Regulatory analysis for the resolution of Generic Safety Issue 106: Piping and the use of highly combustible gases in vital areas

International Nuclear Information System (INIS)

Graves, C.C.

1993-06-01

Highly combustible gases such as hydrogen, propane, and acetylene are used at all nuclear power plants. Hydrogen is of particular importance because it is stored in large quantities and is distributed and used continuously in buildings containing safety-related equipment. Large hydrogen releases at the hydrogen storage facilities or in these buildings could lead to fires or explosions that might result in loss of safety-related equipment. This report gives the regulatory analysis for the resolution of Generic Safety Issue 106, open-quotes Piping and the Use of Highly Combustible Gases in Vital Areas.close quotes Scoping analyses showed that the risk associated with the storage and distribution of hydrogen for cooling electric generators at boiling-water reactors (BWRs), the off-gas system at BWRs, the waste gas system at pressurized-water reactors (PWRs), and station battery rooms and portable bottles of combustible gas used for maintenance at PWRs and BWRs is small. On the basis of generic evaluations, the NRC staff has concluded that several possible methods to reduce risk could provide cost-effective safety benefits at some plants. However, in view of the observed large differences in plant-specific characteristics affecting the risk associated with the use of hydrogen, and the marginal generic safety benefit that can be achieved in a cost-effective manner, it is recommended that this generic issue be resolved simply by making these results available in a generic letter. This information may help licensees in their plant evaluations recommended by Generic Letter 88-20, Supplement 4, open-quotes Individual Plant Examination of External Events for Severe Accident Vulnerabilities,close quotes June 28, 1991

Generic licensing issues applicable to Wolsong 3 and 4 licensing review

International Nuclear Information System (INIS)

Boyd, Frederick C.

1994-01-01

The Wolsong 3 and 4 nuclear power plants are of CANDU type which were designed according to the rules and regulations of the Atomic Energy Control Board (AECB) of Canada. In 1992 AECB staff issued a first formal report (to the AECB Board) on 'generic safety issues affecting power reactors'. This was followed by a second report in 1993. These reports dealt with safety issues associated with Canadian CANDU nuclear power plants that applied to all or several plants and were considered insufficiently resolved. In most cases the concern was lack of certainty in the related safety analyses. The AECB staff report of 1993 identified eight 'generic action items' and six 'long-term research issues', three of which AECB staff have indicated may be moved into the 'action' category. This report, prepared for the Korea Institute of Nuclear Safety (KINS), reviews the background of the AECB 'generic action items' and the three 'long-term research issues' noted above. It also reviews an additional topic - steam line failure outside of containment - which was included in the request from KINS. In all, twelve issues are covered. These background reviews are followed by a discussion of the relevance of each issue to the licensing review (for Construction Permit) of Wolsong 3 and 4 and recommended actions to be taken by KINS

Technical resolution of Generic Safety Issue A-29

International Nuclear Information System (INIS)

1989-09-01

This report summarizes key technical findings related to Generic Safety Issue A-29, ''Nuclear Power Plant Design for Reduction of Vulnerability to Industrial Sabotage.'' The findings in this report deal with (1) a historical review of reported sabotage-related events at nuclear facilities, (2) NRC physical security requirements, (3) industry measures to prevent/mitigate sabotage, (4) design and procedural approaches that could be used to deter sabotage, (5) current NRC and industry initiatives aimed at personnel screening and selection, and (6) design considerations applicable to Advanced Light Water Reactors (ALWRs). The results reveal that insider sabotage at operating nuclear plants has not been a significant problem in the United States to date and that there are no singular design modifications or procedures that by themselves would completely eliminate or mitigate the threat of insider sabotage. Rather, it will take a combination of systematic and focused improvements in the three areas of reliable personnel, effective design features, and plant procedures developed to provide a strategy to deal with prevention of insider sabotage and to be able to mitigate adverse actions. 24 refs., 2 figs., 5 tabs

Value-impact assessment for resolution of generic safety issue 143 - availability of HVAC and chilled water systems

Energy Technology Data Exchange (ETDEWEB)

Daling, P.M.; Marler, J.E.; Vo, T.V. [Pacific Northwest Laboratory, Richland, WA (United States)] [and others

1995-02-01

The Pacific Northwest Laboratory (PNL), under contract to the U.S. Nuclear Regulatory Commission (NRC), has conducted an assessment of the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, {open_quotes}Availability of Heating, Ventilation, and Air Conditioning (HVAC) and Chilled Water Systems.{close_quotes} This assessment was conducted to identify vulnerabilities related to failure of HVAC, chilled water and room cooling systems and develop estimates of the core damage frequencies and public risks associated with failures of these systems. This information was used to develop proposed resolution strategies to this generic issue and perform a value/impact assessment to determine their cost-effectiveness. Probabilistic risk assessments (PRAs) for four representative plants from the basis for the core damage frequency and public risk calculations. Internally-initiated core damage sequences as well as external events were considered. Three proposed resolution strategies were developed for this safety issue and it was determined that all three were not cost-effective. Additional evaluations were performed to develop {open_quotes}generic{close_quotes} insights on potential design-related vulnerabilities and potential high-frequency accident sequences that involve failures of HVAC/room cooling functions.

Generic safety issues for nuclear power plants with pressurized heavy water reactors and measures for their resolution

International Nuclear Information System (INIS)

2007-06-01

be used in reassessing the safety of individual operating plants. In 1998, the IAEA completed IAEA-TECDOC-1044 entitled Generic Safety Issues for Nuclear Power Plants with Light Water Reactors and Measures Taken for their Resolution and established the associated LWRGSIDB database (Computer Manual Series No. 13). The present compilation, which is based on broad international experience, is an extension of this work to cover pressurized heavy water reactors (PHWRs). As in the case of LWRs, it is one element in the framework of IAEA activities to assist Member States in reassessing the safety of operating nuclear power plants. It addresses generic safety issues identified in nuclear power plants using PHWRs. In most cases, the measures taken or planned to resolve these issues are also identified. The work on this report was initiated by the Senior Regulators of Countries Operating CANDU-Type Nuclear Power Plants at one of their annual meetings. It was carried out within the framework of the IAEA's programme on National Regulatory Infrastructure for Nuclear Installation Safety and serves to enhance regulatory effectiveness through the exchange of safety related information

NRC program for the resolution of generic issues related to nuclear power plants. (Includes plans for the resolution of ''unresolved safety issues'' pursuant to Section 210 of the Energy Reorganization Act of 1974, as amended)

International Nuclear Information System (INIS)

1977-12-01

This report provides a description of the Nuclear Regulatory Commission's Program for the Resolution of Generic Issues Related to Nuclear Power Plants. The NRC program is of considerably broader scope than the ''Unresolved Safety Issues Plan'' required by Section 210. The NRC program does include plans for the resolution of ''Unresolved Safety Issues''; however, in addition, it includes generic tasks for the resolution of environmental issues, for the development of improvements in the reactor licensing process and for consideration of less conservative design criteria or operating limitations in areas where over conservatisms may be unnecessarily restrictive or costly

RBMK nuclear power plants: Generic safety issues. A publication of the extrabudgetary programme on the safety of WWER and RBMK nuclear power plants

International Nuclear Information System (INIS)

1996-05-01

This report has been prepared on the basis of above mentioned report and it is intended to provide information on RBMK NPPs generic safety issues. As all other insights, recommendations and conclusions resulting from the IAEA Programme, this report is intended to assist national decision makers, who have sole responsibility for the regulation and safe operation of their nuclear power plants. It also serves to focus national and international projects on priority of the RBMK safety improvements. 23 refs, 10 figs, 3 tabs

Integration of generic issues

International Nuclear Information System (INIS)

Thatcher, D.

1989-01-01

The NRC has recognized the need to integrate generic issues (GIs). The GI process includes a number of phases, all of which should recognize the potential for overlap and conflict among related issues. In addition to the issues themselves, other related NRC and industry programs and activities need to be factored into the GI process. Integration has taken place, or is taking place, for a number of GIs. Each case of integration involves a specific set of circumstances and, as a result, the way in which integration proceeds can vary. This paper discusses the integration of issues in the generic issue process and provides a number of examples

A report by the Health and Safety Executive to the Secretary of State for Energy on a review of the generic safety issues of pressurised water reactors

International Nuclear Information System (INIS)

1979-01-01

The Nuclear Installations Inspectorate (NII) has completed a detailed technical study of certain generic safety aspects of the Pressurized Water Reactor (PWR). Although a particular design has been used as a reference, the conclusions reached are not intended to relate to any specific plant. The NII consider that there is no fundamental reason for regarding safety as an obstacle to the selection of a PWR for commercial electricity generation in Britain. Although there are some safety aspects about which present information and investigations are insufficient to allow final conclusions to be reached, and some areas where more work would lead to greater confidence, the NII are satisfied that these issues are not such as to prejudice an immediate decision in principle about the suitability of the PWR for commercial use in Britain. Further progress would appropriately form part of the more detailed review of any specific design of reactor put forward for licensing. Headings of the report include: organization of the review; the PWR; reactor safety issues; basis of judgement; the generic topics (potential plant faults and their analysis, loss of coolant, integrity of primary coolant circuit, fuel elements, reactor protection system, containment, radiological risk in normal operation, radioactive wastes); alternative PWR concepts; risk evaluation; light water reactor safety R and D; conclusions. (author)

Value-impact assessment for resolution of generic safety issue 143 - availability of HVAC and chilled water systems

International Nuclear Information System (INIS)

Daling, P.M.; Marler, J.E.; Vo, T.V.

