues relating to contrast media. (orig.)

Contrast media. Safety issues and ESUR guidelines. 2. rev. ed.

International Nuclear Information System (INIS)

Thomsen, Henrik S.; Copenhagen Univ., Herlev; Webb, Judith A.W.

2009-01-01

In 1994 the European Society of Urogenital Radiology (ESUR) set up a committee to consider the safety of contrast media used for diagnostic imaging. Subsequently the committee questioned members, reviewed the literature, proposed guidelines and discussed these proposals with participants at the annual symposia of the society. The end result of this work was the successful first edition of this book, published in 2006. This second edition not only updates the previous edition, but also contains some completely new chapters, for example on gadolinium-based contrast agents, meta-analyses in contrast media research and various regulatory issues. Comprehensive consideration is given to the many different safety issues relating to iodinated, MR, ultrasound and barium contrast media. The text includes chapters on both acute and delayed non-renal adverse reactions and on renal adverse reactions. All those questions frequently raised in radiological practice are addressed, and the well-known ESUR guidelines on contrast media are included. This book, presented in a handy, easy to use format, provides an invaluable, unique and unparalleled source of information on the safety issues relating to contrast media. (orig.)

78 FR 54502 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Science.gov (United States)

2013-09-04

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule... Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or ``Commission... or manipulative motivation for the trading activity at issue.\\4\\ Specifically, proposed Supplementary...

The Pro-Cyclical Impact of Basel III Regulatory Capital on Bank Capital Risk

OpenAIRE

Song, Guoxiang

2014-01-01

To raise the quality of regulatory capital, Basel III capital rules recognize unrealized gains and losses on all available-for-sale (AFS) securities in Common Equity Tier 1 Capital (CET1). However, by examining the correlations between U.S. GDP growth rate, interest rates and regulatory capital ratios computed using Basel III regulatory capital definition for six U.S. global systemically important banks (G-SIBs) since 2007, this chapter finds that Basel III regulatory capital will enhance the...

Development of regulatory technology for thermal-hydraulic safety analysis

International Nuclear Information System (INIS)

Bang, Young Seok; Lee, S. H.; Ryu, Y. H.

2001-02-01

The present study aims to develop the regulation capability in thermal-hydraulic safety analysis which was required for the reasonable safety regulation in the current NPP, the next generation reactors, and the future-type reactors. The fourth fiscal year of the first phase of the research was focused on the following research topics: Investigation on the current status of the thermal-hydraulic safety analysis technology outside and inside of the country; Review on the improved features of the thermal-hydraulic safety analysis regulatory audit code, RELAP5/MOD3; Assessments of code with LOFT L9-3 ATWS experiment and LSTF SB-SG-10 multiple SGTR experiment; Application of the RELAP5/CANDU code to analyses of SLB and LBLOCA and evaluation of its effect on safety; Application of the code to IAEA PHWR ISP analysis; Assessments of RELAP5 and TRAC with UPTF downcomer injection test and Analysis of LBLOCA with RELAP5 for the performance evaluation of KNGR DVI; Setup of a coupled 3-D kinetics and thermal-hydraulics and application it to a reactivity accident analysis; and Extension of database and improvement of plant input decks. For supporting the resolution of safety issues, loss of RHR event during midloop operation was analyzed for Kori Unit 3, issues on high burnup fuel were reviewed and performance of FRAPCON-3 assessed. Also MSLB was analyzed to figure out the sensitivity of downcomer temperature supporting the PTS risk evaluation of Kori Unit 1. Thermal stratification in pipe was analyzed using the method proposed. And a method predicting the thermal-hydraulic performance of IRWST of KNGR was explored. The PWR ECCS performance criteria was issued as a MOST Article 200-19.and a regulatory guide on evaluation methodology was improved to cover concerns raised from the related licensing review process

Regulatory issues associated with exclusion, exemption, and clearance related to the mining and minerals processing industries

International Nuclear Information System (INIS)

Metcalf, P.; Woude, S. van der; Keenan, N.; Guy, S.

1997-01-01

The concepts of exclusion, exemption and clearance have been established in international recommendations and, standards for radiation protection and the management of radioactive waste in recent years. The consistent application of these concepts has given rise to various problems in different spheres of use. This is particularly the case in the mining and minerals processing industries dealing with materials exhibiting elevated concentrations of naturally occurring radionuclides. This paper takes the South African mining industry as an example and highlights some of the issues that have arisen in applying these concepts within a regulatory control regime. (author)

Leaseback: An alternative source to raise company working capital

Directory of Open Access Journals (Sweden)

Laušević Ljubica

2014-01-01

Full Text Available This paper offers a description, regulatory framework and the manner of implementation of the leaseback as an alternative manner of raising working capital for companies with a large number and type of users. Leaseback has experienced an explosive growth in Europe, in the first decade of this century, especially during the years of economic prosperity. The value of leaseback in Europe has grown from 6.9 billion EUR in 2004, up to 46 billion EUR in 2007, i.e. during the four years the value was increased for 567%. Leaseback has shown itself to be, according to the analyses made, an 'ideal' manner of financing based on sale-and-leaseback of real estate. Capital that is 'immobilised' on long-term basis, through the leaseback regains its quality of capital ready to be engaged in current activities, i.e. projects and programmes of companies that are making high earnings. The objective of this work is to draw the attention, on the basis of a comprehensive theoretical presentation, empirical analyses and positive world practices, to this, in our business circumstances, a completely novel manner of financing, in the context of raising additional working capital through the inflow of both the domestic and of the foreign capital in Serbia. In order to achieve full implementation of this type of financing, it is necessary to overcome a number of constraints and provide regulatory framework, developed investment funds for investment in real estate, and a properly set in place cadastre register.

Accounting Profession: Oversight, Auditor Independence, and Financial Reporting Issues

National Research Council Canada - National Science Library

Sarbanes, Paul

2002-01-01

...) and other large corporations financial reporting restatements have raised questions about the soundness of the current self-regulatory and financial reporting systems and resulted in substantial...

ATMPs for Cancer Immunotherapy: A Regulatory Overview.

Science.gov (United States)

Galli, Maria Cristina

2016-01-01

This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Science.gov (United States)

Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

2007-01-01

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

ENSI’s regulatory framework strategy; Regelwerksstrategie des ENSI -- Stratégie réglementaire de l’IFSN -- ENSI’s regulatory framework strategy

Energy Technology Data Exchange (ETDEWEB)

NONE

2015-03-15

This short brochure issued by the Swiss Federal Nuclear Safety Inspectorate ENSI defines the organisation’s regulatory framework strategy. Six guiding principles are declared and discussed: Comprehensive harmonisation with relevant international requirements, basing the regulatory framework on existing, tried-and-tested regulations, issuing of its own guidelines only when it is necessary to do so, guidelines to be drawn up transparently and with the involvement of all stakeholders and basing the level of detail of its regulatory framework on hazard potential and risk.

Regulatory analysis for the resolution of Generic Issue 99: Loss of RHR [residual heat removal] capability in PWRs

International Nuclear Information System (INIS)

Spano, A.H.

1989-02-01

Generic Issue 99 is concerned with the loss of residual heat removal (RHR) capability in pressurized water reactors during cold-plant outage operations. The issue focuses on two risk-significant common-cause failure modes of the RHR system: (1) air binding of the RHR pumps during reduced-inventory operations and (2) spurious closure of the RHR suction valves due to misapplication of the autoclosure interlocks. Resolution of this issue involves consideration of the adequacy of plant capabilities for (1) preventing losses of RHR, (2) responding promptly and effectively to such challenges in order to prevent core damage, and (3) ensuring timely containment protection against the release of radioactivity to the environment in the unlikely event of core damage due to loss of shutdown cooling. This entails examination of (1) relevant operational and accident response procedures, (2) the instrumentation available to the operator for accident diagnosis and mitigation, and (3) the administrative controls available for ensuring control room cognizance of ongoing maintenance activities that could potentially affect the stability of the reactor coolant system. This regulatory analysis provides quantitative assessments of the costs and benefits associated with several alternatives considered for the resolution of Generic Issue 99. 24 refs

Carbon Capture and Storage: legal issues

Energy Technology Data Exchange (ETDEWEB)

Mace, M.J.

2006-10-15

Carbon dioxide Capture and Storage (CCS) describes the process of capturing CO2 emissions from industrial and energy-related processes, compressing the gas to a liquid form, transporting it to a storage site (by pipeline, ship, truck or rail), and injecting it into a geological cavity – to isolate it from the atmosphere. CCS has been described as one option in the 'portfolio' of mitigation options - useful as a bridging technology to address the most prevalent greenhouse gases by volume in the short term, while economies make the shift from fossil fuels to low-carbon energy sources, including renewables. The IPCC has estimated that CCS has the potential to contribute 15-55% of the cumulative mitigation effort worldwide until 2100. However, for this to occur, the IPCC estimates that several hundreds or thousands of CO2 capture systems would need to be installed over the next century. Such a prospect raises a host of legal and regulatory issues and concerns. CCS activities will have to be undertaken in a manner consistent with the range of existing regulatory frameworks developed at the national level to address environmental and health and safety risks. But consistency with international law will also be essential where transboundary impacts are possible, transboundary transportation is involved, or offshore storage activities are contemplated.

Steam generators regulatory practices and issues in Spain

International Nuclear Information System (INIS)

Mendoza, C.; Castelao, C.; Ruiz-Colino, J.; Figueras, J.M.

1997-01-01

This paper presents the actual status of Spanish Steam Generator tubes, actions developed by PWR plant owners and submitted to CSN, and regulatory activities related to tube degradation mechanisms analysis; NDT tube inspection techniques; tube, tubesheet and TSPs integrity studies; tube plugging/repair criteria; preventive and corrective measures including whole SGs replacement; tube leak measurement methods and other operational aspects

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

Energy Technology Data Exchange (ETDEWEB)

Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral, E-mail: maryellelg@hotmail.com [PPG BioSaude, Universidade Luterana do Brasil, Canoas, RS (Brazil); Rocha, Bruna Oliveira [Faculty of Biology, Universidade Luterana do Brasil, Canoas, RS (Brazil); Santos-Oliveira, Ralph [Institute of Radiopharmacy Research, Universidade Estadual da Zona Oeste, Rio de Janeiro, RJ (Brazil)

2014-04-15

Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

International Nuclear Information System (INIS)

Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral; Rocha, Bruna Oliveira; Santos-Oliveira, Ralph

2014-01-01

Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

Raising consciousness about the nuclear threat through music

Energy Technology Data Exchange (ETDEWEB)

Ungerleider, J.H.

1987-01-01

This dissertation examines the use of music, in particular topical collaborative group song writing, as a tool for raising consciousness about the threat of nuclear war. Consciousness raising is one way to overcome the phenomenon of denial and to increase discussion and social action in response to the nuclear threat. This dissertation measures the impact of a group song writing workshop on developing critical problem-solving in adult groups; it reviews how music is applied in psychological research and clinical work, has been used historically as a tool in social-change movements in America, and is used in the contemporary field of peace education. The perspectives of several theorists who discuss the potential of music to contribute to social change are presented. It is concluded that consciousness about the nuclear threat - in terms of naming and analyzing - can be raised by working with music's potential for developing affective, expressive, and collaborative capabilities in individuals and groups. Potential applications of the group song writing workshop are in schools, with peace organizations, music groups, and in relation to other social issues.

50 CFR 14.23 - Live farm-raised fish and farm-raised fish eggs.

Science.gov (United States)

2010-10-01

... 50 Wildlife and Fisheries 1 2010-10-01 2010-10-01 false Live farm-raised fish and farm-raised fish eggs. 14.23 Section 14.23 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF... Exportation at Designated Ports § 14.23 Live farm-raised fish and farm-raised fish eggs. Live farm-raised fish...

Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations.

Science.gov (United States)

Gelinas, Luke; Pierce, Robin; Winkler, Sabune; Cohen, I Glenn; Lynch, Holly Fernandez; Bierer, Barbara E

2017-03-01

The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website "terms of use"; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.

Raising Awareness in Science Education for Women (RAISE-W)

Science.gov (United States)

Faherty, Jacqueline K.; Holford, M.

2014-01-01

Raising Awareness in Science Education for Women (RAISE-W) is a 501c non profit corporation whose mission is to aid in increasing and retaining the number of women - especially underrepresented females - engaged in scientific teaching and research. Initiated by a Protein Chemist and an Astronomer, our ultimate goal has been to develop informational tools and create innovative outreach programs for women across all STEM fields. At present RAISE-W is recruiting women at the undergraduate, graduate, and early career stages to participate in a unique, 1-year, executive coaching program modeled after those used in the business sector.

Regulatory guidelines for biosimilars in Malaysia.

Science.gov (United States)

Abas, Arpah

2011-09-01

The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products. Copyright © 2011. Published by Elsevier Ltd.

Grand Gulf-prioritization of regulatory requirements

International Nuclear Information System (INIS)

Meisner, M.J.

1993-01-01

As cost pressures mount, Grand Gulf nuclear station (GGNS) is relying increasingly on various prioritization approaches to implement, modify, eliminate, or defer regulatory requirements. Regulatory requirements can be prioritized through the use of three measures: (1) safety (or risk) significance; (2) cost; and (3) public policy (or political) significance. This paper summarizes GGNS' efforts to implement solutions to regulatory issues using these three prioritization schemes to preserve a balance between cost and safety benefit

Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

Energy Technology Data Exchange (ETDEWEB)

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

2017-08-23

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However, it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory

Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

Energy Technology Data Exchange (ETDEWEB)

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

2015-05-01

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However, it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory

Regulatory and technical reports (abstract index journal)

International Nuclear Information System (INIS)

1994-06-01

This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission (NRC) Staff and its contractors. It is NRC's intention to publish this compilation quarterly and to cumulate it annually

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

Patient safety issues in office-based surgery and anaesthesia in Switzerland: a qualitative study.

Science.gov (United States)

McLennan, Stuart; Schwappach, David; Harder, Yves; Staender, Sven; Elger, Bernice

2017-08-01

To identify the spectrum of patient safety issues in office-based surgery and anaesthesia in Switzerland. Purposive sample of 23 experts in surgery and anaesthesia and quality and regulation in Switzerland. Data were collected via individual qualitative interviews using a researcher-developed semi-structured interview guide between March 2016 and September 2016. Interviews were transcribed and analysed using conventional content analysis. Issues were categorised under the headings "structure", "process", and "outcome". Experts identified two key overarching patient safety and regulatory issues in relation to office-based surgery and anaesthesia in Switzerland. First, experts repeatedly raised the current lack of data and transparency of the setting. It is unknown how many surgeons are operating in offices, how many and what types of operations are being done, and what the outcomes are. Secondly, experts also noted the limited oversight and regulation of the setting. While some standards exists, most experts felt that more minimal safety standards are needed regarding the requirements that must be met to do office-based surgery and what can and cannot be done in the office-based setting are needed, but they advocated a self-regulatory approach. There is a lack of empirical data regarding the quantity and quality office-based surgery and anaesthesia in Switzerland. Further research is needed to address these research gaps and inform health policy in relation to patient safety in office-based surgery and anaesthesia in Switzerland. Copyright © 2017. Published by Elsevier GmbH.

Neuroscientists' everyday experiences of ethics: the interplay of regulatory, professional, personal and tangible ethical spheres.

Science.gov (United States)

Brosnan, Caragh; Cribb, Alan; Wainwright, Steven P; Williams, Clare

2013-11-01

The ethical issues neuroscience raises are subject to increasing attention, exemplified in the emergence of the discipline neuroethics. While the moral implications of neurotechnological developments are often discussed, less is known about how ethics intersects with everyday work in neuroscience and how scientists themselves perceive the ethics of their research. Drawing on observation and interviews with members of one UK group conducting neuroscience research at both the laboratory bench and in the clinic, this article examines what ethics meant to these researchers and delineates four specific types of ethics that shaped their day-to-day work: regulatory, professional, personal and tangible. While the first three categories are similar to those identified elsewhere in sociological work on scientific and clinical ethics, the notion of 'tangible ethics' emerged by attending to everyday practice, in which these scientists' discursive distinctions between right and wrong were sometimes challenged. The findings shed light on how ethical positions produce and are, in turn, produced by scientific practice. Informing sociological understandings of neuroscience, they also throw the category of neuroscience and its ethical specificity into question, given that members of this group did not experience their work as raising issues that were distinctly neuro-ethical. © 2013 The Authors. Sociology of Health & Illness © 2013 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

Fitness for duty in the nuclear power industry: A review of technical issues

International Nuclear Information System (INIS)

Moore, C.; Barnes, V.; Hauth, J.

1989-05-01

This report presents information gathered and analyzed in support of the US Nuclear Regulatory Commission's (NRC's) efforts to develop a rule that will ensure that workers with unescorted access to protected areas of nuclear power plants are fit for duty. This report supplements information previously published in NUREG/CR-5227, Fitness for Duty in the Nuclear Power Industry: A Review of Technical Issues (Barnes et al., 1988). The primary potential fitness-for-duty concern addressed in both of these reports is impairment caused by substance abuse, although other fitness concerns are discussed. This report addresses issues pertaining to workers' use and misuse of alcohol, prescription drugs, and over-the-counter drugs as fitness-for-duty concerns; responds to several questions raised by NRC Commissioners; discusses subversion of the chemical testing process and methods of preventing such subversion; and examines concerns about the urinalysis cutoff levels used when testing for marijuana metabolites, amphetamines, and phencyclidine

Research Issues in Information Access.

Science.gov (United States)

Molholt, Pat

1989-01-01

Discusses traditional library approaches to access to information and the possible impact of information technologies, library automation, and artificial intelligence. Access issues raised by these technologies are identified and a research agenda to explore these issues is outlined. (31 references) (CLB)

20 CFR 410.646 - Consolidated issues.

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Consolidated issues. 410.646 Section 410.646..., Finality of Decisions, and Representation of Parties § 410.646 Consolidated issues. When one or more additional issues are raised by the Administrative Law Judge pursuant to § 410.637, such issues may, in the...

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

Directory of Open Access Journals (Sweden)

Maryelle Moreira Lima Gamboa

2014-04-01

Full Text Available Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ or positrons emitter (β+, linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64. In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs.

Air toxics regulatory issues facing urban settings

Energy Technology Data Exchange (ETDEWEB)

Olden, K.; Guthrie, J. [National Institute of Environmental Health Sciences, Research Triangle Park, NC (United States)

1996-10-01

Biomarker research does not exist in isolation. Its usefulness can only be realized when it is translated into prevention strategies to protect public health. In the context of air toxics, these prevention strategies begin with the development of regulatory standards derived from risk assessment schemes. The Clean Air Act Amendments of 1990 list 189 air toxics, including many volatile organics, metals, and pesticides. The National Institute of Environmental Health Sciences (NIEHS), through its affiliation with the National Toxicology Program, has generated toxicity and carcinogenicity data on more than 100 of these air toxics. The NIEHS extramural and intramural research portfolios support a variety of projects that develop and validate biomarkers for use in environmental health science and risk assessment. Biomarkers have a tremendous potential in the areas of regulating air toxics and protecting public health. Risk assessors need data provided by biomarkers of exposure, biomarkers of close/pharmacokinetics, biomarkers of susceptibility or individual variability, and biomarkers of effects. The greatest benefit would be realized if biomarkers could be employed in four areas of primary and secondary prevention. The first is the use of biomarkers to enhance extrapolation of animal data to human exposure situations in establishing risk standards. The second is the use of biomarkers that assess noncancer, as well as cancer, end points. Important health end points include pulmonary dysfunction, immunotoxicity, and neurotoxicity. Third, biomarkers that serve as early warning signs to detect intermediate effects would enhance our ability to design timely and cost-effective intervention strategies. Finally, biomarkers used to evaluate the effectiveness of intervention strategies both in clinical and regulatory settings, would enable us to ensure that programs designed to protect public health do, in fact, achieve the desired outcome. 9 refs., 2 tabs.

Progress and Updates of Regulatory Challenges and Safety Issues in Korea during Three Years after Fukushima Accident

International Nuclear Information System (INIS)

Lee, Young Eal; Kim, Kyun Tae

2014-01-01

Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency. This paper shares information on the progress and uprates achieved in Korea so far in connection with the safety issues caused during last 3 years and actions taken by the regulatory body. Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency

Progress and Updates of Regulatory Challenges and Safety Issues in Korea during Three Years after Fukushima Accident

Energy Technology Data Exchange (ETDEWEB)

Lee, Young Eal; Kim, Kyun Tae [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2014-10-15

Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency. This paper shares information on the progress and uprates achieved in Korea so far in connection with the safety issues caused during last 3 years and actions taken by the regulatory body. Before the public fear on radiation risk caused by neighboring country's severe accident disappeared, a series of nuclear safety issues last 3 years made a few reactors shut down and the public trust much lower than before. Because of these scandals such as cover-ups, forged certificated items, corruption of manager of licensee and so on, many efforts made during three year after Fukushima accident on improving the nuclear safety were invalidated and even regulators as well as operators have been sharply criticized for its responsibility and transparency.

Space reactor fuels performance and development issues

International Nuclear Information System (INIS)

Wewerka, E.M.

1984-01-01

Three compact reactor concepts are now under consideration by the US Space Nuclear Power Program (the SP-100 Program) as candidates for the first 100-kWe-class space reactor. Each of these reactor designs puts unique constraints and requirements on the fuels system, and raises issues of fuel systems feasibility and performance. This paper presents a brief overview of the fuel requirements for the proposed space reactor designs, a delineation of the technical feasibility issues that each raises, and a description of the fuel systems development and testing program that has been established to address key technical issues

Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

International Nuclear Information System (INIS)

Moe, Wayne Leland

2015-01-01

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a ''critical path'' for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However, it is also important to remember that certain ''minimum'' levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial ''first step'' in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by

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

International Nuclear Information System (INIS)

Vieru, G.

2002-01-01

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

Regulatory Analysis on the Safety Assessment of NPPs against Aircraft Crash

International Nuclear Information System (INIS)

Kim, Sang Yun; Park, Jong Seuk; Chung, Yun Suk; Jung, Rae Young

2011-01-01

Following the 9/11 terror, a new regulation (10CFR 50.150) was enacted in June 2009 in the United States mandating the assessment of new nuclear power plants (NPPs) against intentional aircraft crashes, along with a regulation (10CFR 50.54 (h)(h)) in March 2009 that requires the establishment of accident mitigation measures for NPPs in operation. The UAE requested that the Korean NPP (APR 1400) design meet the U.S.'s new requirements related to the intentional aircraft crash. During the UAE NPP contract bidding process, France claimed that the Korean NPP is vulnerable to aircraft crashes comparing with the French NPP (EPR). Under these international and domestic environments, the necessity to establish a domestic regulation concerning the intentional aircraft crash was raised. This paper proposes a draft regulatory position on this issue through a comprehensive analysis of various influencing factors

NRC Regulatory Agenda

International Nuclear Information System (INIS)

1989-07-01

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

Regulatory Powers in Public Procurement Law of Peruvian Administrative Agencies

Directory of Open Access Journals (Sweden)

Juan Carlos Morón Urbina

2017-12-01

Full Text Available Peruvian law has explicitly recognized regulatory powers to administrative agencies, which allows them to have a preponderant role in the production of rules in public procurement. Although these delegations of legislative authority are positively defined, distortions in the system of legal sources arise when agencies exceed delegated powers or when measures issued by administrative entities are mistaken for regulations. This paper aims to identify regulatory powers of Peruvian administrative agencies, as well as the regulatory measures they issue, and their relation with other sources of law.

Rationales for regulatory activity

Energy Technology Data Exchange (ETDEWEB)

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

1997-02-01

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

Raising Confident Kids

Science.gov (United States)

... First Aid & Safety Doctors & Hospitals Videos Recipes for Kids Kids site Sitio para niños How the Body ... Videos for Educators Search English Español Raising Confident Kids KidsHealth / For Parents / Raising Confident Kids What's in ...

Nuclear regulatory organisations: Learning from stakeholders to enhance communication

International Nuclear Information System (INIS)

Lorin, Aurelie

2015-01-01

Since its creation 15 years ago, the NEA Committee on Nuclear Regulatory Activities (CNRA) Working Group on Public Communication of Nuclear Regulatory Organisations (WGPC) has been addressing a broad range of communication issues, with two reports recently issued on Nuclear Regulatory Organisations, the Internet and Social Media: The What, How and Why of Their Use as Communication Tools and on Nuclear Regulatory Organisations and Communication Strategies. After the Fukushima Daiichi nuclear power plant accident in 2011, nuclear regulatory organisations around the world reaffirmed the need to strengthen stakeholder outreach and communication, and to create more robust avenues for stakeholder involvement in regulatory matters. The WGPC proposed a means for stakeholders to play a more active role in the group by holding one-day workshops in conjunction with regular meetings. These workshops offer a platform for stakeholder exchange with communication experts from nuclear regulatory organisations (NROs). The objective is to stimulate co-operation and improve communication by better understanding stakeholder perceptions, needs and expectations, and by discussing how to use traditional and social media more effectively. While nuclear regulatory organisations may have a common willingness to improve their communication methods and to build constructive relationships with stakeholders, every country has its own practices and cultural background, and thus its own challenges. Following the first workshop in Paris, which brought together European stakeholders, and the second in North America, the NEA is now organising a third workshop in Asia (Japan) to be held in April 2016. This third workshop will enable the NEA to gather stakeholder views from a third continent. A report on the workshops' findings will be issued after the completion of this third workshop, thus giving a broader idea of how to improve the overall communication methods of nuclear regulatory

Reactor aging research. United States Nuclear Regulatory Commission

International Nuclear Information System (INIS)

Vassilaros, M.G.

