Regulatory issues associated with the Multi-Purpose (MPC) system

International Nuclear Information System (INIS)

Roberts, J.P.; Desell, L.J.; Birch, M.L.; Morgan, R.G.

1994-01-01

The US Department of Energy Office of Civilian Radioactive Waste Management is developing a Multi-Purpose Canister system to promote compatibility between the waste program elements of storage, transportation, and disposal. The development of a Multi-Purpose Canister system requires meeting various regulatory requirements. These regulatory requirements are set forth in environmental and Nuclear Regulatory Commission (NRC) regulations. This paper discusses the more significant regulatory issues that must be addressed in the development of a Multi-Purpose Canister system by the Department of Energy

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

Facing the challenge of stakeholders involvement: the Argentine nuclear regulatory case

International Nuclear Information System (INIS)

Acosta, Gabriela M.; Arnaud, Marta I.; Cesario, Pablo A.

2010-01-01

The Nuclear Regulatory Authority of Argentina (ARN) is an autonomous body reporting to the Presidency of Argentina, empowered to regulate and control the nuclear activity with regards to radiation and nuclear safety, physical protection and nuclear non-proliferation issues. Under the executive decree 1172/2003, which makes reference to the accessibility of public information to increase transparency of government actions and specially to promote public involvement, ARN has the legal obligation to inform of its activities in an accurate, comprehensive and understandable manner. The re-launching of the nuclear plan in 2006 and the repercussions this provoked on society highlighted the need to reinforce the legitimacy of the regulatory role and the promotion of confidence on its works to ensure the safety of the people. Therefore it was considered necessary to involve the society further in this programme by achieving greater public understanding and awareness of the nuclear regulatory activities. The more the public is conscious of the role of the regulator, conceiving it as a trustworthy and autonomous authority, the easier it is for the regulator to fulfil its obligations. As ARN has a strong commitment with society and considering that communication with the general public, as an external stakeholder, is a means to establishing and maintaining public trust and confidence, the implementation of a new communication programme became a key issue. In this scenario, ARN faced a challenge it was not prepared to handle and thus created a Division to deal with institutional communication and allow and ease the interaction with society. Within this Division, one of the methods chosen to achieve a better interaction with society was the use of a technological tool to attend possible inquiries, increasing and facilitating a greater involvement of the stakeholders. With this in mind a 'Mail-Info' was established because it allows a fast, accessible, easy and informal way of

Facing the challenge of stakeholders involvement: the Argentine nuclear regulatory case

Energy Technology Data Exchange (ETDEWEB)

Acosta, Gabriela M.; Arnaud, Marta I.; Cesario, Pablo A. [Nuclear Affairs and Institutional Communication Department, Autoridad Regulatoria Nuclear, Av. del Libertador 8250, C1429BNP (Argentina)

2010-07-01

The Nuclear Regulatory Authority of Argentina (ARN) is an autonomous body reporting to the Presidency of Argentina, empowered to regulate and control the nuclear activity with regards to radiation and nuclear safety, physical protection and nuclear non-proliferation issues. Under the executive decree 1172/2003, which makes reference to the accessibility of public information to increase transparency of government actions and specially to promote public involvement, ARN has the legal obligation to inform of its activities in an accurate, comprehensive and understandable manner. The re-launching of the nuclear plan in 2006 and the repercussions this provoked on society highlighted the need to reinforce the legitimacy of the regulatory role and the promotion of confidence on its works to ensure the safety of the people. Therefore it was considered necessary to involve the society further in this programme by achieving greater public understanding and awareness of the nuclear regulatory activities. The more the public is conscious of the role of the regulator, conceiving it as a trustworthy and autonomous authority, the easier it is for the regulator to fulfil its obligations. As ARN has a strong commitment with society and considering that communication with the general public, as an external stakeholder, is a means to establishing and maintaining public trust and confidence, the implementation of a new communication programme became a key issue. In this scenario, ARN faced a challenge it was not prepared to handle and thus created a Division to deal with institutional communication and allow and ease the interaction with society. Within this Division, one of the methods chosen to achieve a better interaction with society was the use of a technological tool to attend possible inquiries, increasing and facilitating a greater involvement of the stakeholders. With this in mind a 'Mail-Info' was established because it allows a fast, accessible, easy and informal

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...

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

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

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

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

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 facing the global nuclear energy partnership

International Nuclear Information System (INIS)

Lyman, Edwin S.

2007-01-01

In January 2006 the Department of Energy (DOE) announced the creation of the Global Nuclear Energy Partnership (GNEP), an ambitious plan to reshape the nuclear energy production sector both in the United States and worldwide. If fully realized in the United States, GNEP would entail the construction of a large number of sodium-cooled fast reactors utilizing actinide-based fuels, multiple commercial-scale reprocessing plants for both light-water and fast reactors, and fast reactor fuel fabrication plants. It appears likely that the first commercial-scale GNEP facilities, as well as a future full-scale GNEP complex, would fall under the licensing jurisdiction of the Nuclear Regulatory Commission (NRC). This will be a challenging endeavor for the NRC, primarily because the proposed GNEP facilities will in large part be based on novel and untested designs and processes that have not been developed on a commercial scale. In order to effectively regulate the GNEP complex, the NRC will have to quickly address the many technical and policy questions that will arise in any GNEP licensing scheme. This paper identifies some difficult issues that will be encountered in GNEP licensing by examining the potential implications of NRC's current policies and regulatory requirements, and analyzing the impacts of some emerging post-9/11 security issues. (author)

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...

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

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.

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.

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.

Papers of the CAMPUT 2003 educational conference : Markets in Transition : The changing face of regulation

International Nuclear Information System (INIS)

2003-01-01

The North American energy landscape is evolving: markets are in transition and regulatory roles are shifting. Regulators, government policy makers, and industry representatives exchanged information concerning the changes facing regulatory agencies, industry and energy users. The eleven sessions of the conference were entitled: (1) the future of the regulator in a continental energy market, (2) gas markets in transition, (3) electricity markets in transition (including Regional Transmission Organization/Standard Market Design issues), (4) are open access markets the answer? (5) the changing face of regulation, what's up? (6) energy policy updates in British Columbia and Atlantic Canada, (7) Ontario electricity update and deregulation one year later, (8) northern issues, (9) intervener funding, (10) affiliate transactions, regulatory and business issues, and (11) cost of capital update. The conference featured 43 presentations, of which two were indexed separately for inclusion in the database

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.

Implementation Issues in Multicultural Education: What Are Secondary Public School Educators Facing?

Directory of Open Access Journals (Sweden)

LaVonne Fedynich

2016-02-01

Full Text Available This mixed method study sought to explore the issues that faced secondary teachers in a rural central Georgia public high school when attempting to implement a multicultural education program.  The key issues of this study centered on the teachers’ multicultural education training and the school’s multicultural education program. Data were gathered from a total of thirty randomly chosen teachers in the Social Studies, Math and English departments at the school. Twenty-five of the thirty teachers received a hard copy four question Likert scale survey to complete. The remaining 5 participants took part in face-to-face interviews discussing six open-ended questions.  The findings pointed to several issues facing the teachers such as the lack of an officially implemented multicultural education program, the lack of support from school administrators, no in-service training available for teachers, parental and student misapprehension, and a lack of an officially defined policy on implementation and support of a multicultural education program from administrators locally and district-wide.

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)

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

Village Health Volunteers: Key Issues Facing Agencies in Malawi

African Journals Online (AJOL)

the key issues facing health care providers in ... gral part of community-based health programmes ... health care services more accessible to everyone s. , .... health; villagers are often more willing to help meet the costs of services they value. 2.

U.S. nuclear fuel cycle regulatory issues on exclusion, exemption, and clearance

International Nuclear Information System (INIS)

Meck, R.A.

1997-01-01

The U.S. Nuclear Regulatory Commission is considering the use of exclusion and clearance in connection with the nuclear fuel cycle regulations. Clearance of licensed lands, buildings, structures, materials, and equipment could expose members of the public to radiation in addition to background. Establishing and implementing dose criteria for allowed concentrations of radioactivity in the various media raise challenging issues for the regulator. Clearance also raises significant regulatory issues, and these issues reflect trade-offs between concerns for protecting public health and safety, as well as other socioeconomic values and concerns. At the heart of the issues are the adequacy of risk analyses, acceptability of risks, underlying rationales, feasibility and cost of implementation, and exposures of the public to man-made radiation in relation to natural sources of radiation. (author)

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)

Strategic Issues Facing U.S. Navy Human Systems Integration Professionals

National Research Council Canada - National Science Library

Duehring, Jeremy L

2007-01-01

.... Strategic issues represent relevant challenges and problems facing this community over the next few years, including appropriate pay-back tours from officers receiving master's degrees from the NPS...

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

Papers of the CAMPUT 2003 educational conference : Markets in Transition : The changing face of regulation

International Nuclear Information System (INIS)

2003-01-01

The North American energy landscape is evolving: markets are in transition and regulatory roles are shifting. Regulators, government policy makers, and industry representatives exchanged information concerning the changes facing regulatory agencies, industry and energy users. The eleven sessions of the conference were entitled: (1) the future of the regulator in a continental energy market, (2) gas markets in transition, (3) electricity markets in transition (including Regional Transmission Organization/Standard Market Design issues), (4) are open access markets the answer? (5) the changing face of regulation, what's up? (6) energy policy updates in British Columbia and Atlantic Canada, (7) Ontario electricity update and deregulation one year later, (8) northern issues, (9) intervener funding, (10) affiliate transactions, regulatory and business issues, and (11) cost of capital update. The conference featured 43 presentations, of which two were indexed separately for inclusion in the database. refs., tabs., figs

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)

Village health volunteers: key issues facing agencies in Malawi ...

African Journals Online (AJOL)

The participants discussed recruitment, training, rewards, retention, and roles of village health volunteers. This paper presents background data on village health volunteers in Malawi and elsewhere and reviews the key issues facing health care providers in working with village health volunteers. A copy of the workshop ...

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

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.

Policy issues facing the Comprehensive Test Ban Treaty and prospects for the future

International Nuclear Information System (INIS)

Sweeney, J.

1999-01-01

This report is divided into the following 5 sections: (1) Background; (2) Major Issues Facing Ratification of CTBT; (3) Current Status on CTBT Ratification; (4) Status of CTBT Signatories and Ratifiers; and (5) CTBT Activities Not Prohibited. The major issues facing ratification of CTBT discussed here are: impact on CTBT of START II and ABM ratification; impact of India and Pakistan nuclear tests; CTBT entry into force; and establishment of the Comprehensive Nuclear Test-Ban Treaty Organization

Policy issues facing the Comprehensive Test Ban Treaty and prospects for the future

Energy Technology Data Exchange (ETDEWEB)

Sweeney, J.

1999-04-01

This report is divided into the following 5 sections: (1) Background; (2) Major Issues Facing Ratification of CTBT; (3) Current Status on CTBT Ratification; (4) Status of CTBT Signatories and Ratifiers; and (5) CTBT Activities Not Prohibited. The major issues facing ratification of CTBT discussed here are: impact on CTBT of START II and ABM ratification; impact of India and Pakistan nuclear tests; CTBT entry into force; and establishment of the Comprehensive Nuclear Test-Ban Treaty Organization.

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

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.

Ethical issues faced by clinician/managers in resource-allocation decisions.

Science.gov (United States)

Lemieux-Charles, L; Meslin, E M; Aird, C; Baker, R; Leatt, P

1993-01-01

This article explores the ethical issues faced by clinicians with management responsibilities (clinician/managers) when making decisions related to resource allocation and utilization at a Canadian teaching hospital. Using a focus group method, 28 individuals participated in four homogeneous groups that included nurse managers, managers from other professional groups, and physician managers. Ethical issues that recurred throughout the discussions included fairness, concern with preventing harm, consumer/patient choice, balancing needs of different groups of patients, conflict between financial incentives and patient needs, and professional autonomy. The particular issue of conflict is analyzed from two perspectives--a theory of professional-bureaucratic roles and of obligation--that illustrate how both management and philosophical issues are related. The findings suggest that decentralizing resource allocation and utilization decisions does raise ethical issues for clinician/managers and that a better understanding of these issues can be obtained using an interdisciplinary perspective.

Issues Facing Pharmacy Leaders in 2015: Suggestions for Pharmacy Strategic Planning

Science.gov (United States)

Weber, Robert J.

2015-01-01

Issues facing pharmacy leaders in 2015 include practice model growth and the role of pharmacy students, clinical privileging of health-system pharmacists and provider status, medication error prevention, and specialty pharmacy services. The goal of this article is to provide practical approaches to 4 issues facing pharmacy leaders in 2015 to help them focus their department’s goals. This article will address (1) advances in the pharmacy practice model initiative and the role of pharmacy students, (2) the current thinking of pharmacists being granted clinical privileges in health systems, (3) updates on preventing harmful medication errors, and (4) the growth of specialty pharmacy services. The sample template of a strategic plan may be used by a pharmacy department in 2015 in an effort to continue developing patient-centered pharmacy services. PMID:25717212

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

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.

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

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

Issues and Impediments Faced by Canadian Teachers While Integrating ICT in Pedagogical Practice

Science.gov (United States)

Saxena, Anoop

2017-01-01

Teachers in many schools struggle to integrate Information and Communications Technology (ICT) as part of their teaching practice. Among the issues faced by teachers when attempting to integrate ICT into their classrooms are gaps in ICT knowledge and skills, lack of training and inadequate support and scaffolding. Other issues include inability to…

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...

The challenges and issues facing the radioactive waste management in Croatia

International Nuclear Information System (INIS)

Subasic', D.; Saler, A.

1994-01-01

There are substantial experiences in Croatia in the field of radioactive waste management concerning both the waste from nuclear applications and waste generated at nuclear power plant. The essential issue now is how set-up infrastructure and to realize institutional and capacity building to get adjusted to needs of the newly independent state. In connection to this, the issues related to national radioactive waste management strategy, past and new organization of the Regulatory Body, and changes in legislation and regulations are discussed. In addition, some on-going projects important for realization of a complete radioactive waste management in the country round up the present situation in the field of radioactive waste management in Croatia

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.

Facing regulatory challenges of on-line hemodiafiltration.

Science.gov (United States)

Kümmerle, Wolfgang

2011-01-01

On-line hemodiafiltration (on-line HDF) is the result of a vision that triggered multifarious changes in very different areas. Driven by the idea to offer better medical treatment for renal patients, technological innovations were developed and established that also constituted new challenges in the field of regulatory affairs. The existing regulations predominantly addressed the quality and safety of those products needed to perform dialysis treatment which were supplied by industrial manufacturers. However, the complexity of treatment system required for the provision of on-line fluids demanded a holistic approach encompassing all components involved. Hence, focus was placed not only on single products, but much more on their interfacing, and the clinical infrastructure, in particular, had to undergo substantial changes. The overall understanding of the interaction between such factors, quite different in their nature, was crucial to overcome the arising regulatory obstacles. This essay describes the evolution of the on-line HDF procedure from the regulatory point of view. A simplified diagram demonstrates the path taken from the former regulatory understanding to the realization of necessary changes. That achievement was only possible through 'management of preview' and consequent promotion of technical and medical innovations as well as regulatory re-evaluations. Copyright © 2011 S. Karger AG, Basel.

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 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.

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

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

Workforce Issues Facing HRD. [Concurrent Symposium Session at AHRD Annual Conference, 1997.

Science.gov (United States)

1997

This document contains three papers from a symposium on work force issues facing human resource development (HRD). "Diversity Management in Nonprofit Women's Health Care Settings: A Qualitative Study of Race, Class, and Gender Influences" (Camille A. Cordak) demonstrates which organizational activities support diversity and how an…

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

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.

Overcoming regulatory and economic challenges facing pharmacogenomics.

Science.gov (United States)

Cohen, Joshua P

2012-09-15

The number of personalized medicines and companion diagnostics in use in the United States has gradually increased over the past decade, from a handful of medicines and tests in 2001 to several dozen in 2011. However, the numbers have not reached the potential hoped for when the human genome project was completed in 2001. Significant clinical, regulatory, and economic barriers exist and persist. From a regulatory perspective, therapeutics and companion diagnostics are ideally developed simultaneously, with the clinical significance of the diagnostic established using data from the clinical development program of the corresponding therapeutic. Nevertheless, this is not (yet) happening. Most personalized medicines are personalized post hoc, that is, a companion diagnostic is developed separately and approved after the therapeutic. This is due in part to a separate and more complex regulatory process for diagnostics coupled with a lack of clear regulatory guidance. More importantly, payers have placed restrictions on reimbursement of personalized medicines and their companion diagnostics, given the lack of evidence on the clinical utility of many tests. To achieve increased clinical adoption of diagnostics and targeted therapies through more favorable reimbursement and incorporation in clinical practice guidelines, regulators will need to provide unambiguous guidance and manufacturers will need to bring more and better clinical evidence to the market place. Copyright © 2012 Elsevier B.V. All rights reserved.

Management challenges faced by managers of New Zealand long-term care facilities.

Science.gov (United States)

Madas, E; North, N

2000-01-01

This article reports on a postal survey of 78 long-term care managers in one region of New Zealand, of whom 45 (58%) responded. Most long-term care managers (73.2%) were middle-aged females holding nursing but not management qualifications. Most long-term care facilities (69%) tended to be stand-alone facilities providing a single type of care (rest home or continuing care hospital). The most prominent issues facing managers were considered to be inadequate funding to match the growing costs of providing long-term care and occupancy levels. Managers believed that political/regulatory, economic and social factors influenced these issues. Despite a turbulent health care environment and the challenges facing managers, long-term care managers reported they were coping well and valued networking.

How 'blended' is blended learning?: students' perceptions of issues around the integration of online and face-to-face learning in a Continuing Professional Development (CPD) health care context.

Science.gov (United States)

Glogowska, Margaret; Young, Pat; Lockyer, Lesley; Moule, Pam

2011-11-01

This paper explores students' perceptions of blended learning modules delivered in a Continuing Professional Development (CPD) health care context in the UK. 'Blended learning' is the term used to describe a hybrid model of learning where traditional face-to-face teaching approaches and newer electronic learning activities and resources are utilised together. A new model of CPD for health care practitioners based on a blended learning approach was developed at a university in the south west of England. As part of the evaluation of the new modules, a qualitative study was conducted, in which 17 students who had experienced the modules were interviewed by telephone. Three main themes emerged from the interviews relating to the 'blended' nature of the blended learning modules. These were i) issues around the opportunities for discussion of online materials face-to-face; ii) issues of what material should be online versus face-to-face and iii) balancing online and face-to-face components. Teaching staff engaged in the development of blended learning courses need to pay particular attention to the ways in which they develop and integrate online and face-to-face materials. More attention needs to be paid to allowing opportunity for students to come together to create a 'community of inquiry'. Copyright © 2011 Elsevier Ltd. All rights reserved.

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

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.

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

Still a hot issue. US fire protection 20 years on

International Nuclear Information System (INIS)

Hathaway, L.R.

1995-01-01

Current fire protection concerns in the US nuclear industry are reviewed. Twenty years ago, a fire at the Brown's Ferry nuclear plant triggered a vigorous programme of regulation by the US Nuclear Regulatory Commission (NRC) and a still active response by power plant operators in seeking protection measures to meet the NRC criteria. The largest fire protection issue facing the industry concerns Thermo-Lag, a product formed from resins, subliming materials and fibreglass. This fire resistant wrap was installed in about 75 plants to provide a barrier between safety related cable systems. The Brown's Ferry fire has re-emphasised the importance of the separation criteria between redundant safety systems. Since 1989, however, there have been doubts about the adequacy of Thermo-Lag barriers and a major testing and analysis project addressing the problem is currently being sponsored by six utilities. Other regulatory- related issues facing the industry are the recently proposed defence-in-depth fire protection methodology, and for the future, fire protection strategies to cover shutdown, turbine generators and penetration seals through fire barriers. (UK)

Issues facing the management of radioactively contaminated lead within the DOE system

International Nuclear Information System (INIS)

Gilmore, M.C.; Kent, S.H.