1995-01-01

The Pacific Northwest Laboratory (PNL), under contract to the U.S. Nuclear Regulatory Commission (NRC), has conducted an assessment of the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, open-quotes Availability of Heating, Ventilation, and Air Conditioning (HVAC) and Chilled Water Systems.close quotes This assessment was conducted to identify vulnerabilities related to failure of HVAC, chilled water and room cooling systems and develop estimates of the core damage frequencies and public risks associated with failures of these systems. This information was used to develop proposed resolution strategies to this generic issue and perform a value/impact assessment to determine their cost-effectiveness. Probabilistic risk assessments (PRAs) for four representative plants from the basis for the core damage frequency and public risk calculations. Internally-initiated core damage sequences as well as external events were considered. Three proposed resolution strategies were developed for this safety issue and it was determined that all three were not cost-effective. Additional evaluations were performed to develop open-quotes genericclose quotes insights on potential design-related vulnerabilities and potential high-frequency accident sequences that involve failures of HVAC/room cooling functions

Generic safety issues. Evaluation of international surveys, studies and expert reports in other countries. Final report; Generische Sicherheitsfragen. Auswertungen von internationalen Untersuchungen, Studien und Gutachten anderer Staaten. Abschlussbericht

Energy Technology Data Exchange (ETDEWEB)

Eismar, Shanna; Wenke, Rainer

2017-09-15

The GeSi and GeSi-International databases developed in the predecessor projects were continued to be maintained and developed further in this project. The GeSi database serves on the one hand for reflecting the current state of the art in science and technology in the field of generic issues and also as a tool in the area of knowledge management. Hence the database can also be used very well as a steering instrument for project planning at GRS and BMUB. Within the term of the project, four issues from national and international operating experience, research results and events or accidents that occurred have been included in the database. The review of the issues contained in the database showed up the more or less strong need for revision or adaptation of a range of generic issues to the state of the art in science and technology. Due to the limited volume of the project, only those issues could be dealt with which were most in need of revision. As a result, 23 issues were subjected to a more detailed review during the project. The 7th review meeting of the contracting parties to the Convention on Nuclear Safety (CNS) was held close to the ending of this project. The national reports of the 5th, 6th and as far as possible from the 7th CNS meeting have been evaluated with respect to important generic safety issues. Within the project 13 issues could be integrated into already existing ones. Eight issues have been removed from the database. Therefore at present (September 2017), there are 288 generic safety issues in the GeSi database.

Status of safety issues at licensed power plants

International Nuclear Information System (INIS)

1991-06-01

As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, a program has been established whereby an annual NUREG report will be published on the status of licensee implementation and NRC verification of safety issues in major NRC requirement areas. This report, the third volume of a three-volume series, addresses the status of generic safety issues (GSIs) at licensed plants. Volume 1 addressed the status of Three Mile Island Action Plan requirements and was published in March 1991. Volume 2 addressed the status of implementation and verification of unresolved safety issues and was published in May 1991. The annual NUREG report will combine these three areas in a single volume to be published in late 1991. The data contained in these NUREG reports are a product of the NRC's Safety Issues Management System (SIMS) database, which is maintained by the Project Management Staff in the Office of Nuclear Reactor Regulation and by NRC regional personnel. The purpose of this report is to provide a comprehensive description of the status of implementation and verification of the 34 GSIs and sub-issues that have been resolved by the NRC and involve implementation of an action or actions by licensees. This NUREG report also serves as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues up until a request for action by licensees is issued by NRC. 3 figs., 6 tabs

Hanford Generic Interim Safety Basis

International Nuclear Information System (INIS)

Lavender, J.C.

1994-01-01

The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports

Hanford Generic Interim Safety Basis

Energy Technology Data Exchange (ETDEWEB)

Lavender, J.C.

1994-09-09

The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports.

Generic Safety Issue (GSI) 171 -- Engineered Safety Feature (ESF) failure from a loop subsequent to LOCA: Assessment of plant vulnerability and CDF contributions

International Nuclear Information System (INIS)

Martinez-Guridi, G.; Samanta, P.; Chu, L.; Yang, J.

1998-01-01

Generic Safety Issue 171 (GSI-171), Engineered Safety Feature (ESF) from a Loss Of Offsite Power (LOOP) subsequent to a Loss Of Coolant Accident (LOCA), deals with an accident sequence in which a LOCA is followed by a LOOP. This issue was later broadened to include a LOOP followed by a LOCA. Plants are designed to handle a simultaneous LOCA and LOOP. In this paper, the authors address the unique issues that are involved i LOCA with delayed LOOP (LOCA/LOOP) and LOOP with delayed LOCA (LOOP/LOCA) accident sequences. LOCA/LOOP accidents are analyzed further by developing event-tree/fault-tree models to quantify their contributions to core-damage frequency (CDF) in a pressurized water reactor and a boiling water reactor (PWR and a BWR). Engineering evaluation and judgments are used during quantification to estimate the unique conditions that arise in a LOCA/LOOP accident. The results show that the CDF contribution of such an accident can be a dominant contributor to plant risk, although BWRs are less vulnerable than PWRs

Generic safety documentation model

International Nuclear Information System (INIS)

Mahn, J.A.

1994-04-01

This document is intended to be a resource for preparers of safety documentation for Sandia National Laboratories, New Mexico facilities. It provides standardized discussions of some topics that are generic to most, if not all, Sandia/NM facilities safety documents. The material provides a ''core'' upon which to develop facility-specific safety documentation. The use of the information in this document will reduce the cost of safety document preparation and improve consistency of information

Current safety issues of CANDU licensing

International Nuclear Information System (INIS)

Lee, Y.; Natalizio, A.

1994-01-01

As requested by Korea Institute of Nuclear Safety(KINS), the status of five generic licensing issues has been examined and their potential impact on a new plant that would be constructed in Canada has been evaluated. The results and conclusions of this evaluation are summarized as follows: steam explosion in calandria, hydrogen explosion in containment, use of PSA in reactor licensing, human factors, safety critical software

Guidelines for nuclear power plant safety issue prioritization information development. Supplement 5

International Nuclear Information System (INIS)

Daling, P.M.; Lavender, J.C.

1996-07-01

This is the sixth in a series of reports to document the development and use of a methodology developed by the Pacific Northwest Laboratory (PNL) to calculate, for prioritization purposes, the risk, dose, and cost impacts of implementing potential resolutions to reactor safety issues (see NUREG/CR-2800, Andrews, et al., 1983). This report contains the results of issue-specific analyses for 34 generic issues. Each issue was considered within the constraints of available information at the time the issues were examined and approximately 2 staff-weeks of labor. The results are referenced as one consideration in NUREG-0933, A Prioritization of Generic Safety Issues (Emrit, et al., 1983)

Guidelines for nuclear power plant safety issue prioritization information development. Supplement 5

Energy Technology Data Exchange (ETDEWEB)

Daling, P.M.; Lavender, J.C. [Pacific Northwest National Lab., Richland, WA (United States)

1996-07-01

This is the sixth in a series of reports to document the development and use of a methodology developed by the Pacific Northwest Laboratory (PNL) to calculate, for prioritization purposes, the risk, dose, and cost impacts of implementing potential resolutions to reactor safety issues (see NUREG/CR-2800, Andrews, et al., 1983). This report contains the results of issue-specific analyses for 34 generic issues. Each issue was considered within the constraints of available information at the time the issues were examined and approximately 2 staff-weeks of labor. The results are referenced as one consideration in NUREG-0933, A Prioritization of Generic Safety Issues (Emrit, et al., 1983).

Enhancing Safety through Generic Competencies

Directory of Open Access Journals (Sweden)

S. Mockel

2014-03-01

Full Text Available This article provides insights into proactive safety management and mitigation. An analysis of accident reports reveals categories of supervening causes of accidents which can be directly linked to the concept of generic competencies (information management, communication and coordination, problem solving, and effect control. These findings strongly suggest adding the human element as another safety-constituting pillar to the concept of ship safety next to technology and regulation. We argue that the human element has unique abilities in dealing with critical and highly dynamic situations which can contribute to the system's recovery from non-routine or critical situations. By educating seafarers in generic competencies we claim to enable the people onboard to successfully deal with critical situations.

Status of generic actions items and safety analysis system of PHWR

Energy Technology Data Exchange (ETDEWEB)

Park, Joo Hwan; Min, Byung Joo

2001-05-01

This report described the review results of a GAIs(Generic Action Item) currently issued on safety analysis of PHWR(Pressurized Heavy Water Reactor) and the research activities and positions to solve the GAIs in each country which possess PHWRs. eviewing the Final Safety Analysis Report for Wolsong-2/3/4 Units, the safety analysis methodology, classification for accident scenarios, safety analysis codes, their interface, etc.. were described. From the present review report, it is intended to establish the CANDU safety analysis system by providing the better understandings and development plans for the safety analysis of PHWR. esults.