1998-01-01

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

Legal, regulatory & institutional issues facing distributed resources development

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-10-01

This report describes legal, regulatory, and institutional considerations likely to shape the development and deployment of distributed resources. It is based on research co-sponsored by the National Renewable Energy Laboratory (NREL) and four investor-owned utilities (Central & South West Services, Cinergy Corp., Florida Power Corporation, and San Diego Gas & Electric Company). The research was performed between August 1995 and March 1996 by a team of four consulting firms experienced in energy and utility law, regulation, and economics. It is the survey phase of a project known as the Distributed Resources Institutional Analysis Project.

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)

Ethical Issues in Online Education

Science.gov (United States)

Anderson, Bill; Simpson, Mary

2007-01-01

Teaching at a distance raises ethical issues particular to the distance context. When distance teaching is also online teaching, the situation is even more complex. Online teaching environments amplify the ethical issues faced by instructors and students. Online sites support complex discourses and multiple relationships; they cross physical,…

Dynamics of psychological safety in mothers raising children with special needs

Directory of Open Access Journals (Sweden)

Atamanova I.

2018-01-01

Full Text Available There is a considerable decrease in psychological well-being among mothers raising children with special needs. Addressing the issues of providing psychological support for them is of particular importance for both researchers and practitioners. The paper presents a study aimed at exploring the dynamics of psychological safety in mothers raising children with special needs. 32 mothers whose children underwent a rehabilitation programme in a rehabilitation centre participated in the study. The key element of the psychological support programme developed for these mothers was a specific psychotherapeutic space combining hippotherapy with environmental, social and personal factors. Compared to the control group, the study participants’ parameters of psychological safety showed statistically significant positive dynamics. The results obtained contribute to studying factors of psychological well-being in mothers raising children with special needs and suggest an effective way of enhancing their sense of psychological safety.

NRC Regulatory Agenda

International Nuclear Information System (INIS)

1992-07-01

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

Addressing issues raised by stakeholders in the development of a deep geological repository in the Czech Republic

International Nuclear Information System (INIS)

Sumberova, Vera

2004-01-01

The mission of the Radioactive Waste Repository Authority (RAWRA) is to ensure the safe disposal of all existing and future radioactive waste. In order to fulfil this task RAWRA, in addition to the operation of radioactive waste repositories in the Czech Republic, coordinates all those activities relating to the construction of a deep geological repository. This long-term goal implies first creating and then building upon the public's confidence in the decision making process and the project as a whole as well as in RAWRA as a competent and efficient implementer since clearly public acceptance is an essential condition for a successful final outcome. Since its establishment in 1997 RAWRA has been looking for ways in which to inform the public about its activities and how to involve the various stakeholders in the development process. The communication tools employed to achieve this goal have, to date, depended on the specific stage of the process but RAWRA has aimed at a continuous improvement in its activities; consequently a large number of changes have been made to RAWRA's policy and approach in recent years. This paper, which aims to describe RAWRA's dialogue with stakeholders (mainly local communities), provides examples of the way in which issues raised by stakeholders concerning a repository are reflected in RAWRA's approach. (author)

Environmental reporting as a strategic issue

DEFF Research Database (Denmark)

Larsen, Lars Bjørn

1997-01-01

Organisations are facing ever increasing demands or pressures from various stakeholder to raise their environmental standards. Raising the environmental standards includes improving and documenting the environmental performance in relation to production processes, products and logistics.This pape...... adresses environmental reporting as an important issue in strategic management, since many of environmental management are related to the availability of environmental information both inside and outside the company.......Organisations are facing ever increasing demands or pressures from various stakeholder to raise their environmental standards. Raising the environmental standards includes improving and documenting the environmental performance in relation to production processes, products and logistics.This paper...

76 FR 5215 - Draft Regulatory Guide: Issuance, Availability

Science.gov (United States)

2011-01-28

... . SUPPLEMENTARY INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public... . From this page, the public can gain entry into ADAMS, which provides text and image files of NRC's... [email protected] . The Regulatory Analysis is available electronically under ADAMS Accession...

Public policy issues in nuclear waste management

International Nuclear Information System (INIS)

Nealey, S.M.; Radford, L.M.

1978-10-01

This document aims to raise issues and to analyze them, not resolve them. The issues were: temporal equity, geographic and socioeconomic equity, implementation of a nuclear waste management system, and public involvement

Electricity and telecommunications regulatory institutions in small and developing countries

Energy Technology Data Exchange (ETDEWEB)

Stern, J. [London Business School, London (United Kingdom)

2000-09-01

The spread of utility liberalisation and privatisation to middle and low income developing countries raises the problem of whether and how they can establish an effective regulatory capability of whether the supply of regulatory services is likely to be insufficient. The paper presents evidence on the size of electricity regulatory agencies in 24 mainly middle and lower income countries as well as the number of high-level, specialist regulatory staff and the potential resource pool from post-school education. The paper also discusses how far the problem can be alleviated and/or avoided by the use of regulation by contract, regulation by multi-national regulatory agency or contracting-out. The paper concludes that such solutions are unlikely to be generally effective but that informal exchanges of information and pooling of resources between national regulators on a market-driven basis, as seen in Southern Africa and the EU, is a promising option. The paper concludes by pointing to the need to ascertain the minimum required regulatory capability in developing countries as perceived by Governments and potential investors. (author)

Safeguards and security issues at the MRS facility

International Nuclear Information System (INIS)

McGuinn, E.; Birch, M.; Jones, J.; Floyd, W.

1993-01-01

The U.S. Department of Energy's (DOE) Office of Civilian Radioactive Waste Management (OCRWM) is responsible for disposing of the nation's high level radioactive waste in a way that ensures the protection of the public from any unacceptable radiological risks and the maintenance of the national security. To achieve these objectives, OCRWM plans to institute a Nuclear Regulatory Commission (NRC)-approved security program at its facilities including the Monitored Retrievable Storage (MRS) facility. This program will safeguard nuclear information and provide not only for the physical protection of facilities but also for the nuclear material being handled and stored. Several key regulatory issues were identified during the development of the safeguards and security (S ampersand S) program for the MRS. These issues relate to developing a realistic definition of the security threat at the MRS and establishing a single set of regulatory requirements. Resolution of these issues is important to implement a realistic S ampersand S program who scope is commensurate with the potential risk at the MRS and complies with all appropriate regulatory requirements. OCRWM is working toward a timely resolution of these issues and on the formulation of an S ampersand S program for implementation at the MRS. As an initial step, DOE has proposed an S ampersand S strategy for the MRS based on a set of assumed resolutions to the key regulatory issues. With this approach, the facility designers will be able to evaluate possible S ampersand S concepts for integration into the MRS early in the design process

Issues in Media Ethics. ERIC Digest.

Science.gov (United States)

Aiex, Nola Kortner; Gottlieb, Stephen S.

Noting that over the past decade incidents have occurred and new technologies have appeared which together have raised questions about the ethical values of American journalists, this Digest seeks to identify some of those ethical issues and to point to the work of those who have studied these issues. It addresses issues of plagiarism and…

Public policy and regulatory implications for the implementation of Opportunistic Cloud Computing Services for Enterprises

DEFF Research Database (Denmark)

Kuada, Eric; Olesen, Henning; Henten, Anders

2012-01-01

Opportunistic Cloud Computing Services (OCCS) is a social network approach to the provisioning and management of cloud computing services for enterprises. This paper discusses how public policy and regulations will impact on OCCS implementation. We rely on documented publicly available government...... and corporate policies on the adoption of cloud computing services and deduce the impact of these policies on their adoption of opportunistic cloud computing services. We conclude that there are regulatory challenges on data protection that raises issues for cloud computing adoption in general; and the lack...... of a single globally accepted data protection standard poses some challenges for very successful implementation of OCCS for companies. However, the direction of current public and corporate policies on cloud computing make a good case for them to try out opportunistic cloud computing services....

Raised intracranial pressure

African Journals Online (AJOL)

is article presents an approach to raised intracranial pressure (ICP) constructed in a question-answer fashion. ..... Given that raised ICP is a serious and potentially life-threatening emergency, fast and reliable referral and transfer mechanisms should be established to ensure patients with this condition are effectively treated.

NRC regulatory agenda

International Nuclear Information System (INIS)

1993-02-01

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

NRC regulatory agenda

International Nuclear Information System (INIS)

1992-11-01

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

Needs of research for regulatory purposes

International Nuclear Information System (INIS)

Wanner, H.

2010-01-01

Hans Wanner, Swiss Federal Nuclear Safety Inspectorate (ENSI), presented a general overview of regulatory research at the international level based on a preliminary input from international colleagues and observed that the question of active involvement of nuclear regulatory and supervisory bodies in R and D projects has become a topic of increasing interest in recent years even if the way in which research is included in regulatory activities varies from country to country. The range spans from countries with no regulatory R and D activities to countries with extensive activities that are often carried out by independent research organisations acting on behalf of the regulatory body. In a few countries, the regulator and implementer have their research carried out by the same research institutes. As an example H. Wanner explained the organisation of R and D work in Switzerland. He presented the potential merits of R and D work carried out by the regulator and introduced a number of questions that would gain from being addressed at an international level. He stressed that the R and D work performed by the implementer must be comprehensive and there should be, in principle, no need for complementary work by the regulatory body. Nevertheless, R and D work of the regulator has still several merits. It improves the regulator's necessary competence to review the safety case allowing it to rely on the scientific community. It provides the regulator's independence, allowing a different view on the safety case from the implementer's view. By bringing to the fore the scientific and technical ability of the regulator, R and D work by the regulator provides additional confidence to the stakeholders in the credibility of the regulator. There may exist further motivations for the regulator to carry out its own R and D projects, among which is the verification of key safety issues or the investigation of topics not addressed by the implementer, i.e., to fill scientific gaps. The

Regulatory Issues and Challenges in Preparing for the Regulation of New Reactor Siting: Malaysia's Experience

International Nuclear Information System (INIS)

Jais, Azlina Mohammad; Hassan, Halimah; Yasir, Muhamad Samudi; Roslan, Ridha

2011-01-01

This paper aims at giving an overview about the issues and challenges facing regulatory authority, the Atomic Energy Licensing Board (AELB) in ensuring nuclear safety, security and safeguards (3S's) and other relevant authorities to meet an impending nuclear power programme post-2020, in particular at the beginning stage of preparation for the regulation of nuclear power reactor siting. A comparison with an international framework and guidelines of the International Atomic Energy Agency (IAEA) and other countries' practice was made to get an overview of the present adequacy of Malaysia's nuclear regulatory framework in preparation for Malaysia to consider and perhaps decide for a safe, secure and peaceful nuclear power project in Malaysia, in utilising nuclear power in a quest for energy diversity and security. The important stage in the development of a nuclear power project is the evaluation of a suitable site to establish the site-related design inputs for the NPP. The evaluation of suitable site is the result of a process to ensure adequate protection of workers, public and the environment from the undue risk of ionizing radiation arising from NPP taking into account impact to the social communities and public acceptance, thus it will depend on the regulators to ensure a high level safety standards and security are met, in addition to its peaceful uses. Development of regulatory criteria for the site evaluation is a pre-initiatives licensing work for a possible nuclear power plant to performing effective nuclear safety and security reviews in an efficient and timely manner regardless whether Malaysia embarks on a nuclear power programme with anticipating challenges, learning from others' experiences in preparing for the demands for new licensing processes by collaborating internationally, in an expanding global environment

The application of RFIDs in libraries : an assessment of technological, management and professional issues

OpenAIRE

Gibb, Forbes; Thornley, Clare V.; Ferguson, Stuart; Weckert, John

2011-01-01

This paper starts by outlining the technologies involved in RFIDs and reviews the issues raised by their general application. It then identifies their potential application areas within the library sector based on a generic process view of library activities. Finally it highlights the issues that are raised by their application in libraries and provides an assessment of which of these issues are likely to raise ethical concerns for library professionals. The purpose is to provide an overview ...

NRC Regulatory Agenda: Quarterly report, July-September 1987

International Nuclear Information System (INIS)

1987-11-01

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

NRC regulatory agenda: Quarterly report, April--June 1988

International Nuclear Information System (INIS)

1988-08-01

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

Cost-benefit and regulatory decision making

International Nuclear Information System (INIS)

Harvie, J.

1996-01-01

The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost benefit issues and work towards some consensus of opinion among stake holders: a task force on the subject could be an appropriate starting point'. (author)

Raising the standards of the calf-raise test: a systematic review.

Science.gov (United States)

Hébert-Losier, Kim; Newsham-West, Richard J; Schneiders, Anthony G; Sullivan, S John

2009-11-01

The calf-raise test is used by clinicians and researchers in sports medicine to assess properties of the calf muscle-tendon unit. The test generally involves repetitive concentric-eccentric muscle action of the plantar-flexors in unipedal stance and is quantified by the number of raises performed. Although the calf-raise test appears to have acceptable reliability and face validity, and is commonly used for medical assessment and rehabilitation of injuries, no universally acceptable test parameters have been published to date. A systematic review of the existing literature was conducted to investigate the consistency as well as universal acceptance of the evaluation purposes, test parameters, outcome measurements and psychometric properties of the calf-raise test. Nine electronic databases were searched during the period May 30th to September 21st 2008. Forty-nine articles met the inclusion criteria and were quality assessed. Information on study characteristics and calf-raise test parameters, as well as quantitative data, were extracted; tabulated; and statistically analysed. The average quality score of the reviewed articles was 70.4+/-12.2% (range 44-90%). Articles provided various test parameters; however, a consensus was not ascertained. Key testing parameters varied, were often unstated, and few studies reported reliability or validity values, including sensitivity and specificity. No definitive normative values could be established and the utility of the test in subjects with pathologies remained unclear. Although adapted for use in several disciplines and traditionally recommended for clinical assessment, there is no uniform description of the calf-raise test in the literature. Further investigation is recommended to ensure consistent use and interpretation of the test by researchers and clinicians.

Accounting-related transmission issues

International Nuclear Information System (INIS)

Niehaus, M.; Bjorn, P.; Pate, G.

1999-01-01

Various initiatives have been undertaken by the Federal Energy Regulatory Commission (FERC) to deregulate wholesale electric energy markets. These initiatives have focused on restructuring the transmission systems in the US and recently have culminated in a proposal requiring formation of and participation in regional transmission organizations. The overall form of regulation selected to determine rates for transmission entities as well as underlying regulatory decisions reached on key issues will have profound implications for transmission entities. For example, traditional cost-based regulation would require one set of accounting and reporting rules, while incentive-based regulation may not be subject to those same rules. An overview of some of the major accounting and financial reporting issues that will need to be considered is presented

Regulatory adequacy of aquatic ecotoxicity testing of nanomaterials

DEFF Research Database (Denmark)

Hjorth, Rune; Skjolding, Lars Michael; Sørensen, Sara Nørgaard

2017-01-01

between studies, which question the regulatory reliability of the data currently available. Accordingly, lack of data suited for regulatory decision-making is still a pressing issue in nanoecotoxicology even though the data availability has increased. Nevertheless, we emphasize that by deliberately...... to question whether ecotoxicity testing is now able to facilitate regulatory decision-making on manufactured nanomaterials (MNs). In this paper, we review the state of aquatic ecotoxicity testing of MNs as well as the overarching issues that challenge the reliability and relevance of such testing. We conclude...... that within the field there is an increased focus on characterization of the exposure rather than controlling exposure as it is traditionally done in guideline testing of chemicals. However, the lack of characterization options under actual testing conditions makes it difficult to make meaningful comparisons...

The core to regulatory reform

International Nuclear Information System (INIS)

Partridge, J.W. Jr.

1993-01-01

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

European regulatory tools for advanced therapy medicinal products.

Science.gov (United States)

Flory, Egbert; Reinhardt, Jens

2013-12-01

Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of biopharmaceuticals as these products are highly research-driven, characterised by innovative manufacturing processes and heterogeneous with regard to their origin, type and complexity. This class of ATMP integrates gene therapy medicinal products, somatic cell therapy medicinal products and tissue engineering products and are often individualized and patient-specific products. Multiple challenges arise from the nature of ATMPs, which are often developed by micro, small and medium sized enterprises, university and academia, for whom regulatory experiences are limited and regulatory requirements are challenging. Regulatory guidance such as the reflection paper on classification of ATMPs and guidelines highlighting product-specific issues support academic research groups and pharmaceutical companies to foster the development of safe and effective ATMPs. This review provides an overview on the European regulatory aspects of ATMPs and highlights specific regulatory tools such as the ATMP classification procedure, a discussion on the hospital exemption for selected ATMPs as well as borderline issues towards transplants/transfusion products.

Developing regulatory approaches

International Nuclear Information System (INIS)

Axelsson, Lars

2012-01-01

Lars Axelsson presented SSM progress on oversight of LMfS/SC since the Chester 1 Workshop in 2007. Current SSM approaches for safety culture oversight include targeted safety management and safety culture inspections, compliance inspections which cover aspects of safety management/safety culture and multi-disciplinary team inspections. Examples of themes for targeted inspections include management of ambiguous operational situations or other weak signals, understanding of and attitudes to Human Performance tools, the Safety Department's role and authority and Leadership for safety. All regulatory activities provide inputs for the SSM yearly safety evaluation of each licensee. A form has been developed to capture safety culture observations from inspections and other interactions with licensees. Analysis will be performed to identify patterns and provide information to support planning of specific Safety Culture activities. Training has been developed for regulatory staff to enhance the quality of regulatory interventions on safety culture. This includes a half-day seminar to provide an overview of safety culture, and a workshop which provides more in-depth discussion on cultural issues and how to capture those during regulatory activities. Future plans include guidance for inspectors, and informal seminars on safety culture with licensees

Personal genome testing: Test characteristics to clarify the discourse on ethical, legal and societal issues

Directory of Open Access Journals (Sweden)

Janssens A Cecile JW

2011-06-01

Full Text Available Abstract Background As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI surrounding genetic testing, which must evolve to encompass these differences. One important development is the rise of personal genome testing on the basis of genetic profiling: the testing of multiple genetic variants simultaneously for the prediction of common multifactorial diseases. Currently, an increasing number of companies are offering personal genome tests directly to consumers and are spurring ELSI-discussions, which stand in need of clarification. This paper presents a systematic approach to the ELSI-evaluation of personal genome testing for multifactorial diseases along the lines of its test characteristics. Discussion This paper addresses four test characteristics of personal genome testing: its being a non-targeted type of testing, its high analytical validity, low clinical validity and problematic clinical utility. These characteristics raise their own specific ELSI, for example: non-targeted genetic profiling poses serious problems for information provision and informed consent. Questions about the quantity and quality of the necessary information, as well as about moral responsibilities with regard to the provision of information are therefore becoming central themes within ELSI-discussions of personal genome testing. Further, the current low level of clinical validity of genetic profiles raises questions concerning societal risks and regulatory requirements, whereas simultaneously it causes traditional ELSI-issues of clinical genetics, such as psychological and health risks, discrimination, and stigmatization, to lose part of their relevance. Also, classic notions of clinical utility are challenged by the

NRC regulatory agenda

International Nuclear Information System (INIS)

1993-07-01

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

75 FR 33853 - Draft Regulatory Guide: Issuance, Availability

Science.gov (United States)

2010-06-15

.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the... provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are... ADAMS Accession Number ML100760364. The regulatory analysis is available electronically under ADAMS...

75 FR 52996 - Draft Regulatory Guide: Issuance, Availability

Science.gov (United States)

2010-08-30

.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the... entry into ADAMS, which provides text and image files of NRC's public documents. If you do not have.../ . The regulatory analysis may be found in ADAMS under Accession No. ML102310331. Federal Rulemaking Web...

76 FR 2425 - Draft Regulatory Guide: Reissuance and Availability

Science.gov (United States)

2011-01-13

... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a..., the public can gain entry into ADAMS, which provides text and image files of NRC's public [email protected] . The Regulatory Analysis is available electronically under ADAMS Accession Number...

Annual Report 2010. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2010-01-01

The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2010. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

Annual Report 2011. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2011-01-01

The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2011. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

Experimental investigations relevant for hydrogen and fission product issues raised by the Fukushima accident

Directory of Open Access Journals (Sweden)

Sanjeev Gupta

2015-02-01

with the operation of passive safety systems in phenomena oriented and coupled effects experiments. In the present paper, potential hydrogen and fission product issues raised by the Fukushima accident are discussed. The discussion focuses on hydrogen and fission product behavior inside nuclear power plant containments under severe accident conditions. The relevant experimental investigations conducted in the technical scale containment THAI (thermal hydraulics, hydrogen, aerosols, and iodine test facility (9.2 m high, 3.2 m in diameter, and 60 m3 volume are discussed in the light of the Fukushima accident.

Assessing the effectiveness of nuclear regulatory system in India

International Nuclear Information System (INIS)

Gandhia, Sonal; Choi, Kwang Sik

2012-01-01

The Fukushima accident brought up the issue of regulatory effectiveness in the fore. One of the causes of the accident has been attributed to the problems in effectiveness of the Japanese regulatory system. Regulatory reform is underway in Japan and in other countries many efforts have also been made to improve the effectiveness and independence of the regulatory bodies. It is important that the regulatory bodies make self-assessment of their weaknesses and strengths, to achieve the ultimate regulatory goal of assuring acceptable level of nuclear safety. In this paper an assessment has been done for the effectiveness of Indian nuclear regulatory system as implemented by the Atomic Energy Regulatory board (AERB). A number of good practices of AERB have been found and some areas have been identified where improvements are necessary

76 FR 23845 - Draft Regulatory Guide: Issuance, Availability

Science.gov (United States)

2011-04-28

... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a... provides text and image files of the NRC's public documents. If you do not have access to ADAMS or if there...- 800-397-4209, 301-415-4737, or by e-mail to [email protected] . The Regulatory Analysis is...

Regulatory review of probabilistic safety assessment (PSA) Level 2

International Nuclear Information System (INIS)

2001-07-01

Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

Regulatory review of probabilistic safety assessment (PSA) level 1

International Nuclear Information System (INIS)

2000-02-01

Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from the deterministic analysis. Many regulatory authorities consider that the current state of the art in PSA (especially Level 1 PSA) is sufficiently well developed that it can be used centrally in the regulatory decision making process - referred to as 'risk informed regulation'. For these applications to be successful, it will be necessary for regulatory authorities to have a high degree of confidence in PSA. However, at the IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process in 1994 and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' Meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997 the IAEA and OECD Nuclear Energy Agency agreed to produce in co-operation a technical document on the regulatory review of PSA. This publication is intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable standard so that it can be used as the basis for taking risk informed decisions within a regulatory decision making process. The document gives guidance on how to set about reviewing a PSA and on the technical issues that need to be addressed. This publication gives guidance for the review of Level 1 PSA for

75 FR 51147 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

Science.gov (United States)

2010-08-18

... ``participation in a public offering'' means for purposes of the Rule and suggested an alternative definition... understood and that the alternative definition suggested by the commenter would be an inappropriate narrowing... underwriter'' under the Rule. FINRA recognized the issue raised by the commenter and stated their intention to...

Introduction strategies raise key questions.

Science.gov (United States)

Finger, W R; Keller, S

1995-09-01

Key issues that must be considered before a new contraceptive is introduced center on the need for a trained provider to begin or terminate the method, its side effects, duration of use, method's ability to meet users' needs and preferences, and extra training or staff requirements. Logistics and economic issues to consider are identifying a dependable way of effectively supplying commodities, planning extra services needed for the method, and cost of providing the method. Each contraceptive method presents a different side effect pattern and burdens the service delivery setting differently. The strategy developed to introduce or expand the 3-month injectable Depo-Provera (DMPA) can be used for any method. It includes a needs assessment and addresses regulatory issues, service delivery policies and procedures, information and training, evaluation, and other concerns. Viet Nam's needs assessment showed that Norplant should not be introduced until the service delivery system becomes stronger. Any needs assessment for expansion of contraceptive services should cover sexually transmitted disease/HIV issues. A World Health Organization strategy helps officials identify the best method mix for local situations. Introductory strategies must aim to improve the quality of family planning programs and expand choices. Many begin by examining existing data and conducting interviews with policymakers, users, providers, and women's health advocates. Introductory programs for Norplant focus on provider training, adequate counseling and informed consent for users, and ready access to removal. They need a well-prepared service delivery infrastructure. The first phase of the DMPA introductory strategy for the Philippines comprised a social marketing campaign and DMPA introduction at public clinics in 10 pilot areas with strong service delivery. Successful AIDS prevention programs show that people tend to use barrier methods when they are available. USAID is currently studying

Status of nuclear regulatory research and its future perspectives

International Nuclear Information System (INIS)

Lee, J. I.; Kim, W. S.; Kim, M. W.