1993-01-01

The purpose of this paper is to discuss and evaluate the issues that managing and operating contractors in the US DOE system should consider that are associated with management of radioactively contaminated elemental lead. There are many instances where DOE contaminated lead fall within Resource Conservation and Recovery Act (RCRA) regulation. In light of the Federal Facilities Compliance Act (FFCA), it is becoming increasingly important for additional regulatory options to be explored in order to facilitate proper treatment, storage and disposal of RCRA regulated lead. Various DOE facilities have initiated processes to reuse or recycle contaminated lead. Technologies such as melt-refining, surface blasting, and electromigration are being explored. One or more of these technologies may be the key to reducing contaminated lead inventories in the DOE system. Many DOE facilities are finding that these efforts need to have stringent regulatory evaluation since some alternatives have proven to be environmentally desirable but not economically feasible

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

How have hospitals faced the pricing issues of the 1990's?

Science.gov (United States)

Kleimenhagen, A; Naidu, G M; Pillari, G D

1994-01-01

National health care expenditures are rising rapidly, bringing on a health care financing crisis. For this reason, it is useful to see how hospitals are facing the price issues of the 1990's. This study examines the price strategies hospitals follow and analyzes their observations on price sensitivity and payer mix. The results clearly show that hospitals have not given much attention to the pricing variable. The study suggests that marketing and finance will have to work closely together in developing future pricing strategies.

Biosimilars--global issues, national solutions.

Science.gov (United States)

Knezevic, Ivana; Griffiths, Elwyn

2011-09-01

Biotechnology derived medicinal products are presently the best characterized biologicals with considerable production and clinical experience, and have revolutionized the treatment of some of the most difficult-to-treat diseases, prolonging and improving the quality of life and patient care. They are also currently one of the fastest growing segments of the pharmaceutical industry market. The critical challenge that the biopharmaceutical industry is facing is the expiry of patents for the first generation of biopharmaceuticals, mainly recombinant DNA derived products, such as interferons, growth hormone and erythropoetin. The question that immediately arose was how should such copies of the originator products be licensed, bearing in mind that they are highly complex biological molecules produced by equally complex biological production processes with their inherent problem of biological variability. Copying biologicals is much more complex than copying small molecules and the critical issue was how to handle the licensing of products if relying in part on data from an innovator product. Since 2004 there has been considerable international consultation on how to deal with biosimilars and biological copy products. This has led to a better understanding of the challenges in the regulatory evaluation of the quality, safety and efficacy of "biosimilars", to the exchange of information between regulators, as well as to the identification of key issues. The aim of this article is to provide a brief overview of the scientific and regulatory challenges faced in developing and evaluating similar biotherapeutic products for global use. It is intended as an introduction to the series of articles in this special issue of Biologicals devoted to similar biotherapeutic products. Copyright © 2011. Published by Elsevier Ltd.

Development of regulatory technologies of key issues of radiation sources in the medical and industrial fields

International Nuclear Information System (INIS)

Lee, Jae Seong; Kim, Byung Soo; Ku, Bon Chul

2006-08-01

The aim of this research is to provide with rational bases to address the key issues raising up during the expansion of RI/RG usage in the medical and industrial fields, thus eventually contribute to enhancing the effectiveness of national regulatory systems. Related key issues that are introduced in the medical and industrial fields are analyzed and some outcomes are produced. The following results are attained. - Estimation Methodology Development of Regulatory Effects for the Use of Radioactive Substances, - Survey on Domestic Status of Nuclear Materials and Review on Domestic/Foreign Regulatory System for Nuclear Materials Regulation, - Comparative Analysis of KSTAR and Fusion Facilities of Advanced Countries, - Radiological Characteristics of Proton Therapy and Analysis of Foreign Cases and Systems, - Detection and Safety Analysis of Leak Radiation of High Energy Medical Generators, - Survey and Analysis on Usage and Requirements of Sealed Sources, - Incidents/Accidents Reporting System for RI-related Facilities, - Development of Audio-Visual Education Materials for Radiation Workers, - Development of Major Safety Procedures for Portable RIs, - Expansion of Existing DB for Radiation Devices including New Domestic Ones, - Survey of Foreign Status of Quality Maintenance System for Radiation equipment

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

Face Attention Network: An Effective Face Detector for the Occluded Faces

OpenAIRE

Wang, Jianfeng; Yuan, Ye; Yu, Gang

2017-01-01

The performance of face detection has been largely improved with the development of convolutional neural network. However, the occlusion issue due to mask and sunglasses, is still a challenging problem. The improvement on the recall of these occluded cases usually brings the risk of high false positives. In this paper, we present a novel face detector called Face Attention Network (FAN), which can significantly improve the recall of the face detection problem in the occluded case without comp...

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.

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)

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)

Researchers and experts faced with legal issues in radon affairs

International Nuclear Information System (INIS)

Massuelle, M.; Pirard, P.; Hubert, P.

1998-01-01

In France, radon has emerged as a public health issue mainly at the initiative of scientists. Public authorities are currently considering regulations but for a long time scientists faced the radon issue alone. As a consequence, scientists were involved and are still involved in producing knowledge, in informing about their results, in giving advice to various bodies and individuals, and in participating in the process of technical standardization. These functions are identified in the paper in order to sketch out a typology of different situations, formal and informal, in which researchers transformed into experts are called to collaborate. During their missions related to radon, experts are exposed to 'legal risks', particularly in terms of civil liability or 'professional' responsibility and even criminal responsibility. They face legal difficulties because their roles are not clearly defined. Such difficulties will be also described in this paper, because they are symptomatic of the lack of a legal framework for public scientific expertise. Indeed, there is a growing need to involve scientific experts in decision-making in the field of public health. At the same time, however, there is increased protest against the technocratic nature of public decision-making. We observe an increase in the attribution of blame and penal responsibility in French society, as shown in the 'contaminated blood' case in which not only blood suppliers but also public officials and now politicians have been or are being prosecuted. Radon, which is a domestic risk whose reduction relies entirely on homeowners, is sui generis in many ways. Nevertheless, in an analysis of scientists' roles/actions and of the legal difficulties they meet, radon can be used to illustrate the problems that arise as expertise is developed about new risks. (authors)

CURRENT ISSUES FACING THE INTRODUCTION OF HUMAN PAPILLOMAVIRUS VACCINE IN MALAYSIA

Directory of Open Access Journals (Sweden)

I-Ching Sam

2007-01-01

Full Text Available Certain human papillomavirus (HPV types are strongly associated with cervical cancer. Recently-described effective vaccines against these HPV types represent a great medical breakthrough in preventing cervical cancer. In Malaysia, the vaccine has just received regulatory approval. We are likely to face similar barriers to implementing HPV vaccination as reported by countries where vaccination has been introduced. Most women have poor understanding of HPV and its link to cervical cancer. Physicians who will be recommending HPV vaccines may not have extensive knowledge or experience with HPV-related disease. Furthermore, a vaccine against a sexually-transmitted infection may elicit negative reactions from potential recipients or their carers, particularly in a conservative society. Given the high cost of the vaccine, reaching the most vulnerable women is a concern. To foster broad acceptance of HPV vaccine, education must be provided to health care providers, parents and young women about the risks of HPV infection and the benefits of vaccination.

A motivational determinant of facial emotion recognition: regulatory focus affects recognition of emotions in faces.

Science.gov (United States)

Sassenrath, Claudia; Sassenberg, Kai; Ray, Devin G; Scheiter, Katharina; Jarodzka, Halszka

2014-01-01

Two studies examined an unexplored motivational determinant of facial emotion recognition: observer regulatory focus. It was predicted that a promotion focus would enhance facial emotion recognition relative to a prevention focus because the attentional strategies associated with promotion focus enhance performance on well-learned or innate tasks - such as facial emotion recognition. In Study 1, a promotion or a prevention focus was experimentally induced and better facial emotion recognition was observed in a promotion focus compared to a prevention focus. In Study 2, individual differences in chronic regulatory focus were assessed and attention allocation was measured using eye tracking during the facial emotion recognition task. Results indicated that the positive relation between a promotion focus and facial emotion recognition is mediated by shorter fixation duration on the face which reflects a pattern of attention allocation matched to the eager strategy in a promotion focus (i.e., striving to make hits). A prevention focus did not have an impact neither on perceptual processing nor on facial emotion recognition. Taken together, these findings demonstrate important mechanisms and consequences of observer motivational orientation for facial emotion recognition.

Empowering the Legitimacy of Municipal Decision-Making - Three Swedish Municipalities Facing the Nuclear Waste Management Issue

International Nuclear Information System (INIS)

Soederberg, Olof

2001-01-01

This paper is focussed on how municipal elected leaders in three Swedish feasibility study municipalities - Nykoeping, Oskarshamn and Tierp - have tried to ensure that future decisions by their respective municipalities will be based both on factual knowledge and on existing opinions held by the general public. These efforts have contributed to an empowerment of the legitimacy of municipal decision-making within the nuclear waste management field and, probably, also served as a factor contributing to trust building with regard to these issues. The three cases show three ways to handle the problem, although there are also common features. The municipalities of Nykoeping and Oskarshamn have been facing these issues since 1995. In the case of Tierp, the municipality was confronted in late 1998 with the task to choose a strategy for its involvement in the site selection process and then, immediately, implement that strategy. A decision to construct a final repository for spent nuclear fuel has an obvious local dimension. It is not enough that an implementer is capable of developing a method that is considered to be safe enough by the regulatory authorities and by the Government. Nor is it enough that the implementer has succeeded to choose a site that these institutions consider to be suitable. A vital condition for a successful result is also that the general public, especially people living close to the site, have trust in the process leading up to the decision - and of course also that the general public is confident that the implementer and the regulator have agreed on a sound technical solution of the disposal problem. In other words, decisions in this area by Government and regulatory authorities do not only have to comply with existing legislation (obviously decisions by such bodies have to be 'legal'); they also should have a democratic legitimacy. In a representative democracy like Sweden, with high voting participation, it may seem self-evident that the

Empowering the Legitimacy of Municipal Decision-Making - Three Swedish Municipalities Facing the Nuclear Waste Management Issue

Energy Technology Data Exchange (ETDEWEB)

Soederberg, Olof [Ministry of the Environment, Stockholm (Sweden)

2001-07-01

This paper is focussed on how municipal elected leaders in three Swedish feasibility study municipalities - Nykoeping, Oskarshamn and Tierp - have tried to ensure that future decisions by their respective municipalities will be based both on factual knowledge and on existing opinions held by the general public. These efforts have contributed to an empowerment of the legitimacy of municipal decision-making within the nuclear waste management field and, probably, also served as a factor contributing to trust building with regard to these issues. The three cases show three ways to handle the problem, although there are also common features. The municipalities of Nykoeping and Oskarshamn have been facing these issues since 1995. In the case of Tierp, the municipality was confronted in late 1998 with the task to choose a strategy for its involvement in the site selection process and then, immediately, implement that strategy. A decision to construct a final repository for spent nuclear fuel has an obvious local dimension. It is not enough that an implementer is capable of developing a method that is considered to be safe enough by the regulatory authorities and by the Government. Nor is it enough that the implementer has succeeded to choose a site that these institutions consider to be suitable. A vital condition for a successful result is also that the general public, especially people living close to the site, have trust in the process leading up to the decision - and of course also that the general public is confident that the implementer and the regulator have agreed on a sound technical solution of the disposal problem. In other words, decisions in this area by Government and regulatory authorities do not only have to comply with existing legislation (obviously decisions by such bodies have to be 'legal'); they also should have a democratic legitimacy. In a representative democracy like Sweden, with high voting participation, it may seem self-evident that

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

Food safety measurement issues. Way forward

International Nuclear Information System (INIS)

Venkatesh Iyengar

2013-01-01

Ensuring food safety (FS) is a persistent concern frequently faced by many countries. Safeguarding the quality of food that is fit for human consumption is the primary responsibility of the governmental regulatory agencies. For most part, agro-industries and food processors assume voluntary leadership for producing safe food. However, in the event of FS breach, the regulatory responsibility kicks into identify and rectify the situation. Notwithstanding whether it is the regulator or the industry that institutes the remedial action (e.g. improved hygiene and refined agricultural and manufacturing practices), the role of laboratory measurements is central in safeguarding the integrity of a functioning FS system. There are many analytical tools available to implement this task, such as validated analytical methods, natural matrix reference materials, field tested monitoring systems (proactive assessment) and effective surveillance systems (constant vigilance to prevent repeat safety violations). Way forward: existing FS tools are insufficient and should be strengthened with innovative approaches. Examples are: assembling swift intervention logistics to face FS breaches; rapid response systems including communication; robust metrology based measurement systems located at strategic locations in the country; and inter-disciplinary human resource to match the need for capacity development. These issues are discussed. (author)

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)

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

A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.

Science.gov (United States)

Hourd, Paul; Medcalf, Nicholas; Segal, Joel; Williams, David J

2015-01-01

Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.

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)

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.

The Janus-Faced Role of Gambling Flow in Addiction Issues.

Science.gov (United States)

Trivedi, Rohit H; Teichert, Thorsten

2017-03-01

Flow experience has been widely investigated in experiential activities such as sports, the performing arts, gaming, and Internet usage. Most studies focus on the positive aspects of flow experience and its effect on performance. In stark contrast, gambling research focusing on the negative side of addiction lacks an in-depth investigation of gamblers' (positive) flow encounters. This separation of research lines seems out of place given that recent research indicates connections between flow and addiction. Joining both constructs in a causal-effects model helps one gain a better understanding of their relationship and its contingencies. This article empirically investigates whether and how it is possible to observe a "Janus face" of flow with its various sub-dimensions in online gambling. Empirical data were collected from 500 online gamblers by applying a structured questionnaire with established scales. The data were analyzed with a confirmatory factor analysis and a double-hurdle model to separate casual gamblers who are unsusceptible to any addiction issues from gamblers affected by initiatory addiction issues. The findings indicate that online gambling addiction is negatively influenced by two sub-dimensions of flow experience, namely a sense of control and concentration on the task at hand, whereas it is enhanced by a transformation of time and autotelic experience.

Challenges in developing TSO to provide technical support in nuclear safety and security to Pakistan Nuclear Regulatory Authority

International Nuclear Information System (INIS)

Mallick, Shahid A.; Sherwani, Uzman Habib; Mehdi, M. Ammar

2010-01-01

This paper highlights the needs for the establishment of a technical support organization (TSO) in Pakistan Nuclear Regulatory Authority (PNRA), challenges faced during its development, application of training need assessment required for the competency development of its technical manpower and difficulties encountered after its evolution. Key issues addressed include recruitment of technical manpower and enhancing their competencies, acquisition of proper tools required for safety review and assessment, development of a sustainable education and training program consistent with the best international practices and taking the measures to get confidence of the regulatory body. (author)

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).

Risk in the Clouds?: Security Issues Facing Government Use of Cloud Computing

Science.gov (United States)

Wyld, David C.

Cloud computing is poised to become one of the most important and fundamental shifts in how computing is consumed and used. Forecasts show that government will play a lead role in adopting cloud computing - for data storage, applications, and processing power, as IT executives seek to maximize their returns on limited procurement budgets in these challenging economic times. After an overview of the cloud computing concept, this article explores the security issues facing public sector use of cloud computing and looks to the risk and benefits of shifting to cloud-based models. It concludes with an analysis of the challenges that lie ahead for government use of cloud resources.

Survey of state regulatory activities on least cost planning for gas utilities

International Nuclear Information System (INIS)

Goldman, C.A.; Hopkins, M.E.

1991-04-01

Integrated resource planning involves the creation of a process in which supply-side and demand-side options are integrated to create a resource mix that reliably satisfies customers' short-term and long-term energy service needs at the lowest cost. Incorporating the concept of meeting customer energy service needs entails a recognition that customers' costs must be considered along with the utility's costs in the economic analysis of energy options. As applied to gas utilities, an integrated resource plan seeks to balance cost and reliability, and should not be interpreted simply as the search for lowest commodity costs. All state commissions were surveyed to assess the current status of gas planning and demand-side management and to identify significant regulatory issues faced by commissions during the next several years. The survey was to determine the extent to which they have undertaken least-cost planning for gas utilities. The survey included the following topics: (1) status of state PUC least-cost planning regulations and practices for gas utilities; (2) type and scope ofnatural gas DSM programs in effect, includeing fuel substitution; (3) economic tests and analysis methods used to evaluate DSM programs; (4) relationship between prudence reviews of gas utility purchasing practices and integrated resource planning; and (5) key regulatory issues facing gas utilities during the next five years. 34 refs., 6 figs., 10 tabs

Financial problems facing the manufacturers of small wind energy conversion systems. Final report

Energy Technology Data Exchange (ETDEWEB)

Bolle, T G

1979-11-01

The financial barriers faced by the manufacturers of small wind energy conversion systems (SWECS) are assessed and found to be similar to those faced by other start up businesses. However, these problems are found to be aggravated by the high expectations for accelerated SWECS industry growth in the face of moderate government support and lack of investment capital. The underlying conditions of limited SWECS entrepreneur business experience, the highly competitive venture capital market, the inability of existing financial institutions to aid infant busineses and public unawareness of SWECS are reviewed. Specific manufacturer-oriented recommendations and federal, state and regulatory policy-oriented recommendations are made. In addition, the dynamics of the SWECS commercialization process are assessed and the variety of financial institutions playing a role in this process is detailed. Issues related to inflation, tax policy, regulation and federal R and D procurement policies are analyzed.

Breast cancer: a study of the psychosocial issues faced by women undergoing radiation therapy

Energy Technology Data Exchange (ETDEWEB)

Burnie, C. [Hamilton Regional Cancer Centre, Hamilton, Ontario (Canada)

2000-09-30

The purpose of this study was to determine the psychosocial issues faced by post lumpectomy women with early stage breast cancer undergoing radical radiation to the affected breast. Twenty-five women in their second to fifth week of treatment were given the survey to determine these issues. Responses were then grouped by age category and results compiled. Regardless of age, a majority of women felt that they and their spouses had become closer since their diagnosis and described their spouses as being supportive. Scheduling appointment times around childcare was important for some women. Almost half of the women experienced a change in employment status as a result of their diagnosis. Appointment times and work schedules were important for some women still working. In all age groups, women experienced fatigue at least sometimes. (author)

Breast cancer: a study of the psychosocial issues faced by women undergoing radiation therapy

International Nuclear Information System (INIS)

Burnie, C.

2000-01-01

The purpose of this study was to determine the psychosocial issues faced by post lumpectomy women with early stage breast cancer undergoing radical radiation to the affected breast. Twenty-five women in their second to fifth week of treatment were given the survey to determine these issues. Responses were then grouped by age category and results compiled. Regardless of age, a majority of women felt that they and their spouses had become closer since their diagnosis and described their spouses as being supportive. Scheduling appointment times around childcare was important for some women. Almost half of the women experienced a change in employment status as a result of their diagnosis. Appointment times and work schedules were important for some women still working. In all age groups, women experienced fatigue at least sometimes. (author)

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

Safety culture and organizational issues during transition from operation to decommissioning of NPPs

International Nuclear Information System (INIS)

Slavcheva, K.; Mori, M.; D'Amico, N.; Sollima, C.