Categorization of reactor safety issues from a risk perspective

International Nuclear Information System (INIS)

1985-03-01

This report presents the results of an effort to identify and rank reactor safety and risk issues identified from past Probabilistic Risk Assessments (PRAs) and other safety analyses. Because of the varied scope of these analyses, the list of issues may be incomplete. Nevertheless, those studies comprised ordered analyses to whatever their respective depths; hence, they warranted scrutiny for whatever insights they could reveal with respect to issue importance. The top-ranked issues in terms of their contribution to the uncertainty in risk are described in some detail. All of these risk issues are compared to the generic safety issues for completeness and omissions

Status of safety issues at licensed power plants

International Nuclear Information System (INIS)

1991-05-01

As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, a program has been established whereby an annual NUREG report will be published on the status of licensee implementation and NRC verification of safety issues in major NRC requirement areas. This report, the second volume of a three-volume series, addresses the status of unresolved safety issues (USIs) at licensed plants. The data contained in these NUREG reports are a product of the NRC's Safety Issues Management System (SIMS) database, which is maintained by the Project Management Staff in the Office of Nuclear Reactor Regulation and by NRC regional personnel. The purpose of this report is to provide a comprehensive description of the status of implementation and verification of the 27 safety issues designated as USIs and to make this information available to other interested parties, including the public. A corollary purpose of this NUREG report is to serve as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues up until requirements are approved for imposition at licensed plants. 3 figs., 4 tabs

Unresolved safety issues: where do we go from here

International Nuclear Information System (INIS)

Aycock, M.B.

1980-01-01

Section 210 of the Energy reorganization Act of 1974, as amended requires the NRC to develop a program for resolving Unresolved Safety Issues related to nuclear power plants. Seventeen Unresolved Safety Issues were identified by the NRC in 1978 and by early 1979 the NRC Unresolved Safety Issues Program was quickly becoming a well defined and manageable effort. Although, the Three Mile Island accident caused the momentum developed in early 1979 to be lost, efforts on ongoing generic tasks were continued by a special NRC Task Force established in June 1979. The momentum that was lost must be regained, however, if the Congressional mandate in Section 210 is to be met. With increased industry involvement and the marriage of the Unresolved Safety Issues Program with the improved and broader safety program development, audit and evaluation activities of the new NRR Division of Safety Technology, this should be possible

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

A generic standard for assessing and managing activities with significant risk to health and safety

International Nuclear Information System (INIS)

Wilde, T.S.; Sandquist, G.M.

2005-01-01

Some operations and activities in industry, business, and government can present an unacceptable risk to health and safety if not performed according to established safety practices and documented procedures. The nuclear industry has extensive experience and commitment to assessing and controlling such risks. This paper provides a generic standard based upon DOE Standard DOE-STD-3007- 93, Nov 1993, Change Notice No. 1, Sep 1998. This generic standard can be used to assess practices and procedures employed by any industrial and government entity to ensure that an acceptable level of safety and control prevail for such operations. When any activity and operation is determined to involve significant risk to health and safety to workers or the public, the organization should adopt and establish an appropriate standard and methodology to ensure that adequate health and safety prevail. This paper uses DOE experience and standards to address activities with recognized potential for impact upon health and safety. Existing and future assessments of health and safety issues can be compared and evaluated against this generic standard for insuring that proper planning, analysis, review, and approval have been made. (authors)

Generic radiation safety design for SSRL synchrotron radiation beamlines

Energy Technology Data Exchange (ETDEWEB)

Liu, James C. [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States)]. E-mail: james@slac.stanford.edu; Fasso, Alberto [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Khater, Hesham [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Prinz, Alyssa [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Rokni, Sayed [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States)

2006-12-15

To allow for a conservative, simple, uniform, consistent, efficient radiation safety design for all SSRL beamlines, a generic approach has been developed, considering both synchrotron radiation (SR) and gas bremsstrahlung (GB) hazards. To develop the methodology and rules needed for generic beamline design, analytic models, the STAC8 code, and the FLUKA Monte Carlo code were used to pre-calculate sets of curves and tables that can be looked up for each beamline safety design. Conservative beam parameters and standard targets and geometries were used in the calculations. This paper presents the SPEAR3 beamline parameters that were considered in the design, the safety design considerations, and the main pre-calculated results that are needed for generic shielding design. In the end, the rules and practices for generic SSRL beamline design are summarized.

Guidelines for nuclear power plant safety issue prioritization information development. Supplement 2

International Nuclear Information System (INIS)

Andrews, W.B.; Gallucci, R.H.V.; Konzek, G.J.; Heaberlin, S.W.; Fecht, B.A.; Allen, C.H.; Allen, R.D.; Bickford, W.E.; Carbaugh, E.H.; Lewis, J.R.

1983-12-01

This is the third in a series of reports to document the use of a methodology developed by the Pacific Northwest Laboratory to calculate, for prioritization purposes, the risk, dose and cost impacts of implementing resolutions to reactor safety issues (NUREG/CR-2800, Andrews et al. 1983). This report contains results of issue-specific analyses for 31 issues. Each issue was considered within the constraints of available information as of summer 1983, and two staff-weeks of labor. The results are referenced, as one consideration in setting priorities for reactor safety issues, in NUREG-0933, A Prioritization of Generic Safety Issues

Unresolved safety issues summary: aqua book

International Nuclear Information System (INIS)

1983-06-01

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. 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 schedule for implementation will not normally be included in the task action plan(s) for the resolution of a USI since the nature and extent of the activities necessary to accomplish the implementation cannot normally be reasonably determined prior to the determination of a technical resolution. 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

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

Generic Safety Requirements for Developing Safe Insulin Pump Software

Science.gov (United States)

Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab

2011-01-01

Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving

Identification of unresolved safety issues relating to nuclear power plants. Report to Congress

International Nuclear Information System (INIS)

1979-01-01

The report describes the review undertaken over the last year that resulted in identifying 17 issues as Unresolved Safety Issues. In addition, the report provides specific discussions of why certain issues were not included. The report also provides a brief background discussion describing Section 210 of the Energy Reorganization Act and the NRC program for the resolution of generic issues described in NUREG-0410

Evaluation of Generic Issue 57: Effects of fire protection system actuation on safety-related equipment

International Nuclear Information System (INIS)

Lambright, J.; Bohn, M.; Lynch, J.; Ross, S.; Brosseau, D.

1992-12-01

Nuclear power plants have experienced actuations of fire protection systems (FPSs) under conditions for which these systems were not intended to actuate and also have experienced advertent actuations with the presence of a fire. These actuations have often damaged safety-related equipment. A review of the impact of past occurrences of both types of such events and their impact on plant safety systems, an analysis of the risk impacts of such events on nuclear power plant safety, and a cost-benefit analysis of potential corrective measures have been performed. Thirteen different scenarios leading to actuation of fire protection systems due to a variety of causes were identified. These scenarios ranged from inadvertent actuation caused by human error to hardware failure, and include seismic root causes and seismic/fire interactions. A quantification of these thirteen root causes, where applicable, was performed on generically applicable scenarios. This document, Volume 4, contains appendices E and F of this report

Safety issues for superconducting fusion magnets

International Nuclear Information System (INIS)

Hsieh, S.Y.; Reich, M.; Powell, J.R.

1978-01-01

Safety issues for future superconducting fusion magnet systems are examined. It is found that safety and failure experience with existing superconducting magnets is not very applicable to predictions as to the safety and reliability of fusion magnets. Such predictions will have to depend on analysis and judgement for many years to come, rather than on accumulated experience. A number of generic potential structural, thermal-hydraulic, and electrical safety problems are identified and analyzed. Prevention of quenches and non-uniform temperature distributions, if quenches should occur, is of great importance, since such events can trigger processes which lead to magnet damage or failure. Engineered safety features will be necessary for fusion magnets. Two of these, an energy dispersion system and external coil containment, appear capable of reducing the probability of coil disruption to very low levels. However, they do not prevent loss of function accidents which are of economic concern. Elaborate detector, temperature equalization, and energy removal systems will be required to minimize the chances of loss of function accidents

Modified enforcement policy relating to 10 CFR 50.49, ''Environmental qualification of electrical equipment important to safety for nuclear power plants'' (Generic Letter 88-07)

International Nuclear Information System (INIS)

Miraglia, F.J.

1992-01-01

Generic Letters, Bulletins, and Information Notices have been issued to provide guidance regarding the application and enforcement of 10 CFR 50.49, ''Environmental Qualification of Electric Equipment Important to Safety for Nuclear Power Plants.'' Generic Letter 85-15, issued August 6, 1985, and Generic Letter 86-15, issued September 22, 1986, provided information related to the deadlines for compliance with 10 CFR 50.49 and possible civil penalties applicable to licensees who were not in compliance with the rule as of the November 30, 1985 deadline. Upon review, the Commission found that the EQ Enforcement Policy promulgated in Generic Letter 86-15, could result in imposition of civil penalties that did not properly reflect the safety significance of EQ violations with respect to civil penalties imposed in the past. In the interest of continuing a tough but fair enforcement policy, the Commission determined that the EQ Enforcement Policy should be revised. The purpose of this letter is to provide a modification to the NRC's enforcement policy, as approved by the Commission, for environmental qualification (EQ) violations. This letter replaces the guidance provided in Generic Letters 85-15 and 86-15

Development of the NIREX generic transport safety assessment to assist in the provision of waste packaging advice

International Nuclear Information System (INIS)

Hutchinson, D.L.; Marrison, A.R.; Sievwright, R.W.T.