1999-01-01

A comprehensive investigation of the regulatory research comprising an examination of the research system, its areas and contents, and the goals and financial resources is undertaken. As a result of this study, the future direction of regulatory research and its implementation strategies are suggested to resolve the current issues emerging from this examination. The major issues identified in the study are; (a) an insufficient investment in nuclear regulatory and safety research, (b) an interfacial discrepancy between similar research areas, and (c) a limitation of utilizing research results. To resolve these issues, several measures are proposed : (1) developing a lead project to establish a comprehensive infrastructure for enhancing research cooperation between nuclear organizations including institutes, industry, and universities, with an aim to improve cooperation between projects and to strengthen overall coordination functions among research projects, (2) introducing a certification system on research outcome to promote the proliferation of both research results themselves and their application with a view to enhancing the research quality, (3) strengthening the cooperative system to promote the international cooperative research, and (4) digitalizing all documents and materials relevant to safety and regulatory research to establish KIMS (knowledge and information based management system). It is expected that the aforementioned measures suggested in this study will enhance the efficiency and effectiveness of both nuclear regulatory and safety research, if they are implemented after deliberating with the government and related nuclear industries in the near future

Regulatory review of safety cases and safety assessments - associated challenges

International Nuclear Information System (INIS)

Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

2006-01-01

Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

Tritium : health risks, regulatory issues and the nuclear future

International Nuclear Information System (INIS)

Chambers, D. B.; Garva, A.

2010-10-01

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

Quality assurance within regulatory bodies

International Nuclear Information System (INIS)

1999-06-01

The IAEA directed extensive efforts during the years 1991 to 1995 to the integral revision of all NUSS quality assurance publications, which were approved and issued as Safety Series No.50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations (1996). When these quality assurance publications were developed, their prime focus was on requirements against which work performed by the licensees could be measured and assessed by the regulatory bodies. In this way, they only helped to facilitate the functions of regulators. No requirements or recommendations were provided on how the regulators should ensure the effective implementation of their own activities. The present publication is a first attempt to collect, integrate and offer available experience to directly support performance of regulatory activities. It presents a comprehensive compilation on the application of quality assurance principles and methods by regulatory bodies to their activities. The aim is consistent good performance of regulatory activities through a systematic approach

Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

Science.gov (United States)

Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan

2014-12-01

Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.

Environmental qualification and functional issues for microprocessor-based reactor protection systems

International Nuclear Information System (INIS)

Korsah, K.; Kisner, R.; Wood, R.T.; Antonescu, C.

1992-01-01

Issues of obsolescence and lack of intrastructural support in (analog) spare parts, coupled with the potential benefits of digital systems, are driving the nuclear industry to retrofit analog instrumentation and control (I ampersand C) systems with digital and microprocessor-based systems. This movement away from analog can be expected to increase in advanced light-water reactors (ALWRs), which will make extensive use of fiber optic transmission, multiplexing techniques, and microprocessor-based technology. Although these technologies have several advantages and, in fact, have been in widespread use in the non-nuclear industry for several years, their application to safety-related systems in nuclear power plants raises key issues relating to the systems' environmental and functional reliability. For example, does the new hardware introduce additional system aging degradation mechanisms that could adversely impact the safety of the plant? Do the systems introduce the possibility of new and different malfunction scenarios or increase the probability of common-mode failures that could reduce the reliability of the safety system?. Are current environmental qualification standards adequate for microprocessor-based I ampersand C systems? Accordingly in 1991 the Nuclear Regulatory Commission (NRC) initiated the qualification of advanced Instrumentation and Control Systems program at ORNL to investigate issues that may arise with the use of advanced digital I ampersand C in ALWRs. The results of our studies to date are summarized in this paper

Performance-Based (Risk-Informed) Regulation: A Regulatory Perspective

International Nuclear Information System (INIS)

Kadambi, N. Prasad

2005-01-01

Performance-based regulation (PBR) has been mandated at the national level in the United States and at the agency level, where appropriate, at the U.S. Nuclear Regulatory Commission (USNRC). Guidance has been developed that implements the USNRC's definitions of PBR and other such conceptual regulatory improvements. This paper describes why PBR is important, what constitutes PBR in the context of direction provided at the USNRC, and how PBR can be implemented using a five-step process. The process steps articulate questions to be posed by the analyst regarding various aspects of a regulatory issue so that a suitably performance-based resolution can be developed. A regulatory alternative thus developed can be included among other options to be considered as part of the regulatory decision-making process

76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

Science.gov (United States)

2011-01-04

... guidance, including memoranda and letters, may no longer be relied upon to the extent they are inconsistent... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the...

Regulatory Risk Management of Advanced Nuclear Power Plants

International Nuclear Information System (INIS)

George, Glenn R.

2002-01-01

Regulatory risk reflects both the likelihood of adverse outcomes during regulatory interactions and the severity of those outcomes. In the arena of advanced nuclear power plant licensing and construction, such adverse outcomes may include, for example, required design changes and construction delays. These, in turn, could significantly affect the economics of the plant and the generation portfolio in which it will operate. In this paper, the author addresses these issues through the lens of risk management. The paper considers various tools and techniques of regulatory risk management, including design diversity and hedging strategies. The effectiveness of alternate approaches is weighed and recommendations are made in several regulatory contexts. (author)

Cost-benefit considerations in regulatory decision-making

International Nuclear Information System (INIS)

Harvie, J.D.

1996-01-01

The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost-benefit issues and work towards some consensus of opinion among stakeholders; a task force on the subject could be an appropriate starting point'. (author)

Safety research programs sponsored by Office of Nuclear Regulatory Research

International Nuclear Information System (INIS)

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

1989-07-01

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

Regulatory analysis technical evaluation handbook. Final report

International Nuclear Information System (INIS)

1997-01-01

The purpose of this Handbook is to provide guidance to the regulatory analyst to promote preparation of quality regulatory analysis documents and to implement the policies of the Regulatory Analysis Guidelines of the US Nuclear Regulatory Commission (NUREG/BR-0058 Rev. 2). This Handbook expands upon policy concepts included in the NRC Guidelines and translates the six steps in preparing regulatory analyses into implementable methodologies for the analyst. It provides standardized methods of preparation and presentation of regulatory analyses, with the inclusion of input that will satisfy all backfit requirements and requirements of NRC's Committee to Review Generic Requirements. Information on the objectives of the safety goal evaluation process and potential data sources for preparing a safety goal evaluation is also included. Consistent application of the methods provided here will result in more directly comparable analyses, thus aiding decision-makers in evaluating and comparing various regulatory actions. The handbook is being issued in loose-leaf format to facilitate revisions. NRC intends to periodically revise the handbook as new and improved guidance, data, and methods become available

Education for the Creative Cities: Awareness Raising on Urban Challenges and Biocultural Preservation

Science.gov (United States)

Mammadova, Aida

2018-01-01

Creative Cities are facing the big challenges due to the demographical, environmental and economic issues. In this study we considered to create the educational fieldworks inside the creative city and raise the awareness in youth about the importance of the biocultural preservations to sustain the city's creativity and sustainability. Our…

Proceedings of the specialists' meeting on regulatory inspection practices in nuclear power plants

International Nuclear Information System (INIS)

1977-01-01

The sessions and contributions of this conference are dealing with: the general problems of regulatory inspection of nuclear power plants and overall national practices (in Canada, France, Germany, Italy, Spain, the United States), specific problems and practical experience of regulatory inspection during site study, evaluation, design, manufacturing and construction of nuclear plants (in Finland, Germany, Spain, Sweden, Great-Britain, United States), quality insurance issues, pressure component regulations, specific problems and practical experience of regulatory inspection during commissioning (in Spain, Sweden, Great-Britain and United States), specific problems and practical experience of regulatory inspection during operation (in Spain, Great-Britain, Unites States, Italy and Sweden), special aspects of regulatory inspection (notably public information issues in Sweden and in Great-Britain, inspection of nuclear fuel transportation in Spain, enforcement programme in the USA)

Ethical issues in cancer screening and prevention.

Science.gov (United States)

Plutynski, Anya

2012-06-01

November 2009's announcement of the USPSTF's recommendations for screening for breast cancer raised a firestorm of objections. Chief among them were that the panel had insufficiently valued patients' lives or allowed cost considerations to influence recommendations. The publicity about the recommendations, however, often either simplified the actual content of the recommendations or bypassed significant methodological issues, which a philosophical examination of both the science behind screening recommendations and their import reveals. In this article, I discuss two of the leading ethical considerations at issue in screening recommendations: respect for patient autonomy and beneficence and then turn to the most significant methodological issues raised by cancer screening: the potential biases that may infect a trial of screening effectiveness, the problem of base rates in communicating risk, and the trade-offs involved in a judgment of screening effectiveness. These issues reach more broadly, into the use of "evidence-based" medicine generally, and have important implications for informed consent.

Categorization and selection of regulatory approaches for nuclear power plants

International Nuclear Information System (INIS)

Sugaya, Junko; Harayama, Yuko

2009-01-01

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

Towards a single European electricity market. A structured approach to regulatory mode decision-making

International Nuclear Information System (INIS)

De Jong, H.M.

2009-01-01

This study focuses on the processes through which the rules and regulations that govern European electricity markets - and inherently, their integration process - are established. So far, European policy makers have largely followed a 'trial-and-error' approach to finding an appropriate regulatory mode (process) for dealing effectively with market integration issues. This unstructured approach to regulatory mode selection leads to several problems: - Today's trial-and-error strategy of shifting from one regulatory mode to another is time-consuming. - In the regulatory mode selection process, certain key principles of good governance are insufficiently considered. - European regulatory processes are experienced as vague, intransparent, and illegitimate by 'outside' stakeholders. This study develops a 'structured approach to regulatory mode decision-making' (STARMODE) based on the theory of decision modelling in policy management and a case study exploring three key market integration issues in the field of electricity markets: interconnector investment, congestion management and market transparency. The main objective is to present a systematic and comprehensive framework for analysing and improving regulatory mode decision-making in the context of the European Union, focusing on electricity market integration. The STARMODE approach is generally applicable to (and relevant for) European market integration issues in industries characterized by a natural monopoly and/or an essential service. The approach may also contribute to national regulatory mode decision-making and multi-state decision-making in other continents.

Raising environmental awareness through applied biochemistry laboratory experiments.

Science.gov (United States)

Salman Ashraf, S

2013-01-01

Our environment is under constant pressure and threat from various sources of pollution. Science students, in particular chemistry students, must not only be made aware of these issues, but also be taught that chemistry (and science) can provide solutions to such real-life issues. To this end, a newly developed biochemistry laboratory experiment is described that guides students to learn about the applicability of peroxidase enzymes to degrade organic dyes (as model pollutants) in simulated waste water. In addition to showing how enzymes can potentially be used for waste water remediation, various factors than can affect enzyme-based reactions such as pH, temperature, concentration of substrates/enzymes, and denaturants can also be tested. This "applied biotechnology" experiment was successfully implemented in an undergraduate biochemistry laboratory course to enhance students' learning of environmental issues as well important biochemistry concepts. Student survey confirmed that this laboratory experiment was successful in achieving the objectives of raising environmental awareness in students and illustrating the usefulness of chemistry in solving real-life problems. This experiment can be easily adopted in an introductory biochemistry laboratory course and taught as an inquiry-guided exercise. © 2013 by The International Union of Biochemistry and Molecular Biology.

Participatory workplace wellness programs: reward, penalty, and regulatory conflict.

Science.gov (United States)

Pomeranz, Jennifer L

2015-06-01

POLICY POINTS: Workplace wellness programs that provide incentives for completing a health risk assessment are a form of participatory programs. There are legal and ethical concerns when employers assess penalties for not completing a health risk assessment, raising questions about the voluntariness of such a program. The Departments of Treasury, Labor, and Health and Human Services' 2013 regulations for participatory programs and employers' current practices conflict with the Equal Employment Opportunity Commission's prevailing interpretation of the Americans with Disabilities Act of 1990. In keeping with the Patient Protection and Affordable Care Act, Congress revised the law related to workplace wellness programs. In June 2013, the Departments of Treasury, Labor, and Health and Human Services passed the final regulations, updating their 2006 regulatory framework. Participatory programs that reward the completion of a health risk assessment are now the most common type of wellness program in the United States. However, legal and ethical concerns emerge when employers utilize incentives that raise questions about the voluntariness of such programs. At issue is that under the Americans with Disabilities Act (ADA) of 1990, employers cannot require health-related inquiries and exams. To analyze the current interpretation of the ADA, I conducted research on both LexisNexis and federal agency websites. The resulting article evaluates the differences in the language of Congress's enabling legislation and the federal departments' regulations and how they may conflict with the ADA. It also reviews the federal government's authority to address both the legal conflict and ethical concerns related to nonvoluntary participatory programs. Employers' practices and the federal departments' regulations conflict with the current interpretation of the ADA by permitting employers to penalize employees who do not complete a health risk assessment. The departments' regulations may be

78 FR 61999 - Hydropower Regulatory Efficiency Act of 2013; Supplemental Notice of Workshop

Science.gov (United States)

2013-10-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD13-9-000] Hydropower Regulatory Efficiency Act of 2013; Supplemental Notice of Workshop As announced in the Notices issued on September 3, 2013 and September 18, 2013, the Federal Energy Regulatory Commission (FERC or Commission...

Math, Science, and Web-Based Activities to Raise Awareness about Nutrition and Obesity

Science.gov (United States)

Zuercher, Deborah K.

2011-01-01

The incidence of child obesity in the United States is increasing at an alarming rate. This article provides information about nutrition, obesity, and related health conditions and suggests some classroom activities to raise awareness about these issues and empower students to live healthier, more active lives. A list of recommended health-related…

Upgrading of regulatory activities in Belarus

International Nuclear Information System (INIS)

Rozdyalovskaya, L.F.; Shabanov, V.V.

1998-01-01

Upgrading of the National regulatory regime in the Republic of Belarus started in fact in 1992 after the Interregional Nuclear and Radiation Safety Inspectorate had been established in the Gostekhnadzor of Belarus. In this connection, the Gostekhnadzor was transformed into the Gospromatomnadzor - the State Committee for Supervision of Industrial and Nuclear Safety. In 1993, by special decrees issued by the Council of Ministers the Gospromatomnadzor was designated a National Competent Body responsible for nuclear materials. Now the Committee is part of the Ministry for Emergencies. In the Committee, the issues of nuclear and radiation safety are dealt with by 6 departments among which the Department for Nuclear and Radiation Safety Regulation and the Interregional Nuclear and Radiation Safety inspectorate play major role. The created regulatory structure makes it possible to fully perform the control of situation at nuclear- and radiation-hazardous facilities and take adequate measures aimed at strengthening their safety. The priority directions of regulatory work by the Promatomnadzor include development and revision of regulations governing radiation and nuclear safety and upgrading of the training procedure to enhance the radiation safety and technical knowledge of the Promatomnadzor staff. (author)

MicroRNAs as regulatory elements in psoriasis

Directory of Open Access Journals (Sweden)

Liu Yuan

2016-01-01

Full Text Available Psoriasis is a chronic, autoimmune, and complex genetic disorder that affects 23% of the European population. The symptoms of Psoriatic skin are inflammation, raised and scaly lesions. microRNA, which is short, nonprotein-coding, regulatory RNAs, plays critical roles in psoriasis. microRNA participates in nearly all biological processes, such as cell differentiation, development and metabolism. Recent researches reveal that multitudinous novel microRNAs have been identified in skin. Some of these substantial novel microRNAs play as a class of posttranscriptional gene regulator in skin disease, such as psoriasis. In order to insight into microRNAs biological functions and verify microRNAs biomarker, we review diverse references about characterization, profiling and subtype of microRNAs. Here we will share our opinions about how and which microRNAs are as regulatory in psoriasis.

A Review of International Telecommunications Industry Issues, Structure, and Regulatory Problems.

Science.gov (United States)

Cole, Jack E.; And Others

Industry structure studies prior to 1968 are briefly reviewed, and an overview of industrial and technological developments up to the present is provided through synopses of more recent studies. Areas covered include overseas telephone and record carriers; the creation of the Communications Satellite Corporation; the current regulatory and…

Regulatory and technical reports (abstract index journal): Annual compilation for 1987

International Nuclear Information System (INIS)

1988-03-01

This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission (NRC) Staff and its contractors. It is NRC's intention to publish this compilation quarterly and to cumulate it annually

Socioeconomic assessment: issues, status, and plans

International Nuclear Information System (INIS)

Boryczka, M.K.

1983-01-01

Numerous public meetings and hearings have been held in Texas, Mississippi, Louisiana and Utah on the issue of siting a nuclear waste repository in salt. Citizens in these potential site areas have raised many questions about how this facility will affect their quality of life. Questions about population and economic changes have been of particular concern. In developing a socioeconomic program, these issues and others have been an integral part of Battelle's socioeconomic studies. The three elements of Battelle's socioeconomic program are comprised of three elements: impact assessment, impact mitigation and community development, and impact monitoring. In addition, our approach to assessing socioeconomic impacts for the environmental assessment (EA) required by the Nuclear Waste Policy Act of 1982 are described. Since the EA analysis will address many of the issues raised in the site areas, these concerns will be elaborated on. Finally, various techniques for managing socioeconomic impacts will be presented. 6 references, 1 figure

Licensing issues

International Nuclear Information System (INIS)

Roberts, J.P.; Desell, L.J.; Birch, M.L.; Berkowitz, L.; Bader, J.F.

1992-01-01

To provide guidance for the Department of Energy's (DOE) Civilian Radioactive Waste Management Program, the Nuclear Regulatory Commission (NRC) has issued a draft regulatory guide on the Format and Content for the License Application for the High-Level Waste Repository (FCRG). To facilitate the development of the FCRG, NRC suggested that DOE use the draft guide as the basis for preparing an annotated outline for a license application. DOE is doing so using an iterative process called the Annotated Outline Initiative. DOE;s use of the Initiative will assist in achieving the desired incorporation of actual experience in the FCRG, contribute to the development of shared interpretation and understanding of NRC regulations, and provide other important programmatic benefits described in this paper

Decisions by regulatory agencies: are they evidence-based?

Directory of Open Access Journals (Sweden)

Furberg Curt D

2007-04-01

Full Text Available Abstract Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory decisions are evidence-based. For the selective COX-2 inhibitors, there are clear contraindications and warnings in Europe, but only a vaguely worded Black Box warning in the United States. All the non-selective agents are given an almost "clean bill of health" in Europe, while all of them are judged to have a similar risk-benefit ratio as celecoxib in the United States. The regulatory agencies have failed to recognize the clinical trial evidence that the risk of cardiovascular events varies substantially among the non-selective agents, with diclofenac carrying the highest risk of harm.

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

Institute of Scientific and Technical Information of China (English)

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

2015-01-01

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

Regulatory aspects of criticality control in Australia

International Nuclear Information System (INIS)

Zimin, Sergei

2003-01-01

With the creation of Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) the Australian approach to criticality safety was revisited. Consistency with international best practices is required by the Act that created ARPANSA and this was applied to practices in criticality safety adopted in other countries. This required extensive regulatory efforts both in auditing the major Australian Nuclear Operator, Australian Nuclear Science and Technology Organisation (ANSTO), and assessing the existing in Australia criticality safety practices and implementing the required changes using the new legislative power of ARPANSA. The adopted regulatory approach is formulated through both the issued by ARPANSA licenses for nuclear installations (including reactors, fuel stores and radioactive waste stores) and the string of new regulatory documents, including the Regulatory Assessment Principles and the Regulatory Assessment Guidelines for criticality safety. The main features of the adopted regulation include the requirements of independent peer-review, ongoing refresher training coupled with annual accreditation and the reliance on the safe design rather than on an administrative control. (author)

Organization of nuclear regulatory activities

International Nuclear Information System (INIS)

Blidaru, Valentin

2008-01-01

The paper presents the structure, missions and organizational aspects of the CNCAN, the National Commission for the control of nuclear activities in Romania. The paper addresses the following main issues: 1.General aspects; 2.Organizational structure of the NRA in Romania; 3.General description of the Division for Nuclear Safety Assessments; 4.Specific activities; 5.Regulatory approaches and practices. Under the title of 'General aspects' the following three basic statements are highlighted: 1.CNCAN is a governmental organization responsible for the development of the regulatory framework, the control of its implementation and the licensing of nuclear facilities; 2.CNCAN is the national authority competent in exercising the regulatory activity, authorization and control in the nuclear field provided by the law No. 111/ 1996 republished in 1998; 3.The Commission exercises its functions independently of the ministries and other authorities of the public control administration being subordinated to the Romanian Government. The organizational structure is as follows: - President, the Managerial Council and the Advisory Council coordinating the four General Divisions that are responsible for: - Nuclear Safety with Division of Nuclear Safety Assessment and Division of Nuclear Objectives Surveillance; - Radiological Safety with Division of Radiological Safety Assessment and Division of Operational Radiation Protection; - Surveillance of Environmental Radioactivity with Division of Assessment and Analysis and Division of National Network; - Development and Resource with the Division of Economy and Division of Human Resources. In addition under direct coordination of the President operate the Division of Radiation Protection, Transport and Radioactive Waste and the Division of International Cooperation and Communication. Specific activities are listed describing among others the issues of: - Safety of nuclear installation; - Evaluation relating to licensing of nuclear

Canadian and United States regulatory models compared: doses from atmospheric pathways

International Nuclear Information System (INIS)

Peterson, S-R.

1997-01-01

CANDU reactors sold offshore are licensed primarily to satisfy Canadian Regulations. For radioactive emissions during normal operation, the Canadian Standards Association's CAN/CSA-N288.1-M87 is used. This standard provides guidelines and methodologies for calculating a rate of radionuclide release that exposes a member of the public to the annual dose limit. To calculate doses from air concentrations, either CSA-N288.1 or the Regulatory Guide 1.109 of the United States Nuclear Regulatory Commission, which has already been used to license light-water reactors in these countries, may be used. When dose predictions from CSA-N288.1 are compared with those from the U.S. Regulatory Guides, the differences in projected doses raise questions about the predictions. This report explains differences between the two models for ingestion, inhalation, external and immersion doses

Holdup-related issues in safeguarding of nuclear materials

International Nuclear Information System (INIS)

Pillay, K.K.S.

1988-03-01

Residual inventories of special nuclear materials (SNM) remaining in processing facilities (holdup) are recognized as an insidious problem for both safety and safeguards. This paper identifies some of the issues that are of concern to the safeguards community at-large that are related to holdup of SNM in large-scale process equipment. These issues range from basic technologies of SNM production to changing regulatory requirements to meet the needs of safeguarding nuclear materials. Although there are no magic formulas to resolve these issues, there are several initiatives that could be taken in areas of facility design, plant operation, personnel training, SNM monitoring, and regulatory guidelines to minimize the problems of holdup and thereby improve both safety and safeguards at nuclear material processing plants. 8 refs

Present regulatory situation in South East European and Black Sea countries

International Nuclear Information System (INIS)

Brenow, K.

2000-01-01

Recently, after the energy reforms beginning, various regulatory models are either actually used or contemplated in the countries of Southeastern Europe and the Black Sea region. The 'models' are country-specific and five of them are described in this report. Certain common issues emerge specific to these countries can be grouped in three categories. The first category, called 'framework issues', includes the policy issues that determine the context in which the regulator will have to evolve. The second category, called 'regulatory issues proper', includes licensing, setting of prices, tariffs, transmission fees, establishment of codes for markets, grids and metering. The third category, called 'international issues', includes these issues requiring the international cooperation among regulators. The countries in Southeastern Europe and around the Black Sea have a long experience with regulation of grid-based energies and this experience should be adapted to the market-oriented context bearing in mind the benefits of competition and of regional integration and markets

Interactions of severe accident research and regulatory positions (ISARRP)

International Nuclear Information System (INIS)

Sehgal, B.R.