2005-01-01

The paper highlights the critical safety issues in a Nuclear Power Plant (NPP) to be managed during the transition period from operation to decommissioning. Pre-shutdown is an important period of a NPP lifetime due to the changes and issues to be faced by the NPP management, which include safety culture issues, organizational issues, plant safety issues and nuclear waste issues. Preservation of staff competence and moral, management and organizational capability, preservation of knowledge and corporate memory, preservation of safety culture, surveillance and permanent control to maintain adequate level of nuclear and radiation safety, development of appropriate solutions for the new incoming issues are the key challenges to be timely faced. The uncertainty regarding the future of the site, the future of the workers and the incoming re-organization originate numerous additional issues including stress for the personnel. It is necessary to take appropriate actions to reduce the uncertainty. The regulatory regime continues with the same rules as during operation. Responsibility for safety remains with the licensee and the regulatory supervision continues and oversees the safe operation and security of the NPP, the safe management and storage of spent nuclear fuel and radioactive waste. Anticipated attention from the Operator and the Regulator to key organizational and safety culture issues during the pre-shutdown phase has shown to be an effective preventive action. The Operator has to aim to preserve staff competence and motivation, preserve corporate memory, safety culture, reinforce monitoring and control on the health risk of workers and population, preserve the technical part of the organization from external disturb and distractions, ensure transparency and develop strategies to solve forthcoming issues. The Regulator has to aim to reorient its supervision, train its personnel and adapt its tools to the new situation, keep adequate presence onsite, keep dialogue

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.

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

NPT: the issues facing the Geneva PrepCom

International Nuclear Information System (INIS)

Hautecouverture, Benjamin

2013-04-01

instigating the organisation of two preparatory seminars in 2011 and 2012. The implementation of chapter 4 of the Action Plan is thus up and running. The postponement of the Helsinki Conference will not concretely undermine the upcoming second PrepCom, despite the fact that ensuring that this conference goes ahead represents one the key issues facing the current review cycle. The examination of issues related to non-respect of NPT provisions and the abuse of the right to withdraw from the Treaty, incommensurate with the setback outline above, has in reality become the major challenge of the five-year cycle. Should the State Parties to the NPT fail to seriously deal with the conventional implications of the two proliferation crises ongoing since the turn of the century (namely Iran and North Korea), they would risk once again accentuating the hiatus between a multilateral diplomatic reality and the regional security consequences that comprise its ultimate goal. Let us not forget that the argument that states that the NPT Review Cycle is not the framework in which to examine regional issues does not hold water: firstly, the examination of the goal of a Middle East WMDFZ demonstrates precisely the opposite; next, it is not the Iranian and North Korean cases in of themselves that should be addressed in the NPT forum - it is clear that the search for a resolution of these two crises should continue along parallel diplomatic paths -, but instead their effects on the global nuclear nonproliferation norm. Finally, it is very much the authority of the NPT as an instrument and a guarantee of international security that is the key stake facing the upcoming PrepCom. This should have been the case in New York in 2010 and was not sufficiently so. (author)

75 FR 18202 - Notice of Indo-U.S. Regulatory Workshop

Science.gov (United States)

2010-04-09

... regulatory challenges faced by commissioners from both nations. The FERC Commissioners, along with other... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Indo-U.S. Regulatory Workshop April 1, 2010. Commissioner Philip D. Moeller will convene a workshop at the Federal Energy Regulatory...

Value-impact analysis of regulatory options for resolution of Generic Issue C-8: MSIV [Main Steam Isolation Valve] leakage and LCS [Leakage Control System] failure

International Nuclear Information System (INIS)

Jamison, J.D.; Vo, T.V.; Tabatabai, A.S.

1990-05-01

This report describes the analysis conducted to establish the basis for answering two remaining regulatory questions facing the NRC staff regarding the resolution of Generic Issue C-8, specifically:(1) What action should the NRC take concerning plants that currently have a leakage control system (LCS)? and, (2) What action should the NRC take concerning plants that do not have an LCS? Using individual MSIV leak test data, the performance of a system of eight such valves in a standard BWR con-figuration was modeled. The performance model was used along with estimates of core damage accident frequency and calculated dose consequences to determine the public risk associated with each of the alternatives. The occupational exposure implications of each alternative were calculated using estimates of labor hours in radiation zones that would be incurred or avoided. The costs to industry of implementing each alternative were estimated using standard cost formulae and NRC staff estimates. The cost to the NRC were estimated based on the effort incurred or avoided for reviews or other staff actions engendered by the selection of or avoided for reviews or other staff actions engendered by the selection of a particular alternative. The cost and risks thus calculated suggest that no regulatory action can be justified on the basis of risk reduction or cost savings. 12 refs., 1 tab

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

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.

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 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.

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.

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)

Introduction to the Social Media + Society Special Issue on Selfies: Me-diated Inter-faces

Directory of Open Access Journals (Sweden)

Katie Warfield

2016-04-01

Full Text Available This introduction to the special issue entitled Me-diated Inter-faces begins by bringing into question the concept of positioning: what is it that we are doing when we take a position within the study of social media? Reviewing the work of the inaugural manifestos of the journal Social Media + Society on one hand, and the introduction to the special issue on selfies for the International Journal of Communications on the other, this introduction provides both critical and creative in-roads for thinking and re-thinking digital self-images shared on social media. Given the constantly changing nature of social media, this paper is a call to researchers of social media to not fall prey to the ossification of our current positions since theorizing the “social” in social media means always at once theorizing the body. As such this intro offers numerous and diverse perspectives on the body that might inform emerging thoughts on the socially media body. The introduction then provides an overview of the papers in this special issue and concludes by offering openings and ruptures for further discussion, rather than closure of conclusions.

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

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

Talking about epilepsy: Challenges parents face when communicating with their child about epilepsy and epilepsy-related issues.

Science.gov (United States)

O'Toole, Stephanie; Lambert, Veronica; Gallagher, Pamela; Shahwan, Amre; Austin, Joan K

2016-04-01

The aim of this qualitative study was to explore the challenges that parents of children with epilepsy experienced when engaging in dialog with their child about epilepsy and epilepsy-related issues. Using a qualitative exploratory approach, interviews were conducted with 34 parents of children with epilepsy (aged 6-16 years), consisting of 27 mothers and 7 fathers. Data were transcribed verbatim and thematically analyzed. Findings revealed five main themes: normalizing epilepsy, the invisibility of epilepsy, information concealment, fear of misinforming the child, and difficulty in discussing particular epilepsy-related issues. Many of the communicative challenges experienced by parents impacted on their ability to engage openly in parent-child dialog about epilepsy in the home. Parents face specific challenges when choosing to communicate with their child about epilepsy, relating to creating a sense of normality, reducing fear of causing their child worry, and having a lack of epilepsy-related knowledge. Healthcare professionals who work closely with families living with epilepsy should remain mindful of the importance of discussing family communication surrounding epilepsy and the challenges parents of children with epilepsy face when talking about epilepsy within the home. Copyright © 2016 Elsevier Inc. All rights reserved.

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

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)

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.

Effects of Face-to-Face and Computer-Mediated Constructive Controversy on Social Interdependence, Motivation, and Achievement

Science.gov (United States)

Roseth, Cary J.; Saltarelli, Andy J.; Glass, Chris R.

2011-01-01

Cooperative learning capitalizes on the relational processes by which peers promote learning, yet it remains unclear whether these processes operate similarly in face-to-face and online settings. This study addresses this issue by comparing face-to-face and computer-mediated versions of "constructive controversy", a cooperative learning procedure…

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 ...

A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.

Science.gov (United States)

Aljadhey, Hisham; Mahmoud, Mansour A; Alshammari, Thamir M; Al-Dhaeefi, Mohammed; Le Louet, Herve; Perez-Gutthann, Susana; Pitts, Peter J

2015-09-01

To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice.  Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training.  The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.

Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective.

Science.gov (United States)

Johnson, F Reed; Zhou, Mo

Demands for greater transparency in US regulatory assessments of benefits and risks, together with growing interest in engaging patients in Food and Drug Administration regulatory decision making, have resulted in several recent regulatory developments. Although Food and Drug Administration's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have established patient-engagement initiatives, CDRH has proposed guidelines for considering quantitative data on patients' benefit-risk perspectives, while CDER has focused on a more qualitative approach. We summarize two significant studies that were developed in collaboration and consultation with CDER and CDRH. CDER encouraged a patient advocacy group to propose draft guidance on engaging patient and caregiver stakeholders in regulatory decision making for Duchenne muscular dystrophy. CDRH sponsored a discrete-choice experiment case study to quantify obese respondents' perspectives on "meaningful benefits." CDRH and CDER issued draft guidance in May and June 2015, respectively, on including patient-preference data in regulatory submissions. Both organizations face challenges. CDER is working on integrating qualitative data into existing evidence-based review processes and is exploring options for therapeutic areas not included on a priority list. CDRH has adopted an approach that requires patient-preference data to satisfy standards of valid scientific evidence. Although that strategy could facilitate integrating patient perspectives directly with clinical data on benefits and harms, generating such data requires building capacity. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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

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

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

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

International Nuclear Information System (INIS)

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

1999-01-01

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

Strengthening Regulatory Effectiveness in India – Lessons Learnt from Fukushima Accident

International Nuclear Information System (INIS)

Solanki, R.

2016-01-01

Following the Fukushima Daiichi accident in Japan, one of the most important lessons learnt, among other things, was the issue of strengthening the effectiveness of the regulatory bodies. Immediately after the Fukushima accident, National level safety audits were conducted on all operating NPPs in India to review safety of NPPs in India. A national action plan has been prepared to implement the identified short term, midterm and long term measures. The assessment indicates that national response to the Fukushima Accident for safety assessment of NPPs and subsequent actions and initiatives taken for safety enhancement of the NPPs in India are in-line with the objectives of the IAEA Action plan. This paper highlights the actions taken by India in the light of Fukushima Daiichi accident in order to strengthen the regulatory effectiveness through improvements in the existing core processes, challenges faced, Insights gained from the recent initiatives on safety performance indicators and assessment of safety culture, relevant observations of IRRS mission report and Indian perspectives on the further cooperation among the member states for enhancing the regulatory effectiveness for nuclear oversight of regulated organizations. (author)

Safety characteristics of options for plasma-facing components for ITER and beyond

International Nuclear Information System (INIS)

Piet, S.J.; McCarthy, K.A.; Holland, D.F.; Longhurst, G.R.; Merrill, B.J.

1991-01-01

Plasma-facing components (PFC) likely dominate the safety hazards of the International Thermonuclear Experimental Reactor (ITER) and post-ITER machines. To gain regulatory approval and for fusion energy to fulfill its ultimate attractive safety and environmental potential, safety must be considered when selecting among PFC options. This paper summarizes current PFC safety information. PFC safety issues fall into seven areas: disruption tolerance, disruption severity, tritium inventory and permeation, accidental energy release, activation/toxin hazards, cooling disturbances, and system issues. RFC options include current ITER mainline options (Be or W coating, C tiles), variants on current ITER options, and liquid metal (LM) divertors. No PFC option that we have examined is free of critical safety concerns. There are also innovative ideas that may improve any PFC's performance -- super-permeable vacuum ducts, helium self-pumping, and gaseous divertors. We conclude with recommendations and a future strategy. 17 refs., 1 fig., 3 tabs

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...

Some issues regarding regulatory policy, political participation, and social implications of geothermal resource development in the Imperial Valley

Energy Technology Data Exchange (ETDEWEB)

Green, P.S.; Steinberger, M.F.

1976-02-01

The early stages of geothermal resource development in the Imperial Valley have been characterized by an emphasis on the technological expertise of private developers and government officials. Government officials have created a complex array of Federal, state and county regulations to monitor the development. Local control is under the jurisdiction of the Imperial County government. The County has as its responsibility the protection of the general welfare of its residents, including any potentially adverse social, economic, or environmental impacts caused by geothermal resource development. Private developers and government officials are interested in the resources as a source of water desalination and electric power generation. An assessment of the interests and concerns of the public was made early in the development stage. In view of all these interests, it is essential in a democratic society that the various interests be identified so government can be representative of, and responsive to, those interests. Therefore, the four issues discussed in the paper are: (1) regulatory problems faced by local government officials in determining the course of development; (2) the social and political context in which the development is taking place; (3) the potential of geothermal development as perceived by community leaders and local government officials; and (4) the desirability of expanding citizen participation in geothermal decision-makingduring a period in which, as public opinion polls indicated, many citizens feel separated from government actions which may significantly affect their lives. Recommendations for regulations of geothermal resources and recommendations for improving public input into geothermal regulation are summarized in depth. (MCW)

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)

Configuration perception and face memory, and face context effects in developmental prosopagnosia.

Science.gov (United States)

Huis in 't Veld, Elisabeth; Van den Stock, Jan; de Gelder, Beatrice

2012-01-01

This study addresses two central and controversial issues in developmental prosopagnosia (DP), configuration- versus feature-based face processing and the influence of affective information from either facial or bodily expressions on face recognition. A sample of 10 DPs and 10 controls were tested with a previously developed face and object recognition and memory battery (Facial Expressive Action Stimulus Test, FEAST), a task measuring the influence of emotional faces and bodies on face identity matching (Face-Body Compound task), and an emotionally expressive face memory task (Emotional Face Memory task, FaMe-E). We show that DPs were impaired in upright, but not inverted, face matching but they performed at the level of controls on part-to-whole matching. Second, DPs showed impaired memory for both neutral and emotional faces and scored within the normal range on the Face-Body Compound task. Third, configural perception but not feature-based processing was significantly associated with memory performance. Taken together the results indicate that DPs have a deficit in configural processing at the perception stage that may underlie the memory impairment.

Cultural and hierarchical influences: ethical issues faced by Taiwanese nursing students.

Science.gov (United States)

Yeh, Mei-Yu; Wu, Shu-Mei; Che, Hui-Lian

2010-05-01

OBJECTIVES Improving nurses' competence in resolving clinical ethical issues must start with ethics education in training and clinical practice. However, many students complain that they cannot apply classroom learning to actual clinical scenarios. This study explored ethical issues and dilemmas, and their impact experienced by student nurses in clinical practice. METHODS Focus groups were conducted with 44 first-year student nurses from a 2-year college course in northern Taiwan. Interviews were tape-recorded and verbatim transcripts were analysed using content analysis. RESULTS Students expressed and discussed their views in eight focus groups. Analysis of interviews revealed five themes: frustration at inability to help some patients; oppression caused by lower status; lack of honesty and ethical courage; powerlessness, and self-encouragement in adversity. CONCLUSIONS Taiwanese nurse ethics training was only recently introduced and the curriculum has not addressed the clinical reality in Taiwan. This reality includes limitations arising from the medical hierarchy and the socio-cultural role of families in medical decision making, which may inhibit ethical judgements and decision making. In clinical dilemmas, the most common problems faced by Taiwanese nursing students involved not knowing how to handle some situations, inability to abide by principles, and a lack of appropriate role models. Hence, we suggest that nursing ethics education should: (i) integrate scenarios involving ethical dilemmas into daily routines; (ii) give students opportunities to discuss their feelings about their experiences; (iii) allow teachers and students to talk about scenarios with ethical implications, and (iv) provide students with opportunities to reflect on clinical scenarios in order to clarify their values and learn how to respect the value of life.

Regulatory frameworks for decentralised energy

International Nuclear Information System (INIS)

Woodman, Bridget; Baker, Philip

2008-01-01

This paper considers aspects of the current regulatory frameworks for markets and infrastructure which can inhibit the deployment of decentralised energy. The government has stated that decentralised energy can make a positive contribution to reducing the UK's carbon emissions, but recognises that at the moment the technologies face market and regulatory barriers. If it is to become a viable alternative to centralised generation, energy market design and the regulation of energy infrastructure will have to evolve to ensure that decentralised options are no longer locked out. (author)

The Wharton Symposium: Facing the Issues.

Science.gov (United States)

Sullivan, David M.

1982-01-01

A public relations practitioner reports enthusiastically on his return to the campus for an "intellectually-broadening" public relations symposium. He summarizes critical social and economic issues addressed by distinguished scholars and experienced practitioners. For journal availability, see CS 705 902. (PD)

Development of a framework for identification of political environmental issues faced by multinational hotel chains in newly industrialized countries in Asia

OpenAIRE

Kim, Chol Yong

1992-01-01

The primary/objective of this study was to develop a framework for identification of political environmental issues faced by multinational hotel chains in newly industrialized countries in Asia. To accomplish the objective, key factors having an impact upon these hotel chains were identified using the Delphi Technique.

International conference on challenges faced by technical and scientific support organizations in enhancing nuclear safety. Contributed papers and presentations

International Nuclear Information System (INIS)

2007-01-01

Over the past two decades, the IAEA has conducted a series of major conferences that have addressed topical issues and strategies critical to nuclear safety for consideration by the world's nuclear regulators. More recently, the IAEA organized the International Conference on Effective Nuclear Regulatory Systems - Facing Safety and Security Challenges, held in Moscow in 2006. The Moscow conference was the first of its kind, because it brought together senior regulators of nuclear safety, radiation safety and security from around the world to discuss how to improve regulatory effectiveness with the objective of improving the protection of the public and the users of nuclear and radioactive material. The International Conference on Challenges Faced by Technical and Scientific Support Organizations in Enhancing Nuclear Safety was held in Aix-en-Provence, France, from 23 to 27 April 2007. This conference, again, was the first of its kind, because it was the first to address technical and scientific support organizations (TSOs), the role they play in supporting either the national regulatory bodies or the industry in making optimum safety decisions and the challenges they face in providing this support. This conference provided a forum for the TSOs to discuss these and other issues with the organizations to which they provide this support - that is, the regulators and the operators/industry - as well as with other stakeholders such as research organizations and public authorities. This conference can also be considered to have a link to the Moscow conference. The Moscow conference concluded that effective regulation of nuclear safety is vital for the safe use of nuclear energy and associated technologies, both now and in the future, and is an essential prerequisite for establishing an effective Global Nuclear Safety Regime. The Moscow conference also highlighted the importance of continued and improved international cooperation in the area of nuclear safety. These

Effects of Synchronicity and Belongingness on Face-to-Face and Computer-Mediated Constructive Controversy

Science.gov (United States)

Saltarelli, Andy J.; Roseth, Cary J.

2014-01-01

Adapting face-to-face (FTF) pedagogies to online settings raises boundary questions about the contextual conditions in which the same instructional method stimulates different outcomes. We address this issue by examining FTF and computer-mediated communication (CMC) versions of constructive controversy, a cooperative learning procedure involving…

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.

The Secrets of Faces

OpenAIRE

Enquist, Magnus; Ghirlanda, Stefano

1998-01-01

This is a comment on an article by Perrett et al., on the same issue of Nature, investigating face perception. With computer graphics, Perrett and colleagues have produced exaggerated male and female faces, and asked people to rate them with respect to femininity or masculinity, and personality traits such as intelligence, emotionality and so on. The key question is: what informations do faces (and sexual signals in general) convey? One view, supported by Perrett and colleagues, is that all a...

Challenges and issues facing the future of nursing education: implications for ethnic minority faculty and students.

Science.gov (United States)

Davis, Sheila P; Davis, Danyetta D

2010-01-01

Current trends in higher education in the United States demand that nursing take stock of how it is prepared or being prepared to face challenges and issues impacting on its future. The intense effort made to attract students to pursue advanced training in science and engineering in the United States pales in comparison to the numbers of science and engineering majors produced yearly in international schools. As a result, more and more jobs are being outsourced to international markets. Could international outsourcing become a method of nursing education? Authors submit that to remain competitive, the nursing profession must attract a younger cohort of technologically savvy students and faculty reflective of the growing diverse population in the United States. Additionally, nursing programs in research universities face even more daunting challenges as it relates to mandates for funded research programs of educational units. This article offers suggestions and recommendations for nursing programs in higher education institutions on ways to attract and retain ethnic minorities and of how to harness the power of research to address burgeoning societal health challenges.

The Effects of Health Education through Face To Face Teaching and Educational Movies, on Suburban Women in Childbearing Age.