2002-01-01

The current Nirex Mission is to provide the United Kingdom with safe, environmentally sound and publicly acceptable options for the long-term management of radioactive materials. As part of this role, Nirex has developed a phased deep geological disposal concept which is defined by six 'generic documents' that describe systems, processes and safety assessments that are not specific to any one location or geology. These generic documents give access to detailed information about the ideas and approaches that underpin the phased disposal concept, and have been published with an invitation to enter into dialogue with Nirex regarding these issues. The generic documents identify the requirements for an integrated transport system that would be necessary for the management of the intermediate-level (ILW) and low-level (LLW) wastes within Nirex's remit - the so-called reference case volume. This has involved Nirex in the development of transport hardware and associated safety reports and modelling and assessment tools for transport system logistics and system safety. Although the phased disposal concept is only one option for the long-term management of waste, the integrated transport system and associated modelling tools, is likely to be of equal relevance to other options. The safety assessment of the generic transport operation for the movement of ILW and LLW waste from waste producers' sites to a future radioactive waste disposal facility is described in one of the generic documents - the generic transport safety assessment (GTSA). The GTSA demonstrates that the transport operation is compliant with Nirex safety principles, and that the nuclear and non-nuclear risks to the public and workers from routine transport and from accidents are acceptable. This paper describes the types of risk that are calculated, and discusses the data requirements and calculation methodology. The verification and validation methodology is outlined, together with a discussion of the results

Ranking of safety issues for WWER-440 model 230 nuclear power plants

International Nuclear Information System (INIS)

1992-02-01

In response to requests from Member States operating Soviet designed WWER-440/230 nuclear power plants (NPPs) for assistance through the IAEA's nuclear safety services, a major international project was established to evaluate these first generation reactors as a complement to relevant ongoing national, bilateral and multilateral activities. The objective is to assist countries operating WWER-440/230 NPPs in performing comprehensive safety reviews aimed at identifying design and operational weaknesses. The scope of the project includes a review of the conceptual design of WWER-440/230 NPPs, safety review missions to each one of the operating reactors to review design and operational aspects and studies to resolve issues of generic safety concern. This report was prepared by a group of international experts and the IAEA staff and discussed by the Project Steering Committee, December 9-13, 1991 in Vienna. An overview of the safety issues identified is presented indicating their effect on the performance of the basic safety functions. Conceptual recommendations related to design issues are given as a technical basis for the safety modifications required

Generic safety questions. evaluation of investigations, studies and expertises of other states for the knowledge base GeSi; Generische Sicherheitsfragen. Auswertung von Untersuchungen, Studien und Gutachten anderer Staaten fuer die Wissensbasis GeSi

Energy Technology Data Exchange (ETDEWEB)

Boenigke, Guenther; Eismar, Shanna

2016-03-15

For the non-profit-making expert organization Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS) gGmbH, maintaining know-how and broadening its knowledge in the field of nuclear safety is of fundamental relevance. One important approach to achieving this goal is to collect and assess national and international findings and events in the field of nuclear safety e.g. in connection with generic issues - i.e. issues that are not specific to a particular plant. The GeSi/GeSi International database and its subsystems serves for reflecting the current state of the art in science and technology in the field of generic issues and also as a tool in the area of knowledge management. Within the framework of Project 3611 I 01500 sponsored by the BMUB, information on these issues was compiled systematically. The aim of the project was to examine the safety issues that are cur-rently discussed at national and international level with regard to their relevance for the conditions prevailing in Germany and to follow up in detail those issues that are of relevance for national safety practice. Similar knowledge databases also exist in other major nuclear-power-plant-operating countries such as the US, Canada, and France. At present (September 2014), there are 303 issues in the overall database, of which 23 are assessed to be of ''high'' significance for German plants. Of these, 16 issues belong to the sub-database for generic safety issues (GSI) and seven belong to the sub-database for generic research issues (GFO). The database GSI currently contains 138 issues that need to be further addressed and 101 issues that are considered as solved. 43 issues from the database GFO require further investigation, while 21 issues are considered as solved.

Study on operational safety issues in the Japanese disposal concept

International Nuclear Information System (INIS)

Suzuki, Satoru; Kitagawa, Yoshito; Hyodo, Hideaki; Kubota, Shigeru; Iijima, Masayoshi; Tamura, Akio; Ishiguro, Katsuhiko; Fujihara, Hiroshi

2014-01-01

In Japan, vitrified high-level radioactive waste (HLW) and certain types of low-level radioactive waste that results from the reprocessing of spent fuel and classified as TRU waste will be disposed of in deep geological formations. NUMO aims to ensure the safety of local residents and workers during the operational phase and after repository closure and will therefore establish a safety case for the geological disposal programme at the end of each stage of the stepwise siting process. Although the Japanese programme is still in the stage before initiation of the siting process, updating the generic (non-site-specific) safety case is required for building confidence among stakeholders. This study focuses on operational safety issues for the Japanese HLW disposal concept. (authors)

Safety issues and their ranking for WWER-440 model 213 nuclear power plants. A publication of the extrabudgetary programme on the safety of WWER and RBMK nuclear power plants

International Nuclear Information System (INIS)

1996-04-01

The objective of this report is to present a consolidated list of generic safety concerns, called safety issues, ranked according to their safety significance and the corrective measures to improve safety. It is intended for use as a reference to facilitate the development of plant specific safety improvement programmes and to serve as a basis for reviewing their implementation. Section 2 provides and overview of the impact of all relevant issues on the main safety functions and other aspects important to overall plant safety. Section 3 presents safety issues identified in design according to the structure described below. Section 4 presents the safety issues in the area of operation, according to the same structure except that no ranking is given. At the end of Section 2, Tables 1 and 2 present a summary of all safety issues in a tabular form. 138 refs, tabs

Benefits of Digital Equipment Generic Qualification Activities

International Nuclear Information System (INIS)

Thomas, James E.; Steiman, Samuel C.

2002-01-01

As a result of nuclear power plant instrumentation and control obsolescence issues, there have been numerous activities during recent years relating to the qualification of digital equipment. Some of these activities have been 'generic' in nature in that the qualification was not limited to plant specific applications, but was intended to cover a broad base of potential applications of the digital equipment. These generic qualifications have been funded by equipment manufacturers and by utility groups and organizations. The generic activities sponsored by the Electric Power Research Institute (EPRI) have been pilot projects for an overall generic qualification approach. The primary benefit resulting from the generic qualification work to date is that a number of digital platforms and digital devices are now available for use in various nuclear safety-related applications. Many of the tests and evaluations necessary to support plant specific applications have been completed. The amount of data and documentation that each utility must develop on a case by case basis has been significantly reduced. There are also a number of additional benefits resulting from these industry efforts. The challenges and difficulties in qualifying digital equipment for safety-related applications are now more clearly understood. EPRI has published a lessons learned document (EPRI Report 1001452, Generic Qualification of Commercial Grade Digital Devices: Lessons Learned from Initial Pilots, which covers several different qualification areas, including device selection, project planning, vendor surveys and design reviews, and electromagnetic compatibility (EMC) qualification. Application of the experience and lessons learned from the EPRI pilot activities should help reduce the effort and cost required for future qualification work. Most generic qualification activities for commercial equipment have been conducted using the approach of EPRI TR-106439, Guideline on Evaluation and Acceptance

Technical findings related to Generic Issue 23: Reactor coolant pump seal failure

International Nuclear Information System (INIS)

Ruger, C.J.; Luckas, W.J. Jr.

1989-03-01

Reactor coolant pumps contain mechanical seals to limit the leakage of pressurized coolant from the reactor coolant system to the containment. These seals have the potential to leak, and a few have degraded and even failed resulting in a small break loss of coolant accident (LOCA). As a result, ''Reactor Coolant Pump Seal Failure,'' Generic Issue 23 was established. This report summarizes the findings of a technical investigation generated as part of the program to resolve this issue. These technical findings address the various fact-finding issue tasks developed for the action plan associated with the generic issue, namely background information on seal failure, evaluation of seal cooling, and mechanical- and maintenance-induced failure mechanisms. 46 refs., 15 figs., 14 tabs

Request for information related to the resolution of generic issue 130, ''Essential service water system failures at multi-unit sites,'' pursuant to 10 CFR 50.54(f) - Generic Letter 91-13

International Nuclear Information System (INIS)

Partlow, J.G.

1993-01-01

The essential service water system (ESWS) is important in maintaining plant safety during power operation, shutdown, and accident conditions. As part of the Nuclear Regulatory Commission's (NRC) evaluation of loss of essential service water (LOSW), extensive analyses of this issue were performed at the Brookhaven National Laboratory (BNL). In addition, the NRC staff performed a regulatory analysis to evaluate the safety benefits and implementation costs associated with various equipment and the administrative-type improvements that were considered. These analyses assume that the flushing and flow testing provisions of Generic Letter (GL) 89-13, ''Service Water System Problems Affecting Safety-Related Equipment,'' will be applied to the crosstie lines as part of addressees' implementation of the resolution of GI-51, ''Improving the Reliability of Open-Cycle Service Water Systems'' (GL 89-13 and Supplement 1). On the basis of results of these evaluations of this generic safety issue, the NRC staff has concluded that the following administrative-type improvements would significantly enhance the availability of the ESWS in affected plants, and their implementation is warranted in view of the safety benefit to be derived and the cost of implementation: technical specification (TS) changes contained in Enclosure 1 to enhance the availability of the ESWS as applied to the design configuration of affected plants; and improvement of emergency procedures for a LOSW using existing design features, specifically: (a) operating and maintaining high-pressure injection (HPI) pump integrity in the event of loss of reactor coolant pump (RCP) seals as a result of ESWS failure, and (b) testing and manipulating the ESWS crosstie between the units during a LOSW accident

Unresolved safety issues summary. Volume 3, Number 3. Aqua book

International Nuclear Information System (INIS)

1981-01-01

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 Management and Program Analysis. The definition of what constitutes completion of an unresolved safety issue (USI) has recently been expanded to include the implementation of the technical resolution. This is in acknowledgement of the fact that real safety benefits occur only after the implementation has taken place. 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 schedule for implementation will not normally be included in the task action plan(s) for the resolution of a USI since the nature and extent of the activities necessary to accomplish the implementation cannot normally be reasonably determined prior to the determination of a technical resolution. 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

Safety and efficacy of generic drugs with respect to brand formulation.