2001-12-01

The work Programme of the ISARRP Project was divided into several work packages. The work was conducted in the form of presentations and discussions, held during several meetings whose character was that of workshops. Short reports were prepared by the partners assigned to each task. Work Package 1: Critical review of the SA phenomenological research. The objective of this work package was to consider the progress made world-wide in research on the resolution of the outstanding phenomenological issues posed by severe accidents. Work Package 2: Relevance of severe accident research to SAMG requirements and implementation. The objective of this work package was to relate the progress made in the resolution of the SA issues to the practical matter of what results are required or have been used for the management of severe accidents. Clearly, the SAMG is the most important avenue employed by the regulatory organizations to assure themselves of the safe (from public perspective) performance of a nuclear plant in a postulated severe accident event. Work Package 3: Relevance of severe accident research to PSA and the risk informed regulatory approach. The objectives of this work package is to relate the results obtained by the severe accident research to the requirements of a PSA and of the new trend of employing the risk informed approach in promulgating regulations. Clearly a PSA identifies vulnerabilities in the knowledge base, however, their importance is decidedly plant specific. Nevertheless the uncertainties in the phenomenology or in resolution of issues lead to uncertainties in the PSA conclusions and in the adoption of the risk informed approach. Work Package 4: Questionnaire and the evaluation of responses to the questions. The purpose of this work package is to solicit the views of the regulatory organizations towards the results of the SA research and the benefits they have derived from it in terms of regulatory actions, or in the confidence they have gained

Interactions of severe accident research and regulatory positions (ISARRP)

Energy Technology Data Exchange (ETDEWEB)

Sehgal, B.R. (comp.) [Royal Inst. of Tech., Stockholm (Sweden). Nuclear Power Safety

2001-12-01

The work Programme of the ISARRP Project was divided into several work packages. The work was conducted in the form of presentations and discussions, held during several meetings whose character was that of workshops. Short reports were prepared by the partners assigned to each task. Work Package 1: Critical review of the SA phenomenological research. The objective of this work package was to consider the progress made world-wide in research on the resolution of the outstanding phenomenological issues posed by severe accidents. Work Package 2: Relevance of severe accident research to SAMG requirements and implementation. The objective of this work package was to relate the progress made in the resolution of the SA issues to the practical matter of what results are required or have been used for the management of severe accidents. Clearly, the SAMG is the most important avenue employed by the regulatory organizations to assure themselves of the safe (from public perspective) performance of a nuclear plant in a postulated severe accident event. Work Package 3: Relevance of severe accident research to PSA and the risk informed regulatory approach. The objectives of this work package is to relate the results obtained by the severe accident research to the requirements of a PSA and of the new trend of employing the risk informed approach in promulgating regulations. Clearly a PSA identifies vulnerabilities in the knowledge base, however, their importance is decidedly plant specific. Nevertheless the uncertainties in the phenomenology or in resolution of issues lead to uncertainties in the PSA conclusions and in the adoption of the risk informed approach. Work Package 4: Questionnaire and the evaluation of responses to the questions. The purpose of this work package is to solicit the views of the regulatory organizations towards the results of the SA research and the benefits they have derived from it in terms of regulatory actions, or in the confidence they have gained

Establishment of regulatory framework for the development reactor licensing

International Nuclear Information System (INIS)

Jo, Jong C.; Yune, Young G.; Kim, Woong S.; Ahn, Sang K.; Kim, In G.; Kim, Hho J.

2003-01-01

With a trend that various types of advanced reactor designs are currently under development worldwide, the Korea Atomic Energy Research Institute has been developing an advanced reactor called ' System-integrated Modular Advanced Reactor (SMART)', which is a small sized integral type pressurized water reactor with a rated thermal power of 330 MW. To demonstrate the safety and the performance of the SMART reactor design, the SMART Research and Development Center has embarked to build a scaled-down pilot plant of SMART, called 'SMART-P' with a rated thermal power of 65 MW. In preparation for the forthcoming applications for both construction permit and operating license of SMART-P in the near future, the Korea Institute of Nuclear Safety is developing a new regulatory framework for licensing review of such a development reactor, which covers establishment of licensing process, identification and resolution of technical and safety issues, development of regulatory evaluation or verification-purpose computer codes and analytical methods, and establishment of design-specific, general design and operating criteria, regulations, and associated regulatory guides. This paper presents the current activities for establishing a regulatory framework for the licensing of a research and development reactor. Discussions are made on the SMART-P development program, the current Korean regulatory framework for reactor licensing, the SMART-P licensing-related issues, and the approach and strategy for developing an effective regulatory framework for the SMART-P licensing

Structural evaluation of WIPP disposal room raised to clay seam G

International Nuclear Information System (INIS)

Park, Byoung Yoon; Holland, John F.

2007-01-01

An error was discovered in the ALGEBBRA script used to calculate the disturbed rock zone around the disposal room and the shear failure zone in the anhydrite layers in the original version. To correct the error, a memorandum of correction was submitted according to the Waste Isolation Pilot Plant (WIPP) Quality Assurance program. The recommended course of action was to correct the error, to repeat the post-process, and to rewrite Section 7.4, 7.5, 8, and Appendix B in the original report. The sections and appendix revised by the post-process using the corrected ALGEBRA scripts are provided in this revision. The original report summarizes a series of structural calculations that examine effects of raising the WIPP repository horizon from the original design level upward 2.43 meters. Calculations were then repeated for grid changes appropriate for the new horizon raised to Clay Seam G. Results are presented in three main areas: (1) Disposal room porosity, (2) Disturbed rock zone characteristics, and (3) Anhydrite marker bed failure. No change to the porosity surface for the compliance re-certification application is necessary to account for raising the repository horizon, because the new porosity surface is essentially identical. The disturbed rock zone evolution and devolution are charted in terms of a stress invariant criterion over the regulatory period. This model shows that the propagation of the DRZ into the surrounding rock salt does not penetrate through MB 139 in the case of both the original horizon and the raised room. Damaged salt would be expected to heal in nominally 150 years. The shear failure does not occur in either the upper or lower anhydrite layers at the moment of excavation, but appears above and below the middle of the pillar one day after the excavation. The damaged anhydrite is not expected to heal as the salt in the DRZ is expected to

Identity Management issues in Cloud Computing

OpenAIRE

Saini, Smita; Mann, Deep

2014-01-01

Cloud computing is providing a low cost on demand services to the users, omnipresent network,large storage capacity due to these features of cloud computing web applications are moving towards the cloud and due to this migration of the web application,cloud computing platform is raised many issues like privacy, security etc. Privacy issue are major concern for the cloud computing. Privacy is to preserve the sensitive information of the cloud consumer and the major issues to the privacy are un...

Legal and institutional issues

International Nuclear Information System (INIS)

Anon.

1991-01-01

Leaving aside the natural desire to avoid the difficulties imposed by the enormously complex siting and certification process, a utility might decide to forego adding new capacity because of a variety of legal and institutional disincentives. Some of these are discussed in this chapter. The addition of new lines to support a competitive generating market also raises unique institutional issues. Perhaps the most important of these is the question of who should pay for the necessary capital expenditures. This issue also is discussed in this section

Food control concept: Food safety/ingestion issues

International Nuclear Information System (INIS)

Armstrong, B.

1995-01-01

This talk outlines the issues in food safety/ingestion in the case of radiation accidents at nuclear power plants and how emergency preparedness plans can/should be tailored. The major topics are as follows: In Washington: food safety/ingestion issues exist at transition between response and regulatory worlds; agricultural concerns; customer concerns; Three Mile Island: detailed maps; development of response procedures; development of tools; legal issues

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

Regulatory governance of telecommunications liberalisation in Taiwan

International Nuclear Information System (INIS)

Cheng, Kuo-Tai; Hebenton, Bill

2008-01-01

This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

Regulatory governance of telecommunications liberalisation in Taiwan

Energy Technology Data Exchange (ETDEWEB)

Cheng, Kuo-Tai [Department of Regional Studies in Humanity and Social Sciences, National Hsin-Chu University of Education, No. 521 Nan-Da Road, Hsin-Chu 300 (China); Hebenton, Bill [School of Law, University of Manchester, M13 9PP (United Kingdom)

2008-12-15

This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

Unresolved safety issues summary: aqua book

International Nuclear Information System (INIS)

1982-06-01

The unresolved safety issues summary is designed to provide the management of the Nuclear Regulatory Commission with a quarterly overview of the progress and plans for completion of generic tasks addressing unresolved safety issues reported to Congress pursuant to Section 210 of the Energy Reorganization Act of 1974 as amended. This summary utilizes data collected from the Office of Nuclear Reactor Regulation, Office of Nuclear Regulatory Research, and the National Laboratories and is prepared by the Office of Resource Management. The schedules in this book include a milestone at the end of each action plan which represents the initiation of the implementation process both with respect to incorporation of the technical resolution in the NRC official guidance or requirements and also the application of changes to individual operating plants. The progress and status for implementation of unresolved safety issues for which a technical resolution has been completed are reported specifically in a separate table provided in this summary

Carbon Capture and Storage Legal and Regulatory Review. Edition 2

Energy Technology Data Exchange (ETDEWEB)

NONE

2011-07-01

The International Energy Agency (IEA) estimates that 100 carbon capture and storage (CCS) projects must be implemented by 2020 and over 3000 by 2050 if CCS is to fully contribute to the least-cost technology portfolio for CO2 mitigation. To help countries address the many legal and regulatory issues associated with such rapid deployment, the IEA launched the Carbon Capture and Storage Legal and Regulatory Review (CCS Review) in October 2010. The CCS Review gathers contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum that supports national-level CCS regulatory development. Each contribution provides a short summary of recent and anticipated developments and highlights a particular regulatory theme (such as financial contributions to long-term stewardship). To introduce each edition, the IEA provides a brief analysis of key advances and trends. Produced bi-annually, the CCS Review provides an up-to-date snapshot of global CCS regulatory developments. The theme for the second edition of the CCS Review, released in May 2011, is long-term liability for stored CO2. Other key issues addressed include: national progress towards implementation of the EU CCS Directive; developments in marine treaties relevant to CCS; international climate change negotiations; and the development process for CCS regulation.

NRC regulatory agenda. Seminnual progress report, January 1996--June 1996

International Nuclear Information System (INIS)

1996-08-01

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 rule making which have been received by the Commission and are pending disposition by the Commission. The regulatory Agenda is updated and issued semiannually

Brand names of Portuguese medication: understanding the importance of their linguistic structure and regulatory issues.

Science.gov (United States)

Pires, Carla; Vigário, Marina; Cavaco, Afonso

2015-08-01

Among other regulatory requirements, medicine brands should be composed of single names without abbreviations to prevent errors in prescription of medication. The purposes of the study were to investigate the compliance of a sam ple of Portuguese medicine brand names with Portuguese pharmaceutical regulations. This includes identifying their basic linguistic characteristics and comparing these features and their frequency of occurrence with benchmark values of the colloquial or informal language. A sample of 474 brand names was selected. Names were analyzed using manual (visual analyses) and computer methods (FreP - Frequency Patterns of Phonological Objects in Portuguese and MS word). A significant number of names (61.3%) failed to comply with the Portuguese phonologic system (related to the sound of words) and/or the spelling system (related to the written form of words) contained more than one word, comprised a high proportion of infrequent syllable types or stress patterns and included abbreviations. The results suggest that some of the brand names of Portuguese medication should be reevaluated, and that regulation on this issue should be enforced and updated, taking into consideration specific linguistic and spelling codes.

Regulatory and Non-regulatory Responses to Hydraulic Fracturing in Local Communities

Science.gov (United States)

Phartiyal, P.

2015-12-01

The practice of extracting oil and gas from tight rock formations using advances in technology, such as hydraulic fracturing and directional drilling, has expanded exponentially in states and localities across the country. As the scientific data collection and analysis catches up on the many potential impacts of this unconventional oil and gas development, communities are turning to their local officials to make decisions on whether and how fracking should proceed. While most regulatory authority on the issue rests with the state agencies, local officials have experimented with a wide range of regulatory, non-regulatory, and fiscal tools to manage the impacts of fracking. These impacts can occur on the local air, water, seismicity, soil, roads, schools, and affect residents, on-site workers, emergency and social services. Local officials' approaches are often influenced by their prior experience with minerals extraction in their localities. The speaker will present examples of the kinds of information sources, tools and approaches communities across the country are using, from noise barriers to setback requirements to information sharing in order to be able to balance the promise and perils of oil and gas development in their jurisdictions.

Human Factors Regulatory Research Program Plan, FY 1989--FY 1992

International Nuclear Information System (INIS)

Coffman, F.; Persensky, J.; Ryan, T.; Ramey-Smith, A.; Goodman, C.; Serig, D.; Trager, E; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC

1989-10-01

This report describes the currently ongoing (FY 1989) and planned (FY 1989-1992) Human Factors Regulatory Research Program in the NRC Office of Nuclear Regulatory Research (RES). Examples of the influence of human factors on nuclear safety are presented, and the role of personnel is discussed. Current regulatory issues associated with human factors in the nuclear system and the purpose of the research plan are provided. The report describes the research process applied to the human factors research issues and the program activities: Personnel Performance Measurement, Personnel Subsystem, Human-System Interface. Organization and Management, and Reliability Assessment. The research being conducted within each activity is summarized along with the objectives, background information, and expected regulatory products. Budget and personnel forecasts are provided along with a summary of contractors performing some of the ongoing research. Appendices contain a chronology of human factors research at NRC, a description of the research approach, an update on human factors programs and initiatives in RES and other NRC offices, and the integration among these programs. 46 refs., 5 tabs

Regulatory alerts for dietary supplements in Canada and the United States, 2005-13.

Science.gov (United States)

Abe, Andrew M; Hein, Darren J; Gregory, Philip J

2015-06-01

Dietary supplement regulatory alerts published by the Food and Drug Administration (FDA) and Health Canada were evaluated and characterized. FDA MedWatch and Health Canada websites were reviewed to identify regulatory alerts regarding dietary supplements from January 1, 2005, through December 31, 2013. Alerts were analyzed to identify product characteristics that may be predictive of product quality issues and potential patient harm. A total of 1560 dietary supplement-related regulatory alerts were identified. Of those, 1287 (83%) were identified through Health Canada, and 273 (18%) were identified through FDA MedWatch. The country of origin of dietary supplements associated with regulatory alerts was not provided in most regulatory alerts; however, when their origin was provided, the United States was the most common. Dietary supplements intended for sexual enhancement were the subject of 33% of all regulatory alerts identified. Products purchased online were the most likely to be associated with a regulatory alert. Dietary supplements intended for sexual enhancement, weight loss, and bodybuilding or athletic performance appeared to pose the greatest risk for patient harm due to product contamination with a pharmaceutical such as a phosphodiesterase-5 inhibitor or sibutramine. Analysis of Canadian and U.S. regulatory alerts concerning dietary supplements revealed that more than 80% of the composite alerts were issued by Health Canada. The most common intended uses of supplements for which alerts were issued were sexual enhancement, weight loss, and bodybuilding or athletic performance. The most common reason for alerts was the presence of a pharmaceutical contaminant. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Regulatory and biosafety issues in relation to transgenic animals in food and agriculture, feeds containing genetically modified organisms (GMO) and veterinary biologics

International Nuclear Information System (INIS)

Kochhar, H.P.S.; Gifford, G.A.; Kahn, S.

2005-01-01

Development of an effective regulatory system for genetically engineered animals and their products has been the subject of increasing discussion among researchers, industry and policy developers, as well as the public. Since transgenesis and cloning are relatively new scientific techniques, transgenic animals are new organisms for which there is limited information. The issues associated with the regulation and biosafety of transgenic animals pertain to environmental impact, human food safety, animal health and welfare, trade and ethics. To regulate this new and powerful technology predicated on limited background information is a challenge not only for the regulators, but also for the developers of such animals, who strive to prove that the animals are safe and merit bio-equivalency to their conventional counterparts. In principle, an effective regulatory sieve should permit safe products while forming a formidable barrier for those assessed of posing an unacceptable risk. Adoption of transgenic technology for use in agriculture will depend upon various factors that range from perceived benefits for humans and animals, to safe propagation, animal welfare considerations and integrity of species, as well as effects on bio-diversity. A regulatory framework designed to address the concerns connected with the environmental release of transgenic animals needs to also take into account the ability of genetically modified animals to survive and compete with conventional populations. Regulatory initiatives for biotechnology-derived animals and their products should ensure high standards for human and animal health; a sound scientific basis for evaluation; transparency and public involvement; and maintenance of genetic diversity. Feeds obtained by use of biotechnology have to be evaluated for animal and human safety by using parameters that define their molecular characterization, nutritional qualities and toxicological aspects, while veterinary biologics derived from

Issues related to geothermal development

International Nuclear Information System (INIS)

Lesperance, G.O.

1990-01-01

This paper reports on a number of potential barriers to geothermal development in Hawaii which have been overcome but some remain. Efforts continue to address issues relating to transmission, project economics, the regulatory process, resource verification, and public acceptance

Regulatory and technical reports: compilation for 1975-1978

International Nuclear Information System (INIS)

1982-04-01

This brief compilation lists formal reports issued by the US Nuclear Regulatory Commission in 1975 through 1978 that were not listed in the Regulatory and Technical Reports Compilation for 1975 to 1978, NUREG-0304, Vol. 3. This compilation is divided into two sections. The first consists of a sequential listing of all reports in report-number order. The second section consists of an index developed from keywords in report titles and abstracts

Meeting the regulatory information needs of users of radioactive materials

International Nuclear Information System (INIS)

MacDurmon, G.W.

1996-01-01

The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff

Meeting the regulatory information needs of users of radioactive materials

Energy Technology Data Exchange (ETDEWEB)

MacDurmon, G.W. [American Cyanamid Company, Princeton, NJ (United States)

1996-10-01

The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff.

Development of nuclear safety issues program

Energy Technology Data Exchange (ETDEWEB)

Cho, J. C.; Yoo, S. O.; Yoon, Y. K.; Kim, H. J.; Jeong, M. J.; Noh, K. W.; Kang, D. K

2006-12-15

The nuclear safety issues are defined as the cases which affect the design and operation safety of nuclear power plants and also require the resolution action. The nuclear safety issues program (NSIP) which deals with the overall procedural requirements for the nuclear safety issues management process is developed, in accordance with the request of the scientific resolution researches and the establishment/application of the nuclear safety issues management system for the nuclear power plants under design, construction or operation. The NSIP consists of the following 4 steps; - Step 1 : Collection of candidates for nuclear safety issues - Step 2 : Identification of nuclear safety issues - Step 3 : Categorization and resolution of nuclear safety issues - Step 4 : Implementation, verification and closure The NSIP will be applied to the management directives of KINS related to the nuclear safety issues. Through the identification of the nuclear safety issues which may be related to the potential for accident/incidents at operating nuclear power plants either directly or indirectly, followed by performance of regulatory researches to resolve the safety issues, it will be possible to prevent occurrence of accidents/incidents as well as to cope with unexpected accidents/incidents by analyzing the root causes timely and scientifically and by establishing the proper flow-up or remedied regulatory actions. Moreover, the identification and resolution of the safety issues related to the new nuclear power plants completed at the design stage are also expected to make the new reactor licensing reviews effective and efficient as well as to make the possibility of accidents/incidents occurrence minimize. Therefore, the NSIP developed in this study is expected to contribute for the enhancement of the safety of nuclear power plants.

Development of nuclear safety issues program

International Nuclear Information System (INIS)

Cho, J. C.; Yoo, S. O.; Yoon, Y. K.; Kim, H. J.; Jeong, M. J.; Noh, K. W.; Kang, D. K.

2006-12-01

The nuclear safety issues are defined as the cases which affect the design and operation safety of nuclear power plants and also require the resolution action. The nuclear safety issues program (NSIP) which deals with the overall procedural requirements for the nuclear safety issues management process is developed, in accordance with the request of the scientific resolution researches and the establishment/application of the nuclear safety issues management system for the nuclear power plants under design, construction or operation. The NSIP consists of the following 4 steps; - Step 1 : Collection of candidates for nuclear safety issues - Step 2 : Identification of nuclear safety issues - Step 3 : Categorization and resolution of nuclear safety issues - Step 4 : Implementation, verification and closure The NSIP will be applied to the management directives of KINS related to the nuclear safety issues. Through the identification of the nuclear safety issues which may be related to the potential for accident/incidents at operating nuclear power plants either directly or indirectly, followed by performance of regulatory researches to resolve the safety issues, it will be possible to prevent occurrence of accidents/incidents as well as to cope with unexpected accidents/incidents by analyzing the root causes timely and scientifically and by establishing the proper flow-up or remedied regulatory actions. Moreover, the identification and resolution of the safety issues related to the new nuclear power plants completed at the design stage are also expected to make the new reactor licensing reviews effective and efficient as well as to make the possibility of accidents/incidents occurrence minimize. Therefore, the NSIP developed in this study is expected to contribute for the enhancement of the safety of nuclear power plants

Some outstanding issues in severe accidents containment performance

International Nuclear Information System (INIS)

Sehgal, B.R.

2004-01-01

This paper describes the current status of the outstanding issues in severe accident performance of Light Water Reactor containments that have been raised in the last several years. The results of the research that has been performed on the topics concerning these issues will be described. Some of these issues have been resolved, some are close to resolution, while others need further evaluation and research results. (author)

Regulatory and institutional issues impending cleanup at US Department of Energy sites: Perspectives gained from an office of environmental restoration workshop

Energy Technology Data Exchange (ETDEWEB)

Fallon, W E; Gephart, J M; Gephart, R E; Quinn, R D; Stevenson, L A

1991-05-01

The US Department of Energy's (DOE) nuclear weapons and energy operations are conducted across a nation-wide industrial complex engaged in a variety of manufacturing, processing, testing, and research and development activities. The overall mission of DOE Office of Environmental Restoration and Waste Management (EM) is to protect workers, the public, and the environment from waste materials generated by past, current, and future DOE activities and to bring the DOE complex into compliance with all applicable laws, regulations, and agreements related to health, safety, and the environment. EM addresses this broad mandate through related and interdependent programs that include corrective actions, waste operations, environmental restoration, and technology development. The EM Office of Environmental Restoration (EM-40) recognizes the importance of implementing a complex-wide process to identify and resolve those issues that may impede progress towards site cleanup. As a first step in this process, FM-40 sponsored an exercise to identify and characterize major regulatory and institutional issues and to formulate integrated action steps towards their resolution. This report is the first product of that exercise. It is intended that the exercise described here will mark the beginning of an ongoing process of issue identification, tracking, and resolution that will benefit cleanup activities across the DOE complex.

Regulatory agencies and regulatory risk

OpenAIRE

Knieps, Günter; Weiß, Hans-Jörg

2008-01-01

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

Perspectives: Using Historical Documents To Think about NIF Issues.

Science.gov (United States)

National Archives and Records Service (GSA), Washington, DC.

The purpose of using historical documents in the classroom is to generate and enhance discussion by providing a historical perspective for issues. Five documents are included in this packet and are to be used as a supplemental material for the National Issues Forum (NIF) topics. Issues raised include (1) an analysis of the documents and (2)…

75 FR 63725 - Nuclear Energy Institute; Consideration of Petition in the Rulemaking Process

Science.gov (United States)

2010-10-18

... NUCLEAR REGULATORY COMMISSION 10 CFR Part 70 [Docket No. PRM-70-8; NRC-2009-0184] Nuclear Energy Institute; Consideration of Petition in the Rulemaking Process AGENCY: Nuclear Regulatory Commission. ACTION... Commission (NRC) will consider five of the issues raised in a petition submitted by the Nuclear Energy...

76 FR 46651 - Petition for Rulemaking Submitted by the California Association of Marriage and Family Therapists

Science.gov (United States)

2011-08-03

... NUCLEAR REGULATORY COMMISSION 10 CFR Part 26 [Docket No. PRM-26-4; NRC-2010-0269] Petition for Rulemaking Submitted by the California Association of Marriage and Family Therapists AGENCY: Nuclear... U.S. Nuclear Regulatory Commission (NRC) has decided to consider in a rulemaking the issues raised...

Regulatory affairs for biomaterials and medical devices

CERN Document Server

Amato, Stephen F; Amato, B

2015-01-01

All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller co

Unresolved safety issues summary. Aqua Book. Volume 6, No. 3

International Nuclear Information System (INIS)

Butts, J.

1984-01-01

The unresolved safety issues summary is designed to provide the management of the Nuclear Regulatory Commission with a quarterly overview of the progress and plans for completion of generic tasks addressing unresolved safety issues reported to Congress pursuant to Section 210 of the Energy Reorganization Act of 1974 as amended. This summary utilizes data collected from the Office of Nuclear Reactor Regulation, Office of Nuclear Regulatory Research, and the national laboratories and is prepared by the Office of Nuclear Reactor Regulation

Economic analysis requirements in support of orbital debris regulatory policy

Science.gov (United States)

Greenberg, Joel S.