Science.gov (United States)

Vameghi, R; Mohammad, K; Karimloo, M; Soleimani, F; Sajedi, F

2010-01-01

The aim of the study was to compare the effects of 'face-to-face education' and 'educational movies' on 'knowledge' and 'practice' of women of child-bearing-age, in terms of health-care during pregnancy and during infancy in a suburban region near Tehran City, Iran. In this quasi-experimental study, the sample included 873 married women. Questionnaires for knowledge and practice assessment were designed. The women were assigned to three groups: control (group I), face-to-face education (group II), and educational movie (group III). Knowledge questionnaires were completed before and immediately after intervention. Practice questionnaires were completed before and three months after intervention. Both questionnaires consisted of two types of questions: type A (concerning infant care issues) and type B (concerning prenatal health care). There was a significant difference in post-test knowledge between groups I and II and between groups I and III, but not between groups II and III. In terms of post-test practice, the changes were determined for every individual question, and significantly, better results were seen in group II, especially concerning type B questions. Face to face education lead to better practice than educational movies. In addition, significantly better practice occurred regarding child health care issues rather than prenatal issues in both groups. Realistic and tangible issues, those easy to practice, and with little or no economical burden imposed on the family, progressed from the knowledge state to the practice state more successfully in both groups.

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.

Urban science education: examining current issues through a historical lens

Science.gov (United States)

McLaughlin, Cheryl A.

2014-12-01

This paper reviews and synthesizes urban science education studies published between 2000 and 2013 with a view to identifying current challenges faced by both teachers and students in urban classrooms. Additionally, this paper considers the historical events that have shaped the conditions, bureaucracies, and interactions of urban institutions. When the findings from these urban science education studies were consolidated with the historical overview provided, it was revealed that the basic design and regulatory policies of urban schools have not substantively changed since their establishment in the nineteenth century. Teachers in urban science classrooms continue to face issues of inequality, poverty, and social injustice as they struggle to meet the needs of an increasingly diverse student population. Furthermore, persistent concerns of conflicting Discourses, cultural dissonance, and oppression create formidable barriers to science learning. Despite the many modifications in structure and organization, urban students are still subjugated and marginalized in systems that emphasize control and order over high-quality science education.

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

Collaborative Random Faces-Guided Encoders for Pose-Invariant Face Representation Learning.

Science.gov (United States)

Shao, Ming; Zhang, Yizhe; Fu, Yun

2018-04-01

Learning discriminant face representation for pose-invariant face recognition has been identified as a critical issue in visual learning systems. The challenge lies in the drastic changes of facial appearances between the test face and the registered face. To that end, we propose a high-level feature learning framework called "collaborative random faces (RFs)-guided encoders" toward this problem. The contributions of this paper are three fold. First, we propose a novel supervised autoencoder that is able to capture the high-level identity feature despite of pose variations. Second, we enrich the identity features by replacing the target values of conventional autoencoders with random signals (RFs in this paper), which are unique for each subject under different poses. Third, we further improve the performance of the framework by incorporating deep convolutional neural network facial descriptors and linking discriminative identity features from different RFs for the augmented identity features. Finally, we conduct face identification experiments on Multi-PIE database, and face verification experiments on labeled faces in the wild and YouTube Face databases, where face recognition rate and verification accuracy with Receiver Operating Characteristic curves are rendered. In addition, discussions of model parameters and connections with the existing methods are provided. These experiments demonstrate that our learning system works fairly well on handling pose variations.

Regulatory system reform of occupational health and safety in China.

Science.gov (United States)

Wu, Fenghong; Chi, Yan

2015-01-01

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

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)

Issues facing the U. S. mirror program

Energy Technology Data Exchange (ETDEWEB)

George, T.V.

1978-07-01

Some of the current issues associated with the U.S. Magnetic Mirror Program are analyzed. They are presented as five separate papers entitled: (1) Relevant Issues Broughtup by the Mirror Reactor Design Studies. (2) An Assessment of the Design Study of the 1 MeV Neutral Beam Injector Required for a Tandem Mirror Reactor. (3) The Significance of the Radial Plasma Size Measured in Units of Ion Gyroradii in Tandem Mirrors and Field Reversed Mirrors. (4) Producing Field Reversed Mirror Plasmas by Methods used in Field Reversed Theta Pinch. (5) RF Stoppering of Mirror Confined Plasma.

The critical issue of nuclear power plant safety in developing countries

International Nuclear Information System (INIS)

Rosen, M.

1977-01-01

A little more than a decade from now, large commercial nuclear power facilities will be in operation in almost 40 countries, of which approximately one-half are presently considered industrially less developed. Ambitious nuclear programmes coupled with minimal and frequently under-staffed regulatory and utility organizations are only one aspect of the difficulties related to the safety of nuclear plants that face these developing countries. Inherent problems of meeting current safety standards and requirements for the significantly non-standard nuclear power plant exports can be compounded by financial considerations that may lead to purchases of reactors of various types, from more than one supplier country and with different safety standards and requirements. An examination of these issues points to the necessity and opportunity for effective action which could include provision for adequate funding for safety considerations in the purchase contract, and for sufficient regulatory assistance and training from the developed countries. The article will introduce the topic, discuss specific examples, and offer some suggestions. (author)

State policies affecting natural gas consumption (Notice of inquiry issued on August 14, 1992)

International Nuclear Information System (INIS)

Lemon, R.; Kamphuis-Zatopa, W.

1993-01-01

On August 14, 1992, the United States Department of Energy issued a Request for Comments Concerning State Policies Affecting Natural Gas Consumption. This Notice of (NOI) noted the increasing significance of the role played by states and sought to gain better understanding of how state policies impact the gas industry. The general trend toward a. more competitive marketplace for natural gas, as well as recent regulatory and legislative changes at the Federal level, are driving State regulatory agencies to reevaluate how they regulate natural gas. State action is having a significant impact on the use of natural gas for generating electricity, as well as affecting the cost-effective trade-off between conservation expenditures and gas use. Additionally, fuel choice has an impact upon the environment and national energy security. In light of these dimensions, the Department of Energy initiated this study of State regulation. The goals of this NOI are: (1) help DOE better understand the impact of State policies on the efficient use of gas; (2) increase the awareness of the natural gas industry and Federal and State officials to the important role of State policies and regulations; (3) create an improved forum for dialogue on State and Federal natural gas issues; and, (4) develop a consensus on an analytical agenda that would be most helpful in addressing the regulatory challenges faced by the States. Ninety-seven parties filed comments, and of these ninety-seven, fifteen parties filed reply comments. Appendix One lists these parties. This report briefly syntheses the comments received. The goal is to assist parties to judging the extent of consensus on the problems posed and the remedies suggested, aid in identifying future analytical analyses, and assist parties in assessing differences in strategies and regulatory philosophies which shape these issues and their resolution

Regulatory control, nuclear safety regulation and waste management in Spain

International Nuclear Information System (INIS)

Martin, A.

2000-01-01

This article presents the challenges that faces the spanish regulatory authority. The deregulation of electricity industry imposes severe changes in nuclear power economics and forces nuclear power to compete with other sources of electricity. A pressure is perceived for regulatory effectiveness primarily since the cost of regulation is a component of the cost of the product. This effectiveness gain in regulatory control will be reached through systematic strategic analysis, formulation and implementation. The regulatory aspects of plant life extension and of waste management are examined

The management of high-level nuclear wastes - Issues politicians face regarding the risk of ionizing radiation

International Nuclear Information System (INIS)

Bataille, C.

1992-01-01

The management of ionizing radiation is not a new issue, and it is not a subject that could be easily communicated with the general public. Politicians responsible for decision making are faced with the public who are concerned with the risks. Without general acceptance and support from the public, nuclear programs can not be pursued. The author provides three key guidelines for politicians to follow, the same advice given to the French Parliament earlier: addressing the protection of the population and environment in a responsible manner, assuming an open, non secretive and transparent approach, and adopting a democratic attitude to allow public participation in decision making

A face a mother could love: depression-related maternal neural responses to infant emotion faces.

Science.gov (United States)

Laurent, Heidemarie K; Ablow, Jennifer C

2013-01-01

Depressed mothers show negatively biased responses to their infants' emotional bids, perhaps due to faulty processing of infant cues. This study is the first to examine depression-related differences in mothers' neural response to their own infant's emotion faces, considering both effects of perinatal depression history and current depressive symptoms. Primiparous mothers (n = 22), half of whom had a history of major depressive episodes (with one episode occurring during pregnancy and/or postpartum), were exposed to images of their own and unfamiliar infants' joy and distress faces during functional neuroimaging. Group differences (depression vs. no-depression) and continuous effects of current depressive symptoms were tested in relation to neural response to own infant emotion faces. Compared to mothers with no psychiatric diagnoses, those with depression showed blunted responses to their own infant's distress faces in the dorsal anterior cingulate cortex. Mothers with higher levels of current symptomatology showed reduced responses to their own infant's joy faces in the orbitofrontal cortex and insula. Current symptomatology also predicted lower responses to own infant joy-distress in left-sided prefrontal and insula/striatal regions. These deficits in self-regulatory and motivational response circuits may help explain parenting difficulties in depressed mothers.

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 system reform of occupational health and safety in China

Science.gov (United States)

WU, Fenghong; CHI, Yan

2015-01-01

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

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

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

Energy Technology Data Exchange (ETDEWEB)

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

1996-07-01

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

IAEA Mission Concludes Peer Review of Jordan's Nuclear Regulatory Framework

International Nuclear Information System (INIS)

2014-01-01

Senior international nuclear safety and radiation protection experts today concluded an 11-day International Atomic Energy Agency (IAEA) Integrated Regulatory Review Service (IRRS) mission to review the regulatory framework for nuclear and radiation safety in Jordan. The mission team said in its preliminary findings that Jordan's nuclear regulator, the Energy and Minerals Regulatory Commission (EMRC), faces challenges because it is a relatively new body that handles a high workload while also working to recruit, train and keep competent staff. The team also noted that a recent merger provided the regulator with more of the resources it needs to perform its duty. The team made recommendations and suggestions to the regulatory body and the Government to help them strengthen the effectiveness of Jordan's regulatory framework and functions in line with IAEA Safety Standards. The main observations of the IRRS Review team comprised the following: The regulatory body, founded in 2007 and merged with other regulators in April 2014 to form EMRC, faces large challenges in terms of its regulatory workload, management system building and staff recruitment and training; The new EMRC structure and revision of the radiation and nuclear safety law represents an important opportunity to strengthen Jordan's radiation and nuclear safety infrastructure; The Government has shown commitment to radiation and nuclear safety through measures including becoming party to international conventions. It could further demonstrate its commitment by adopting a formal national policy and strategy for safety that defines the role of the Minister of Energy in relation to EMRC and protects the independence of regulatory decision-making

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.

Facing Diabetes: What You Need to Know

Science.gov (United States)

... of this page please turn Javascript on. Feature: Diabetes Facing Diabetes: What You Need to Know Past Issues / Fall ... your loved ones. Photos: AP The Faces of Diabetes Diabetes strikes millions of Americans, young and old, ...

Limits of the current EU regulatory framework on GMOs: risk of not authorized GM event-traces in imports

Directory of Open Access Journals (Sweden)

Roïz Julie

2014-11-01

Full Text Available Since their first commercialization in the 1990’s, the number of genetically modified organisms (GMOs cultivated around the world has steadily increased. This development has been accompanied by the development of regulatory and policy environments which vary from one country to another. Today, the European food and feed sectors are faced with the increasing risk of finding traces of not authorized GMOs in imports. Under the EU zero tolerance for unapproved GMOs, this situation may lead to trade disruptions with important cost implications. A regulatory environment which minimizes the risk of such disruption is therefore indispensable. To address this issue, the EU has adopted the “technical solution” but this remains insufficient to provide the necessary legal certainty which is needed to operate in such context. More comprehensive approaches are considered globally through low level presence policies.

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.

Interpersonal Similarity between Body Movements in Face-To-Face Communication in Daily Life

OpenAIRE

Higo, Naoki; Ogawa, Ken-ichiro; Minemura, Juichi; Xu, Bujie; Nozawa, Takayuki; Ogata, Taiki; Ara, Koji; Yano, Kazuo; Miyake, Yoshihiro

2014-01-01

Individuals are embedded in social networks in which they communicate with others in their daily lives. Because smooth face-to-face communication is the key to maintaining these networks, measuring the smoothness of such communication is an important issue. One indicator of smoothness is the similarity of the body movements of the two individuals concerned. A typical example noted in experimental environments is the interpersonal synchronization of body movements such as nods and gestures dur...

Challenges in Strengthening Regulatory Infrastructure in a Non-Nuclear Country

International Nuclear Information System (INIS)

Bosnjak, J.

2016-01-01

The State Regulatory Agency for Radiation and Nuclear Safety (SRARNS) is established as the effectively independent regulatory body for radiation and nuclear safety based on the Law on Radiation and Nuclear Safety in Bosnia and Herzegovina promulgated in November 2007. After its complete reorganization in the last few years, the regulatory system is compatible with relevant IAEA Safety Standards and Guides for safety and security of radioactive sources. The paper gives an overview of the new regulatory framework in Bosnia and Herzegovina, with special focus on challenges faced by Bosnia and Herzegovina, which are actually typical challenges for regulator in small non-nuclear country in strengthening regulatory infrastructure in regulating radiation sources and radioactive waste. (author)

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

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

Dissociation between face perception and face memory in adults, but not children, with developmental prosopagnosia

Directory of Open Access Journals (Sweden)

Kirsten A. Dalrymple

2014-10-01

Full Text Available Cognitive models propose that face recognition is accomplished through a series of discrete stages, including perceptual representation of facial structure, and encoding and retrieval of facial information. This implies that impaired face recognition can result from failures of face perception, face memory, or both. Studies of acquired prosopagnosia, autism spectrum disorders, and the development of normal face recognition support the idea that face perception and face memory are distinct processes, yet this distinction has received little attention in developmental prosopagnosia (DP. To address this issue, we tested the face perception and face memory of children and adults with DP. By definition, face memory is impaired in DP, so memory deficits were present in all participants. However, we found that all children, but only half of the adults had impaired face perception. Thus, results from adults indicate that face perception and face memory are dissociable, while the results from children provide no evidence for this division. Importantly, our findings raise the possibility that DP is qualitatively different in childhood versus adulthood. We discuss theoretical explanations for this developmental pattern and conclude that longitudinal studies are necessary to better understand the developmental trajectory of face perception and face memory deficits in DP.

Dissociation between face perception and face memory in adults, but not children, with developmental prosopagnosia.

Science.gov (United States)

Dalrymple, Kirsten A; Garrido, Lúcia; Duchaine, Brad

2014-10-01

Cognitive models propose that face recognition is accomplished through a series of discrete stages, including perceptual representation of facial structure, and encoding and retrieval of facial information. This implies that impaired face recognition can result from failures of face perception, face memory, or both. Studies of acquired prosopagnosia, autism spectrum disorders, and the development of normal face recognition support the idea that face perception and face memory are distinct processes, yet this distinction has received little attention in developmental prosopagnosia (DP). To address this issue, we tested the face perception and face memory of children and adults with DP. By definition, face memory is impaired in DP, so memory deficits were present in all participants. However, we found that all children, but only half of the adults had impaired face perception. Thus, results from adults indicate that face perception and face memory are dissociable, while the results from children provide no evidence for this division. Importantly, our findings raise the possibility that DP is qualitatively different in childhood versus adulthood. We discuss theoretical explanations for this developmental pattern and conclude that longitudinal studies are necessary to better understand the developmental trajectory of face perception and face memory deficits in DP. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Recycling of radioactively contaminated materials: Public policy issues

International Nuclear Information System (INIS)

Hocking, E.K.

1994-01-01

Recycling radioactively contaminated materials requires varying degrees of interaction among Federal regulatory agencies such as the Nuclear Regulatory Commission (NRC) and the Environmental Protection Agency (EPA), State governments and regulators, the public, and the Department of Energy. The actions of any of these parties can elicit reactions from the other parties and will raise issues that must be addressed in order to achieve a coherent policy on recycling. The paper discusses potential actions and reactions of Federal regulatory agencies (defined as NRC and EPA), the States, and the Department and the policy issues they raise

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.

Critical plasma-wall interaction issues for plasma-facing materials and components in near-term fusion devices

International Nuclear Information System (INIS)

Federici, G.; Coad, J.P.; Haasz, A.A.; Janeschitz, G.; Noda, N.; Philipps, V.; Roth, J.; Skinner, C.H.; Tivey, R.; Wu, C.H.

2000-01-01

The increase in pulse duration and cumulative run-time, together with the increase of the plasma energy content, will represent the largest changes in operation conditions in future fusion devices such as the International Thermonuclear Experimental Reactor (ITER) compared to today's experimental facilities. These will give rise to important plasma-physics effects and plasma-material interactions (PMIs) which are only partially observed and accessible in present-day experiments and will open new design, operation and safety issues. For the first time in fusion research, erosion and its consequences over many pulses (e.g., co-deposition and dust) may determine the operational schedule of a fusion device. This paper identifies the most critical issues arising from PMIs which represent key elements in the selection of materials, the design, and the optimisation of plasma-facing components (PFCs) for the first-wall and divertor. Significant advances in the knowledge base have been made recently, as part of the R and D supporting the engineering design activities (EDA) of ITER, and some of the most relevant data are reviewed here together with areas where further R and D work is urgently needed

Economic issues relating to power sector

International Nuclear Information System (INIS)

Nair, S.K.N.; Mohan, Rakesh

1998-01-01

Financial distress alongside high rates of growth, stagnant organizations coexistent with upgraded technologies, richly endowed regions marked by low levels of electricity consumption and the long wait for private power in face of mounting shortfalls are among the contradictions marking the power sector. Decades of public financing support could shore up the rates of growth but forms of past intervention failed to address critical institutional and regulatory issues. Key areas that need intervention have now been identified, although several are yet to be tackled. This paper discusses the more important of the problem areas holding up significant economic gains that could be realized through cost reductions, the needed levels of investments, operation of market forces and targeting of resources to promote equitable growth. The slow pace of progress is a matter for concern. Effectiveness of many of the policy initiatives of government is also dependent on providing well thought out policy supports. (author)

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

Families Facing the Nuclear Taboo.

Science.gov (United States)

Jacobs, Judith Bula

1988-01-01

Discusses attitudes of 12 families participating in group which was formed to focus on issues related to the possibility of a nuclear disaster. Why and how these families are facing the nuclear taboo plus various outcomes of doing so are discussed as well as the role of the professional in encouraging such openness about these difficult issues.…

Legal and Regulatory Barriers to Reverse Innovation.

Science.gov (United States)

Rowthorn, Virginia; Plum, Alexander J; Zervos, John

Reverse innovation, or the importation of new, affordable, and efficacious models to high-income countries from the developing world, has emerged as a way to improve the health care system in the United States. Reverse innovation has been identified as a key emerging trend in global health systems in part because low-resourced settings are particularly good laboratories for low-cost/high-impact innovations that are developed out of necessity. A difficult question receiving scant attention is that of legal and regulatory barriers. The objective of this paper is to understand and elucidate the legal barriers faced by innovators bringing health interventions to the United States. Semistructured qualitative interviews were conducted with 9 key informants who have directly participated in the introduction of global health care approaches to the United States health system. A purposive sampling scheme was employed to identify participants. Phone interviews were conducted over one week in July 2016 with each participant and lasted an average of 35 minutes each. Purely legal barriers included questions surrounding tort liability, standard of care, and concerns around patient-administered self-care. Regulatory burdens included issues of international medical licensure, reimbursement, and task shifting and scope of work challenges among nonprofessionals (e.g. community health workers). Finally, perceived (i.e. not realized or experienced) legal and regulatory barriers to innovative modalities served as disincentives to bringing products or services developed outside of the United States to the United States market. Conflicting interests within the health care system, safety concerns, and little value placed on low-cost interventions inhibit innovation. Legal and regulatory barriers rank among, and contribute to, an anti-innovation atmosphere in healthcare for domestic and reverse innovators alike. Reverse innovation should be fostered through the thoughtful development of

Special Issues in Working with Gifted Minority Adolescents.