Science.gov (United States)

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-12-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

Team of experts concludes review of safety issues at Temelin

International Nuclear Information System (INIS)

2001-01-01

Full text: At the request of the Czech Government, the International Atomic Energy Agency (IAEA) assembled a team of national experts from Bulgaria, France, Germany, Spain, and the United Kingdom, with an observer from Austria, to review safety issues at the Temelin power plant that were identified in 1996 as relevant to reactors of the generic Temelin design (WWER-1000/320 type). Following a detailed on-site review from 18 to 23 November 2001, the experts concluded that most identified issues had been addressed and resolved. Work is continuing on the few remaining issues. These issues, however, are not judged by them to be significant and would not from the experts' standpoint preclude the safe operation of the Temelin nuclear power plant. The final report of the team of experts will be available to the Czech Government in one month's time. (author)

Pharmacokinetics and 48-week safety and efficacy of generic lopinavir/ritonavir in Thai HIV-infected patients

NARCIS (Netherlands)

Ramautarsing, Reshmie A.; van der Lugt, Jasper; Gorowara, Meena; Sophonphan, Jiratchaya; Ananworanich, Jintanat; Lange, Joep M. A.; Burger, David M.; Phanuphak, Praphan; Ruxthungtham, Kiat; Avihingsanon, Anchalee

2013-01-01

Background: Generic products reduce the costs of HIV treatment. Few generic second-line antiretroviral products are available. We assessed pharmacokinetics, safety and efficacy of generic lopinavir/ritonavir (LPV/r) produced by the Government Pharmaceutical Organization (GPO) of Thailand in Thai

Twenty-fifth water reactor safety information meeting: Proceedings. Volume 1: Plenary sessions; Pressure vessel research; BWR strainer blockage and other generic safety issues; Environmentally assisted degradation of LWR components; Update on severe accident code improvements and applications

Energy Technology Data Exchange (ETDEWEB)

Monteleone, S. [comp.] [Brookhaven National Lab., Upton, NY (United States)

1998-03-01

This three-volume report contains papers presented at the conference. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Japan, Norway, and Russia. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting. This volume contains the following information: (1) plenary sessions; (2) pressure vessel research; (3) BWR strainer blockage and other generic safety issues; (4) environmentally assisted degradation of LWR components; and (5) update on severe accident code improvements and applications. Selected papers have been indexed separately for inclusion in the Energy Science and Technology Database.

Twenty-fifth water reactor safety information meeting: Proceedings. Volume 1: Plenary sessions; Pressure vessel research; BWR strainer blockage and other generic safety issues; Environmentally assisted degradation of LWR components; Update on severe accident code improvements and applications

International Nuclear Information System (INIS)

Monteleone, S.

1998-03-01

This three-volume report contains papers presented at the conference. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Japan, Norway, and Russia. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting. This volume contains the following information: (1) plenary sessions; (2) pressure vessel research; (3) BWR strainer blockage and other generic safety issues; (4) environmentally assisted degradation of LWR components; and (5) update on severe accident code improvements and applications. Selected papers have been indexed separately for inclusion in the Energy Science and Technology Database

Safety and efficacy of generic drugs with respect to brand formulation

OpenAIRE

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-01-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to gener...

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

Science.gov (United States)

Borg, John Joseph; Tomasi, Paolo; Pani, Luca; Aislaitner, George; Pirozynski, Michal; Leufkens, Hubert; Melchiorri, Daniela

2014-01-01

When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.

Generic safety insights for inspection of boiling water reactors

International Nuclear Information System (INIS)

Higgins, J.C.; Taylor, J.H.; Fresco, A.N.; Hillman, B.M.

1987-01-01

As the number of operating nuclear power plants (NPP) increases, safety inspection has increased in importance. However, precisely what is important, and what is not important? What should one focus inspection efforts on. Over the last two years Probabilistic Risk Assessment (PR) techniques have been developed to aid in the inspection process. Broad interest in generic PRA-based methods has arisen in the past year, since only about 25% of the US nuclear power plants have completed PRAs, and also, inspectors want PRA-based tools for these plants. This paper describes the BNL program to develop generic BWR PRA-based inspection insights or inspection guidance designed to be applied to plants without PRAs

Nuclear safety - Topical issues

International Nuclear Information System (INIS)

1995-01-01

The following topical issues related to nuclear safety are discussed: steam generators; maintenance strategies; control rod drive nozzle cracks; core shrouds cracks; sump strainer blockage; fire protection; computer software important for safety; safety during shutdown; operational safety experience; external hazards and other site related issues. 5 figs, 5 tabs

Aviation Safety Issues Database

Science.gov (United States)

Morello, Samuel A.; Ricks, Wendell R.

2009-01-01

The aviation safety issues database was instrumental in the refinement and substantiation of the National Aviation Safety Strategic Plan (NASSP). The issues database is a comprehensive set of issues from an extremely broad base of aviation functions, personnel, and vehicle categories, both nationally and internationally. Several aviation safety stakeholders such as the Commercial Aviation Safety Team (CAST) have already used the database. This broader interest was the genesis to making the database publically accessible and writing this report.

A study for the domestic application plan of the Generic Safety Issue(GSI) for the Pressurized Heavy Water Reactor

International Nuclear Information System (INIS)

Lee, Un Chul; Jang, Jin Wook; Lee, Sang Kyung; Lee, Doo Yong; Park, Chang Hwan

2002-03-01

In this study, a base work to construct the database of the domestic and foreign GSls were done through performing the deviation of GSls for the PHWR by investigating the development trend of international joint studies and the GSls of 4 countries as the PHWR state and examined the IAEA acceptance of GSls classification for the GSls of Canada, Korea Republic of, Argentina and India. We evaluated the possibility of application of the safety Issue for PHWR by investigating causes, contents and follow-up measures of each items. To evaluate the domestic application validity of the safety issue, We made the investigation matrix for the safety issue of each countries and also are reflecting new results in investigation matrix by examining IAEA PHWR GSI development trend. We intended to derive the GSls which are most appropriate in our PHWR by examining every issues. the derived GSls are divided into the design parts and the operation parts. And they have to be solved as soon as possible

A study for the domestic application plan of the Generic Safety Issue(GSI) for the Pressurized Heavy Water Reactor

Energy Technology Data Exchange (ETDEWEB)

Lee, Un Chul; Jang, Jin Wook; Lee, Sang Kyung; Lee, Doo Yong; Park, Chang Hwan [Seoul National Univ., Seoul (Korea, Republic of)

2002-03-15

In this study, a base work to construct the database of the domestic and foreign GSls were done through performing the deviation of GSls for the PHWR by investigating the development trend of international joint studies and the GSls of 4 countries as the PHWR state and examined the IAEA acceptance of GSls classification for the GSls of Canada, Korea Republic of, Argentina and India. We evaluated the possibility of application of the safety Issue for PHWR by investigating causes, contents and follow-up measures of each items. To evaluate the domestic application validity of the safety issue, We made the investigation matrix for the safety issue of each countries and also are reflecting new results in investigation matrix by examining IAEA PHWR GSI development trend. We intended to derive the GSls which are most appropriate in our PHWR by examining every issues. the derived GSls are divided into the design parts and the operation parts. And they have to be solved as soon as possible.

Value impact analysis of Generic Issue 143, Availability of Heating, Ventilation, Air Conditioning (HVAC) and Chilled Water Systems

Energy Technology Data Exchange (ETDEWEB)

Daling, P.M.; Marler, J.E.; Vo, T.V.; Phan, H.; Friley, J.R. [Pacific Northwest Lab., Richland, WA (United States)

1993-11-01

This study evaluates the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, ``Availability of HVAC and Chilled Water Systems.`` The study identifies vulnerabilities related to failures of HVAC, chilled water, and room cooling systems; develops estimates of room heatup rates and safety-related equipment vulnerabilities following losses of HVAC/room cooler systems; develops estimates of the core damage frequencies and public risks associated with failures of these systems; develops three proposed resolution strategies to this generic issue; and performs a value/impact analysis of the proposed resolutions. Existing probabilistic risk assessments for four representative plants, including one plant from each vendor, form the basis for the core damage frequency and public risk calculations. Both internal and external events were considered. It was concluded that all three proposed resolution strategies exceed the $1,000/person-rem cost-effectiveness ratio. Additional evaluations were performed to develop ``generic`` insights on potential design-related and configuration-related vulnerabilities and potential high-frequency ({approximately}1E-04/RY) accident sequences that involve failures of HVAC/room cooling functions. It was concluded that, although high-frequency accident sequences may exist at some plants, these high-frequency sequences are plant-specific in nature or have been resolved through hardware and/or operational changes. The plant-specific Individual Plant Examinations are an effective vehicle for identification and resolution of these plant-specific anomalies and hardware configurations.