1996-10-01

As the number of Earth orbiting objects increases so does the potential for generating orbital debris with the consequent increase in the likelihood of impacting and damaging operating satellites. Various debris remediation approaches are being considered that encompass both in-orbit and return-to-Earth schema and have varying degrees of operations, cost, international competitiveness, and safety implications. Because of the diversity of issues, concerns and long-term impacts, there is a clear need for the setting of government policies that will lead to an orderly abatement of the potential orbital debris hazards. These policies may require the establishment of a supportive regulatory regime. The Department of Transportation is likely to have regulatory responsibilities relating to orbital debris stemming from its charge to protect the public health and safety, safety of property, and national security interests and foreign policy interests of the United States. This paper describes DOT's potential regulatory role relating to orbital debris remediation, the myriad of issues concerning the need for establishing government policies relating to orbital debris remediation and their regulatory implications, the proposed technological solutions and their economic and safety implications. Particular emphasis is placed upon addressing cost-effectiveness and economic analyses as they relate to economic impact analysis in support of regulatory impact analysis.

More Proficient vs. Less Proficient EFL Learners’ Perceptions of Teachers ‘Motivation Raising Strategies

Directory of Open Access Journals (Sweden)

Nasrin Yousefi

2022-09-01

Full Text Available Motivation raising strategies are frequently used in English as a Foreign Language (EFL classes; nevertheless, learners’ perceptions of such strategies used by language teachers have not sufficiently been explored. Also, there are not enough studies on differences and similarities between more and less proficient EFL learners regarding this issue. To scrutinize this topic, a groups of more (No=50 and less proficient EFL learners (No=50 participated in this study by completing to a validated, researcher-made questionnaire with a five-point Likert type format. Non-parametric Mann-Whiteny U test was run in the SPSS ver. 23 to check the differences between the two groups. The results of the study verified that, regardless of each individual scale in the utilized questionnaire, overall, the more proficient ones manifested significantly less perceptions on teachers’ motivation raising strategies based on the total estimated mean ranks compared with the less proficient learners.  However, within the surveyed scales, only in the classroom atmosphere scale, the results showed that the less proficient learners were more mindful of teacher strategies for motivation raising. The findings from this study have implications for motivation raising strategy instructions for a language classroom.

Air cleaning issues with contaminated sites

Energy Technology Data Exchange (ETDEWEB)

Bellamy, R.R. [Nuclear Regulatory Commission, King of Prussia, PA (United States)

1997-08-01

The US Nuclear Regulatory Commission has developed a list of contaminated sites that warrant special USNRC attention because they pose unique or complex decommissioning issues. This list of radiologically contaminated sites is termed the Site Decommissioning Management Plan (SDMP), and was first issued in 1990. A site is placed on the SDMP list if it has; (1) Problems with the viability of the responsible organization (e.g., the licensee for the site is unable or unwilling to pay for the decommissioning); (2) Large amounts of soil contamination or unused settling ponds or burial grounds that may make the waste difficult to dispose of; (3) The long-term presence of contaminated, unused buildings; (4) A previously terminated license; or (5) Contaminated or potential contamination of the ground water from on-site wastes. In deciding whether to add a site to the SDMP list, the NRC also considers the projected length of time for decommissioning and the willingness of the responsible organization to complete the decommissioning in a timely manner. Since the list was established, 9 sites have been removed from the list, and the current SDMP list contains 47 sites in 11 states. The USNRC annually publishes NUREG-1444, {open_quotes}Site Decommissioning Management Plan{close_quotes}, which updates the status of each site. This paper will discuss the philosophical goals of the SDMP, then will concentrate on the regulatory requirements associated with air cleaning issues at the SDMP sites during characterization and remediation. Both effluent and worker protection issues will be discussed. For effluents, the source terms at sites will be characterized, and measurement techniques will be presented. Off-site dose impacts will be included. For worker protection issues, air sampling analyses will be presented in order to show how the workers are adequately protected and their doses measured to satisfy regulatory criteria during decontamination operations. 1 tab.

Carbon Capture and Storage Legal and Regulatory Review. Edition 3

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-01

The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA estimates that emissions can be reduced to a level consistent with a 2°C global temperature increase through the broad deployment of low-carbon energy technologies – and that CCS would contribute about one-fifth of emission reductions in this scenario. Achieving this level of deployment will require that regulatory frameworks – or rather a lack thereof – do not unnecessarily impede environmentally safe demonstration and deployment of CCS, so in October 2010 the IEA launched the IEA Carbon Capture and Storage Legal and Regulatory Review. The CCS Review is a regular review of CCS regulatory progress worldwide. Produced annually, it collates contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum to support CCS framework development. Each two page contribution provides a short summary of recent and anticipated CCS regulatory developments and highlights a particular, pre-nominated regulatory theme. To introduce each edition, the IEA provides a brief analysis of key advances and trends, based on the contributions submitted. The theme for this third edition is stakeholder engagement in the development of CO2 storage projects. Other issues addressed include: regulating CO2-EOR, CCS and CO2-EOR for storage; CCS incentive policy; key, substantive issues being addressed by jurisdictions taking steps to finalise CCS regulatory framework development; and CCS legal and regulatory developments in the context of the Clean Energy Ministerial Carbon Capture, Use and Storage Action Group.

29 CFR 780.123 - Raising of bees.

Science.gov (United States)

2010-07-01

... 29 Labor 3 2010-07-01 2010-07-01 false Raising of bees. 780.123 Section 780.123 Labor Regulations... Raising of Livestock, Bees, Fur-Bearing Animals, Or Poultry § 780.123 Raising of bees. The term “raising of * * * bees” refers to all of those activities customarily performed in connection with the...

State-of-art report on digital I and C system reliability issues for nuclear power plants

International Nuclear Information System (INIS)

Hwang, In Koo; Lee, Dong Gyoung; Cha, Kyung Ho; Kwon, Kee Choon; Wood, Richard T.

2000-01-01

As the instrumentation and control (Iand C) equipment suppliers tend to provide digital components rather than conventional analog type components for instrument and control systems of nuclear power plants(NPPs), it is unavoidable to adopt digital equipment for safety I and C systems as well as non-safety systems. However, the full introduction of digital equipment to I and C systems of nuclear power plants raises several concerns which have not been considered for conventional analog I and C systems. The two major examples of the issues of digital systems are electromagnetic compatibility (EMC) and software reliability. KAERI invited a technical expert, Dr. Richard T. Wood, from Oak Ridge National Laboratory (ORNL) in Unites States and held seminars to recognize the state-of-art of the above issues and to share the information on techniques dealing with the problems. Dr. Wood has been working on the development of EMC guidelines and technical basis in using digital equipment for safety systems in nuclear power plants on the sponsorship of US Nuclear Regulatory Commission (NRC). Being based on his statements and discussions during his visit, this report describes technical considerations and issues on digital safety I and C system application in NPPs, EMC methods, environmental effects vulnerable to digital components, reliability assurance methods, etc. (author)

Veterinary applications of ionising radiation HERCA Task Force on Veterinary Applications. Main results of the Questionnaire 'National regulatory requirements with regard to veterinary medical applications of ionising radiation' and conclusions of the TF

International Nuclear Information System (INIS)

Van Bladel, Lodewijk; Berlamont, Jolien; Michalczak, Herbert; Balogh, Lajos; Peremans, Kathelijne

2013-11-01

In the fall of 2012, the subject of radiation protection in veterinary medicine was raised during the meeting of the HERCA Board. Issues with regard to this subject had been brought to the attention of HERCA by the European College of Veterinary Diagnostic Imaging (ECVDI). In October 2012, the Board decided to charge a small Task Force (TF) to further explore the issues in this field. This TF drew up a questionnaire which looked at the general radiation protection regulatory requirements in veterinary medicine applications of ionizing radiation. The results of this study showed large differences in the requirements applicable in the HERCA member countries. The TF also noticed the increasing use of more complex imaging procedures and of different radio-therapeutic modalities, which may imply greater risks of exposure of humans to ionising radiation. These results were presented during the HERCA Board meeting in Berlin, Germany and on which the Board decided to establish a Working Group on veterinary applications of ionising radiations (WG Vet). The main results of the Questionnaire 'National regulatory requirements with regard to veterinary medicine applications of ionising radiation' is attached in Appendix

Materials and design bases issues in ASME Code Case N-47

International Nuclear Information System (INIS)

Huddleston, R.L.; Swindeman, R.W.

1993-04-01

A preliminary evaluation of the design bases (principally ASME Code Case N-47) was conducted for design and operation of reactors at elevated temperatures where the time-dependent effects of creep, creep-fatigue, and creep ratcheting are significant. Areas where Code rules or regulatory guides may be lacking or inadequate to ensure the operation over the expected life cycles for the next-generation advanced high-temperature reactor systems, with designs to be certified by the US Nuclear Regulatory Commission, have been identified as unresolved issues. Twenty-two unresolved issues were identified and brief scoping plans developed for resolving these issues

Live weight and body measurements of male and female native ducks raised in different raising systems

Directory of Open Access Journals (Sweden)

Kadir Önk

2018-05-01

Full Text Available ABSTRACT The purpose of this study was to determine live weight and body measurements of male and female native ducks raised in different raising systems. One hundred and twenty native ducks (60 males, 60 females were used in the study. The ducks were raised in deep litter floor and cage systems. Live weight and body values were measured every two weeks, until they were 56 days old. Three-parameter logistic regression and Gompertz model were used to determine growth model of male and female ducks. Interactions of time-raising system and time-sex were statistically significant in terms of live weight. At the end of eight weeks, live weights of ducks raised in deep litter floor were higher than ducks raised in cage system. In addition, live weights of male ducks were higher than female ducks. Consequently, deep litter floor is more appropriate for live weight in native ducks. Accuracy rate of Three-parameter Logistic and Gompertz models for estimation of growth in ducks was between 0.91-0.95 and similar results were obtained from both models. The Gompertz model is appropriate for the data structure of this study because it contains fewer iterations than the Three-Parameter Logistic model.

Recent NRC research activities addressing valve and pump issues

Energy Technology Data Exchange (ETDEWEB)

Morrison, D.L.

1996-12-01

The mission of the U.S. Nuclear Regulatory Commission (NRC) is to ensure the safe design, construction, and operation of commercial nuclear power plants and other facilities in the U.S.A. One of the main roles that the Office of Nuclear Regulatory Research (RES) plays in achieving the NRC mission is to plan, recommend, and implement research programs that address safety and technical issues deemed important by the NRC. The results of the research activities provide the bases for developing NRC positions or decisions on these issues. Also, RES performs confirmatory research for developing the basis to evaluate industry responses and positions on various regulatory requirements. This presentation summarizes some recent RES supported research activities that have addressed safety and technical issues related to valves and pumps. These activities include the efforts on determining valve and motor-operator responses under dynamic loads and pressure locking events, evaluation of monitoring equipment, and methods for detecting and trending aging of check valves and pumps. The role that RES is expected to play in future years to fulfill the NRC mission is also discussed.

Cooperation of Ukrainian regulatory authorities in the SIP

Energy Technology Data Exchange (ETDEWEB)

Kutina, L.; Bachner, D.; Bykov, V.; Erickson, L.; Kondralyev, S.; Redko, V.; Simonov, I.; Vasilchenko, V. [SSTC NRS, Stusa St. 35-37, 03142, Kyiv (Ukraine)

2003-07-01

The State Nuclear Regulatory Committee of Ukraine (SNRCU) supported by the State Scientific and Technical Center (SSTC) and the Licensing consultant (LC - RISKAUDIT/SCIENTECH) coordinates the activities of other regulatory authorities (RA) within the Shelter Implementation Plan (SIP) licensing. A protocol on cooperation and differentiation of competence in the SIP has been agreed between SNRCU and other RA (Ecology, Health, Construction, Occupational safety, Fire). The RA intended to carry out their activities such that SIP be implemented in the most efficient way by: - providing the Chernobyl NPP with a possibility to choose optimal variants for Shelter transformation; - minimizing required regulatory steps for SIP; - reviewing SIP documents at the initial stages of development of SIP designs; - providing consultative support by technical support organizations (TSO) on the SIP designs; - relating regulatory decisions on safety issues to the competence of the inspection at the Chernobyl NPP site. Coordination of regulatory activity and cooperation in safety areas are presented.

Space proliferation versus space-type dissemination: from semantic issues to political issues

International Nuclear Information System (INIS)

Gaillard-Sborowsky, Florence

2015-01-01

The space and ballistic capabilities relationships are regularly revisited in forums on international security, in particular about Iran and North Korea cases. The term 'space proliferation' is commonly used by analogy with nuclear proliferation. However, is this analogy relevant? Beyond the semantic aspects, this shift raises political issues that this paper will consider. The study of the assumptions regarding the analysis of nuclear and missile proliferation and their space counterparts will highlight some approximations and presuppositions, such as the amalgam between sounding rockets, launchers and missiles technologies, in order to suggest new thinking of these sensitive issues. (author)

Regulatory Activities for Licensee's Safety Culture

International Nuclear Information System (INIS)

Choi, Young Sung; Choi, Kwang Sik

2008-01-01

Weaknesses in safety culture have contributed to a number of incidents/accidents in the nuclear and other high hazard sectors worldwide in the past. These events have fostered an increasing awareness of the need for licensees to develop a strong safety culture to support successful and sustainable nuclear safety performance. Regulatory bodies are taking a growing interest in this issue, and several are actively working to develop and implement approaches to maintaining regulatory oversight of licensee safety culture. However, these approaches are not yet well-established, and it was considered prudent to share experiences and developing methodologies in order to disseminate good practices and avoid potential pitfalls. This paper presents the findings, conclusions and recommendations of international meetings and other countries' activities on safety culture and gives some suggestions for regulators to consider when planning regulatory oversight for licensee's safety culture

Ethical issues for librarians

Directory of Open Access Journals (Sweden)

Francisca Rasche

2005-04-01

Full Text Available It approaches the librarian ethics comprehending the Librarianship constitution from a systemic view. In this way, with the objective to raise issues to discuss professional ethics, it places the librarian in the work world and points approaches between exertion and relation context of the professionals themselves with the human rights and alteration ethics.

Regulatory aspects of the Leak Before Break application

International Nuclear Information System (INIS)

Korosec, D.; Vojvodic Tuma, J.

2000-01-01

In the present paper the Leak Before Break (LBB) methodology is described on the way, as it was evaluated in Slovenian Nuclear Safety Administration in the process of the nuclear power plant (NPP) Krsko modernization process. In the recent decade, reviewed regulatory position regarding elimination the dynamic effects of the postulated primary coolant pipe ruptures in some countries was issued. The basis for such new approach are research achievements on different areas of science like metallurgy, fracture mechanics, dynamic analysis and testing of materials. By this new regulatory position the utility has the possibility to adopt LBB concept, but has to fulfill at least general prerequisites, described in standard review plan, where the basic principles and objectives of the evaluation process are described. World wide practice shows that more intensive and detailed evaluation is necessary as it is described in the standard review plan. The concerns and requests raising during evaluation of the consequences of the adopted LBB concept have generally some common points comparing regulatory experience of different countries which have already accepted this methodology or are currently under the process of evaluation. But nevertheless every nuclear power plant is unique, comparing specific material properties, dynamic analysis assumptions, safety analyses performed etc. One of the most important areas in the LBB evaluation process is reliable primary piping material evaluation. Several generic material studies were performed and the applicability of these studies for the justification of LBB has to be carefully performed. Elimination of the double ended guillotine break from the safety analysis has very strong impact to the safety analysis results and finally to the structures, systems and components too. Nuclear safety administration has made a lot of effort to make its position on this methodology clear. The expertise of the authorized institutions is in such process

Regulatory and technical reports (abstract index journal)

International Nuclear Information System (INIS)

1994-03-01

This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission staff and its contractors. There are four types of reports included: staff reports, conference reports, contractor reports, and international agreement reports. In addition to the main citations with abstracts, the following are also included: Secondary report number index; Personal author index; Subject index; NRC originating organization indices for staff reports and international agreement reports; NRC contract sponsor index; Contractor index; International organization index; and Licensed facility index

Regulatory and technical reports compilation for 1980

International Nuclear Information System (INIS)

Oliu, W.E.; McKenzi, L.

1981-04-01

This compilation lists formal regulatory and technical reports and conference proceedings issued in 1980 by the US Nuclear Regulatory Commission. The compilation is divided into four major sections. The first major section consists of a sequential listing of all NRC reports in report-number order. The second major section of this compilation consists of a key-word index to report titles. The third major section contains an alphabetically arranged listing of contractor report numbers cross-referenced to their corresponding NRC report numbers. Finally, the fourth section is an errata supplement

Ethical and regulatory issues with conducting sexuality research with LGBT adolescents: a call to action for a scientifically informed approach.

Science.gov (United States)

Mustanski, Brian

2011-08-01

Lesbian, gay, bisexual, and transgender (LGBT) adolescents experience disparities in mental and sexual health. There is also a lack of research on this population relative to other adolescents, which limits our ability to effectively address these health disparities. Researchers may unfortunately avoid conducting research with this population because of anticipated or actual experiences with difficulties in obtaining IRB approval. A case example is provided to illustrate the ethical and regulatory issues related to research with LGBT adolescents. Relevant U.S. federal and local regulations related to research on sexual and mental health with adolescents is then reviewed. Data are presented demonstrating that requiring parental consent for LGBT youth under age 18 would likely alter study result. Data are also presented on participants' appraisals of the risks and discomforts associated with research participation. The provision of such empirical data on the risks of research participation is consistent with the goal of moving the IRB process of risk/benefit assessment from being entirely subjective to being evidence-based. Finally, recommendations are provided on how to approach these issues in IRB applications and investigators are called to help to build a corpus of scholarship that can advance empirical knowledge in this area.

Use Of Renewable Energy In The Electric Power Generation Sector In Mexico: Political, Regulatory, Economic And Technical Issues From 1965 To 2018

Energy Technology Data Exchange (ETDEWEB)

Elizalde-Baltierra, Alberto; Sasse, Diana; Zeferino-Abundis, Yolanda; Quiroz-Juarez, Carolina; Lopez-Satow, Edgar; Beltran-Mora, Hector; Crisostomo-Ramirez, David

2010-09-15

The aim of this work is to analyze the political, regulatory, economic and technical issues that have determined the use of primary energies for power generation in Mexico from 1965 to 2008, and its perspectives for the next 10 years, in particular the prospects of using renewable energies. In the 60's, hydro was the preferred source of energy to produce electricity for economical and technical reasons. Under the 'oil boom' in the 70s, transition to hydrocarbons resources (fuel oil) was progressive. As a result of implementing environmental policies, electricity has mainly been generated with natural gas since the early 2000.

Resolution of regulatory issues facing the DOE in situ vitrification program

International Nuclear Information System (INIS)

Corathers, L.A.

1992-03-01

In situ vitrification (ISV) is being developed by researchers at the Pacific Northwest Laboratory (PNL), Idaho National Engineering Laboratory (INEL), and Oak Ridge National Laboratory (ORNL) as a technology for remediating soils, underground storage tank residuals, and buried materials that have been contaminated with hazardous, radioactive, and mixed wastes (i.e., wastes containing both radioactive and hazardous wastes) at US Department of Energy (DOE) facilities. The goal of the DOE ISV technology development program (i.e., the ISV Integrated Program) is to ensure that ISV is a workable technology for environmental restoration applications for DOE and other agencies. A DOE complex-wide plan was prepared during Fiscal Year 1991 to coordinate all levels of activities associated with the deployment of ISV. As part of this plan, a programmatic regulatory strategy was developed which focused on the federal environmental, health, safety, and nuclear regulations, including the US Environmental Protection Agency (EPA) and DOE regulations, believed to have the most significant near-term impact on the use of ISV as a remediation technology. The portion of the programmatic regulatory strategy addressing compliance with the Comprehensive Environmental Response, Compensation and Liability Act, as amended, and the Resource Conservation and Recovery Act, as amended, is presented in this paper

The roles of antitrust law and regulatory oversight in the restructured electricity industry

Energy Technology Data Exchange (ETDEWEB)

Glazer, C.A.; Little, M.B.

1999-05-01

The introduction of retail wheeling is changing the roles of regulators and the courts. When states unbundle the vertically integrated investor-owned utility (IOU) into generation companies, transmission companies, and distribution companies, antitrust enforcement and policy setting by the state public utility/service commissions (PUCs) will be paramount. As was seen in the deregulation of the airline industry, vigorous enforcement of antitrust laws by the courts and proper policy setting by the regulators are the keys to a successful competitive market. Many of the problems raised in the airline deregulation movement came about due to laxity in correcting clear antitrust violations and anti-competitive conditions before they caused damage to the market. As retail wheeling rolls out, it is critical for state PUCs to become attuned to these issues and, most of all, to have staff trained in these disciplines. The advent of retail wheeling changes the application of the State Action Doctrine and, in turn, may dramatically alter the role of the state PUC--meaning antitrust law and regulatory oversight must step in to protect competitors and consumers from monopolistic abuse.

Regulatory control of maintenance activities in Argentine nuclear power plants

International Nuclear Information System (INIS)

Calvo, J.C.; Caruso, G.

2000-01-01

The main maintenance objective is to assure that the safety features of structures, components and systems of nuclear power plants are kept as designed. Therefore, there is a direct relationship between safety and maintenance. Owing to the above mentioned, maintenance activities are considered a relevant regulatory issue for the Argentine Nuclear Regulatory Authority (ARN). This paper describes the regulatory control to maintenance activities of Argentine nuclear power plants. It also addresses essential elements for maintenance control, routine inspections, special inspections during planned outages, audits and license conditions and requirements. (author)

Can the EVIDEM Framework Tackle Issues Raised by Evaluating Treatments for Rare Diseases: Analysis of Issues and Policies, and Context-Specific Adaptation.

Science.gov (United States)

Wagner, Monika; Khoury, Hanane; Willet, Jacob; Rindress, Donna; Goetghebeur, Mireille

2016-03-01

The multiplicity of issues, including uncertainty and ethical dilemmas, and policies involved in appraising interventions for rare diseases suggests that multicriteria decision analysis (MCDA) based on a holistic definition of value is uniquely suited for this purpose. The objective of this study was to analyze and further develop a comprehensive MCDA framework (EVIDEM) to address rare disease issues and policies, while maintaining its applicability across disease areas. Specific issues and policies for rare diseases were identified through literature review. Ethical and methodological foundations of the EVIDEM framework v3.0 were systematically analyzed from the perspective of these issues, and policies and modifications of the framework were performed accordingly to ensure their integration. Analysis showed that the framework integrates ethical dilemmas and issues inherent to appraising interventions for rare diseases but required further integration of specific aspects. Modification thus included the addition of subcriteria to further differentiate disease severity, disease-specific treatment outcomes, and economic consequences of interventions for rare diseases. Scoring scales were further developed to include negative scales for all comparative criteria. A methodology was established to incorporate context-specific population priorities and policies, such as those for rare diseases, into the quantitative part of the framework. This design allows making more explicit trade-offs between competing ethical positions of fairness (prioritization of those who are worst off), the goal of benefiting as many people as possible, the imperative to help, and wise use of knowledge and resources. It also allows addressing variability in institutional policies regarding prioritization of specific disease areas, in addition to existing uncertainty analysis available from EVIDEM. The adapted framework measures value in its widest sense, while being responsive to rare disease

The Tumorigenic Roles of the Cellular REDOX Regulatory Systems

Directory of Open Access Journals (Sweden)

Stéphanie Anaís Castaldo

2016-01-01

Full Text Available The cellular REDOX regulatory systems play a central role in maintaining REDOX homeostasis that is crucial for cell integrity, survival, and proliferation. To date, a substantial amount of data has demonstrated that cancer cells typically undergo increasing oxidative stress as the tumor develops, upregulating these important antioxidant systems in order to survive, proliferate, and metastasize under these extreme oxidative stress conditions. Since a large number of chemotherapeutic agents currently used in the clinic rely on the induction of ROS overload or change of ROS quality to kill the tumor, the cancer cell REDOX adaptation represents a significant obstacle to conventional chemotherapy. In this review we will first examine the different factors that contribute to the enhanced oxidative stress generally observed within the tumor microenvironment. We will then make a comprehensive assessment of the current literature regarding the main antioxidant proteins and systems that have been shown to be positively associated with tumor progression and chemoresistance. Finally we will make an analysis of commonly used chemotherapeutic drugs that induce ROS. The current knowledge of cancer cell REDOX adaptation raises the issue of developing novel and more effective therapies for these tumors that are usually resistant to conventional ROS inducing chemotherapy.

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

Regulatory and technical reports (abstract index journal): Annual compilation for 1996, Volume 21, No. 4

Energy Technology Data Exchange (ETDEWEB)

Sheehan, M.A.

1997-04-01

This compilation is the annual cumulation of bibliographic data and abstracts for the formal regulatory and technical reports issued by the U.S. Nuclear Regulatory Commission (NRC) Staff and its contractors.

Regulatory and technical reports (abstract index journal): Annual compilation for 1996, Volume 21, No. 4

International Nuclear Information System (INIS)

Sheehan, M.A.

1997-04-01

This compilation is the annual cumulation of bibliographic data and abstracts for the formal regulatory and technical reports issued by the U.S. Nuclear Regulatory Commission (NRC) Staff and its contractors

Vicarious liability and criminal prosecutions for regulatory offences.