Science.gov (United States)

Lindstrom, Rena R.; Van Sant, Sondra

1986-01-01

Gifted adolescents from minority groups face the same issues all gifted young people face, but the addition of racial and cultural factors increases the complexity of these issues. Discusses individual versus cultural pressures that affect identity, issues related to assisting students with long-range planning, and two models for programming.…

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)

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

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...

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

Regulatory measures for traffic safety

International Nuclear Information System (INIS)

Veerapur, R.D.; Bharambe, S.D.; Patnaik, S.K.; Tandle, A.K.; Sonawane, K.A.; Kumar, Rajesh; Venkat Subramanian, K.

2017-01-01

Traffic safety is an issue related to occupational safety not restricted alone to the transportation but extends beyond. BARC has many facilities spread across large area in Mumbai and outside Mumbai. BARC deploys large number of buses, mini buses, jeeps and cars for commuting its employees to reach BARC and for commuting within BARC premises. Additionally, trucks, fire tenders, trailers etc. are also deployed for transportation of materials. No moving vehicle is ever free of the possibility of involvement in an accident. Vehicular accidents and the fatalities on road are the result of inter-play of a number of factors. The vehicle population has been steadily increasing with the pace picking up significantly in recent past. Increase in vehicle population in the face of limited road space used by a large variety of traffic has heightened the need and urgency for a well-thought-out road safety. Therefore, existence of regulatory authority to regulate traffic and vehicles to ensure safety of its employees and vehicles is very essential. BARC Traffic Safety Committee (BTSC), which is the regulating body for traffic safety is responsible for ensuring overall traffic safety. (author)

Sexual and reproductive health issues facing Southeast Asian beer promoters: a qualitative pilot study.

Science.gov (United States)

Webber, Gail C; Spitzer, Denise L

2010-07-01

In Southeast Asia, hundreds of thousands of young rural women migrate from their villages to the larger cities in search of work. Many find employment with beer companies or in the clubs where beer is sold, promoting the sale of beer. Previous research suggests these young migrants are in a highly vulnerable position. This paper will describe the findings of an October 2009 meeting to develop a research agenda on the sexual and reproductive health of beer promoters and a subsequent pilot study of focus groups with beer promoters to review this agenda. Participants of the research meeting representing beer promoters, academics, non-governmental organizations (NGOs), government and the beer industry from Cambodia, Thailand, Laos, and Vietnam collaborated in the development of three key research themes. The themes were verified in focus group discussions with beer promoters organized by local research partners in all four countries. The focus group participants were asked what they felt were the key sexual and reproductive health issues facing them in a non-directive and unstructured manner, and then asked to comment more specifically on the research priorities developed at the meeting. The focus groups were recorded digitally, transcribed, and translated into English. The data were analyzed by coding for common themes and then developing matrices to compare themes between groups. The participants of the meeting identified three key research themes: occupational health (including harassment and violence, working conditions, and fair pay), gender and social norms (focusing on the impact of power relations between the genders on women's health), and reproductive health (knowledge and access to reproductive health care services). The participants in the focus groups in all four countries agreed that these were key priorities for them, though the emphasis on the most important issues varied between groups of women. Sexual harassment in the workplace and challenges in

Sexual and reproductive health issues facing Southeast Asian beer promoters: a qualitative pilot study

Directory of Open Access Journals (Sweden)

Spitzer Denise L

2010-07-01

Full Text Available Abstract Background In Southeast Asia, hundreds of thousands of young rural women migrate from their villages to the larger cities in search of work. Many find employment with beer companies or in the clubs where beer is sold, promoting the sale of beer. Previous research suggests these young migrants are in a highly vulnerable position. This paper will describe the findings of an October 2009 meeting to develop a research agenda on the sexual and reproductive health of beer promoters and a subsequent pilot study of focus groups with beer promoters to review this agenda. Methods Participants of the research meeting representing beer promoters, academics, non-governmental organizations (NGOs, government and the beer industry from Cambodia, Thailand, Laos, and Vietnam collaborated in the development of three key research themes. The themes were verified in focus group discussions with beer promoters organized by local research partners in all four countries. The focus group participants were asked what they felt were the key sexual and reproductive health issues facing them in a non-directive and unstructured manner, and then asked to comment more specifically on the research priorities developed at the meeting. The focus groups were recorded digitally, transcribed, and translated into English. The data were analyzed by coding for common themes and then developing matrices to compare themes between groups. Results The participants of the meeting identified three key research themes: occupational health (including harassment and violence, working conditions, and fair pay, gender and social norms (focusing on the impact of power relations between the genders on women's health, and reproductive health (knowledge and access to reproductive health care services. The participants in the focus groups in all four countries agreed that these were key priorities for them, though the emphasis on the most important issues varied between groups of women

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

Comparison of Fiscal and Regulatory Policies to Prevent Non ...

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

India is facing a rising burden of cardiovascular disease and obesity-related diabetes ... As a result, fiscal and regulatory strategies such as food taxes have been ... International Water Resources Association, in close collaboration with IDRC, ...

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

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.

Regulatory pathways for vaccines for developing countries.

Science.gov (United States)

Milstien, Julie; Belgharbi, Lahouari

2004-01-01

Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

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)

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

Dietary Supplements: Regulatory Challenges and Research Resources.

Science.gov (United States)

Dwyer, Johanna T; Coates, Paul M; Smith, Michael J

2018-01-04

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

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

Traffic- Croatia Facing the Global Issues

Directory of Open Access Journals (Sweden)

Ivan Mahalec

2012-10-01

Full Text Available Traffic today is an indispensable part of our lives and oneof the basic preconditions of what is called social progress. Likeblood in our body it circulates across the whole globe and allowsfor the necessary flow of people and materials. This workconsiders the impact of traffic on the lives of people and on theenvironment, analyses the available energy sources and vehiclepropulsion systems and illustrates global climatic issues. Thepaper presents the methodology created by EU for monitoringof harmful emissions at the national/eve! and gives data on differencesin emissions of individualtransp01t modes. The trafficcondition in the Republic of Croatia is analysed and a thesis isgiven regarding possible solution of the stated problems.

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

Crisis Communication of Nuclear Regulatory Organisations: Towards global thinking

International Nuclear Information System (INIS)

Martell, Meritxell; Menendez, Susan; Calvo, Marina

2013-01-01

The OECD Nuclear Energy Agency (NEA) Committee on Nuclear Regulatory Activities (CNRA) Working Group on Public Communication of Nuclear Regulatory Organisations (WGPC) organised the workshop 'Crisis communication: facing the challenges' on 9-10 May 2012 in Madrid to address the international dimension of the communicative responses to crises by assessing the experience of Nuclear Regulatory Organisations of the NEA member countries and their stakeholders. The CNRA/WGPC also prepared in 2011, before the Fukushima-Daiichi nuclear accident occurred, a Road Map for Crisis Communication of Nuclear Regulatory Organisations which focused only on national aspects. This 'road map' had not considered the international dimension. CNRA mandated the WGPC to expand the Road Map so as to conclude the follow-up activity on crisis communication. The objective of the present document is to firstly, identify the key messages which can be extracted from three surveys carried out among the WGPC members after Fukushima-Daiichi's accident (Appendices II, III and IV), and incorporate them into the Road Map for Crisis Communication. Secondly, the good practices on public communication of NROs, which were presented during the OECD/NEA Workshop on Crisis Communication: Facing the Challenges, are reported. Following the structure of the road map for public communication responses during crisis included in the NEA report entitled 'Road Map for Crisis Communication of Nuclear Regulatory Organisations - National aspects', the good practices on communication before, during and after a crisis are provided. Overall, the emphasis of this report is on the international aspects of crisis communication, rather than the national dimension. (authors)

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.)

Interpersonal similarity between body movements in face-to-face communication in daily life.

Science.gov (United States)

Higo, Naoki; Ogawa, Ken-ichiro; Minemura, Juichi; Xu, Bujie; Nozawa, Takayuki; Ogata, Taiki; Ara, Koji; Yano, Kazuo; Miyake, Yoshihiro

2014-01-01

Individuals are embedded in social networks in which they communicate with others in their daily lives. Because smooth face-to-face communication is the key to maintaining these networks, measuring the smoothness of such communication is an important issue. One indicator of smoothness is the similarity of the body movements of the two individuals concerned. A typical example noted in experimental environments is the interpersonal synchronization of body movements such as nods and gestures during smooth face-to-face communication. It should therefore be possible to estimate quantitatively the smoothness of face-to-face communication in social networks through measurement of the synchronization of body movements. However, this is difficult because social networks, which differ from disciplined experimental environments, are open environments for the face-to-face communication between two individuals. In such open environments, their body movements become complicated by various external factors and may follow unstable and nonuniform patterns. Nevertheless, we consider there to be some interaction during face-to-face communication that leads to the interpersonal synchronization of body movements, which can be seen through the interpersonal similarity of body movements. The present study aims to clarify such interaction in terms of body movements during daily face-to-face communication in real organizations of more than 100 people. We analyzed data on the frequency of body movement for each individual during face-to-face communication, as measured by a wearable sensor, and evaluated the degree of interpersonal similarity of body movements between two individuals as their frequency difference. Furthermore, we generated uncorrelated data by resampling the data gathered and compared these two data sets statistically to distinguish the effects of actual face-to-face communication from those of the activities accompanying the communication. Our results confirm an

Interpersonal similarity between body movements in face-to-face communication in daily life.

Directory of Open Access Journals (Sweden)

Naoki Higo

Full Text Available Individuals are embedded in social networks in which they communicate with others in their daily lives. Because smooth face-to-face communication is the key to maintaining these networks, measuring the smoothness of such communication is an important issue. One indicator of smoothness is the similarity of the body movements of the two individuals concerned. A typical example noted in experimental environments is the interpersonal synchronization of body movements such as nods and gestures during smooth face-to-face communication. It should therefore be possible to estimate quantitatively the smoothness of face-to-face communication in social networks through measurement of the synchronization of body movements. However, this is difficult because social networks, which differ from disciplined experimental environments, are open environments for the face-to-face communication between two individuals. In such open environments, their body movements become complicated by various external factors and may follow unstable and nonuniform patterns. Nevertheless, we consider there to be some interaction during face-to-face communication that leads to the interpersonal synchronization of body movements, which can be seen through the interpersonal similarity of body movements. The present study aims to clarify such interaction in terms of body movements during daily face-to-face communication in real organizations of more than 100 people. We analyzed data on the frequency of body movement for each individual during face-to-face communication, as measured by a wearable sensor, and evaluated the degree of interpersonal similarity of body movements between two individuals as their frequency difference. Furthermore, we generated uncorrelated data by resampling the data gathered and compared these two data sets statistically to distinguish the effects of actual face-to-face communication from those of the activities accompanying the communication. Our results

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

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)

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...

Comparison of Fiscal and Regulatory Policies to Prevent Non ...

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

India is facing a rising burden of cardiovascular disease and obesity-related diabetes due to ... As a result, fiscal and regulatory strategies such as food taxes have been ... L'Association internationale de ressources en eau (IWRA), en étroite ...

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

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

Science.gov (United States)

Tong, E K; Glantz, S A

2004-12-01

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

Contribution of a fuzzy expert system to regulatory impact analysis

Directory of Open Access Journals (Sweden)

Marco Antônio da Cunha

2015-09-01

Full Text Available Regulatory Impact Analysis (RIA has been consolidating in Brazilian regulatory agencies throughout the last decades. The RIA methodology aims to examine the regulatory process, measure the costs and benefits generated, as well as other effects of social, political or economic nature caused by a new or an existing regulation. By analysing each regulatory option, the expert or regulator faces a myriad of variables, usually of qualitative nature, that are difficult to measure and with a high degree of uncertainty. This research complements the existing literature, given the scarcity of decision support models in RIA that – regardless of the problem treated – incorporate the tacit knowledge of the regulation expert. This paper proposes an exploratory approach using a Fuzzy Expert System, which therefore helps to enrich the decision process in the final stage of comparison of the regulatory options.

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 aspects of management of change - Summary and conclusions

International Nuclear Information System (INIS)

2002-01-01

Nuclear licensees are increasingly required to adapt to a more challenging commercial environment as moves to de-regulate electricity markets gather pace. One of the costs that is often perceived as being amenable to control is staffing, and hence there is significant exploration of new strategies for managing staffing levels. This report presents the outputs from a Workshop convened by the Special Experts' Group in Human and Organisational Factors (SEGHOF) of the Committee for the Safety of Nuclear Installations (CSNI) and organised by the UK Nuclear Installations Inspectorate (NII). The purpose of the workshop was to facilitate the exchange of views on, and approaches towards, the regulation of organisational change. The major risks associated with organisational change were discussed, and a range of regulatory challenges was identified for detailed discussion. There was agreement that the licensee must retain the responsibility to manage its own business but that organisational issues should be subject to regulatory scrutiny if they have the potential to impact on safety. The regulator should be able to demonstrate an approach to oversight of organisational change which is valid, transparent and consistent, and should inform the licensee of its expectations in terms of information supplied, communication and timing. The workshop confirmed that there is significant agreement between regulators concerning the need for licensees to put in place arrangements to manage organisational change. There was also broad consensus on what should constitute the elements of a licensee's management of change process. Differing views were evident about the balance between regulatory scrutiny of the process, as opposed to the outcomes of change, which largely represents differing regulatory regimes and philosophies. However, it was acknowledged that the regulator must be capable of taking an early view of the adequacy of proposed changes, rather than monitoring outcomes alone

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

Current status of developmental neurotoxicity: regulatory view

DEFF Research Database (Denmark)

Hass, Ulla

2003-01-01

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

Everyday risk taking as a function of regulatory focus

NARCIS (Netherlands)

Hamstra, Melvyn R. W.; Bolderdijk, Jan Willem; Veldstra, Janet L.

Uncertainty is an inherent aspect of everyday life. However, faced with uncertainty, some individuals take risks more eagerly than others. Regulatory focus theory may explain such differences because risky behavior may arise naturally from the eagerness of promotion focused individuals, while safe

Review of decision methodologies for evaluating regulatory actions affecting public health and safety

International Nuclear Information System (INIS)

Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

1976-12-01

This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels

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

Towards a sustainable coffee market: paradoxes faced by a multinational company

NARCIS (Netherlands)

Kolk, A.

2012-01-01

This paper examines the case of sustainable coffee as faced by Sara Lee's International Coffee and Tea Division (SL), asking which strategic direction the company should take considering its regulatory, competitive, and societal contexts. More than a decade after sustainable coffee became a

Riverine ecosystem services and the thermoelectric sector: strategic issues facing the Northeastern United States

Science.gov (United States)

Miara, A.; Vorosmarty, C. J.; Stewart, R.; Wollheim, W. M.; Rosenzweig, B.

2013-12-01

Major strategic issues facing the global thermoelectric sector include environmental regulation, climate change and increasing electricity demand. We have addressed such issues by modeling thermoelectric generation in the Northeastern United States that is reliant on cooling under five sensitivity tests to evaluate losses/gains in power production, thermal pollution and suitable aquatic habitat, comparing the contemporary baseline (2000-2010) with potential future states. Integral to the analysis, we developed a methodology to quantify river water availability for cooling, which we define as an ecosystem service. Projected climate conditions reduce river water available for efficient power plant operations and the river's capacity to absorb waste heat, causing a loss of regional thermoelectric generation (RTG) (2.5%) in some summers that, compared to the contemporary baseline, is equal to the summertime electricity consumption of 1.3 million Northeastern US homes. Vulnerabilities to warm temperatures and thermal pollution can be alleviated through the use of more efficient natural gas (NG) power plants that have a reduced reliance on cooling water. Conversion of once-through (OT) to cooling tower (CT) systems and the Clean Water Act (CWA) temperature limit regulation, both of which reduce efficiencies at the single plant level, show potential to yield beneficial increases in RTG. This is achieved by obviating the need for large volumes of river water, thereby reducing plant-to-plant interferences through lowering the impact of upstream thermal pollution and preserving a minimum standard of cooling water. The results and methodology framework presented here, which can be extrapolated to other regional assessments with contrasting climates and thermoelectric profiles, can identify opportunities and support decision-making to achieve more efficient energy systems and riverine ecosystem protection.

The Regulatory Framework for Privacy and Security

Science.gov (United States)

Hiller, Janine S.

The internet enables the easy collection of massive amounts of personally identifiable information. Unregulated data collection causes distrust and conflicts with widely accepted principles of privacy. The regulatory framework in the United States for ensuring privacy and security in the online environment consists of federal, state, and self-regulatory elements. New laws have been passed to address technological and internet practices that conflict with privacy protecting policies. The United States and the European Union approaches to privacy differ significantly, and the global internet environment will likely cause regulators to face the challenge of balancing privacy interests with data collection for many years to come.

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.

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)

Ethical Issues in Maternal and Child Health Nursing: Challenges ...

African Journals Online (AJOL)

2016-06-28

Jun 28, 2016 ... and neonatal nurses, face ethical issues possibly because of their ... Aim: To identify the ethical issues related to maternal and child care, the challenges faced by ...... Lucas V.A. The business of women's health care. In: E.T. ...

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)

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}.

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.)

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

In your face: Transcendence in embodied interaction

Directory of Open Access Journals (Sweden)

Shaun eGallagher

2014-07-01

Full Text Available In cognitive psychology, studies concerning the face tend to focus on questions about face recognition, theory of mind and empathy. Questions about the face, however, also fit into a very different set of issues that are central to ethics. Based especially on the work of Levinas, philosophers have come to see that reference to the face of another person can anchor conceptions of moral responsibility and ethical demand. Levinas points to a certain irreducibility and transcendence implicit in the face of the other. In this paper I argue that the notion of transcendence involved in this kind of analysis can be given a naturalistic interpretation by drawing on recent interactive approaches to social cognition found in developmental psychology, phenomenology, and the study of autism.

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

Issues and Challenges Facing the Minority Woman Dentist.

Science.gov (United States)

Sinkford, Jeanne C.

1992-01-01

The status of minority women dentists is reviewed, and initiatives to improve it are noted. Issues and challenges for African-American female dentists are outlined, including negative racial/gender stereotypes, lack of advancement opportunities, difficulties in starting practices and securing professional and social support systems, lack of…

Critical issues facing R&D managers in China

NARCIS (Netherlands)

de Boer, S.J.; Gan, Weibing; Shan, Guogang

1998-01-01

R&D managers in China experienced significant changes in the past decade, in particular because of Government policies of economic reform and opening to the outside world. These developments have brought about a number of rather specific R&D management issues and problems. The paper addresses the

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)

Bringing nanomedicines to market: regulatory challenges, opportunities, and uncertainties.

Science.gov (United States)

Nijhara, Ruchika; Balakrishnan, Krishna

2006-06-01

Scientists and entrepreneurs who contemplate developing nanomedicine products face several unique challenges in addition to many of the traditional hurdles of product development. In this review we analyze the major physicochemical, biologic and functional characteristics of several nanomedicine products on the market and explore the question of what made them unique. What made them successful? We also focus on the regulatory challenges faced by nanomedicine product developers. Based on these analyses, we propose the factors that are most likely to contribute to the success of nanomedicine products.

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)

Inflammation, Self-Regulation, and Health: An Immunologic Model of Self-Regulatory Failure.