Value impact analysis of Generic Issue 143, Availability of Heating, Ventilation, Air Conditioning (HVAC) and Chilled Water Systems

International Nuclear Information System (INIS)

Daling, P.M.; Marler, J.E.; Vo, T.V.; Phan, H.; Friley, J.R.

1993-11-01

This study evaluates the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, ''Availability of HVAC and Chilled Water Systems.'' The study identifies vulnerabilities related to failures of HVAC, chilled water, and room cooling systems; develops estimates of room heatup rates and safety-related equipment vulnerabilities following losses of HVAC/room cooler systems; develops estimates of the core damage frequencies and public risks associated with failures of these systems; develops three proposed resolution strategies to this generic issue; and performs a value/impact analysis of the proposed resolutions. Existing probabilistic risk assessments for four representative plants, including one plant from each vendor, form the basis for the core damage frequency and public risk calculations. Both internal and external events were considered. It was concluded that all three proposed resolution strategies exceed the $1,000/person-rem cost-effectiveness ratio. Additional evaluations were performed to develop ''generic'' insights on potential design-related and configuration-related vulnerabilities and potential high-frequency (∼1E-04/RY) accident sequences that involve failures of HVAC/room cooling functions. It was concluded that, although high-frequency accident sequences may exist at some plants, these high-frequency sequences are plant-specific in nature or have been resolved through hardware and/or operational changes. The plant-specific Individual Plant Examinations are an effective vehicle for identification and resolution of these plant-specific anomalies and hardware configurations

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

Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

Directory of Open Access Journals (Sweden)

Garth Boehm

2013-09-01

Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

Exploring knowledge perceptions and attitudes about generic medicines among finalyear health science students

Directory of Open Access Journals (Sweden)

Varsha Bangalee

2016-05-01

Full Text Available Background. The use of generic medicines to reduce healthcare costs has become a mandated policy in South Africa. An increase in the use of generics can be achieved through improved knowledge, attitudes and perceptions of generic medicine among healthcare professionals. Objective. To explore knowledge, attitudes and perceptions among final-year health science students on generic medication. Methods. A cross-sectional survey was carried out among the final-year audiology, dental therapy, pharmacy, physiotherapy, occupational therapy, optometry, speech-language and sport science students enrolled at the University of KwaZulu-Natal. A questionnaire was used as the study tool, developed using information adapted from literature reviews. Data analysis was completed using Statistical Package for the Social Sciences (SPSS version 21, and computed using descriptive statistics. Results. Total number of participants was 211, as follows: audiology (n=14, dental therapy (n=15, pharmacy (n=81, physiotherapy (n=41, occupational therapy (n=6, optometry (n=25, speech-language (n=6 and sport science (n=23. A total of 90.0% of students had heard of generic medicines, with 20.9% of them agreeing that generic medicines are less effective than brand-name medicines. Concerning safety, 30.4% believed that brand-name medicines are required to meet higher safety standards than generic medicines. Regarding the need for information on issues pertaining to safety and efficacy of medicines, 53.3% of participants felt that this need was not being met. Conclusion. All groups had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

Generic medicine and prescribing: A quick assessment

Directory of Open Access Journals (Sweden)

Mainul Haque

2017-01-01

Full Text Available Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts. The Food and Drug Administration (FDA describes that generic drugs are essential possibilities that allow better access to healthcare for all Americans. They are replicas of brand-name drugs and are the identical as those of brand-name drugs in dosage form, safety, strength, route of administration, quality, performance features, and anticipated to use. Healthcare authorities and users can be guaranteed that FDA-approved generic drug products have met the same stiff principles as the innovator drug. The company that made Bayer aspirin fought in court enthusiastically to keep generic versions off the shelves, in the 1920s. The company lost in court, and consumers suddenly had an array of choices in generic aspirin. The Supreme Court of India uttering ‘the Supreme Court's ruling will prevent companies from further seeking unwarranted patents on HIV and other essential medicines.’ Generic medicine cannot be sold at a price higher than the branded medicine, so it is regularly a low-priced option. Thereafter, both the end user and the government who pay for part of the price of the medicine under the Pharmaceutical Benefits Scheme in Australia are benefitted. The treatment of diseases using essential drugs, prescribed by their generic names, has been emphasised by the WHO and many national health policies. Although there are some improvements in generic medicine prescribing, it has been advised by the WHO that ‘countries should intensify efforts to measure and regularly monitor medicine prices and availability, and adopt policy measures to address the issues identified.’

Regulatory analysis for the resolution of generic issue 57: Effects of Fire Protection System Actuation on Safety-Related Equipment

International Nuclear Information System (INIS)

Woods, H.W.

1993-10-01

Actuation of Fire Protection Systems (FPS) in Nuclear Power Plants have resulted in adverse interactions with equipment important to safety. Precursor operational experience has shown that 37% of all FPS actuations damaged some equipment, and 20% of all FPS actuations have resulted in a plant transient and reactor trip. On an average 0.17 FPS actuations per reactor year have been experienced in nuclear power plants in this country. This report presents the regulatory analysis for GI-57, ''Effects of Fire Protection System Actuation on Safety-Related Equipment''. The risk reduction estimates, cost/benefit analyses, and other insights gained during this effort have shown that implementation of the recommendations contained in this report can significantly reduce risk, and that these improvements can be warranted in accordance with the backfit rule, 10 CFR 50.109(a)(3). However, plant specific analyses are required in order to identify such improvements. Generic analyses can not serve to identify improvements that could be warranted for individual, specific plants. Plant specific analyses of the type needed for this purpose are underway as part of the Individual Plant Examination of External Events (IPEEE) program

Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA)

DEFF Research Database (Denmark)

Leuschner, R. G. K.; Robinson, T. P.; Hugas, M.

2010-01-01

Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments across different scientific Panels and Units. The aim of this review is to outline the implementation...... and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through...

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...

Prescribing Generic Medication in Chronic Musculoskeletal Pain Patients: An Issue of Representations, Trust, and Experience in a Swiss Cohort.

Directory of Open Access Journals (Sweden)

Valérie Piguet

Full Text Available Parallel to an ever stronger advocacy for the use of generics, various sources of information report concerns regarding substitution. The literature indicates that information regarding substitution is not univocal. The aim of this qualitative study was to explore patients' representations regarding generics in patients suffering from non-specific disabling chronic musculoskeletal pain, as these patients are confronted with the issue of the prescription and/or substitution of original formulations with generics.Qualitative methods were selected because the aim was to access the range of patients' representations and to consider their conceptions. Standardized face-to-face semi-structured interviews were used, and transcripts were submitted to content analysis.Patients' representations suggest that they might be confident in taking a generic medication: when he/she has an understanding of generics as resulting from a development process that has become part of the public domain; the generic medication is prescribed by the physician; each prescription is discussed, i.e., the patient is prescribed the generic version of a given medication and not a generic medication.Economic arguments are not sufficient to justify substitution, and may even raise issues calling upon cognitive dissonance. Even in non-life-threatening diseases, negative cues require attention and need be de-emphasized - in particular lower price as an indication of lower quality, and generic status as contradictory with advocating individualization of medication.

Resolution of thermal-hydraulic safety and licensing issues for the system 80+trademark design

International Nuclear Information System (INIS)

Carpentino, S.E.; Ritterbusch, S.E.; Schneider, R.E.

1995-01-01

The System 80+ trademark Standard Design is an evolutionary Advanced Light Water Reactor (ALWR) with a generating capacity of 3931 MWt (1350 MWe). The Final Design Approval (FDA) for this design was issued by the Nuclear Regulatory Commission (NRC) in July 1994. The design certification by the NRC is anticipated by the end of 1995 or early 1996. NRC review of the System 80+ design has involved several new safety issues never before addressed in a regulatory atmosphere. In addition, conformance with the Electric Power Research Institute (EPRI) ALWR Utility Requirements Document (URD) required that the System 80+ plant address nuclear industry concerns with regard to design, construction, operation and maintenance of nuclear power plants. A large number of these issues/concerns deals with previously unresolved generic thermal-hydraulic safety issues and severe accident prevention and mitigation. This paper discusses the thermal-hydraulic analyses and evaluations performed for the System 80+ design to resolve safety and licensing issues relevant to both the Nuclear Stream Supply System (NSSS) and containment designs. For the NSSS design, the Safety Depressurization System mitigation capability and resolution of the boron dilution concern are described. Examples of containment design issues dealing with containment shell strength, robustness of the reactor cavity walls and hydrogen mixing under severe accident conditions are also provided. Finally, the overall approach used in the application of NRC's new (NUREG-1465) radiological source term for System 80+ evaluation is described. The robustness of the System 80+ containment design to withstand severe accident consequences was demonstrated through detailed thermal-hydraulic analyses and evaluations. This advanced design to shown to meet NRC severe accident policy goals and ALWR URD requirements without any special design features and unnecessary costs

BWR feedwater nozzle and control rod drive return line nozzle cracking: resolution of generic technical activity A-10. Technical report

International Nuclear Information System (INIS)

Snaider, R.

1980-11-01

This report summarizes work performed by the NRC staff in the resolution of Generic Technical Activity A-10, 'BWR Nozzle Cracking'. Generic Technical Activity A-10 is one of the generic technical subjects designated as 'unresolved safety issues' pursuant to Section 210 of the Energy Reorganization Act of 1974. The report describes the technical issues, the technical studies and analyses performed by the General Electric Company and the NRC staff, the staff's technical positions based on these studies, and the staff's plans for continued implementation of its technical positions. It also provides information for further work to resolve the non-destructive examination issue

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...