Science.gov (United States)

Freckelton, Ian

2006-08-01

The parameters of vicarious liability of corporations for the conduct of their employees, especially in the context of provisions that criminalise breaches of regulatory provisions, are complex. The decision of Bell J in ABC Developmental Learning Centres Pty Ltd v Wallace [2006] VSC 171 raises starkly the potential unfairness of an approach which converts criminal liability of corporations too readily into absolute liability, irrespective of the absence of any form of proven culpability. The author queries whether fault should not be brought back in some form to constitute a determinant of criminal liability for corporations.

Policy and regulatory responses to dual practice in the health sector.

Science.gov (United States)

García-Prado, Ariadna; González, Paula

2007-12-01

Physician dual practice is a widespread phenomenon which has implications for the equity, efficiency and quality of health care provision. Central to the analysis of physician dual practice is the trade-off between its benefits and costs, as well as the convenience of regulating it to undermine its adverse consequences. In this paper, we study and analyze different governmental responses to this activity. We find that internationally, there are wide variations in how governments tackle this issue. While some governments fully prohibit this practice, others regulate or restrict dual job holding with different intensities and regulatory instruments. The measures implemented include limiting the income physicians can earn through dual job holding, offering work benefits to physicians in exchange for their working exclusively in the public sector, raising public salaries, and allowing physicians to perform private practice at public facilities. We present the pros and cons of each of these alternatives and show how the health care market and institutional arrangements are crucial for the design and implementation of each of these strategies. The paper also identifies the need for empirical evidence on the effect of different government strategies on dual practice.

Legal issues in cash balance pension plan conversions.

Science.gov (United States)

Forman, J B

2001-01-01

Replacing a traditional pension with a cash balance plan raises a number of complicated and unsettled legal issues, including the protection of accrued benefits, the rate of benefit accrual, age discrimination and notice requirements. This article discusses those issues and concludes that routine conversions to cash balance plans appear to be legal both currently and into the foreseeable future.

Comparative regulatory approaches for groups of new plant breeding techniques.

Science.gov (United States)

Lusser, Maria; Davies, Howard V

2013-06-25

This manuscript provides insights into ongoing debates on the regulatory issues surrounding groups of biotechnology-driven 'New Plant Breeding Techniques' (NPBTs). It presents the outcomes of preliminary discussions and in some cases the initial decisions taken by regulators in the following countries: Argentina, Australia, Canada, EU, Japan, South Africa and USA. In the light of these discussions we suggest in this manuscript a structured approach to make the evaluation more consistent and efficient. The issue appears to be complex as these groups of new technologies vary widely in both the technologies deployed and their impact on heritable changes in the plant genome. An added complication is that the legislation, definitions and regulatory approaches for biotechnology-derived crops differ significantly between these countries. There are therefore concerns that this situation will lead to non-harmonised regulatory approaches and asynchronous development and marketing of such crops resulting in trade disruptions. Copyright © 2013 Elsevier B.V. All rights reserved.

Deferred Tax Assests and Bank Regulatory Capital

NARCIS (Netherlands)

Gallemore, J.

2012-01-01

Abstract: In this study, I examine three issues: (1) whether the probability of bank failure is increasing in the proportion of regulatory capital composed of deferred tax assets (DTA), (2) whether market participants incorporate the increased failure risk associated with the DTA component of

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

Crisis, criticism, change: Regulatory reform in the wake of nuclear accidents

International Nuclear Information System (INIS)

Sexton, Kimberly A.; )

2015-01-01

Accidents are a forcing function for change in the nuclear industry. While these events can shed light on needed technical safety reforms, they can also shine a light on needed regulatory system reforms. The TEPCO Fukushima Daiichi nuclear power plant (NPP) accident in Japan is the most recent example of this phenomenon, but it is not the only one. In the wake of the three major accidents that have occurred in the nuclear power industry - Three Mile Island (TMI) in the United States; Chernobyl in Ukraine, in the former Soviet Union; and the Fukushima Daiichi NPP accident in Japan - a commission or committee of experts issued a report (or reports) with harsh criticism of the countries' regulatory system. And each of these accidents prompted changes in the respective regulatory systems. In looking at these responses, however, one must ask if this crisis, criticism, change approach is working and whether regulatory bodies around the world should instead undertake their own systematic reviews, un-prompted by crisis, to better ensure safety. This article will attempt to analyse the issue of regulatory reform in the wake of nuclear accidents by first providing a background in nuclear regulatory systems, looking to international and national legal frameworks. Next, the article will detail a cross-section of current regulatory systems around the world. Following that, the article will analyse the before and after of the regulatory systems in the United States, the Soviet Union and Japan in relation to the TMI, Chernobyl and Fukushima accidents. Finally, taking all this together, the article will address some of the international and national efforts to define exactly what makes a good regulator and provide conclusions on regulatory reform in the wake of nuclear accidents. (author)

Geochemical characteristics of peat from two raised bogs of Germany

Science.gov (United States)

Mezhibor, A. M.

2016-11-01

Peat has a wide range of applications in different spheres of human activity, and this is a reason for a comprehensive study. This research represents the results of an ICP-MS study of moss and peat samples from two raised bogs of Germany. Because of the wide use of sphagnum moss and peat, determining their geochemical characteristics is an important issue. According to the results obtained, we can resume that the moss samples from Germany are rich in Cu, As, Y, Zr, Nb, and REE. The geochemical composition of the bogs reflects the regional environmental features and anthropogenic influence.

Regulatory risk assessments: Is there a need to reduce uncertainty and enhance robustness?

Science.gov (United States)

Snodin, D J

2015-12-01

A critical evaluation of several recent regulatory risk assessments has been undertaken. These relate to propyl paraben (as a food additive, cosmetic ingredient or pharmaceutical excipient), cobalt (in terms of a safety-based limit for pharmaceuticals) and the cancer Threshold of Toxicological Concern as applied to food contaminants and pharmaceutical impurities. In all cases, a number of concerns can be raised regarding the reliability of the current assessments, some examples being absence of data audits, use of single-dose and/or non-good laboratory practice studies to determine safety metrics, use of a biased data set and questionable methodology and lack of consistency with precedents and regulatory guidance. Drawing on these findings, a set of recommendations is provided to reduce uncertainty and improve the quality and robustness of future regulatory risk assessments. © The Author(s) 2015.

Regulatory analysis for resolution of Unresolved Safety Issue A-46, seismic qualification of equipment in operating plants

International Nuclear Information System (INIS)

Chang, T.Y.; Anderson, N.R.

1987-02-01

The margin of safety provided in existing nuclear power plant equipment to resist seismically induced loads and perform required safety functions may vary considerably, because of significant changes in design criteria and methods for the seismic qualification of equipment over the years. Therefore, the seismic qualification of equipment in operating plants must be reassessed to determine whether requalification is necessary. The objective of technical studies performed under Task Action Plan A-46 was to establish an explicit set of guidelines and acceptance criteria to judge the adequacy of equipment under seismic loading at all operating plants, in lieu of requiring these plants to meet the criteria that are applied to new plants. This report presents the regulatory analysis for Unresolved Safety Issue (USI) A-46. It includes: Statement of the Problem; the Objective of USI A-46; a Summary of A-46 Tasks; a Proposed Implementation Procedure; a Value-Impact Analysis; Application of the Backfit Rule; 10 CFR 50.109; Implementation; and Operating Plants To Be Reviewed to USI A-46 Requirements

Raising Critical Issues in the Analysis of Gender and Science in Children's Literature

Science.gov (United States)

Martin, Sonya N.; Siry, Christina A.

2009-01-01

Trevor Owens' paper provides a critique of the role of gender and authority in selected children's books that presented biographies of Albert Einstein and Marie Curie. In the context of discussing Trevor's (2009) article about children's literature, this forum explores issues related to the (a) representation and construction of gender, science,…

Perfumed historic buildings: Issues of authenticity

Directory of Open Access Journals (Sweden)

Tošić Jovana

2016-01-01

Full Text Available Contemporary historical preservation practice includes olfactory preservation as an experimental method of architectural preservation. The implementation of manufactured scents in historic buildings raises important issues of authenticity. This paper focuses on three important issues in the relation between olfactory preservation and authenticity: the importance of phenomenology in memory evocation; the relative character of the authenticity concept; and the significance of social values in historic preservation. This requires a critical examination of charters, documents and theoretical interpretations which reflect a broader concept of authenticity. The paper discusses certain articles of the Venice Charter, the Nara Document on Authenticity, as well as the sense of smell in architectural experience through critical analysis of the theories of John Ruskin, Viollet-le-Duc, Roger Scruton and Juhani Pallasmaa and their concepts of authenticity. Authenticity issues are illustrated by the examples of olfactory preservation: olfactory reconstruction of Philip Johnson’s Glass House; interior restoration and olfactory reconstruction of the Arts Club in Mayfair, London; and the creation process of the perfume brand Arquiste, a meaningful example which relocates the olfactory reconstruction context. These critical analyses raise the question of scent in historic buildings as a value in itself.

Regulatory Expectations for Safety Culture

Energy Technology Data Exchange (ETDEWEB)

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

2014-05-15

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

Regulatory Expectations for Safety Culture

International Nuclear Information System (INIS)

Jung, Su Jin; Oh, Jang Jin; Choi, Young Sung

2014-01-01

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

Teaching Gender Issues in Storytelling and in the College Teaching Class.

Science.gov (United States)

Hanson, Trudy L.

An instructor, who teaches both graduate and undergraduate courses in storytelling, incorporates discussions of gender issues throughout the semester in various ways. In one course, class discussions are used to raise issues of the origin of Grimm's fairy tales and of story variants. Students are also encouraged to choose gender issues in…

Raising HDL cholesterol in women

Directory of Open Access Journals (Sweden)

Danny J Eapen

2009-11-01

Full Text Available Danny J Eapen1, Girish L Kalra1, Luay Rifai1, Christina A Eapen2, Nadya Merchant1, Bobby V Khan11Emory University School of Medicine, Atlanta, GA, USA; 2University of South Florida School of Medicine, Tampa, FL, USAAbstract: High-density lipoprotein cholesterol (HDL-C concentration is essential in the determination of coronary heart disease (CHD risk in women. This is especially true in the postmenopausal state, where lipid profiles and CHD risk mimic that of age-matched men. Thus, interventions designed to reduce CHD risk by raising HDL-C levels may have particular significance during the transition to menopause. This review discusses HDL-C-raising therapies and the role of HDL in the primary prevention of CHD in women. Lifestyle-based interventions such as dietary change, aerobic exercise regimens, and smoking cessation are initial steps that are effective in raising HDL-C, and available data suggest women respond similarly to men with these interventions. When combined with pharmacotherapy, the effects of these lifestyle alterations are further amplified. Though studies demonstrating gender-specific differences in therapy are limited, niacin continues to be the most effective agent in raising HDL-C levels, especially when used in combination with fibrate or statin therapy. Emerging treatments such as HDL mimetic therapy show much promise in further raising HDL-C levels and improving cardiovascular outcomes.Keywords: high-density lipoprotein, HDL, women, cholesterol, heart disease

Foreign and Foreign-Born Engineers in the United States: Infusing Talent, Raising Issues.

Science.gov (United States)

National Academy of Sciences - National Research Council, Washington, DC. Office of Scientific and Engineering Personnel.

Immigrants have provided a transfusion of new talent throughout U.S. history to support the nation's economic and cultural growth and development. The absorption of these successive groups of immigrants has often been accompanied by issues associated with their integration into the work force and society. In recent years, there has been a marked…

NRC Regulatory Agenda semiannual report, July--December 1995. Volume 14, No. 2

International Nuclear Information System (INIS)

1996-02-01

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 semianually

NRC regulatory agenda: Semiannual report, July--December 1996. Volume 15, Number 2

International Nuclear Information System (INIS)

1997-03-01

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 semiannually

Current status of herbal product: Regulatory overview

Science.gov (United States)

Sharma, Sanjay

2015-01-01

A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. PMID:26681886

Strengthening the regulatory control of consumer goods through international harmonization

International Nuclear Information System (INIS)

Yus Rusdian Akhmad

2013-01-01

The International Atomic Energy Agency (IAEA) is currently working on a recommendation in the form of guidelines for regulating consumer goods. Preparation of this document has a significant dimension of international issues, especially in terms of the application of the principles of justification and application of the concept of exemption. International harmonization among regulators ranging from the regional to the global level is a central issue and considering the complex issues that arise in addition to covering the scientific aspects also involve consideration of the legal aspects or values espoused by any State which may differ from one another. PERKA BAPETEN on consumer goods is still in the preparation stage so that the discussion of the material will be useful for improving the quality of the regulation in time. There is a significant gap of understanding to the related materials by the parties concerned (between local and international parties were among the local party). This paper intends to propose the understanding and views on radiation protection and regulatory control for consumer goods and hopely could contributed significantly to strengthening its regulatory control which is primarily through a reduction in the gap of understanding to the related concept that potentially multi perceptions and encourage stronger cooperation among regulatory bodies. (author)

Ethical issues in neuroscience.

Science.gov (United States)

Fuchs, Thomas

2006-11-01

The study gives an overview of ethical questions raised by the progress of neuroscience in identifying and intervening in neural correlates of the mind. Ethical problems resulting from brain research have induced the emergence of a new discipline termed neuroethics. Critical questions concern issues, such as prediction of disease, psychopharmacological enhancement of attention, memory or mood, and technologies such as psychosurgery, deep-brain stimulation or brain implants. Such techniques are capable of affecting the individual's sense of privacy, autonomy and identity. Moreover, reductionist interpretations of neuroscientific results challenge notions of free will, responsibility, personhood and the self which are essential for western culture and society. They may also gradually change psychiatric concepts of mental health and illness. These tendencies call for thorough, philosophically informed analyses of research findings and critical evaluation of their underlying conceptions of humans. Advances in neuroscience raise ethical, social and legal issues in relation to the human person and the brain. Potential benefits of applying neuroimaging, psychopharmacology and neurotechnology to mentally ill and healthy persons have to be carefully weighed against their potential harm. Questions concerning underlying concepts of humans should be actively dealt with by interdisciplinary and public debate.

Safety culture in regulatory expert organization : analysis result of survey for KINS employees

International Nuclear Information System (INIS)

Choi, G. S.; Choi, Y. S.

2003-01-01

Much has been discussed on safety culture of operating organizations, however, little has been done on that of regulatory organization. Current issues and activities related to nuclear safety culture at IAEA, OECD/NEA, etc. were investigated and relevant literatures were reviewed. Elements essential for safety culture of regulatory organization were proposed and survey questionnaire for employees of regulatory expert organization, KINS, was developed based on the elements proposed. The survey result was presented and its implications were discussed. Based on the result, elements of safety culture in regulatory organization were proposed. The result of this survey can be used in developing safety culture model of regulatory organization, measurement method and also promotion of safety culture in regulatory organization

Effect of generic issues program on improving safety

International Nuclear Information System (INIS)

Fard, M. R.; Kauffman, J. V.

2010-01-01

The U.S. Nuclear Regulatory Commission (NRC) identifies (by its assessment of plant operation) certain issues involving public health and safety, the common defense and security, or the environment that could affect multiple entities under NRC jurisdiction. The Generic Issues Program (GIP) addresses the resolution of these Generic Issues (GIs). The resolution of these issues may involve new or revised rules, new or revised guidance, or revised interpretation of rules or guidance that affect nuclear power plant licensees, nuclear material certificate holders, or holders of other regulatory approvals. U.S. NRC provides information related to the past and ongoing GIP activities to the general public by the use of three main resources, namely NUREG-0933, 'Resolution of Generic Safety Issues, ' Generic Issues Management Control System (GIMCS), and GIP public web page. GIP information resources provide information such as historical information on resolved GIs, current status of the open GIs, policy documents, program procedures, GIP annual and quarterly reports and the process to contact GIP and propose a GI This paper provides an overview of the GIP and several examples of safety improvements resulting from the resolution of GIs. In addition, the paper provides a brief discussion of a few recent GIs to illustrate how the program functions to improve safety. (authors)

Natural gas 1994: Issues and trends

International Nuclear Information System (INIS)

1994-07-01

This report provides an overview of the natural gas industry in 1993 and early 1994 (Chapter 1), focusing on the overall ability to deliver gas under the new regulatory mandates of Order 636. In addition, the report highlights a range of issues affecting the industry, including: restructuring under Order 636 (Chapter 2); adjustments in natural gas contracting (Chapter 3); increased use of underground storage (Chapter 4); effects of the new market on the financial performance of the industry (Chapter 5); continued impacts of major regulatory and legislative changes on the natural gas market (Appendix A)

Natural gas 1994: Issues and trends

Energy Technology Data Exchange (ETDEWEB)

1994-07-01

This report provides an overview of the natural gas industry in 1993 and early 1994 (Chapter 1), focusing on the overall ability to deliver gas under the new regulatory mandates of Order 636. In addition, the report highlights a range of issues affecting the industry, including: restructuring under Order 636 (Chapter 2); adjustments in natural gas contracting (Chapter 3); increased use of underground storage (Chapter 4); effects of the new market on the financial performance of the industry (Chapter 5); continued impacts of major regulatory and legislative changes on the natural gas market (Appendix A).

Nuclear regulatory communication with the public: 10 years of progress

International Nuclear Information System (INIS)

Gauvain, J.; Jorle, A.; Chanial, L.

2008-01-01

The NEA has an acknowledged role to assist its member countries in maintaining and developing, through international co-operation, the scientific, technological and legal bases required for a safe, environmentally friendly and economical use of nuclear energy. In this context, the NEA Committee on Nuclear Regulatory Activities (CNRA) provides a forum for senior representatives from nuclear regulatory bodies to exchange information and experience on nuclear regulatory policies and practices in NEA member countries and to review developments which could affect regulatory requirements. Public confidence in government and in risk management structures is important to all developed countries with an open society. The use of nuclear power in a democracy is built upon a certain trust in the political system and the national authorities. To foster and maintain such trust in a period of greater public scrutiny of nuclear activities, a number of nuclear regulatory organisations (NROs) initiated various processes to pro-actively inform the public about their supervision and control of nuclear activities, or when appropriate to involve the public in decision making. In 1998 the question was raised within the CNRA of whether public trust in the regulator might be very different from one country to another, and an activity was started among member countries to exchange experience and best practices and to learn lessons about NRO communication with their publics. Three workshops were organised by the NEA, and a Working Group on Public Communication of Nuclear Regulatory Organisations was set up in 2001. The activities and findings are summarised below. (author)

Learning gene regulatory networks from only positive and unlabeled data

Directory of Open Access Journals (Sweden)

Elkan Charles

2010-05-01

Full Text Available Abstract Background Recently, supervised learning methods have been exploited to reconstruct gene regulatory networks from gene expression data. The reconstruction of a network is modeled as a binary classification problem for each pair of genes. A statistical classifier is trained to recognize the relationships between the activation profiles of gene pairs. This approach has been proven to outperform previous unsupervised methods. However, the supervised approach raises open questions. In particular, although known regulatory connections can safely be assumed to be positive training examples, obtaining negative examples is not straightforward, because definite knowledge is typically not available that a given pair of genes do not interact. Results A recent advance in research on data mining is a method capable of learning a classifier from only positive and unlabeled examples, that does not need labeled negative examples. Applied to the reconstruction of gene regulatory networks, we show that this method significantly outperforms the current state of the art of machine learning methods. We assess the new method using both simulated and experimental data, and obtain major performance improvement. Conclusions Compared to unsupervised methods for gene network inference, supervised methods are potentially more accurate, but for training they need a complete set of known regulatory connections. A supervised method that can be trained using only positive and unlabeled data, as presented in this paper, is especially beneficial for the task of inferring gene regulatory networks, because only an incomplete set of known regulatory connections is available in public databases such as RegulonDB, TRRD, KEGG, Transfac, and IPA.

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)

PATHOGENESIS OF OPTIC DISC EDEMA IN RAISED INTRACRANIAL PRESSURE

Science.gov (United States)

Hayreh, Sohan Singh

2015-01-01

Optic disc edema in raised intracranial pressure was first described in 1853. Ever since, there has been a plethora of controversial hypotheses to explain its pathogenesis. I have explored the subject comprehensively by doing basic, experimental and clinical studies. My objective was to investigate the fundamentals of the subject, to test the validity of the previous theories, and finally, based on all these studies, to find a logical explanation for the pathogenesis. My studies included the following issues pertinent to the pathogenesis of optic disc edema in raised intracranial pressure: the anatomy and blood supply of the optic nerve, the roles of the sheath of the optic nerve, of the centripetal flow of fluids along the optic nerve, of compression of the central retinal vein, and of acute intracranial hypertension and its associated effects. I found that, contrary to some previous claims, an acute rise of intracranial pressure was not quickly followed by production of optic disc edema. Then, in rhesus monkeys, I produced experimentally chronic intracranial hypertension by slowly increasing in size space-occupying lesions, in different parts of the brain. Those produced raised cerebrospinal fluid pressure (CSFP) and optic disc edema, identical to those seen in patients with elevated CSFP. Having achieved that, I investigated various aspects of optic disc edema by ophthalmoscopy, stereoscopic color fundus photography and fluorescein fundus angiography, and light microscopic, electron microscopic, horseradish peroxidase and axoplasmic transport studies, and evaluated the effect of opening the sheath of the optic nerve on the optic disc edema. This latter study showed that opening the sheath resulted in resolution of optic disc edema on the side of the sheath fenestration, in spite of high intracranial CSFP, proving that a rise of CSFP in the sheath was the essential pre-requisite for the development of optic disc edema. I also investigated optic disc edema with

Creating a safety culture in the regulatory authority: The Cuban experience

International Nuclear Information System (INIS)

Ferro Fernandez, R.; Guillen Campos, A.

2002-01-01

The Cuban regulatory authority has been working during several years for the fostering and development of a high Safety Culture level in nuclear activities in the country. As starting point to achieve this objective the assessment of the Safety Culture level in the regulatory authority performance was considered an important issue. For this purpose a preliminary diagnosis was carried out by means of a national survey that allowed identifying some areas of the regulatory activity that required improvements in order to achieve a higher Safety Culture and to immediately implement appropriate actions. Two of the most important actions undertaken were: the statement of the regulatory authority Safety Policy which governs and determines the performance of this organization and its staff and also the implementation of a new interaction practice at top level between the regulatory authority and the utilities of the nuclear sector through the Annual Regulatory Conference. The present paper summarizes these two introduced practices into the Cuban regulatory activity. (author)

Raising the Titanic.

Science.gov (United States)

Baker, Romona

1990-01-01

Described is an activity in which groups of students investigate engineering principles by writing a feasibility study to raise the luxury liner, Titanic. The problem statement and directions, and suggestions for problem solutions are included. (CW)

Regulatory issues of natural gas distribution; Aspectos regulatorios acerca da distribuicao de gas natural

Energy Technology Data Exchange (ETDEWEB)

Leite, Fabio Augusto C.C.M.; Costa, Hirdan Katarina de M. [Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN (Brazil). Faculdade de Direito

2004-07-01

In these past few years, natural gas in Brazil has arised as one of the alternatives for the energetic crisis suffered by the country. Such situation was one of the motives for its expansion, rising, after that, the importance of the regulation of its distribution. The regulation of canalized natural gas distribution can be found in the Federal Constitution, after Constitutional Amendment n. 05/95, in the article n. 25, para. 2nd, which say that belongs to the Federal States the concession or direct exercise of canalized natural gas services, now clearly classified as a public service. In order of these events, its imperative the analysis of natural gas distribution's public service, because it belongs to the Federal States. According to this situation, the study of the new regulatory function of the Administration and the tracing of action for the regulatory state agencies are the main goals of this work. As so, the present research aims to focus the reflexes from the actual dimension of natural gas distribution, specially referring to its regulatory statements, the limitations of state agencies, the National Petroleum Agency and the market where distribution belongs, and particularly the open access of new agents. (author)

Raised fields in the Llanos de Moxos, Bolivia - description and analysis of their morphology

Science.gov (United States)

Rodrigues, Leonor; Lombardo, Umberto; Veit, Heinz

2014-05-01

The disturbance of Pre Columbian populations on Amazonian ecosystems is being actively debated. The traditional view of amazon being an untouched landscape because of its poor soils and harsh climate has been challenged and the extreme opposite idea of highly modified landscapes with complex societies is growing. Recent research has led to new impulses and issues requesting about the agricultural strategies people developed to survive in this climate. The Llanos de Moxos, situated in the Bolivian Lowlands in south-eastern Amazonia is one important region which was densely altered and where a great variety of earthworks can be found. One of the most impressive earth works are the raised fields, which are earth platforms for cultivation of differing shape and dimension that are elevated above the landscapes natural surface. In contrast to the "terra preta" formation where artefacts and amendments like charcoal and kitchen waste have been clearly identified, raised fields have shown to be artefact poor and studies up till now couldn't find any evidence of additional amendments which could have improved soil quality in the long term. As a result the function and productivity of raised fields is still not well understood and is being actively discussed. Detailed investigations on raised fields located in the indigenous community of Bermeo, in the vicinity of San Ignacio de Moxos provides data showing a novel explanation of the Pre-Columbian management of raised fields, and a chronological sequence of their utilization and abandonment. OSL dating has shown that the raised fields had been in use since as early as 600 AD. Comparison of Geochemistry with a reference profile, away from raised fields, showed that there is no evidence for manure amendments deriving from kitchen waste or animal residues suggesting a rather extensive use of those fields. Complementary the description of intern morphology and laboratory analysis of this raised fields, combined with radiocarbon

Issues and regulatory requirements for the connection of wind generation

Energy Technology Data Exchange (ETDEWEB)

Gimenez Alvarez, J.M. [National University of San Juan (Argentina)], E-mail: jgimenez@unsj.edu.ar; Gomez Targarona, J.C. [National University of Rio Cuarto, Cordoba (Argentina). Electric Power Systems Protection Institute (IPSEP)], E-mail: jcgomez@ing.unrc.edu.ar

2009-07-01

Pollution problems such as greenhouse effect as well as the high value and volatility of fuel prices have forced and accelerated the development and use of renewable energy sources. In this work a complete revision of wind generation is presented. In the first part a brief history of the wind energy developments is detailed. Next, some commentaries related to the present and future state are made. Then, a revision of the modern structures of wind generation is realized. In fourth place it is included a brief comparison between small and big size turbines. Then, different types of energy storage are mentioned. Finally regulatory aspects are discussed, respect to the treatment of the technical problems. (author)

Advanced alarm systems: Display and processing issues

Energy Technology Data Exchange (ETDEWEB)

O`Hara, J.M. [Brookhaven National Lab., Upton, NY (United States); Wachtel, J.; Perensky, J. [US Nuclear Regulatory Commission, Washington, DC (United States). Office of Nuclear Regulatory Research

1995-05-01

This paper describes a research program sponsored by the US Nuclear Regulatory Commission to address the human factors engineering (HFE) deficiencies associated with nuclear power plant alarm systems. The overall objective of the study is to develop HFE review guidance for alarm systems. In support of this objective, human performance issues needing additional research were identified. Among the important issues were alarm processing strategies and alarm display techniques. This paper will discuss these issues and briefly describe our current research plan to address them.