Science.gov (United States)

Shields, Grant S; Moons, Wesley G; Slavich, George M

2017-07-01

Self-regulation is a fundamental human process that refers to multiple complex methods by which individuals pursue goals in the face of distractions. Whereas superior self-regulation predicts better academic achievement, relationship quality, financial and career success, and lifespan health, poor self-regulation increases a person's risk for negative outcomes in each of these domains and can ultimately presage early mortality. Given its centrality to understanding the human condition, a large body of research has examined cognitive, emotional, and behavioral aspects of self-regulation. In contrast, relatively little attention has been paid to specific biologic processes that may underlie self-regulation. We address this latter issue in the present review by examining the growing body of research showing that components of the immune system involved in inflammation can alter neural, cognitive, and motivational processes that lead to impaired self-regulation and poor health. Based on these findings, we propose an integrated, multilevel model that describes how inflammation may cause widespread biobehavioral alterations that promote self-regulatory failure. This immunologic model of self-regulatory failure has implications for understanding how biological and behavioral factors interact to influence self-regulation. The model also suggests new ways of reducing disease risk and enhancing human potential by targeting inflammatory processes that affect self-regulation.

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.

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...

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)

Riverine ecosystem services and the thermoelectric sector: strategic issues facing the Northeastern United States

International Nuclear Information System (INIS)

Miara, Ariel; Vörösmarty, Charles J; Rosenzweig, Bernice; Stewart, Robert J; Wollheim, Wilfred M

2013-01-01

Major strategic issues facing the global thermoelectric sector include environmental regulation, climate change and increasing electricity demand. We have addressed such issues by modeling thermoelectric generation in the Northeastern United States that is reliant on cooling under five sensitivity tests to evaluate losses/gains in power production, thermal pollution and suitable aquatic habitat, comparing the contemporary baseline (2000–2010) with potential future states. Integral to the analysis, we developed a methodology to quantify river water availability for cooling, which we define as an ecosystem service. Projected climate conditions reduce river water available for efficient power plant operations and the river’s capacity to absorb waste heat, causing a loss of regional thermoelectric generation (RTG) (2.5%) in some summers that, compared to the contemporary baseline, is equal to the summertime electricity consumption of 1.3 million Northeastern US homes. Vulnerabilities to warm temperatures and thermal pollution can be alleviated through the use of more efficient natural gas (NG) power plants that have a reduced reliance on cooling water. Conversion of once-through (OT) to cooling tower (CT) systems and the Clean Water Act (CWA) temperature limit regulation, both of which reduce efficiencies at the single plant level, show potential to yield beneficial increases in RTG. This is achieved by obviating the need for large volumes of river water, thereby reducing plant-to-plant interferences through lowering the impact of upstream thermal pollution and preserving a minimum standard of cooling water. The results and methodology framework presented here, which can be extrapolated to other regional assessments with contrasting climates and thermoelectric profiles, can identify opportunities and support decision-making to achieve more efficient energy systems and riverine ecosystem protection. (letter)

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…

Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial.

Science.gov (United States)

Lancee, Jaap; van Straten, Annemieke; Morina, Nexhmedin; Kaldo, Viktor; Kamphuis, Jan H

2016-01-01

To compare the efficacy of guided online and individual face-to-face cognitive behavioral treatment for insomnia (CBT-I) to a wait-list condition. A randomized controlled trial comparing three conditions: guided online; face-to-face; wait-list. Posttest measurements were administered to all conditions, along with 3- and 6-mo follow-up assessments to the online and face-to-face conditions. Ninety media-recruited participants meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia were randomly allocated to either guided online CBT-I (n = 30), individual face-to-face CBT-I (n = 30), or wait-list (n = 30). At post-assessment, the online (Cohen d = 1.2) and face-to-face (Cohen d = 2.3) intervention groups showed significantly larger treatment effects than the wait-list group on insomnia severity (insomnia severity index). Large treatment effects were also found for the sleep diary estimates (except for total sleep time), and anxiety and depression measures (for depression only in the face-to-face condition). Face-to-face treatment yielded a statistically larger treatment effect (Cohen d = 0.9) on insomnia severity than the online condition at all time points. In addition, a moderate differential effect size favoring face-to-face treatment emerged at the 3- and 6-mo follow-up on all sleep diary estimates. Face-to-face treatment further outperformed online treatment on depression and anxiety outcomes. These data show superior performance of face-to-face treatment relative to online treatment. Yet, our results also suggest that online treatment may offer a potentially cost-effective alternative to and complement face-to-face treatment. Clinicaltrials.gov, NCT01955850. A commentary on this article appears in this issue on page 13. © 2016 Associated Professional Sleep Societies, LLC.

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

Alternatives to the face-to-face consultation in general practice: focused ethnographic case study.

Science.gov (United States)

Atherton, Helen; Brant, Heather; Ziebland, Sue; Bikker, Annemieke; Campbell, John; Gibson, Andy; McKinstry, Brian; Porqueddu, Tania; Salisbury, Chris

2018-04-01

NHS policy encourages general practices to introduce alternatives to the face-to-face consultation, such as telephone, email, e-consultation systems, or internet video. Most have been slow to adopt these, citing concerns about workload. This project builds on previous research by focusing on the experiences of patients and practitioners who have used one or more of these alternatives. To understand how, under what conditions, for which patients, and in what ways, alternatives to face-to-face consultations present benefits and challenges to patients and practitioners in general practice. Focused ethnographic case studies took place in eight UK general practices between June 2015 and March 2016. Non-participant observation, informal conversations with staff, and semi-structured interviews with staff and patients were conducted. Practice documents and protocols were reviewed. Data were analysed through charting and the 'one sheet of paper' mind-map method to identify the line of argument in each thematic report. Case study practices had different rationales for offering alternatives to the face-to-face consultation. Beliefs varied about which patients and health issues were suitable. Co-workers were often unaware of each other's practice; for example, practice policies for use of e-consultations systems with patients were not known about or followed. Patients reported benefits including convenience and access. Staff and some patients regarded the face-to-face consultation as the ideal. Experience of implementing alternatives to the face-to-face consultation suggests that changes in patient access and staff workload may be both modest and gradual. Practices planning to implement them should consider carefully their reasons for doing so and involve the whole practice team. © British Journal of General Practice 2018.

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

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.

Westinghouse electric company, LLC regulatory trends in the USA nuclear power industry

International Nuclear Information System (INIS)

Molnar, C. M.; Cheung, A. C.; Gresham, J. A.

2007-01-01

The United States (US) nuclear industry is in a dynamic, exciting, and challenging time. On one hand, since the mid 90s, the US nuclear utilities have continued to demonstrate improved safety, efficient and reliable operation for the whole nuclear fleet, thus making generation costs for nuclear energy extremely attractive. On the other hand the US utilities are projecting the need to add significant new generation capacities to replace the aging fleet and to sustain the expected economic growth. In addition to the demonstrated improved operation and financial performance, the financial incentives offered in the federal energy bill passed in 2005 enticed many utilities to actively consider the purchase of new nuclear power plants. This paper will highlight the regulatory trends in the USA, the major initiatives and improvements undertaken as well as other operation support issues faced by the US nuclear power industry

Environment and T regulatory cells in allergy.

Science.gov (United States)

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

2012-04-15

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

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

Safety of research reactors. Topical issues paper no. 4

International Nuclear Information System (INIS)

Alcala-Ruiz, F.; Ferraz-Bastos, J.L.; Kim, S.C.; Voth, M.; Boeck, H.; Dimeglio, F.; Litai, D.

2001-01-01

Assessment of Research Reactors (INSARR) missions. The prime objective of these missions has been to conduct a comprehensive operational safety review of the research reactor facility and to verify compliance with the IAEA Safety Standards. The methods used during an INSARR mission have been collected and analysed. Some of the important issues identified are the following: general ageing of the facility; uncertain status of many research reactors (in extended shutdown); indefinite deferral of return to operation or decommissioning; inadequate regulatory supervision; insufficient systematic (periodic) reassessment of safety; lack of quality assurance (QA) programmes; lack of an international safety convention or arrangement; lack of financial support for safety measures (e.g. safety reassessment, safety upgrading, decommissioning) and utilization; lack of clear utilization programmes; inadequate emergency preparedness; inadequate safety documentation (e.g. safety analysis report, operating rules and procedures, emergency plan); inadequate funding of shutdown reactors; weak safety culture; loss of expertise and corporate memory; loss of information concerning radioactive materials contained in retired experimental devices stored in the facility indefinitely; obsolescence of equipment and lack of spare parts; inadequate training and qualifications of regulators and operators; safety implications of new fuel types. These issues have been addressed by the IAEA Secretariat and the chairman of the International Nuclear Safety Advisory Group (INSAG). INSAG has identified three major safety issues that are: the increasing age of research reactors, the number of research reactors that are not operating anymore but have not been decommissioned, and the number of research reactors in countries that do not have appropriate regulatory authorities. This issue paper discusses the concerns generated by an analysis of the results of INSARR missions and those expressed by INSAG. The

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

Energy Technology Data Exchange (ETDEWEB)

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

2008-06-01

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

Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions.

Science.gov (United States)

Tralau, Tewes; Oelgeschläger, Michael; Gürtler, Rainer; Heinemeyer, Gerhard; Herzler, Matthias; Höfer, Thomas; Itter, Heike; Kuhl, Thomas; Lange, Nikola; Lorenz, Nicole; Müller-Graf, Christine; Pabel, Ulrike; Pirow, Ralph; Ritz, Vera; Schafft, Helmut; Schneider, Heiko; Schulz, Thomas; Schumacher, David; Zellmer, Sebastian; Fleur-Böl, Gaby; Greiner, Matthias; Lahrssen-Wiederholt, Monika; Lampen, Alfonso; Luch, Andreas; Schönfelder, Gilbert; Solecki, Roland; Wittkowski, Reiner; Hensel, Andreas

2015-06-01

The advent of new testing systems and "omics"-technologies has left regulatory toxicology facing one of the biggest challenges for decades. That is the question whether and how these methods can be used for regulatory purposes. The new methods undoubtedly enable regulators to address important open questions of toxicology such as species-specific toxicity, mixture toxicity, low-dose effects, endocrine effects or nanotoxicology, while promising faster and more efficient toxicity testing with the use of less animals. Consequently, the respective assays, methods and testing strategies are subject of several research programs worldwide. On the other hand, the practical application of such tests for regulatory purposes is a matter of ongoing debate. This document summarizes key aspects of this debate in the light of the European "regulatory status quo", while elucidating new perspectives for regulatory toxicity testing.

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

Random-Profiles-Based 3D Face Recognition System

Directory of Open Access Journals (Sweden)

Joongrock Kim

2014-03-01

Full Text Available In this paper, a noble nonintrusive three-dimensional (3D face modeling system for random-profile-based 3D face recognition is presented. Although recent two-dimensional (2D face recognition systems can achieve a reliable recognition rate under certain conditions, their performance is limited by internal and external changes, such as illumination and pose variation. To address these issues, 3D face recognition, which uses 3D face data, has recently received much attention. However, the performance of 3D face recognition highly depends on the precision of acquired 3D face data, while also requiring more computational power and storage capacity than 2D face recognition systems. In this paper, we present a developed nonintrusive 3D face modeling system composed of a stereo vision system and an invisible near-infrared line laser, which can be directly applied to profile-based 3D face recognition. We further propose a novel random-profile-based 3D face recognition method that is memory-efficient and pose-invariant. The experimental results demonstrate that the reconstructed 3D face data consists of more than 50 k 3D point clouds and a reliable recognition rate against pose variation.

Towards new regulatory concepts for the regulation of audiovisual media

NARCIS (Netherlands)

Schulz, W.; van Eijk, N.

2016-01-01

European media regulation currently faces several challenges: technology, media and markets have become convergent, while – at the same time – the situations in the individual member states differ in respect of media use, the usage of end devices as well as regulatory aims and frameworks. These

[Health and humanization Diploma: the value of reflection and face to face learning].

Science.gov (United States)

Martínez-Gutiérrez, Javiera; Magliozzi, Pietro; Torres, Patricio; Soto, Mauricio; Walker, Rosa

2015-03-01

In a rapidly changing culture like ours, with emphasis on productivity, there is a strong need to find the meaning of health care work using learning instances that privilege reflection and face to face contact with others. The Diploma in Health and Humanization (DSH), was developed as an interdisciplinary space for training on issues related to humanization. To analyze the experience of DSH aiming to identify the elements that students considered key factors for the success of the program. We conducted a focus group with DSH graduates, identifying factors associated with satisfaction. Transcripts were coded and analyzed by two independent reviewers. DSH graduates valued a safe space, personal interaction, dialogue and respect as learning tools of the DSH. They also appreciates the opportunity to have emotional interactions among students and between them and the teacher as well as the opportunity to share personal stories and their own search for meaning. DSH is a learning experience in which their graduates value the ability to think about their vocation and the affective interaction with peers and teachers. We hope to contribute to the development of face to face courses in the area of humanization. Face to face methodology is an excellent teaching technique for contents related to the meaning of work, and more specifically, to a group of learners that require affective communication and a personal connection of their work with their own values and beliefs.

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

Visual and associated affective processing of face information in schizophrenia: A selective review.

Science.gov (United States)

Chen, Yue; Ekstrom, Tor

Perception of facial features is crucial in social life. In past decades, extensive research showed that the ability to perceive facial emotion expression was compromised in schizophrenia patients. Given that face perception involves visual/cognitive and affective processing, the roles of these two processing domains in the compromised face perception in schizophrenia were studied and discussed, but not clearly defined. One particular issue was whether face-specific processing is implicated in this psychiatric disorder. Recent investigations have probed into the components of face perception processes such as visual detection, identity recognition, emotion expression discrimination and working memory conveyed from faces. Recent investigations have further assessed the associations between face processing and basic visual processing and between face processing and social cognitive processing such as Theory of Mind. In this selective review, we discuss the investigative findings relevant to the issues of cognitive and affective association and face-specific processing. We highlight the implications of multiple processing domains and face-specific processes as potential mechanisms underlying compromised face perception in schizophrenia. These findings suggest a need for a domain-specific therapeutic approach to the improvement of face perception in schizophrenia.

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)

Holistic face representation is highly orientation-specific.

Science.gov (United States)

Rosenthal, Gideon; Levakov, Gidon; Avidan, Galia

2017-09-29

It has long been argued that face processing requires disproportionate reliance on holistic processing (HP), relative to that required for nonface object recognition. Nevertheless, whether the holistic nature of face perception is achieved via a unique internal representation or by the employment of an automated attention mechanism is still debated. Previous studies had used the face inversion effect (FIE), a unique face-processing marker, or the face composite task, a gold standard paradigm measuring holistic processing, to examine the validity of these two different hypotheses, with some studies combining the two paradigms. However, the results of such studies remain inconclusive, particularly pertaining to the issue of the two proposed HP mechanisms-an internal representation as opposed to an automated attention mechanism. Here, using the complete composite paradigm design, we aimed to examine whether face rotation yields a nonlinear or a linear drop in HP, thus supporting an account that face processing is based either on an orientation-dependent internal representation or on automated attention. Our results reveal that even a relatively small perturbation in face orientation (30 deg away from upright) already causes a sharp decline in HP. These findings support the face internal representation hypothesis and the notion that the holistic processing of faces is highly orientation-specific.

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,…

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

Neonates' responses to repeated exposure to a still face.

Science.gov (United States)

Nagy, Emese; Pilling, Karen; Watt, Rachel; Pal, Attila; Orvos, Hajnalka

2017-01-01

The main aims of the study were to examine whether human neonates' responses to communication disturbance modelled by the still-face paradigm were stable and whether their responses were affected by their previous experience with the still-face paradigm. The still face procedure, as a laboratory model of interpersonal stress, was administered repeatedly, twice, to 84 neonates (0 to 4 day olds), with a delay of an average of 1.25 day. Frame-by-frame analysis of the frequency and duration of gaze, distressed face, crying, sleeping and sucking behaviours showed that the procedure was stressful to them both times, that is, the still face effect was stable after repeated administration and newborns consistently responded to such nonverbal violation of communication. They averted their gaze, showed distress and cried more during the still-face phase in both the first and the second administration. They also showed a carry-over effect in that they continued to avert their gaze and displayed increased distress and crying in the first reunion period, but their gaze behaviour changed with experience, in the second administration. While in the first administration the babies continued averting their gaze even after the stressful still-face phase was over, this carry-over effect disappeared in the second administration, and the babies significantly increased their gaze following the still-face phase. After excluding explanations of fatigue, habituation and random effects, a self-other regulatory model is discussed as a possible explanation for this pattern.

Complementary Cohort Strategy for Multimodal Face Pair Matching

DEFF Research Database (Denmark)

Sun, Yunlian; Nasrollahi, Kamal; Sun, Zhenan

2016-01-01

Face pair matching is the task of determining whether two face images represent the same person. Due to the limited expressive information embedded in the two face images as well as various sources of facial variations, it becomes a quite difficult problem. Towards the issue of few available images...... provided to represent each face, we propose to exploit an extra cohort set (identities in the cohort set are different from those being compared) by a series of cohort list comparisons. Useful cohort coefficients are then extracted from both sorted cohort identities and sorted cohort images...... for complementary information. To augment its robustness to complicated facial variations, we further employ multiple face modalities owing to their complementary value to each other for the face pair matching task. The final decision is made by fusing the extracted cohort coefficients with the direct matching...

The role of women in nuclear - attracting public participation in regulatory decision-making process

Science.gov (United States)

Mohamad Jais, Azlina; Hassan, Najwa

2018-01-01

Public participation is vital in demonstrating transparency and enhancing effectiveness of a nuclear regulatory process. As such, it is necessary for nuclear practitioners to involve the public in key nuclear delivery milestones. This paper specifically discusses challenges faced in attracting public participation throughout the nuclear regulatory decision-making process, and highlights the roles of women in nuclear (WiN) in initiating the said public discourse.

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.

Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.

Science.gov (United States)

Halioua-Haubold, Celine-Lea; Peyer, James G; Smith, James A; Arshad, Zeeshaan; Scholz, Matthew; Brindley, David A; MacLaren, Robert E

2017-12-01

Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs fall in the United States, the European Union, and Japan, and a comprehensive overview of the regulatory guidance applicable to the developer of GTP. Understanding the regulatory requirements for seeking GTP market approval in these major jurisdictions is crucial for an effective and expedient path to market. The novel challenges facing GTP developers is highlighted by a case study of alipogene tiparvovec (Glybera).

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

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

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...

Intacting Integrity in coping with health issues

DEFF Research Database (Denmark)

Jepsen, Stine Leegaard; Bastrup Jørgensen, Lene; Fridlund, Bengt

2017-01-01

The aim of this study was to develop a formal substantive theory (FST) on the multidimensional behavioral process of coping with health issues. Intacting integrity while coping with health issues emerged as the core category of this FST. People facing health issues strive to safeguard and keep...

Environmental problems facing the electricity industry

International Nuclear Information System (INIS)

Johnson, S.

1988-01-01

The paper on the environmental problems facing the electricity industry was first presented at the World Electricity Conference, Nov. 1987. According to the author, the biggest immediate environmental challenge the electricity industry faces is the need for the role and importance of nuclear power to be reasserted clearly and unambiguously. The main environmental problems from electricity generation are air pollution and the carbon dioxide/greenhouse issue, and the author thinks that both could be reduced by an increased use of nuclear power as an energy source. (U.K.)