Regulatory analysis for the resolution of Generic Safety Issue 105: Interfacing system loss-of-coolant accident in light-water reactors

International Nuclear Information System (INIS)

1993-07-01

An interfacing systems loss of coolant accident (ISLOCA) involves failure or improper operation of pressure isolation valves (PIVs) that compose the boundary between the reactor coolant system and low-pressure rated systems. Some ISLOCAs can bypass containment and result in direct release of fission products to the environment. A cost/benefit evaluation, using three PWR analyses, calculated the benefit of two potential modifications to the plants. Alternative 1 is improved plant operations to optimize the operator's performance and reduce human error probabilities. Alternative 2 adds pressure sensing devices, cabling, and instrumentation between two PIVs to provide operators with continuous monitoring of the first PIV. These two alternatives were evaluated for the base case plants (Case 1) and for each plant, assuming the plants had a particular auxiliary building design in which severe flooding would be a problem if an ISLOCA occurred. The auxiliary building design (Case 2) was selected from a survey that revealed a number of designs with features that provided less than optimal resistance to ECCS equipment loss caused by a ISLOCA-induced environment. The results were judged not to provide sufficient basis for generic requirements. It was concluded that the most viable course of action to resolve Generic Issue 105 is licensee participation in individual plant examinations (IPEs)

Evaluation on safety issues of SMART

International Nuclear Information System (INIS)

Kim, W. S.; Seol, K. W.; Yoon, Y. K.; Lee, J. H.

2001-01-01

Safety issues on the SMART were evaluated in the light of the compliance with the Ministerial Ordinance of Technical Requirements applying to Nuclear Installations, which was recently revised. Evaluation concludes that regulatory requirements associated with following items have to be developed as the licensing criteria for the SMART: (1) proving the safety of design or materials different form existing reactors; (2) coping with beyond design basis accidents; (3) rulemaking on the safety of reactor safeguard vessel ; (4) ensuring integrity of steam generator tubes; and (5) classifying equipment based on their safety significance. Appropriate actions including implementation of new requirements under development should be taken for safety issues such as diversity of reactivity control and in-service inspection of steam generator tubes that are not complied with the current Technical Requirements. Safety level of the SMART design will be evaluated further by the more detailed assessment according to the Technical Requirements, and additional safety issues will be identified and resolved, if it necessary

Mark I containment long-term program safety evaluation report, resolution of generic technical activity A-7. Report for February 1977-December 1979

International Nuclear Information System (INIS)

1980-07-01

During testing for an advanced Boiling Water Reactor (BWR) containment system design (Mark III), suppression pool hydrodynamic loads were identified which had not been considered in the original design of the Mark I containment system. To address this issue, a Mark I Owners Group was formed and the assessment was divided into a short-term and long-term program. The results of the NRC staff's review of the Mark I Containment Short Term Program are described in NUREG-0408. This report describes the results of the NRC staff's review of the generic Mark I Containment Long Term Program (LTP). The LTP was conducted to provide a generic basis to define suppression pool hydrodynamic loads and the related structural acceptance criteria, such that a comprehensive reassessment of each Mark I containment system would be performed. A series of experimental and analytical programs were conducted by the Mark I Owners Group to provide the necessary bases for the generic load definition and structural assessment techniques. The generic methods proposed by the Mark I Owners Group, as modified by the NRC staff's requirements, will be used to perform plant-unique analyses, which will identify the plant modifications, if any, that will be needed to restore the originally intended margin of safety in the Mark I containment designs

Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

Science.gov (United States)

Chong, Chee Ping; Hassali, Mohamed Azmi; Bahari, Mohd Baidi; Shafie, Asrul Akmal

2011-02-01

To evaluate the Malaysian community pharmacists' views on generic medicines. A sample of 1419 Malaysian community pharmacies with resident pharmacists. A cross-sectional nationwide survey using a self-completed mailing questionnaire. Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

Resolution of thermal-hydraulic safety and licensing issues for the system 80+{sup {trademark}} design

Energy Technology Data Exchange (ETDEWEB)

Carpentino, S.E.; Ritterbusch, S.E.; Schneider, R.E. [ABB-Combustion Engineering, Windsor, CT (United States)] [and others

1995-09-01

The System 80+{sup {trademark}} Standard Design is an evolutionary Advanced Light Water Reactor (ALWR) with a generating capacity of 3931 MWt (1350 MWe). The Final Design Approval (FDA) for this design was issued by the Nuclear Regulatory Commission (NRC) in July 1994. The design certification by the NRC is anticipated by the end of 1995 or early 1996. NRC review of the System 80+ design has involved several new safety issues never before addressed in a regulatory atmosphere. In addition, conformance with the Electric Power Research Institute (EPRI) ALWR Utility Requirements Document (URD) required that the System 80+ plant address nuclear industry concerns with regard to design, construction, operation and maintenance of nuclear power plants. A large number of these issues/concerns deals with previously unresolved generic thermal-hydraulic safety issues and severe accident prevention and mitigation. This paper discusses the thermal-hydraulic analyses and evaluations performed for the System 80+ design to resolve safety and licensing issues relevant to both the Nuclear Stream Supply System (NSSS) and containment designs. For the NSSS design, the Safety Depressurization System mitigation capability and resolution of the boron dilution concern are described. Examples of containment design issues dealing with containment shell strength, robustness of the reactor cavity walls and hydrogen mixing under severe accident conditions are also provided. Finally, the overall approach used in the application of NRC`s new (NUREG-1465) radiological source term for System 80+ evaluation is described. The robustness of the System 80+ containment design to withstand severe accident consequences was demonstrated through detailed thermal-hydraulic analyses and evaluations. This advanced design to shown to meet NRC severe accident policy goals and ALWR URD requirements without any special design features and unnecessary costs.

EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA

Directory of Open Access Journals (Sweden)

J. E. Semyonova

2015-12-01

Full Text Available Aim. To assess in a short-term study efficiency and safety of hypolipidemic therapy with atorvastatine generic, Tulip, in comparison with simvastatine generic, Vasilip, in hyperlipidemic patients.Material and methods. Open, randomized, comparative, cross over study included 87 patients with hyperlipidemia, who didn’t receive hypolipidemic drugs within 6 weeks, or followed hypolipidemic diet for 4 weeks. Each patient received therapy with one of the studied drugs within 6 weeks. Then after 4-week wash-out period the second therapy with the other drug was held. Consequence of courses with each drug was set by randomization. Initial dose of both drugs was 10 mg daily. Dose was adjusted after 3 weeks. The dose was increased to 20 mg daily if cholesterol of low density lipoproteid (CLDL hadn’t reached target level (< 115 mg/dl. of Treatment safety was assessed on the basis of clinical data, hepatic enzymes activity and creatine phosphokinase levels.Results. It is shown, that to reach target figures of plasma lipid spectrum, Vasilip dose was increased significantly more often, than Tulip dose. Average Tulip dose after titration was 14,8 mg daily, Vasilip dose – 15,6 mg daily. Patients with initially higher level of triglycerides (TG > 170 mg/dl after 6 weeks with Tulip treatment showed TG reduction by 38% and with Vasilip treatment – by 20%. Both drugs showed good tolerance, no significant differences in number of side-effects were observed.Conclusion. 6-week treatment with atorvastatine generic Tulip shows significant hypolipidemic effect, which appears in significant reduction of CLDL, total cholesterol, TG compared to the initial levels. Degree of total cholesterol reduction is significantly higher with Tulip treatment compared to Vasilip treatment. Analyses shown that target levels of the assessed figures were reached in more patients, treated with Tulip. Side-effects in Tulip treatment were not severe.

EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA

Directory of Open Access Journals (Sweden)

J. E. Semyonova

2005-01-01

Full Text Available Aim. To assess in a short-term study efficiency and safety of hypolipidemic therapy with atorvastatine generic, Tulip, in comparison with simvastatine generic, Vasilip, in hyperlipidemic patients.Material and methods. Open, randomized, comparative, cross over study included 87 patients with hyperlipidemia, who didn’t receive hypolipidemic drugs within 6 weeks, or followed hypolipidemic diet for 4 weeks. Each patient received therapy with one of the studied drugs within 6 weeks. Then after 4-week wash-out period the second therapy with the other drug was held. Consequence of courses with each drug was set by randomization. Initial dose of both drugs was 10 mg daily. Dose was adjusted after 3 weeks. The dose was increased to 20 mg daily if cholesterol of low density lipoproteid (CLDL hadn’t reached target level (< 115 mg/dl. of Treatment safety was assessed on the basis of clinical data, hepatic enzymes activity and creatine phosphokinase levels.Results. It is shown, that to reach target figures of plasma lipid spectrum, Vasilip dose was increased significantly more often, than Tulip dose. Average Tulip dose after titration was 14,8 mg daily, Vasilip dose – 15,6 mg daily. Patients with initially higher level of triglycerides (TG > 170 mg/dl after 6 weeks with Tulip treatment showed TG reduction by 38% and with Vasilip treatment – by 20%. Both drugs showed good tolerance, no significant differences in number of side-effects were observed.Conclusion. 6-week treatment with atorvastatine generic Tulip shows significant hypolipidemic effect, which appears in significant reduction of CLDL, total cholesterol, TG compared to the initial levels. Degree of total cholesterol reduction is significantly higher with Tulip treatment compared to Vasilip treatment. Analyses shown that target levels of the assessed figures were reached in more patients, treated with Tulip. Side-effects in Tulip treatment were not severe.