Ethical issues in irregular migration research

NARCIS (Netherlands)

Duvell, F.; Triandafyllidou, A.; Vollmer, B.

2008-01-01

This paper is concerned with the ethical issues arising for researchers engaged in the study of irregular migration. Irregular migration is by definition an elusive phenomenon as it takes place in violation of the law and at the margins of society. This very nature of the phenomenon raises important

RNA regulatory elements and polyadenylation in plants

Directory of Open Access Journals (Sweden)

Arthur G. Hunt

2012-01-01

Full Text Available Alternative poly(A site choice (also known as alternative polyadenylation, or APA has the potential to affect gene expression in qualitative and quantitative ways. Alternative polyadenylation may affect as many as 82% of all expressed genes in a plant. The consequences of APA include the generation of transcripts with differing 3’-UTRs (and thus differing potential regulatory potential and of transcripts with differing protein-coding potential. Genome-wide studies of possible APA suggest a linkage with pre-mRNA splicing, and indicate a coincidence of and perhaps cooperation between RNA regulatory elements that affect splicing efficiency and the recognition of novel intronic poly(A sites. These studies also raise the possibility of the existence of a novel class of polyadenylation-related cis elements that are distinct from the well-characterized plant polyadenylation signal. Many potential APA events, however, have not been associated with identifiable cis elements. The present state of the field reveals a broad scope of APA, and also numerous opportunities for research into mechanisms that govern both choice and regulation of poly(A sites in plants.

Regulatory Regime and its influence in the nuclear safety

International Nuclear Information System (INIS)

Laaksonen, J.

1999-01-01

A leading internationally agreed principle is that the prime responsibility for nuclear safety rests with each user of nuclear energy. A proper regulatory regime is needed to ensure that this responsibility is met. In the first place it provides a verification that all relevant safety issues are understood and taken into account in the practical measures by the users but it is equally important that the regulatory regime supports the users in their strive to achieve an adequate level of safety (author)

Application of a methodology to determine priorities for nuclear power plant safety issues

International Nuclear Information System (INIS)

Daling, P.M.

1988-01-01

The Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) is sponsoring a research program to determine priorities of nuclear power plant safety issues. A methodology has been developed at the Pacific Northwest Laboratory (PNL) to provide technical assistance in the development of risk and cost estimates for implementing resolutions to the safety issues. The information development methods are intended to provide the NRC with a consistent level of information for use in ranking the issues. The NRC uses this information, along with judgmental factors, to rank the issues for further consideration by the NRC staff. The primary purpose of the priority rankings are to assist in the allocation of resources to issues that have high potential for reducing public risk as well as to remove issues from further consideration that have little safety significance

Preliminary Consideration for the Development of Regulatory Level 2 PSA Model

International Nuclear Information System (INIS)

Lee, Chang-Ju

2006-01-01

In order to assess the validity of PSA (probabilistic safety assessment) results and to establish regulatory requirements for relevant safety issues most of the regulators want to develop an independent and convenient risk assessment model including Level 2 PSA area. As this model and framework should be implicitly independent on the licensee's PSA model, it has a primary objective directly for applying to the risk-informed regulatory affairs and for supporting those kinds of works. According this, the regulator can take an objective view for the uncertainty of risk information made by the licensee and keep up the capability and decision-making framework for overall risk assessment results. In addition, the regulatory model may be used to verify and validate the operational risk levels of all engineered safety features of nuclear power plants (NPPs). An issue for plant-specific application of safety goals was previously identified in the US NRC's risk-informed regulatory guidance development activities, and discussed in many Commission papers, e. g. SECY-97-287, which identifies the goal for large early release frequency (LERF). LERF defines a containment performance criteria derived from the quantitative health objectives. As we know, the LERF was chosen to assess risk significance in Regulatory Guide 1.174 (2002) again, which provides one measure of the performance of the containment barrier, and represents a surrogate for early health effects

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

Evaluating the effectiveness of a smoking warning label on raising patient awareness of smoking and bladder cancer.

Science.gov (United States)

Johnson, B; Abouassaly, R; Ghiculete, D; Stewart, R J

2013-08-01

We assessed the knowledge of patients with regard to the association between smoking and bladder cancer, and examined the impact of a novel smoking warning label on raising awareness of this issue. We conducted a prospective cross-sectional study involving patients who presented to urology and family practice clinics. A questionnaire was used to assess knowledge regarding the association between smoking and various diseases. Participants were also asked to evaluate a novel smoking warning label for bladder cancer. A total of 291 (97%) patients responded to the questionnaire including 143 (95.3%) at urology clinics and 148 (98.7%) at family practice clinics. Overall only 45.2% of respondents were aware of the association between smoking and bladder cancer compared to 97.4% who knew that there was an association between smoking and lung cancer. There were no significant differences in knowledge between those at urology and family practice clinics. After viewing the warning label, 58.1% of respondents stated that it had changed their opinion on smoking and bladder cancer, and 74.8% felt that this label would be an effective tool to raise awareness of the issue. Patients who changed their opinion had statistically significantly less initial knowledge about the association between smoking and bladder cancer (36.7% vs 57.5% for those who did not change their opinion, p Awareness of the link between smoking and bladder cancer remains low. The use of a smoking warning label may help raise awareness of this important public health issue. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Ethical issues when using social media for health outside professional relationships.

Science.gov (United States)

DeCamp, Matthew

2015-04-01

Social media have the potential to revolutionize health and healthcare, but fulfilling this potential requires attention to the ethical issues social media may raise. This article reviews the major ethical issues arising when social media are used for research, public health, mobile health applications, and global health. It focuses on social media use outside fiduciary relationships between healthcare professionals and patients. Emphasis is given to the potential of social media in these contexts, the ethical issues relatively unique to each, and where possible how existing ethical principles and frameworks could help navigate these issues. In some cases social media create the circumstance for particular ethical issues but also facilitate managing them, such as in informed consent for research. In other cases, disagreement exists about whether social media - despite their potential - should be used for certain purposes, such as in public health surveillance (where confidentiality represents a significant ethical concern). In still others, ethical uncertainty exists about how social media will affect ethical issues, such as inequality in global health. As social media technologies continue to develop, identifying and managing the ethical issues they raise will be critical to their success in improving health while preserving fundamental ethical values.

Setting priorities for non-regulatory animal health in Ireland: results from an expert Policy Delphi study and a farmer priority identification survey.

Science.gov (United States)

More, Simon J; McKenzie, Ken; O'Flaherty, Joe; Doherty, Michael L; Cromie, Andrew R; Magan, Mike J

2010-07-01

Agriculture is a very important contributor to the Irish economy. In Ireland, national animal health services have been a government, rather than an industry, responsibility. In 2009, Animal Health Ireland (AHI) was established to provide a partnership approach to national leadership of non-regulatory animal health issues (those not subject to national and/or EU regulation). The objectives of this study were to elicit opinion from experts and farmers about non-regulatory animal health issues facing Irish livestock industries, including prioritisation of animal health issues and identification of opportunities to maximise the effective use of AHI resources. The study was conducted with experts using Policy Delphi methodology over three rounds, and with farmers using a priority identification survey. Non-regulatory bovine diseases/conditions were prioritised by both experts and farmers based on impact and international competitiveness. For each high-priority disease/condition, experts were asked to provide an assessment based on cost, impact, international perception, impediment to international market access and current resource usage effectiveness. Further information was also sought from experts about resource allocation preferences, methods to improve education and coordination, and innovative measures to improve prevention and management. There was close agreement between responses from experts and dairy farmers: each gave highest priority to 3 diseases with a biosecurity risk (subsequently termed 'biosecure diseases') (bovine viral diarrhoea [BVD], infectious bovine rhinotracheitis [IBR], paratuberculosis) and 4 diseases/conditions generally without a biosecurity risk ('non-biosecure diseases/conditions') (fertility, udder health/milk quality, lameness, calf health). Beef farmers also prioritised parasitic conditions and weanling pneumonia. The adverse impact of biosecure diseases is currently considered relatively minor by experts, but would increase

The Choice between Rights-Preserving Issue Methods: Regulatory and Financial Aspects of Issuing Seasoned Equity in the UK

OpenAIRE

Korteweg, A.G.; Renneboog, L.D.R.

2002-01-01

This paper examines the choice between two rights-preserving issue methods of seasoned equity offers in the UK as well as the factors determining the offer price and stock market announcement reactions.Firstly, equity issues in the UK are underwritten for different reasons than in other countries.Only severely financially distressed companies choose not to underwrite their share offer. Second, the average announcement reaction to non-underwritten issues is much more negative than to underwrit...

77 FR 2556 - Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public...

Science.gov (United States)

2012-01-18

...] Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public Workshop... Administration (FDA), Office of Pediatric Therapeutics, is announcing a public workshop entitled ``Ethical and... provide a forum for careful consideration of scientific, ethical, and regulatory issues confronting FDA...

Regulatory and technical reports (abstract index journal). Annual compilation for 1984. Volume 9, No. 4

International Nuclear Information System (INIS)

1985-01-01

This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission (NRC) Staff and its contractors. It is NRC's intention to publish this compilation quarterly and to cumulate it annually

Regulatory approvals in a large multinational clinical trial: the ESPRIT experience.

Science.gov (United States)

McNay, Laura A; Tavel, Jorge A; Oseekey, Karen; McDermott, Cathy M; Mollerup, David; Bebchuk, Judith D

2002-02-01

While accepted as serving an important function to safeguard human subjects, the process of obtaining regulatory approvals to conduct clinical trials is generally regarded as cumbersome and time-consuming. For large multinational trials, U.S. federally sponsored human subject research abroad involves specific U.S. regulatory requirements, in addition to those of the host country, that act as further hurdles. These requirements may include obtaining an Assurance of Protection for Human Subjects from the Office of Human Research Protection of the U.S. Department of Health and Human Services, maintaining specific Ethics Committee/Institutional Review Board (EC/IRB) composition, and incorporating mandated elements in informed consents, all of which may differ from local policies and guidelines. Specific examples of issues that led to delays in regulatory approvals for sites participating in the multinational clinical trial entitled Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) are presented here. While the goal of these requirements is to protect the rights and welfare of human subjects, they may create substantial delays and engender resentment over the notion of lack of respect for individual country sovereignty. Substudies within ESPRIT have been undertaken to obtain feedback from EC/IRB chairpersons, site personnel responsible for processing the required assurances, ESPRIT investigators, and study participants regarding aspects of current U.S. regulatory requirements related to human subject protection and ethical issues in multinational research. The purpose of these substudies is to compare the attitudes and experiences across countries regarding important ethical issues associated with conducting ESPRIT. One objective of the substudies is to gather additional insight to the impact of U.S. regulatory processes. Another is to help to inform the debate about how to best maximize the rights and welfare of clinical trial

Workshop on rules for exemption from regulatory control: Proceedings

International Nuclear Information System (INIS)

1989-04-01

This conference report documents the proceedings of an International Workshop on the subject of exempting radiation sources and practices from regulatory control. The purpose of the workshop was to provide national regulatory authorities an opportunity to exchange information on their respective approaches and practices involving exemptions and to enhance international understanding and cooperation on the derivation and practical application of the underlying principles. In addition, input from the workshop was intended to assist the NRC in the development of a policy statement on this issue. The workshop was divided into five sessions. During the first four sessions, papers were presented which defined the relative terms and concepts, outlined the national situations and approaches to the establishment and development of exemption rules, identified and discussed the existing issues, and gave the status of the international guidelines on exemption rules. The fifth session was devoted to summarizing the workshop and identifying the areas of consensus, the outstanding issues and the areas for future work. Individual papers were processed separately for the data base

[Discussion on solutions to ethical issues of clinical researches in a real world].

Science.gov (United States)

Wang, Si-Cheng; Liu, Bao-Yan; Xiong, Ning-Ning; Xie, Qi; Zhang, Run-Shun; Zhou, Xue-Zhong; Qiao, Jie

2013-04-01

The paradigm of a real world study has become the frontiers of clinical researches, especially in the field of Chinese medicine, all over the world in recent years. In this paper, ethical issues which probably exist in real-world studies are raised and reviewed. Moreover, some preliminary solutions to these issues such as protecting subjects during the process of real-world studies and performing ethical review are raised based on recent years' practices to enhance the scientificity and ethical level of real-world studies.

78 FR 21015 - Noninsured Crop Disaster Assistance Program

Science.gov (United States)

2013-04-09

...), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), generally... leadership in each region on the rules. No issues about this rule were raised during that consultation. FSA...

Romania - NPP PLiM Between Regulatory Requirement / Oversight and Operator Safety / Financial Interest

International Nuclear Information System (INIS)

Goicea, Lucian

2012-01-01

Cernavoda Unit 1 PLiM started in the first third of its design life, to develop as regulatory requirements of the components of standards and programmes and to benefit by earlier implementation of the measures for achieving maximum operating life. CNCAN regulatory present approach on the utility PLiM combines the regulatory requirements on management system, ageing management provisions of periodic safety review, detailed technical requirements of ageing programmes and different techniques focusing only on safety issues. (author)

USNRC regulatory guidance for engineered safety feature air cleaning systems

International Nuclear Information System (INIS)

Bellamy, R.R.

1991-01-01

The need for clear, technically appropriate, and easily implementable guidance for the design, testing, and maintenance of nuclear air cleaning systems has long been recognized. Numerous industry consensus standards have been issued and revised over the last 30 years. Guidance has also been published by the US Nuclear Regulatory Commission in the form of regulations, regulatory guides, standard review plans, NUREG documents, and information notices. This paper will summarize the latest revisions to these documents and emphasize Regulatory Guide 1.52, Design, Testing, and Maintenance Criteria for Post-Accident Engineered-Safety-Feature Atmosphere Cleanup System Air Filtration and Adsorption Units of Light-Water-Cooled Nuclear Power Plants, which was last revised in 1978. The USNRC has undertaken a project to revise this regulatory guide, and the status of that revision is highlighted

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

Steam Generator tube integrity -- US Nuclear Regulatory Commission perspective

International Nuclear Information System (INIS)

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

1997-01-01

In the US, the current regulatory framework was developed in the 1970s when general wall thinning was the dominant degradation mechanism; and, as a result of changes in the forms of degradation being observed and improvements in inspection and tube repair technology, the regulatory framework needs to be updated. Operating experience indicates that the current U.S. requirements should be more stringent in some areas, while in other areas they are overly conservative. To date, this situation has been dealt with on a plant-specific basis in the US. However, the NRC staff is now developing a proposed steam generator rule as a generic framework for ensuring that the steam generator tubes are capable of performing their intended safety functions. This paper discusses the current U.S. regulatory framework for assuring steam generator (SG) tube integrity, the need to update this regulatory framework, the objectives of the new proposed rule, the US Nuclear Regulatory Commission (NRC) regulatory guide (RG) that will accompany the rule, how risk considerations affect the development of the new rule, and some outstanding issues relating to the rule that the NRC is still dealing with

Challenges and Enhancements to the Safety Culture of the Regulatory Body

International Nuclear Information System (INIS)

Niel, Jean-Christophe; Chevet, Pierre Franck; Sheron, Brian; Boyd, Michael; Carlsson, Lennart; Tiippana, Petteri; Burns, Stephen; Jamieson, Terry; Fuketa, Toyoshi; Rzentkowski, Greg; Weiss, Frank Peter; Le Guen, Bernard

2015-06-01

The workshop opened with presentations by both the NEA Director-General and the chair of the three committees directly involved with the safety culture of the regulatory body (SCRB). The opening session set the scene and gave an overview of the SCRB together with presentations and discussions on priorities and challenges. The main session focused on the principles of the SCRB, its implementation and the challenges and enhancements that are being raised and considered. The workshop concluded with a session that looked at findings and conclusions, the way forward and an agreed position on the SCRB. This document brings together the available presentations (slides) given at the workshop: 1 - Introduction: Challenges and Enhancements to the Safety Culture of the Regulatory Body (J-C. Niel); 2 - Thoughts on Safety Culture from a CSNI Perspective (B. Sheron); 3 - Radiological Protection Culture: CRPPH Work (M. Boyd); 4 - Challenges and Enhancements to Safety Culture of the Regulatory Body (L. Carlsson); 5 - Principles for the safety culture of the regulatory body (P. Tiippana); 6 - NRC's Internal Safety Culture: Successes, Challenges, and the Path Forward (S.G. Burns); 7 - Insights on the Canadian Nuclear Safety Commission's Safety Culture Journey (T. Jamieson); 8 - Lessons Learned from the Fukushima Dai-ichi Accident regarding Safety Culture of Regulatory Body (T. Fuketa); 9 - Challenges to Regulatory Bodies' safety culture (P-F. Chevet); 10 - Regulatory Safety Culture: International Perspective (G. Rzentkowski); 11 - Integration of Safety Research into Safety Culture Concepts (F-P. Weiss); 12 - Radiation Protection and Emergency Management Aspects: Culture drawn up by RP professionals (B. Le Guen); 13 - Closing session panel (L. Carlsson)

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

International Nuclear Information System (INIS)

Colvin, J.F.

1995-01-01

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

Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines.

Science.gov (United States)

Johnston, John D; Feldschreiber, Peter

2014-03-01

The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed. © 2013 The British Pharmacological Society.

Ethical Issues in Engineering Models : Personal Reflections

NARCIS (Netherlands)

Kleijnen, Jack P.C.

2010-01-01

I start this contribution with an overview of my personal involvement—as an Operations Research consultant—in several engineering case-studies that may raise ethical questions; these case studies employ simulation models. Next, I present an overview of the recent literature on ethical issues in

Health care technology as a policy issue

NARCIS (Netherlands)

Banta, H.D.

1994-01-01

Health care technology has become an increasingly visible issue in many countries, primarily because of the rising costs of health care. In addition, many questions concerning quality of care are being raised. Health care technology assessment has been seen as an aid in addressing questions

Regulatory Guidance for Lightning Protection in Nuclear Power Plants

International Nuclear Information System (INIS)

Kisner, Roger A.; Wilgen, John B.; Ewing, Paul D.; Korsah, Kofi; Antonescu, Christina E.

2006-01-01

Oak Ridge National Laboratory (ORNL) was engaged by the U.S. Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) to develop the technical basis for regulatory guidance to address design and implementation practices for lightning protection systems in nuclear power plants (NPPs). Lightning protection is becoming increasingly important with the advent of digital and low-voltage analog systems in NPPs. These systems have the potential to be more vulnerable than older analog systems to the resulting power surges and electromagnetic interference (EMI) when lightning strikes facilities or power lines. This paper discusses the technical basis for guidance to licensees and applicants covered in Regulatory Guide (RG) 1.204, Guidelines for Lightning Protection of Nuclear Power Plants, issued August 2005. RG 1.204 describes guidance for practices that are acceptable to the NRC staff for protecting nuclear power structures and systems from direct lightning strikes and the resulting secondary effects.

Issues And Concerns In The Presentation And Conception Of Commercial And Fine Art Holography

Science.gov (United States)

Cossette, Marie A.

1987-06-01

This paper will address the issues raised by the "commercialization" of holography that has taken place since the mid-1980's. The paper examines the range of these issues as they apply to the practise of fine-art holography, the author's area of expertise. The effect of mass-produced and readily available holograms on the public's perception of holographic art will be discussed in light of the presence of holographic images on credit cards and national magazine covers. A major portion of the paper will examine the specific issues raised by the commercialization and mass production of holographic art. These issues will centre on the professional, ethical and artistic implications of commercialized holography as they apply to the practice of fine art holography.

75 FR 82420 - Self-Regulatory Organizations, The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

Science.gov (United States)

2010-12-30

...). SPACs are companies that raise capital in an initial public offering (``IPO'') to enter into future undetermined business combinations through mergers, capital stock exchanges, asset acquisitions, stock... issue additional shares at the time of the business combination to raise capital.\\17\\ According to the...

South African Regulatory Framework for Nuclear Power Plant Life Management

International Nuclear Information System (INIS)

Mbebe, B.Z.

2012-01-01

The paper presents the regulatory approach to plant life management (PLiM) adopted by the National Nuclear Regulator (NNR) in South Africa, the licensing basis and regulatory requirements for Koeberg Nuclear Power Station (KNPS),operational programmes ensuring continued safe operation, issues related to the ageing of the plant, and the requirements for spent fuel as well as radioactive waste management. The paper will further present insights from the Periodic Safety Review (PSR) and Long Term Asset Management. (author)

Regulatory and technical reports (abstract index journal). Compilation for third quarter 1997, July--September

International Nuclear Information System (INIS)

Stevenson, L.L.

1998-01-01

This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission (NRC) Staff and its contractors. It is NRC's intention to publish this compilation quarterly and to cumulate it annually. This report contains the third quarter 1997 abstracts

Learning from Change: Issues and Experiences in Participatory ...

International Development Research Centre (IDRC) Digital Library (Canada)

Learning from Change provides an overview of the common themes and ... Read the e-book ... The third raises the key issues and challenges arising from the case studies and discussions, and proposes areas for future research and action.

Regulatory practices and safety standards for nuclear power plants

International Nuclear Information System (INIS)

1989-01-01

The International Symposium on Regulatory Practices and Safety Standards for Nuclear Power Plants was jointly organized by the International Atomic Energy Agency (IAEA), for Nuclear Energy Agency of the OECD and the Government of the Federal Republic of Germany with the objective of providing an international forum for the exchange of information on regulatory practices and safety standards for nuclear power plants. The Symposium was held in Munich, Federal Republic of Germany, from 7 to 10 November 1988. It was attended by 201 experts from some 32 Member States and 4 international organizations. Fifty-one papers from 19 Member States and 2 international organizations were presented and discussed in 5 technical sessions covering the following subjects: National Regulatory Practices and Safety Standards (14 papers); Implementation of Regulatory Practices - Technical Issues (8 papers); Implementation of Regulatory Practices - Operational Aspects (8 papers); Developments and Trends in Safety Standards and Practices (11 papers); International Aspects (10 papers). A separate abstract was prepared for each of these papers. Refs, figs and tabs

Electronic cigarettes: patterns of use, health effects, use in smoking cessation and regulatory issues.