Analysis of Worldwide Regulatory Framework for On-Line Maintenance

International Nuclear Information System (INIS)

Ahn, Sang Kyu; Oh, Kyu Myung; Lee, Chang Ju

2010-01-01

With the increasing economic pressures being faced and the potential for shortening outage times under the conditions of deregulated electricity markets in the world, licensees are motivated to get an increasing amount of online maintenance (OLM). OLM means a kind of planned maintenance of nuclear reactor facilities, including structure, systems, and components (SSCs), during power operation. In Korea, a similar situation is made up, so it needs to establish a regulatory framework for OLM. A few years ago, foreign countries' practices related to OLM were surveyed by the Working Group on Inspection Practices (WGIP) of OECD/NEA/CNRA. The survey results and additional new information of countries' status will be helpful to establish our own regulatory framework for OLM, which are analyzed in this paper. From the analysis, some considerable points to be addressed for establishing a regulatory framework for OLM are suggested

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.

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.

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.

Regulatory trends and practices related to nuclear reactor decommissioning

International Nuclear Information System (INIS)

Cantor, R.A.

1984-01-01

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

Psychosocial oncofertility issues faced by adolescents and young adults over their lifetime: a review of the research.

Science.gov (United States)

Crawshaw, Marilyn

2013-03-01

This review considers psychosocial oncofertility research relevant to adolescents and young adults over their lifetime. There is growing awareness of the fertility preservation needs of younger males including lowering practical barriers and attending to emotional impact. Despite decisional challenges facing females--the experimental nature of procedures, time involved and potential involvement of partners/donors (for embryo cryopreservation)--findings suggest they too benefit from fertility information at diagnosis and access to fertility specialists. Studies consistently report that fertility concerns affect well-being, relationships and life planning. Both genders thus want fertility issues to be raised proactively by professionals in the years following diagnosis: to help them make informed decisions at a time relevant to them, develop coping strategies for current and future related areas and to be referred to specialist and/or therapeutic help if needed. Little is known about why cancer survivors are less likely to marry or have children, or about their parenthood experiences.

Ethical tensions faced by dietetic students during fieldwork | Nortje ...

African Journals Online (AJOL)

Research confirms that students carrying out their fieldwork are faced with various ethical conundrums and are unsure as to how to address these. This study identifies and discusses four major issues in this regard, namely confidentiality issues, the distribution of limited resources, power struggles and conflicting values with ...

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

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

A note on age differences in mood-congruent vs. mood-incongruent emotion processing in faces.

Science.gov (United States)

Voelkle, Manuel C; Ebner, Natalie C; Lindenberger, Ulman; Riediger, Michaela

2014-01-01

(1) Does experienced mood affect emotion perception in faces and is this perception mood-congruent or mood-incongruent?(2) Are there age-group differences in the interplay between experienced mood and emotion perception? (3) Does emotion perception in faces change as a function of the temporal sequence of study sessions and stimuli presentation, and (4) does emotion perception in faces serve a mood-regulatory function? One hundred fifty-four adults of three different age groups (younger: 20-31 years; middle-aged: 44-55 years; older adults: 70-81 years) were asked to provide multidimensional emotion ratings of a total of 1026 face pictures of younger, middle-aged, and older men and women, each displaying six different prototypical (primary) emotional expressions. By analyzing the likelihood of ascribing an additional emotional expression to a face whose primary emotion had been correctly recognized, the multidimensional rating approach permits the study of emotion perception while controlling for emotion recognition. Following up on previous research on mood responses to recurring unpleasant situations using the same dataset (Voelkle et al., 2013), crossed random effects analyses supported a mood-congruent relationship between experienced mood and perceived emotions in faces. In particular older adults were more likely to perceive happiness in faces when being in a positive mood and less likely to do so when being in a negative mood. This did not apply to younger adults. Temporal sequence of study sessions and stimuli presentation had a strong effect on the likelihood of ascribing an additional emotional expression. In contrast to previous findings, however, there was neither evidence for a change from mood-congruent to mood-incongruent responses over time nor evidence for a mood-regulatory effect.

Regulatory practices for nuclear power plants in India

International Nuclear Information System (INIS)

Bajaj, S.S.

2013-01-01

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

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.

Facing Fibromyalgia | NIH MedlinePlus the Magazine

Science.gov (United States)

... of this page please turn JavaScript on. Feature: Fibromyalgia Facing Fibromyalgia Past Issues / Spring 2016 Table of Contents Amy ... conditions. When did you start having symptoms of fibromyalgia? I actually think I've had it since ...

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

Transmission issues in Alberta

International Nuclear Information System (INIS)

Levson, D.

2002-01-01

This paper outlined the major issues and concerns facing users of the transmission system in Alberta. They include congestion management issues that make investors uncertain about power generation. It is necessary to know the difference between which transmission price signals will be faced by low cost cogeneration at Fort McMurray and Cold Lake coal-fired generation near Edmonton compared to combined cycle gas generation near Calgary. Import and export policy tariffs are another concern. Most new generation opportunities in Alberta require access to export markets, but transmission facilities for export need policy support and appropriate tariffs. It was noted that the past actions of Alberta's Transmission Administrator and balancing pool may be distorting market signals for ancillary service markets, and that loss studies and calculations need upgrading

Neonates’ responses to repeated exposure to a still face

Science.gov (United States)

Pilling, Karen; Watt, Rachel; Pal, Attila; Orvos, Hajnalka

2017-01-01

Aim The main aims of the study were to examine whether human neonates’ responses to communication disturbance modelled by the still-face paradigm were stable and whether their responses were affected by their previous experience with the still-face paradigm. Methods The still face procedure, as a laboratory model of interpersonal stress, was administered repeatedly, twice, to 84 neonates (0 to 4 day olds), with a delay of an average of 1.25 day. Results Frame-by-frame analysis of the frequency and duration of gaze, distressed face, crying, sleeping and sucking behaviours showed that the procedure was stressful to them both times, that is, the still face effect was stable after repeated administration and newborns consistently responded to such nonverbal violation of communication. They averted their gaze, showed distress and cried more during the still-face phase in both the first and the second administration. They also showed a carry-over effect in that they continued to avert their gaze and displayed increased distress and crying in the first reunion period, but their gaze behaviour changed with experience, in the second administration. While in the first administration the babies continued averting their gaze even after the stressful still-face phase was over, this carry-over effect disappeared in the second administration, and the babies significantly increased their gaze following the still-face phase. Conclusion After excluding explanations of fatigue, habituation and random effects, a self-other regulatory model is discussed as a possible explanation for this pattern. PMID:28771555

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

Research Article Special Issue

African Journals Online (AJOL)

pc

2017-11-10

Nov 10, 2017 ... 1Faculty of Sports Science and Coaching, Universiti Pendidikan ... face obesity issues because of several factors such as changes in diet intake, lifestyle, physical ...... and its implications for policy and intervention strategies.

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.

Face recognition ability matures late: evidence from individual differences in young adults.

Science.gov (United States)

Susilo, Tirta; Germine, Laura; Duchaine, Bradley

2013-10-01

Does face recognition ability mature early in childhood (early maturation hypothesis) or does it continue to develop well into adulthood (late maturation hypothesis)? This fundamental issue in face recognition is typically addressed by comparing child and adult participants. However, the interpretation of such studies is complicated by children's inferior test-taking abilities and general cognitive functions. Here we examined the developmental trajectory of face recognition ability in an individual differences study of 18-33 year-olds (n = 2,032), an age interval in which participants are competent test takers with comparable general cognitive functions. We found a positive association between age and face recognition, controlling for nonface visual recognition, verbal memory, sex, and own-race bias. Our study supports the late maturation hypothesis in face recognition, and illustrates how individual differences investigations of young adults can address theoretical issues concerning the development of perceptual and cognitive abilities. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Identity Issues and Challenges Faced by Russian Immigrants in New Zealand

Directory of Open Access Journals (Sweden)

Elena Maydell

2009-08-01

Full Text Available Among the processes cosmopolitan societies undergo at the present moment, is the unprecedented increase in mass migration across cultures. What challenges are faced by both immigrants, who have to settle in novel socio-cultural environments, and by the host populations accepting them? The current qualitative study investigates the nature of identity construction among Russian-speaking immigrants in New Zealand, applying thematic analysis for the interpretation of the data collected via 23 in-depth interviews. Among the most common themes articulated by the participants was the feeling of identity loss. A taken-for-granted sense of identity, brought by the participants from their culture of origin, was not validated by their new society of residence, mostly due to the lack of appropriate cultural resources. The participants were faced with a challenge of re-constructing their old identity, or constructing a new one, utilising the available resources in the community around them. At the same time, there was a sub-group for whom this challenge brought the realisation that the nature of their identity is cosmopolitan, rather than located within any particular culture or geographical space.

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)

On the relation between face and object recognition in developmental prosopagnosia

DEFF Research Database (Denmark)

Gerlach, Christian; Klargaard, Solja; Starrfelt, Randi

2016-01-01

There is an ongoing debate about whether face recognition and object recognition constitute separate cognitive domains. Clarification of this issue can have important theoretical consequences as face recognition is often used as a prime example of domain-specificity in mind and brain. An importan...

Facing the Issues: Challenges, Censorship, and Reflection through Dialogue

Science.gov (United States)

Lent, ReLeah Cossett

2008-01-01

ReLeah Cossett Lent provides practical advice for ensuring that books are kept on shelves and in classrooms for students to read. She outlines steps for creating professional learning communities that engage with censorship issues and prepare schools to deal with book challenges in thoughtful, supportive ways. (Contains 4 figures.)

Review of decision methodologies for evaluating regulatory actions affecting public health and safety. [Nuclear industry site selection

Energy Technology Data Exchange (ETDEWEB)

Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

1976-12-01

This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels.

Safeguards inventory and process monitoring regulatory comparison

Energy Technology Data Exchange (ETDEWEB)

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

2013-06-27

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

Familiar face + novel face = familiar face? Representational bias in the perception of morphed faces in chimpanzees

Directory of Open Access Journals (Sweden)

Yoshi-Taka Matsuda

2016-08-01

Full Text Available Highly social animals possess a well-developed ability to distinguish the faces of familiar from novel conspecifics to induce distinct behaviors for maintaining society. However, the behaviors of animals when they encounter ambiguous faces of familiar yet novel conspecifics, e.g., strangers with faces resembling known individuals, have not been well characterised. Using a morphing technique and preferential-looking paradigm, we address this question via the chimpanzee’s facial–recognition abilities. We presented eight subjects with three types of stimuli: (1 familiar faces, (2 novel faces and (3 intermediate morphed faces that were 50% familiar and 50% novel faces of conspecifics. We found that chimpanzees spent more time looking at novel faces and scanned novel faces more extensively than familiar or intermediate faces. Interestingly, chimpanzees looked at intermediate faces in a manner similar to familiar faces with regards to the fixation duration, fixation count, and saccade length for facial scanning, even though the participant was encountering the intermediate faces for the first time. We excluded the possibility that subjects merely detected and avoided traces of morphing in the intermediate faces. These findings suggest a bias for a feeling-of-familiarity that chimpanzees perceive familiarity with an intermediate face by detecting traces of a known individual, as 50% alternation is sufficient to perceive familiarity.

The key issues facing the electricity systems of developing countries

International Nuclear Information System (INIS)

Oliveira, A. de

1991-01-01

This report covers a common project designed to investigate the major issues and possible future direction in the electricity systems of developing countries in AFRICA, ASIA and LATIN AMERICA. Individual centres each had responsibility for preparing a detailed report on the experiences and issues in their own country plus a regional report, in less detail, to cover neighbouring countries. In this disaggregated way, a picture of the whole of the developing world (with the exception of the Middle East, the problems of which are in some ways distinct from those of other developing countries) has been built up. 30 Refs.; 14 Figs.; 33 Tabs

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

Counseling Issues for Adult Women in Career Transition

Science.gov (United States)

Ronzio, Cynthia R.

2012-01-01

This article addresses current psychosocial issues facing women in career transition and the implications of those issues for career counselors. Specifically, psychosocial developmental trajectories, the roles of family and relationships, the importance of underlying physical and mental health issues, and sociocultural and contextual stressors are…

Establishing neural crest identity: a gene regulatory recipe

Science.gov (United States)

Simões-Costa, Marcos; Bronner, Marianne E.

2015-01-01

The neural crest is a stem/progenitor cell population that contributes to a wide variety of derivatives, including sensory and autonomic ganglia, cartilage and bone of the face and pigment cells of the skin. Unique to vertebrate embryos, it has served as an excellent model system for the study of cell behavior and identity owing to its multipotency, motility and ability to form a broad array of cell types. Neural crest development is thought to be controlled by a suite of transcriptional and epigenetic inputs arranged hierarchically in a gene regulatory network. Here, we examine neural crest development from a gene regulatory perspective and discuss how the underlying genetic circuitry results in the features that define this unique cell population. PMID:25564621

ITER plasma facing components

International Nuclear Information System (INIS)

Kuroda, T.; Vieider, G.; Akiba, M.

1991-01-01

This document summarizes results of the Conceptual Design Activities (1988-1990) for the International Thermonuclear Experimental Reactor (ITER) project, namely those that pertain to the plasma facing components of the reactor vessel, of which the main components are the first wall and the divertor plates. After an introduction and an executive summary, the principal functions of the plasma-facing components are delineated, i.e., (i) define the low-impurity region within which the plasma is produced, (ii) absorb the electromagnetic radiation and charged-particle flux from the plasma, and (iii) protect the blanket/shield components from the plasma. A list of critical design issues for the divertor plates and the first wall is given, followed by discussions of the divertor plate design (including the issues of material selection, erosion lifetime, design concepts, thermal and mechanical analysis, operating limits and overall lifetime, tritium inventory, baking and conditioning, safety analysis, manufacture and testing, and advanced divertor concepts) and the first wall design (armor material and design, erosion lifetime, overall design concepts, thermal and mechanical analysis, lifetime and operating limits, tritium inventory, baking and conditioning, safety analysis, manufacture and testing, an alternative first wall design, and the limiters used instead of the divertor plates during start-up). Refs, figs and tabs

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

International Nuclear Information System (INIS)

Pramono, Y.

2016-01-01

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

Nuclear standards: current issues and future trends

International Nuclear Information System (INIS)

Landis, J.W.

1985-01-01

A summary of the important issues that currently face the nuclear standards field is presented and a discussion of how each of these issues is being resolved is given. The economic benefits that properly developed standards produce are listed

NEW CHALLENGES FACED BY EUROPEAN COMPANIES AND THEIR STAKEHOLDERS

Directory of Open Access Journals (Sweden)

BOBE Claudia-Maria

2010-07-01

Full Text Available The European Union is currently affected by the financial crisis that spread internationally. The member states face difficulties such as price volatility, uncertainties, liquidity issues, cases of bankruptcy, increased unemployment rate, and decreasing GDP. The present paper analyses the challenges faced under these new circumstances by the European companies and their stakeholders. By taking into consideration the threats and weaknesses faced by firms and other interested parties, we emphasize the importance that transparency and communication among companies and their stakeholder have in overcoming financial difficulties.

Future Public Policy and Ethical Issues Facing the Agricultural and Microbial Genomics Sectors of the Biotechnology Industry: A Roundtable Discussion

Energy Technology Data Exchange (ETDEWEB)

Diane E. Hoffmann

2003-09-12

On September 12, 2003, the University of Maryland School of Law's Intellectual Property and Law & Health Care Programs jointly sponsored and convened a roundtable discussion on the future public policy and ethical issues that will likely face the agricultural and microbial genomics sectors of the biotechnology industry. As this industry has developed over the last two decades, societal concerns have moved from what were often local issues, e.g., the safety of laboratories where scientists conducted recombinant DNA research on transgenic microbes, animals and crops, to more global issues. These newer issues include intellectual property, international trade, risks of genetically engineered foods and microbes, bioterrorism, and marketing and labeling of new products sold worldwide. The fast paced nature of the biotechnology industry and its new developments often mean that legislators, regulators and society, in general, must play ''catch up'' in their efforts to understand the issues, the risks, and even the benefits, that may result from the industry's new ways of conducting research, new products, and novel methods of product marketing and distribution. The goal of the roundtable was to develop a short list of the most significant public policy and ethical issues that will emerge as a result of advances in these sectors of the biotechnology industry over the next five to six years. More concretely, by ''most significant'' the conveners meant the types of issues that would come to the attention of members of Congress or state legislators during this time frame and for which they would be better prepared if they had well researched and timely background information. A concomitant goal was to provide a set of focused issues for academic debate and scholarship so that policy makers, industry leaders and regulators would have the intellectual resources they need to better understand the issues and concerns at stake. The

Legal and Institutional Issues of Transportable Nuclear Power Plants: A Preliminary Study

International Nuclear Information System (INIS)

2013-01-01

jointly the international and national actions required for ensuring the sustainability of nuclear energy through innovations in technology and/or institutional arrangements. A transportable nuclear power plant (TNPP) is a factory manufactured, transportable and relocatable nuclear power plant which, when fuelled, is capable of producing final energy products such as electricity and heat. Introducing a TNPP may require fewer financial and human resources from the host State. However, the deployment of such reactors will face new legal issues in the international context which need to be resolved to enable the deployment of such reactors in countries other than the country of origin. The objective of this report is to study the legal and institutional issues for the deployment of TNPPs, to reveal challenges that might be faced in their deployment, and to outline pathways for resolution of the identified issues and challenges in the short and long terms. It is addressed to senior legal, regulatory and technical officers in Member States planning to embark on a nuclear power programme or to expand an existing one by considering the introduction of a TNPP

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

Short-term Internet search using makes people rely on search engines when facing unknown issues.

Science.gov (United States)

Wang, Yifan; Wu, Lingdan; Luo, Liang; Zhang, Yifen; Dong, Guangheng

2017-01-01

The Internet search engines, which have powerful search/sort functions and ease of use features, have become an indispensable tool for many individuals. The current study is to test whether the short-term Internet search training can make people more dependent on it. Thirty-one subjects out of forty subjects completed the search training study which included a pre-test, a six-day's training of Internet search, and a post-test. During the pre- and post- tests, subjects were asked to search online the answers to 40 unusual questions, remember the answers and recall them in the scanner. Un-learned questions were randomly presented at the recalling stage in order to elicited search impulse. Comparing to the pre-test, subjects in the post-test reported higher impulse to use search engines to answer un-learned questions. Consistently, subjects showed higher brain activations in dorsolateral prefrontal cortex and anterior cingulate cortex in the post-test than in the pre-test. In addition, there were significant positive correlations self-reported search impulse and brain responses in the frontal areas. The results suggest that a simple six-day's Internet search training can make people dependent on the search tools when facing unknown issues. People are easily dependent on the Internet search engines.

Short-term Internet search using makes people rely on search engines when facing unknown issues.

Directory of Open Access Journals (Sweden)

Yifan Wang

Full Text Available The Internet search engines, which have powerful search/sort functions and ease of use features, have become an indispensable tool for many individuals. The current study is to test whether the short-term Internet search training can make people more dependent on it. Thirty-one subjects out of forty subjects completed the search training study which included a pre-test, a six-day's training of Internet search, and a post-test. During the pre- and post- tests, subjects were asked to search online the answers to 40 unusual questions, remember the answers and recall them in the scanner. Un-learned questions were randomly presented at the recalling stage in order to elicited search impulse. Comparing to the pre-test, subjects in the post-test reported higher impulse to use search engines to answer un-learned questions. Consistently, subjects showed higher brain activations in dorsolateral prefrontal cortex and anterior cingulate cortex in the post-test than in the pre-test. In addition, there were significant positive correlations self-reported search impulse and brain responses in the frontal areas. The results suggest that a simple six-day's Internet search training can make people dependent on the search tools when facing unknown issues. People are easily dependent on the Internet search engines.

Issues facing families of infants discharged after cardiac surgery: the perceptions of charity helpline staff.

Science.gov (United States)

Wray, Jo; Tregay, Jenifer; Bull, Catherine; Knowles, Rachel L; Crowe, Sonya; Brown, Katherine

2018-03-05

To elicit the perceptions of helpline staff who talk to parents of children discharged after cardiac surgery in infancy about parents' key concerns. A qualitative study involving semistructured interviews with 10 staff at four heart charities. Interviews were recorded, transcribed and analysed using Framework analysis. Staff identified the knowledge, communication and support needs of parents which they described in terms of the impact of patient and family factors, sources of support and systems. Staff perceptions of helplines, in terms of the function of a helpline and the roles of its staff, together with staff's personal views based on their experience of multiple encounters with many families, influenced how they viewed families' needs and responded to their requests. Helpline staff provided important, previously uncaptured evidence about the challenges faced by parents of children discharged after cardiac surgery in infancy. Staff have an important role in supporting communication, in terms of speaking to families about how to talk to professionals and talking to professionals directly to get or give information when parents are unable to do so. Capturing the perspective of helpline staff about communication issues has highlighted the need for interventions with professionals as well as parents. ©2018 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

The most critical issues facing managers in South Africa today

Directory of Open Access Journals (Sweden)

G. Maritz

2002-12-01

Full Text Available South African managers today find themselves squeezed between juxtapositions, such as international competition and simultaneous skill development programmes to combat illiteracy. A second example is high unemployment and the concurrent shortage of IT specialists. Affirmative action has led to troublesome labour relations. HIV/AIDS has an enormous impact on business and must be managed. South African managers need to change their managerial approaches to cope with the increasing demands of this country. Managers must be aware of the realities facing them and know how to turn them into potential growth opportunities for their organisations and South Africa as a country.

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

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

Research Article Special Issue

African Journals Online (AJOL)

pc

2018-05-16

May 16, 2018 ... This paper discusses the issues and challenges faced during .... provision of this AELF's office is costly and need permission from the university's management. .... This is to deduct weeks for the assignment and tests because ...

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)

A note on age differences in mood-congruent versus mood-incongruent emotion processing in faces

Directory of Open Access Journals (Sweden)

Manuel C. Voelkle

2014-06-01

Full Text Available This article addresses four interrelated research questions: (1 Does experienced mood affect emotion perception in faces and is this perception mood-congruent or mood-incongruent? (2 Are there age-group differences in the interplay between experienced mood and emotion perception? (3 Does emotion perception in faces change as a function of the temporal sequence of study sessions and stimuli presentation, and (4 does emotion perception in faces serve a mood-regulatory function? One hundred fifty-four adults of three different age groups (younger: 20–31 years; middle-aged: 44–55 years; older adults: 70–81 years were asked to provide multidimensional emotion ratings of a total of 1,026 face pictures of younger, middle-aged, and older men and women, each displaying six different prototypical (primary emotional expressions. By analyzing the likelihood of ascribing an additional emotional expression to a face whose primary emotion had been correctly recognized, the multidimensional rating approach permits the study of emotion perception while controlling for emotion recognition. Following up on previous research on mood responses to recurring unpleasant situations using the same dataset (Voelkle, Ebner, Lindenberger, & Riediger, 2013, crossed random effects analyses supported a mood-congruent relationship between experienced mood and perceived emotions in faces. In particular older adults were more likely to perceive happiness in faces when being in a positive mood and less likely to do so when being in a negative mood. This did not apply to younger adults. Temporal sequence of study sessions and stimuli presentation had a strong effect on the likelihood of ascribing an additional emotional expression. In contrast to previous findings, however, there was neither evidence for a change from mood-congruent to mood-incongruent responses over time nor evidence for a mood-regulatory effect.

Strategic issues for the oil majors - 1992

Energy Technology Data Exchange (ETDEWEB)

Oppenheimer, P M [Oxford Univ. (United Kingdom)

1992-01-01

Strategic issues facing major oil producers in the 1990s are very diffuse - in contrast with both the 1970s (when strategy meant the response to high oil prices) and the 1980s (when it meant anticipating and exploiting a drop in prices). Mainly upstream issues include the future of price management by OPEC or a successor, the speed of development of new markets for natural gas in power generation and the role of Russia in world energy markets. Other issues include the impact of environmental regulations and taxes on the product mix and on marketing. Human-resource management will continue to face the task of reconciling career opportunities with static or declining manpower requirements; and corporate cash mountains may periodically recur. (Author).

Strategic issues for the oil majors - 1992

International Nuclear Information System (INIS)

Oppenheimer, P.M.

1992-01-01

Strategic issues facing major oil producers in the 1990s are very diffuse - in contrast with both the 1970s (when strategy meant the response to high oil prices) and the 1980s (when it meant anticipating and exploiting a drop in prices). Mainly upstream issues include the future of price management by OPEC or a successor, the speed of development of new markets for natural gas in power generation and the role of Russia in world energy markets. Other issues include the impact of environmental regulations and taxes on the product mix and on marketing. Human-resource management will continue to face the task of reconciling career opportunities with static or declining manpower requirements; and corporate cash mountains may periodically recur. (Author)

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

Issues in the implementation and evolution of the commercial recreational cannabis market in Colorado.

Science.gov (United States)

Subritzky, Todd; Pettigrew, Simone; Lenton, Simon

2015-12-15

For almost a century, the cultivation, sale and use of recreational cannabis has been prohibited by law in most countries. Recently, however, under ballot initiatives four states in the US have legalised commercial, non-medical (recreational) cannabis markets. Several other states will initiate similar ballot measures attached to the 2016 election that will also appoint a new President. As the first state to implement the legislation in 2014, Colorado is an important example to begin investigating early consequences of specific policy choices while other jurisdictions consider their own legislation although the empirical evidence base is only beginning to accrue. This paper brings together material sourced from peer reviewed academic papers, grey literature publications, reports in mass media and niche media outlets, and government publications to outline the regulatory model and process in Colorado and to describe some of the issues that have emerged in the first 20 months of its operation. These issues include tension between public health and profit, industry and investment, new methods of consumption, the black market and product testing. The paper concludes that, while it is too early to determine the impact of the scheme, and noting that it includes some features designed to mitigate adverse impacts, it faces major challenges. Not least of these are the lack of an effective overarching federal regulatory structure, as a consequence of the federal prohibition on cannabis, combined with a rapidly growing cannabis industry which, like other industries, will seek to exploit loopholes to maximise profit. Copyright © 2015 Elsevier B.V. All rights reserved.

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

The impact of holiday eating cues on self-regulatory bolstering for dieters and non-dieters.

Science.gov (United States)

Martins, Chrissy M; Vallen, Beth

2014-01-01

Two studies examined the hypothesis that the presence vs. absence of holiday food cues leads dieters to bolster self-regulatory resources and reduce consumption of a snack food. Study 1 evaluated snack-food consumption on a holiday vs. a non-holiday and in Study 2, the proposed underlying mechanism--the bolstering of self-regulatory resources when facing holiday-related cues--was explored. Study 1 followed a quasi-experimental design in which participants (N = 152) consumed candies either on a holiday or a non-holiday. Dieting behaviour was measured and the main outcome measure was consumption quantity. In Study 2, a true experiment, participants (N = 110) read primes associated with holiday eating, holiday history or a neutral topic. Self-regulatory bolstering was assessed as the main outcome measure. Study 1 showed that dieters consume more of a food item on an ordinary day relative to a holiday; the consumption patterns of non-dieters did not vary based on holiday cues. Study 2 demonstrated that dieters, but not non-dieters, bolster self-regulatory resources to a greater extent in the presence vs. absence of a holiday food cue. Dieters are better equipped to defend their diet-related goals when facing strong holiday-related temptations than weaker, everyday temptations.

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)

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).

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)

Neural synchronization during face-to-face communication.

Science.gov (United States)

Jiang, Jing; Dai, Bohan; Peng, Danling; Zhu, Chaozhe; Liu, Li; Lu, Chunming

2012-11-07

Although the human brain may have evolutionarily adapted to face-to-face communication, other modes of communication, e.g., telephone and e-mail, increasingly dominate our modern daily life. This study examined the neural difference between face-to-face communication and other types of communication by simultaneously measuring two brains using a hyperscanning approach. The results showed a significant increase in the neural synchronization in the left inferior frontal cortex during a face-to-face dialog between partners but none during a back-to-back dialog, a face-to-face monologue, or a back-to-back monologue. Moreover, the neural synchronization between partners during the face-to-face dialog resulted primarily from the direct interactions between the partners, including multimodal sensory information integration and turn-taking behavior. The communicating behavior during the face-to-face dialog could be predicted accurately based on the neural synchronization level. These results suggest that face-to-face communication, particularly dialog, has special neural features that other types of communication do not have and that the neural synchronization between partners may underlie successful face-to-face communication.

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)

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)

Face to Faith: Teaching Global Citizenship

Science.gov (United States)

Beauchamp, Marcia

2011-01-01

The Tony Blair Faith Foundation has created a program that enables students to learn directly with, from, and about one another's culture, religion and beliefs. Face to Faith is a state-of-the-art educational program that addresses cross-cultural and inter-religious understanding in the context of study about global issues. The program uses…

Exploring morally relevant issues facing families in their decisions to monitor the health-related behaviours of loved ones.

Science.gov (United States)

Gammon, D; Christiansen, E K; Wynn, R

2009-07-01

Patient self-management of disease is increasingly supported by technologies that can monitor a wide range of behavioural and biomedical parameters. Incorporated into everyday devices such as cell phones and clothes, these technologies become integral to the psychosocial aspects of everyday life. Many technologies are likely to be marketed directly to families with ill members, and families may enlist the support of clinicians in shaping use. Current ethical frameworks are mainly conceptualised from the perspective of caregivers, researchers, developers and regulators in order to ensure the ethics of their own practices. This paper focuses on families as autonomous decision-makers outside the regulated context of healthcare. We discuss some morally relevant issues facing families in their decisions to monitor the health-related behaviours of loved ones. An example - remote parental monitoring of adolescent blood glucose - is presented and discussed through the lens of two contrasting accounts of ethics; one reflecting the predominant focus on health outcomes within the health technology assessment (HTA) framework and the other that attends to the broader sociocultural contexts shaping technologies and their implications. Issues discussed include the focus of assessments, informed consent and child assent, and family co-creation of system characteristics and implications. The parents' decisions to remotely monitor their child has relational implications that are likely to influence conflict levels and thus also health outcomes. Current efforts to better integrate outcome assessments with social and ethical assessments are particularly relevant for informed decision-making about health monitoring technologies in families.

The use of conversation mapping to frame key perceptual issues facing the general dental practice system in England.

Science.gov (United States)

Harris, R V; Dancer, J M; Smith, D; Campbell, S

2009-06-01

To demonstrate the use of a novel qualitative methodology namely conversation mapping, which can be used to capture differences in stakeholder perspectives and give a root definition of the problem in a complex policy area. The methodology is used in the context of the changes introduced in the English general dental practice system in April 2006, to investigate the key issues facing the system, as perceived by general dental practitioners (GDPs). From a broad trigger statement, three transformational statements were produced. Each participant recorded their contribution on a hard diagrammatic form as a 'map', with others responding with their own written comment, thus generating three conversation maps. Thematic analysis resulted in the generation of a preliminary model summarising key perceptual issues. The five emergent themes identified were: financing, dentists' wants/needs, the role of the public and patients, system goals and policy level decision making. Financing was identified as the core category to which all other categories were related. Conversation mapping, a methodology arising from a systems approach, can be used to develop a 'rich picture' of an oral health care system in order to define the core problem within this policy area. Findings suggest that GDPs identify the financing of the system as a fundamental source of problems within the general dental practice system. This appears to be at variance with the perception of policy makers, who report a more limited view, identifying the system of remuneration as the 'heart of the problem'.

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)

Strategic Management Planning of Soybean Store Hadijanto Trisno with the Purpose of Developing Business and Facing Competition

OpenAIRE

Tedjalaksana, Retta Margaretta; Aldianto, Leo

2013-01-01

Every development demand a change, include in business world. Small businesses that are still using traditional management system face a challenge to maintaining the business continuity and facing competition in this modern era. Soybean Store Hadijanto Trisno, a hereditary business is facing some issues in running the business, which are company doesn't have functional division, lack of workers and transport during peak hours, and no database system. Those business issues are explored throu...

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.

Building control in Australia; experiences with private sector involvement

NARCIS (Netherlands)

Van der Heijden, J.J.

2008-01-01

Facing issues with regulatory enforcement through municipal agencies, governments in Australia have reformed the enforcement of public building regulations. As a result, the private sector has been introduced in building regulatory enforcement regimes with differences amongst jurisdictions. In this

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)

Linked health data for pharmacovigilance in children: perceived legal and ethical issues for stakeholders and data guardians.

Science.gov (United States)

Hopf, Yvonne Marina; Bond, Christine B; Francis, Jill J; Haughney, John; Helms, Peter J

2014-02-12

The inclusion of the Community Health Index in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilisation. This linkage could be the basis for identification of adverse drug reactions. The aim of this article is to report the views of healthcare professionals on data sharing, ownership and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data. Qualitative study using semistructured face-to-face interviews addressing the study aims. Purposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach. Participants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important factors to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified. A large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source datasets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership and responsibilities of data owners.

Environmental issues related to oil and gas access

International Nuclear Information System (INIS)

Antoniuk, T.

1998-01-01

This presentation discussed the environmental issues that petroleum companies face in northeast British Columbia. Petroleum exploration, development, production, abandonment and transportation activities in the province must follow provincial and federal regulations as well as government policies and guidelines which define environmental assessment, protection, and mitigation standards. A discussion about the regulatory framework in British Columbia can be found in the 'British Columbia Oil and Gas Handbook' which is available on the INTERNET at http://natural.gov.bc.ca/handpubs/oilgashb/bcoghb.htm. It was suggested that companies wishing to conduct drilling or exploration activities in sensitive areas should allow extra time (up to one year) to obtain approval for such activities. British Columbia's environmental setting includes five zones - the Alpine Tundra, the Spruce-Willow-Birch zone, the Engelmannn Spruce-Subalpine Fir forests, the Sub-Boreal Spruce zone, and the Boreal White and Black Spruce zone. Four discrete oil and gas guideline zones with differing standards have been developed. These are: (1) the Northern Rocky Mountains, (2) the Northeastern Slopes, (3) the Southeastern Slopes, and (4) the Northern Plains. A set of interim environmental guidelines are in effect to direct activity away from any sensitive area. Three sub-regional land use planning areas have also been established in the Prince George Forest Region which includes Dawson Creek, Fort St. John and Fort Nelson. Petroleum operators in these regions are obliged to deal with issues regarding aboriginal involvement, stream crossings, access management, and air quality. 40 refs

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

Decoding of faces and face components in face-sensitive human visual cortex

Directory of Open Access Journals (Sweden)

David F Nichols

2010-07-01

Full Text Available A great challenge to the field of visual neuroscience is to understand how faces are encoded and represented within the human brain. Here we show evidence from functional magnetic resonance imaging (fMRI for spatially distributed processing of the whole face and its components in face-sensitive human visual cortex. We used multi-class linear pattern classifiers constructed with a leave-one-scan-out verification procedure to discriminate brain activation patterns elicited by whole faces, the internal features alone, and the external head outline alone. Furthermore, our results suggest that whole faces are represented disproportionately in the fusiform cortex (FFA whereas the building blocks of faces are represented disproportionately in occipitotemporal cortex (OFA. Faces and face components may therefore be organized with functional clustering within both the FFA and OFA, but with specialization for face components in the OFA and the whole face in the FFA.

Oxytocin eliminates the own-race bias in face recognition memory.

Science.gov (United States)

Blandón-Gitlin, Iris; Pezdek, Kathy; Saldivar, Sesar; Steelman, Erin

2014-09-11

The neuropeptide Oxytocin influences a number of social behaviors, including processing of faces. We examined whether Oxytocin facilitates the processing of out-group faces and reduce the own-race bias (ORB). The ORB is a robust phenomenon characterized by poor recognition memory of other-race faces compared to the same-race faces. In Experiment 1, participants received intranasal solutions of Oxytocin or placebo prior to viewing White and Black faces. On a subsequent recognition test, whereas in the placebo condition the same-race faces were better recognized than other-race faces, in the Oxytocin condition Black and White faces were equally well recognized, effectively eliminating the ORB. In Experiment 2, Oxytocin was administered after the study phase. The ORB resulted, but Oxytocin did not significantly reduce the effect. This study is the first to show that Oxytocin can enhance face memory of out-group members and underscore the importance of social encoding mechanisms underlying the own-race bias. This article is part of a Special Issue entitled Oxytocin and Social Behav. Copyright © 2013 Elsevier B.V. All rights reserved.

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

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)

Famous face recognition, face matching, and extraversion.

Science.gov (United States)

Lander, Karen; Poyarekar, Siddhi

2015-01-01

It has been previously established that extraverts who are skilled at interpersonal interaction perform significantly better than introverts on a face-specific recognition memory task. In our experiment we further investigate the relationship between extraversion and face recognition, focusing on famous face recognition and face matching. Results indicate that more extraverted individuals perform significantly better on an upright famous face recognition task and show significantly larger face inversion effects. However, our results did not find an effect of extraversion on face matching or inverted famous face recognition.

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

Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.

Science.gov (United States)

Buchholzer, Marie-Luise; Werner, Christine; Knoess, Werner

2014-03-01

For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products. Copyright © 2014 Elsevier Inc. All rights reserved.

Regulatory Challenges for Cartilage Repair Technologies.

Science.gov (United States)

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

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

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

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

AN ILLUMINATION INVARIANT TEXTURE BASED FACE RECOGNITION

Directory of Open Access Journals (Sweden)

K. Meena

2013-11-01

Full Text Available Automatic face recognition remains an interesting but challenging computer vision open problem. Poor illumination is considered as one of the major issue, since illumination changes cause large variation in the facial features. To resolve this, illumination normalization preprocessing techniques are employed in this paper to enhance the face recognition rate. The methods such as Histogram Equalization (HE, Gamma Intensity Correction (GIC, Normalization chain and Modified Homomorphic Filtering (MHF are used for preprocessing. Owing to great success, the texture features are commonly used for face recognition. But these features are severely affected by lighting changes. Hence texture based models Local Binary Pattern (LBP, Local Derivative Pattern (LDP, Local Texture Pattern (LTP and Local Tetra Patterns (LTrPs are experimented under different lighting conditions. In this paper, illumination invariant face recognition technique is developed based on the fusion of illumination preprocessing with local texture descriptors. The performance has been evaluated using YALE B and CMU-PIE databases containing more than 1500 images. The results demonstrate that MHF based normalization gives significant improvement in recognition rate for the face images with large illumination conditions.

Learning Race from Face: A Survey.

Science.gov (United States)

Fu, Siyao; He, Haibo; Hou, Zeng-Guang

2014-12-01

Faces convey a wealth of social signals, including race, expression, identity, age and gender, all of which have attracted increasing attention from multi-disciplinary research, such as psychology, neuroscience, computer science, to name a few. Gleaned from recent advances in computer vision, computer graphics, and machine learning, computational intelligence based racial face analysis has been particularly popular due to its significant potential and broader impacts in extensive real-world applications, such as security and defense, surveillance, human computer interface (HCI), biometric-based identification, among others. These studies raise an important question: How implicit, non-declarative racial category can be conceptually modeled and quantitatively inferred from the face? Nevertheless, race classification is challenging due to its ambiguity and complexity depending on context and criteria. To address this challenge, recently, significant efforts have been reported toward race detection and categorization in the community. This survey provides a comprehensive and critical review of the state-of-the-art advances in face-race perception, principles, algorithms, and applications. We first discuss race perception problem formulation and motivation, while highlighting the conceptual potentials of racial face processing. Next, taxonomy of feature representational models, algorithms, performance and racial databases are presented with systematic discussions within the unified learning scenario. Finally, in order to stimulate future research in this field, we also highlight the major opportunities and challenges, as well as potentially important cross-cutting themes and research directions for the issue of learning race from face.