Science.gov (United States)

Rahman, Muhammad Aziz; Hann, Nicholas; Wilson, Andrew; Worrall-Carter, Linda

2014-01-01

Electronic cigarettes (e-cigarettes) are battery-powered devices that vaporize a liquid solution to deliver a dose of inhaled nicotine to the user. There is ongoing debate regarding their regulation. This comprehensive narrative review aimed to discuss key issues including usage patterns, health effects, efficacy in smoking cessation and regulatory concerns with a view to informing future regulation and research agendas. PubMed, Scopus and Web of Science databases were searched using the terms (electronic cigarettes OR e-cigarettes) for articles in English, relevant to humans and published during January 2009-January 2014. The literature search revealed 37 relevant articles. Findings suggest that e-cigarettes are mostly used by middle-aged current smokers, particularly males, to help them for quitting or for recreation. E-cigarettes contain very low levels of multiple toxic substances such as formaldehyde and acrolein, but these levels are many times lower than those found in cigarettes. They were found to have effectiveness in aiding smoking cessation to a limited degree. Debate continues regarding regulating their use for cessation versus heavy restrictions to control recreational use on the basis that it perpetuates nicotine addiction. The cytotoxicity and long term health effects of e-cigarettes are unknown. Nevertheless the e-cigarette market continues to expand, largely driven by middle-aged smokers who claim to be using e-cigarettes in an attempt to reduce or quit smoking. E-cigarettes may have some potential as smoking cessation aids and, in the researchers' view, should therefore be subject to further research and regulation similar to other nicotine replacement therapies.

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

Ethical Issues in Cooperative Education--The Practitioner's Perspective.

Science.gov (United States)

Mark, Joan

2001-01-01

Raises issues of unethical student behavior in cooperative education, with examples of theft, abuse of workplace e-mail, fraudulent timesheets, and wrongful unemployment claims. Discusses new opportunities for unethical behavior created by technology and ways educators can respond. (SK)

The Regulatory Emotional Self-Efficacy Scale: Issues of Reliability and Validity Within a Turkish Sample Group

Directory of Open Access Journals (Sweden)

Tarık Totan

2014-10-01

Full Text Available The purpose of this study was to psychometrically evaluate the Turkish version of the Regulatory Emotional Self-efficacy Scale (RESE. The RESE, the Emotional Self-efficacy Scale, the Self-liking/Self-competence Scale, and the Oxford Happiness Questionnaire were applied to 303 university students in total, 180 were women (59.4% and 123 were men (40.6%. According to results of confirmatory factor analysis applied in the study are founded enough conformity between the priori hypothesis model and the data. In addition, the metric invariance model shows that there were no gender differences on this confirmatory model. Internal consistency coefficients were all above the acceptable for the RESE’s sub-scale and total. Moreover, positive correlations were found between regulatory emotional self-efficacy dimensions and emotional self-efficacy, self-esteem, and happiness. According to these research findings, the RESE is a valid and reliable instrument for measuring regulatory self-efficacy in Turkish.

Safety and Regulatory Issues of the Thorium Fuel Cycle

Energy Technology Data Exchange (ETDEWEB)

Ade, Brian [ORNL; Worrall, Andrew [ORNL; Powers, Jeffrey [ORNL; Bowman, Steve [ORNL; Flanagan, George [ORNL; Gehin, Jess [ORNL

2014-02-01

Thorium has been widely considered an alternative to uranium fuel because of its relatively large natural abundance and its ability to breed fissile fuel (233U) from natural thorium (232Th). Possible scenarios for using thorium in the nuclear fuel cycle include use in different nuclear reactor types (light water, high temperature gas cooled, fast spectrum sodium, molten salt, etc.), advanced accelerator-driven systems, or even fission-fusion hybrid systems. The most likely near-term application of thorium in the United States is in currently operating light water reactors (LWRs). This use is primarily based on concepts that mix thorium with uranium (UO2 + ThO2), add fertile thorium (ThO2) fuel pins to LWR fuel assemblies, or use mixed plutonium and thorium (PuO2 + ThO2) fuel assemblies. The addition of thorium to currently operating LWRs would result in a number of different phenomenological impacts on the nuclear fuel. Thorium and its irradiation products have nuclear characteristics that are different from those of uranium. In addition, ThO2, alone or mixed with UO2 fuel, leads to different chemical and physical properties of the fuel. These aspects are key to reactor safety-related issues. The primary objectives of this report are to summarize historical, current, and proposed uses of thorium in nuclear reactors; provide some important properties of thorium fuel; perform qualitative and quantitative evaluations of both in-reactor and out-of-reactor safety issues and requirements specific to a thorium-based fuel cycle for current LWR reactor designs; and identify key knowledge gaps and technical issues that need to be addressed for the licensing of thorium LWR fuel in the United States.

Licensing evaluation of CANDU-PHW nuclear power plants relative to U.S. regulatory requirements

International Nuclear Information System (INIS)

Erp, J.B. van

1978-01-01

Differences between the U.S. and Canadian approach to safety and licensing are discussed. U.S. regulatory requirements are evaluated as regards their applicability to CANDU-PHW reactors; vice-versa the CANDU-PHW reactor is evaluated with respect to current Regulatory Requirements and Guides. A number of design modifications are proposed to be incorporated into the CANDU-PHW reactor in order to facilitate its introduction into the U.S. These modifications are proposed solely for the purpose of maintaining consistency within the current U.S. regulatory system and not out of a need to improve the safety of current-design CANDU-PHW nuclear power plants. A number of issues are identified which still require resolution. Most of these issues are concerned with design areas not (yet) covered by the ASME code. (author)

Group Counseling in the Schools: Considerations for Child and Family Issues

Science.gov (United States)

Crespi, Tony D.; Gustafson, Amy L.; Borges, Silvia M.

2006-01-01

School psychologists are increasingly being confronted with a wide spectrum of psychological, psychosocial, familial, and home-school issues impacting child development. With one in six children raised in alcoholic families, with divorce impacting approximately 60% of families, and with such issues as teenage pregnancy, parental neglect, as well…

Key technologies of drilling process with raise boring method

Directory of Open Access Journals (Sweden)

Zhiqiang Liu

2015-08-01

Full Text Available This study presents the concept of shaft constructed by raise boring in underground mines, and the idea of inverse construction can be extended to other fields of underground engineering. The conventional raise boring methods, such as the wood support method, the hanging cage method, the creeping cage method, and the deep-hole blasting method, are analyzed and compared. In addition, the raise boring machines are classified into different types and the characteristics of each type are described. The components of a raise boring machine including the drill rig, the drill string and the auxiliary system are also presented. Based on the analysis of the raise boring method, the rock mechanics problems during the raise boring process are put forward, including rock fragmentation, removal of cuttings, shaft wall stability, and borehole deviation control. Finally, the development trends of raise boring technology are described as follows: (i improvement of rock-breaking modes to raise drilling efficiency, (ii development of an intelligent control technique, and (iii development of technology and equipment for nonlinear raise boring.

Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

Science.gov (United States)

Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

2015-09-01

Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

Argentina's regulatory body: its communication activities

International Nuclear Information System (INIS)

Cesario, Pablo A.; Terigi, Gabriel E.

2008-01-01

Full text: The Nuclear Regulatory Authority of Argentina (ARN) is empowered to regulate and control the nuclear activity with regard to radiation and nuclear safety, physical protection and nuclear non-proliferation issues. It must also advise the Executive on issues under its purview. The objective of the Nuclear Regulatory Authority is to establish, develop and enforce a regulatory system applicable to all nuclear activities carried out in Argentina. Two of the goals of this regulatory system are to provide an appropriate standard of protection for individuals against the harmful effects of ionizing radiation, and to maintain a reasonable degree of radiological and nuclear safety in the nuclear activities performed in Argentina. The responsibility of the radiation protection community in performing the tasks to accomplish this goals is twofold. On one hand, it must ensure a high technical quality in performing these functions. It must also provide information on its activities which has to be accurate, comprehensive and understandable. The way a society understands the concept of 'risk' needs to be kept in mind. Risk perception is the subjective judgment that people make about the characteristics and severity of a risk. Cultural theory refers to theories of risk perception that focus on culture, rather than individual psychology as an explanation for differences in risk judgments. It is widely agreed that trust is a key factor in influencing people's perceptions of risk. It is understood there are two main ways trust may impact in risk perceptions: an activity is perceived as more risky if the people or agencies managing it are perceived as untrustworthy; and information presented by trusted sources is given more credibility than information from untrusted sources. One of the primary purposes of ARN's Communication Program is to provide a means whereby those engaged in radiation protection activities may communicate more readily with each other and the public and

Raising Public Awareness of Mathematics

CERN Document Server

Behrends, Ehrhard; Rodrigues, José Francisco

2012-01-01

This collective book aims to encourage and inspire actions directed towards raising public awareness of the importance of mathematical sciences for our contemporary society in a cultural and historical perspective. Mathematical societies, in Europe and around the world, can find ideas, blueprints and suggestions for activities - including concerted actions with other international organizations - directed towards raising public awareness of science, technology and other fields where mathematics plays a strong role. The material is divided into four parts: * National experiences * Exhibitions /

Requirements for US regulatory approval of the International Thermonuclear Experimental Reactor (ITER)

International Nuclear Information System (INIS)

Petti, D.A.; Haire, J.C.

1993-12-01

The International Thermonuclear Experimental Reactor (ITER) is the first fusion machine that will have sufficient decay heat and activation product inventory to pose potential nuclear safety concerns. As a result, nuclear safety and environmental issues will be much more important in the approval process for the design, siting, construction, and operation of ITER in the United States than previous fusion devices, such as the Tokamak Fusion Test Reactor. The purpose of this report is (a) to provide an overview of the regulatory approval process for a Department of Energy (DOE) nuclear facility; (b) to present the dose limits used by DOE to protect workers, the public, and the environment from the risks of exposure to radiation and hazardous materials; (c) to discuss some key nuclear safety-related issues that must be addressed early in the Engineering Design Activities (EDA) to obtain regulatory approval; and (d) to provide general guidelines to the ITER Joint Central Team (JCT) concerning the development of a regulatory framework for the ITER project

Status of safety issues at licensed power plants: TMI Action Plan requirements; unresolved safety issues; generic safety issues; other multiplant action issues

International Nuclear Information System (INIS)

1993-12-01

As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, the NRC established a program for publishing an annual report on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was initially compiled and reported in three NUREG-series volumes. Volume 1, published in March 1991, addressed the status of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). The first annual supplement, which combined these volumes into a single report and presented updated information as of September 30, 1991, was published in December 1991. The second annual supplement, which provided updated information as of September 30, 1992, was published in December 1992. Supplement 2 also provided the status of licensee implementation and NRC verification of other multiplant action (MPA) issues not related to TMI Action Plan requirements, USIs, or GSIs. This third annual NUREG report, Supplement 3, presents updated information as of September 30, 1993. This report gives a comprehensive description of the implementation and verification status of TMI Action Plan requirements, safety issues designated as USIs, GSIs, and other MPAs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. Additionally, this report serves as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

Inbound medical tourism to Barbados: a qualitative examination of local lawyers' prospective legal and regulatory concerns.

Science.gov (United States)

Crooks, Valorie A; Cohen, I Glenn; Adams, Krystyna; Whitmore, Rebecca; Morgan, Jeffrey

2015-07-28

Enabled by globalizing processes such as trade liberalization, medical tourism is a practice that involves patients' intentional travel to privately obtain medical care in another country. Empirical legal research on this issue is limited and seldom based on the perspectives of destination countries receiving medical tourists. We consulted with diverse lawyers from across Barbados to explore their views on the prospective legal and regulatory implications of the developing medical tourism industry in the country. We held a focus group in February 2014 in Barbados with lawyers from across the country. Nine lawyers with diverse legal backgrounds participated. Focus group moderators summarized the study objective and engaged participants in identifying the local implications of medical tourism and the anticipated legal and regulatory concerns. The focus group was transcribed verbatim and analyzed thematically. Five dominant legal and regulatory themes were identified through analysis: (1) liability; (2) immigration law; (3) physician licensing; (4) corporate ownership; and (5) reputational protection. Two predominant legal and ethical concerns associated with medical tourism in Barbados were raised by participants and are reflected in the literature: the ability of medical tourists to recover medical malpractice for adverse events; and the effects of medical tourism on access to health care in the destination country. However, the participants also identified several topics that have received much less attention in the legal and ethical literature. Overall this analysis reveals that lawyers, at least in Barbados, have an important role to play in the medical tourism sector beyond litigation - particularly in transactional and gatekeeper capacities. It remains to be seen whether these findings are specific to the ecology of Barbados or can be extrapolated to the legal climate of other medical tourism destination countries.

Romania's flag raised at CERN

CERN Multimedia

Corinne Pralavorio

2016-01-01

A ceremony was held for the raising of the Romanian flag alongside the flags of CERN’s 21 other Member States.   The Romanian flag is raised alongside the flags of CERN’s other Member States, in the presence of the Romanian President, CERN’s Director-General, the President of the CERN Council and a large Romanian delegation. (Image: Maximilien Brice/ Sophia Bennett/CERN) On Monday, 5 September, the Romanian flag was raised in front of CERN for the first time, marking the country’s accession to Membership of the Organization. The blue, yellow and red flag joined those of the other 21 Member States of CERN in a ceremony attended by the President of Romania, Klaus Iohannis, the Romanian Minister for Education and Scientific Research, Mircea Dumitru, and several other members of the President’s office, the government and academia in Romania. The country officially became a CERN Member State on 17 July 2016, after 25 years of collaboration between the...

Issues for the Traveling Team Physician.

Science.gov (United States)

Kaeding, Christopher C; Borchers, James

2016-07-01

This article outlines the value of having the team physician traveling with athletes to away venues for competitions or training sessions. At present, this travel presents several issues for the team physician who crosses state lines for taking care of the athletes. In this article, these issues and their possible remedies are discussed. A concern for the travelling team physician is practicing medicine while caring for the team in a state where the physician is not licensed. Another issue can be the transportation of controlled substances in the course of providing optimal care for the team athletes. These two issues are regulatory and legislative issues at both the state and federal levels. On the practical side of being a team physician, the issues of emergency action plans, supplies, and when to transport injured or ill patients are also reviewed. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Comparing Distributions of Environmental Outcomes for Regulatory Environmental Justice Analysis

Directory of Open Access Journals (Sweden)

Glenn Sheriff

2011-05-01

Full Text Available Economists have long been interested in measuring distributional impacts of policy interventions. As environmental justice (EJ emerged as an ethical issue in the 1970s, the academic literature has provided statistical analyses of the incidence and causes of various environmental outcomes as they relate to race, income, and other demographic variables. In the context of regulatory impacts, however, there is a lack of consensus regarding what information is relevant for EJ analysis, and how best to present it. This paper helps frame the discussion by suggesting a set of questions fundamental to regulatory EJ analysis, reviewing past approaches to quantifying distributional equity, and discussing the potential for adapting existing tools to the regulatory context.

The Choice between Rights-Preserving Issue Methods : Regulatory and Financial Aspects of Issuing Seasoned Equity in the UK

NARCIS (Netherlands)

Korteweg, A.G.; Renneboog, L.D.R.

2002-01-01

This paper examines the choice between two rights-preserving issue methods of seasoned equity offers in the UK as well as the factors determining the offer price and stock market announcement reactions.Firstly, equity issues in the UK are underwritten for different reasons than in other

Regulatory T cells and immunity to pathogens.

Science.gov (United States)

Rouse, Barry T; Suvas, Susmit

2007-09-01

Immune responses to pathogens are modulated by one or more types of cells that perform a regulatory function. Some cells with this function, such as CD4+ Foxp3+ natural regulatory T cells (nTreg), pre-exist prior to infections whereas others may be induced as a consequence of infection (adaptive Treg). With pathogens that have a complex pathogenesis, multiple types of regulatory cells could influence the outcome. One major property of Treg is to help minimize collateral tissue damage that can occur during immune reactions to a chronic infection. The consequence is less damage to the host but in such situations the pathogen is likely to establish persistence. In some cases, a fine balance is established between Treg responses, effector components of immunity and the pathogen. Treg responses to pathogens may also act to hamper the efficacy of immune control. This review discusses these issues as well as the likely mechanisms by which various pathogens can signal the participation of Treg during infection.

Office of Geologic Respositories issues hierarchy for a Mined Geologic Disposal System (OGR/B-10)

International Nuclear Information System (INIS)

1986-09-01

The Office of Geologic Repositories (OGR) has adopted an issues hierarchy for use by all Project Offices. The issues hierarchy provides a framework for representing issues related to regulatory requirements for siting and licensing a mined geologic disposal system (MGDS) and for describing the work that needs to be completed during site characterization to resolve those issues. The issues in the issues hierarchy are defined as the questions relating to the performance of the MGDS that must be resolved to demonstrate compliance with the applicable federal regulations (including 10 CFR Part 60, 10 CFR Part 960, 40 CFR Part 191, and 10 CFR Part 20). The issues hierarchy is structured around four broad areas of regulatory concern related to the requirements for siting and licensing an MGDS (postclosure performance, preclosure radiological safety, non-radiological environmental impacts, and feasibility and cost of MGDS development), and provides the framework for definition of the information needed to satisfy the applicable regulatory requirements in each of these areas. The purpose of this document is to present the issues hierarchy, describe the rationale used to develop the hierarchy, and describe how the issues hierarchy is used in program planning. Section 2 presents the overall rationale for the issues hierarchy, and explains the structure and organization of the hierarchy. Section 3 presents the issues hierarchy itself and Section 4 describes the basis for the development of individual issues. Section 5 provides a correlation between the issues and the applicable federal regulations being addressed. Section 6 describes how the issues drive development of plans in support of siting and licensing requirements through use of an issue resolution strategy that includes performance allocation

Wetlands: The changing regulatory landscape

International Nuclear Information System (INIS)

Glick, R.M.

1993-01-01

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

Transsexualism: An Issue of Sex-Role Stereotyping.

Science.gov (United States)

Raymond, Janice

Transsexualism offers a unique perspective on gender identity, sex-role stereotyping, and sex differences in a patriarchal society. It is also an important medical ethical issue which raises questions of bodily mutilation and integrity, nature versus technology, medical research priorities, unnecessary surgery, and the medical model, as well as…

Issues of Cultural Diversity in School Mathematics.

Science.gov (United States)

Ruthven, Kenneth

2001-01-01

Explores cultural diversity in school mathematics and the issues raised for mathematics education. Examines the curricular roots of school mathematics in relation to scholarly mathematics, and the mathematics of past generations and different social groups. Notes some of the complexities in seeking to 'culturalize' school mathematics by bringing…

RAISED BOGS ON THE NORTH-EAST OF EUROPE

Directory of Open Access Journals (Sweden)

T. K. YURKOVSKAYA

2004-01-01

Full Text Available In the Northeastern Europe 2 types of raised bogs are distinguished: coastal (Southern White Sea raised hogs and continental (Pechora-Onega raised bogs. They have been compared as to their flora, prevailing syntaxa, characteristics of their complexes, structure of mire massifs and composition of peat deposits.

Smart grids and power systems efficiency: regulatory tools and demand-side management impacts

International Nuclear Information System (INIS)

Bergaentzle, Claire

2015-01-01

induced by peak shedding. To this end, we develop and use a linear optimization model and expand our analysis to interconnected countries endowed with differentiated generation means. The thesis shows dominant regulatory frameworks are unsuited to provide the necessary sets of incentive to efficiently develop smart technologies. This can cause delays in their integration to power grids. The quantitative evaluation of the impacts generated by demand-side management shows significant efficiency gains are achievable through final consumers' flexibility. However, such measures create new discrepancies regarding installed capacities profitability, future capacity adequacy, and highlight potential antagonism between missing money for flexible peak capacities and the development of low carbon energies. It is clear the issues raised by the development of smart grids call for informed public debate as power industries are essential to our societies. Among the considerable amount of elements to discuss, issues relative to financing the investment projects and the inclusion of the new sources of flexibility induced by the technology in competitive markets will be of priority. (author) [fr

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)

Legal and regulatory issues regarding classification and disposal of wastes from actinide partitioning and transmutation

International Nuclear Information System (INIS)

Kocher, D.C.

1989-01-01

Partitioning and transmutation of actinide radioelements in spent nuclear fuel from civilian power reactors is potentially attractive because the resulting wastes might be acceptable for disposal using systems which are considerably less costly than a deep geologic repository. At present, there are no legal or regulatory prohibitions to seeking alternatives to a geologic repository for disposal of such wastes. However, additional laws and regulations would be needed, and the Nuclear Regulatory Commission has been reluctant to alter the current framework for radioactive waste management, in which geologic repositories or near-surface facilities are the only disposal options established in law and regulations unless a compelling need for alternatives with intermediate waste-isolation capabilities is demonstrated. There are also important technical considerations which are not encouraging with regard to the development of intermediate disposal systems for wastes from partitioning and transmutation of actinides in civilian spent fuel. First, the wastes may contain sufficient concentrations of fission products. Second, defense reprocessing wastes may contain sufficient concentrations of fission products and long-lived actinides. Thus, in developing the legal and regulatory framework for alternative disposal systems, there is a need to establish maximum concentrations of fission products and long-lived actinides that would be acceptable for intermediate disposal. 19 refs

Preparation of safety regulatory requirements for new technology like digital system

International Nuclear Information System (INIS)

2012-01-01

The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG of MDEP. MDEP DICWG held in OECD/NEA gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance on digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed process and framework. The following two general common positions are discussed and to be issued in this fiscal year. Verification and Validation throughout the life cycle of safety systems using digital computers. The Impact of Cyber Security Features on Digital I and C Safety Systems. (author)

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

International Nuclear Information System (INIS)

Elsheikh, B.M.

2012-01-01

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

Ownership options, financing structures, and regulatory considerations affecting independent power production projects

International Nuclear Information System (INIS)

Knapp, G.M.

1990-01-01

In this paper is a framework for analysis of the legal, financing, and policy differences between independent power production projects (IPPs) and projects with qualifying facility status (QFs) under the Public Utility Regulatory Policies Act (PURPA). At a basic level, there is no fundamental difference in types of ownership and financing structures available to IPPs and QFS. The key consideration, though, is the regulatory and legal implications to project participants. Significant issues arise for equity participants, lenders, developers, and project operators that are considering IPP projects. Of course, many of these same issues apply to certain types of QF projects that are not fully exempt from the Public Utility Holding Company Act (PUHCA) and the Federal Power Act (FPA)

Regulatory framework and safety requirements for new (gen III) reactors

International Nuclear Information System (INIS)

Mourlon, Sophie

2014-01-01

Sophie Mourlon, ASN Deputy General Director, described the international process to enhance safety between local safety authorities through organizations such as WENRA. Then she explained to the participants the regulatory issues for the next generation of NPPs

Institutional review board and regulatory solutions in the dental PBRN

DEFF Research Database (Denmark)

Gilbert, Gregg H; Qvist, Vibeke; Moore, Sheila D

2010-01-01

Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network...

Infrastructure of the Regulatory Authority and Performance Indexes

International Nuclear Information System (INIS)

Velasquez, Silvia

2001-01-01

This presentation overviews the following issues: elements of a control regulatory program, inspections program, procedures, indexes of users performance, priorities on: registration, criteria for practices of low risk, dose levels in medical exposures, dose constraints and training of personnel. These aspects are considered in the guides prepared within ARCAL XX framework

Identification of regulatory barriers in the production of biodiesel in Brazil; Identificacao de entraves regulatorios na producao de biodiesel no Brasil

Energy Technology Data Exchange (ETDEWEB)

Silva, Marcelo Santana [Instituto Federal de Educacao, Ciencia e Tecnologia da Bahia (IFBA), Santo Amaro, BA (Brazil)], email: marcelosilva@ifba.edu.br; Teixeira, Francisco Lima Cruz [Universidade Federal da Bahia (UFBA), Salvador, BA (Brazil); Torres, Ednildo Andrade [Universidade Federal da Bahia (CIEnAm/UFBA), Salvador, BA (Brazil). Centro Interdisciplinar de Energia e Ambiente

2010-07-01

At a time when biofuels are in evidence in the international arena, it is essential to discuss this new market, in particular the biodiesel. To achieve agricultural and industrial sustainability, the main argument is that replacing oil with biofuels raises some questions, because of the lack of experience with the new productive chains. Due to the way the Biodiesel program is being implemented, this program presents several obstacles. Thus, this study aims to investigate the elements in the regulatory hurdles for the production of Biodiesel. In this work it was adopted qualitative descriptive and exploratory procedures, including desk research and recognition of perceptions through questionnaires to staff intentionally selected from different parts of the productive chain, through non-probabilistic sampling. The survey showed the following barriers: differentiated subsidies, which hinder the production of biodiesel by intensive agriculture and benefit familiar agriculture, do not encourage other regions of the country, or other raw material (animal tallow and ORG); incoherent taxation considering the quantity purchased raw materials; strict control on the region distribution to claim the Social Fuel Seal; it isn't prioritized environmental issues in their regulatory context; there's no prestige to small industry, cooperatives and associations; there is a tax for alcohol applied in biodiesel production; and the law penalizes biodiesel plants for the sale of hydrated alcohol. It was observed that these obstacles hinder the increase in biodiesel production, resulting in countless idle biodiesel plants. In this sense, it was found that the regulatory framework needs to be revised due to the investigated barriers. (author)

Regulatory limits in radiation injury cases