Sharing, samples, and generics: an antitrust framework.

Science.gov (United States)

Carrier, Michael A

Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified

COMPARATIVE EFFICACY AND SAFETY OF HYPOLIPIDEMIC THERAPY WITH GENERIC AND ORIGINAL MEDICINAL PRODUCTS OF SIMVASTATIN

Directory of Open Access Journals (Sweden)

E. I. Tarlovskaya

2011-01-01

Full Text Available Aim. To compare efficacy , safety and pharmacoeconomical characteristics of generic and original medicinal products of simvastatin in achievement of cholesterol and low density lipoprotein target levels. Material and methods. 38 patients with arterial hypertension accompanied by type 2 diabetes with dyslipidemia were included into the study. They had no clinically obvious ischemic heart disease and did not receive hypolipidemic pharmacotherapy for a month before the study start. The patients were randomized into group A or group B. Patients of group A (n=18 received original simvastatin, patients of group B (n=20 received generic simvastatin. Initial simvastatin dose was 20 mg daily. Lipid plasma profile, liver enzymes, creatine phosphokinase were evaluated every 4 weeks. Cost-effectiveness ratio was calculated. Results. 11 patients (61% in group A and only 5 patients (25% in group B (χ2=5.05; р<0.05 achieved cholesterol target level with simvastatin in dose of 20 mg daily in 3 months of the treatment. Creatine phosphokinase blood level did not increase significantly. Achievement of cholesterol target level cost 814 and 952 RUB per patient in groups A and B, respectively , in 1 month of simvastatin treatment. These costs were 643 and 417 RUB per patient in groups A and B, respectively , in 3 months of treatment. Conclusion. The original simvastatin in comparison with generic one has advantages in hypolipidemic effect. Safety profile is similar for both medications. Original simvastatin therapy has lower cost than this for generic simvastatin therapy in achievement of cholesterol target level in 1 month of treatment. In 3 months the cost of treatment per patient is 227 RUB higher for original medication in comparison with this for generic medication.

Hydrogen Safety Issues Compared to Safety Issues with Methane and Propane

International Nuclear Information System (INIS)

Green, Michael A.

2005-01-01

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs

Hydrogen Safety Issues Compared to Safety Issues with Methane andPropane

Energy Technology Data Exchange (ETDEWEB)

Green, Michael A.

2005-08-20

The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.

Control of heavy loads at nuclear power plants: Resolution of Generic Technical Activity A-36. Technical report

International Nuclear Information System (INIS)

George, H.J.

1980-07-01

This report summarizes work performed by the NRC staff in the resolution of Generic Technical Activity A-36, Control of Heavy Loads Near Spent Fuel. Generic Technical Activity A-36 is one of the generic technical subjects designated as unresolved safety issues pursuant to Section 210 of the Energy Reorganization Act of 1974. The report describes the technical studies and evaluations performed by the NRC staff, the staff's guidelines based on these studies, and the staff's plans for implementaton of its technical guidelines

Editorial safety science special issue road safety management.

NARCIS (Netherlands)

Wegman, F.C.M. & Hagezieker, M.P.

2014-01-01

The articles presented in this Special Issue on Road Safety Management represent an illustration of the growing interest in policy-related research in the area of road safety. The complex nature of this type of research combined with the observation that scientific journals pay limited attention to

High-heat tank safety issue resolution program plan

International Nuclear Information System (INIS)

Wang, O.S.

1993-12-01

The purpose of this program plan is to provide a guide for selecting corrective actions that will mitigate and/or remediate the high-heat waste tank safety issue for single-shell tank (SST) 241-C-106. This program plan also outlines the logic for selecting approaches and tasks to mitigate and resolve the high-heat safety issue. The identified safety issue for high-heat tank 241-C-106 involves the potential release of nuclear waste to the environment as the result of heat-induced structural damage to the tank's concrete, if forced cooling is interrupted for extended periods. Currently, forced ventilation with added water to promote thermal conductivity and evaporation cooling is used to cool the waste. At this time, the only viable solution identified to resolve this safety issue is the removal of heat generating waste in the tank. This solution is being aggressively pursued as the permanent solution to this safety issue and also to support the present waste retrieval plan. Tank 241-C-106 has been selected as the first SST for retrieval. The program plan has three parts. The first part establishes program objectives and defines safety issues, drivers, and resolution criteria and strategy. The second part evaluates the high-heat safety issue and its mitigation and remediation methods and alternatives according to resolution logic. The third part identifies major tasks and alternatives for mitigation and resolution of the safety issue. Selected tasks and best-estimate schedules are also summarized in the program plan

Generic immunosuppression in transplantation: current evidence and controversial issues.

Science.gov (United States)

El Hajj, Sandra; Kim, Miae; Phillips, Karen; Gabardi, Steven

2015-05-01

The overall success of organ transplantation in the 21st century has been predicated, in part, on the use of newer, more potent, and selective immunosuppressive agents. However, the high cost of lifelong immunosuppression represents a financial burden for many patients. In the past 15 years, regulatory agencies in Europe and America have approved several generic immunosuppressants. One concern is whether the conversion between innovator and generic immunosuppressants will prove to be problematic. This manuscript aims to compare and contrast the bioequivalence requirements among regulatory authorities in the USA, Europe, and Canada, evaluate published studies of generic immunosuppressants in transplant recipients, summarize consensus statements made by transplant organizations and discuss how to engage patients in discussion regarding the choice between innovator and generic immunosuppressants.

Method for developing cost estimates for generic regulatory requirements

International Nuclear Information System (INIS)

1985-01-01

The NRC has established a practice of performing regulatory analyses, reflecting costs as well as benefits, of proposed new or revised generic requirements. A method had been developed to assist the NRC in preparing the types of cost estimates required for this purpose and for assigning priorities in the resolution of generic safety issues. The cost of a generic requirement is defined as the net present value of total lifetime cost incurred by the public, industry, and government in implementing the requirement for all affected plants. The method described here is for commercial light-water-reactor power plants. Estimating the cost for a generic requirement involves several steps: (1) identifying the activities that must be carried out to fully implement the requirement, (2) defining the work packages associated with the major activities, (3) identifying the individual elements of cost for each work package, (4) estimating the magnitude of each cost element, (5) aggregating individual plant costs over the plant lifetime, and (6) aggregating all plant costs and generic costs to produce a total, national, present value of lifetime cost for the requirement. The method developed addresses all six steps. In this paper, we discuss on the first three

Hospital safety climate surveys: measurement issues.

Science.gov (United States)

Jackson, Jeanette; Sarac, Cakil; Flin, Rhona

2010-12-01

Organizational safety culture relates to behavioural norms in the workplace and is usually assessed by safety climate surveys. These can be a diagnostic indicator on the state of safety in a hospital. This review examines recent studies using staff surveys of hospital safety climate, focussing on measurement issues. Four questionnaires (hospital survey on patient safety culture, safety attitudes questionnaire, patient safety climate in healthcare organizations, hospital safety climate scale), with acceptable psychometric properties, are now applied across countries and clinical settings. Comparisons for benchmarking must be made with caution in case of questionnaire modifications. Increasing attention is being paid to the unit and hospital level wherein distinct cultures may be located, as well as to associated measurement and study design issues. Predictive validity of safety climate is tested against safety behaviours/outcomes, with some relationships reported, although effects may be specific to professional groups/units. Few studies test the role of intervening variables that could influence the effect of climate on outcomes. Hospital climate studies are becoming a key component of healthcare safety management systems. Large datasets have established more reliable instruments that allow a more focussed investigation of the role of culture in the improvement and maintenance of staff's safety perceptions within units, as well as within hospitals.

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

Exploring knowledge, perceptions and attitudes about generic ...

African Journals Online (AJOL)

Exploring knowledge, perceptions and attitudes about generic medicines among final-year health science students. ... had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

Developing a generic environmental safety case

International Nuclear Information System (INIS)

Bailey, Lucy

2014-01-01

The Nuclear Decommissioning Authority (NDA) has been charged with implementing the United Kingdom government's policy for the long-term management of higher activity radioactive waste by planning, building and operating a geological disposal facility (GDF). Within the NDA, we - the Radioactive Waste Management Directorate (RWMD) - are tasked with the development of a GDF. The UK government has also decided that a process of voluntarism and partnership will be followed to identify a suitable site for the GDF. To date there is no volunteer community and the site selection process to find a volunteer host community is under review. RWMD has an ongoing role to provide advice to UK radioactive waste producers on the conditioning and packaging of wastes and to undertake disposability assessments of waste packaging proposals to determine their suitability for eventual disposal in a GDF. We also need to demonstrate our confidence that a GDF would be safe. Therefore RWMD has published a generic Environmental Safety Case (ESC) (NDA, 2010) to demonstrate that we are confident that a GDF could be developed to meet the guidelines set down by the environmental regulators (EA/NIEA, 2009) in a range of geological settings. The ESC includes reference case calculations that are used as a benchmark for disposability assessments. (author)

The safety issues of medical robotics

Energy Technology Data Exchange (ETDEWEB)

Fei Baowei; Ng, W.S.; Chauhan, Sunita; Kwoh, Chee Keong

2001-08-01

In this paper, we put forward a systematic method to analyze, control and evaluate the safety issues of medical robotics. We created a safety model that consists of three axes to analyze safety factors. Software and hardware are the two material axes. The third axis is the policy that controls all phases of design, production, testing and application of the robot system. The policy was defined as hazard identification and safety insurance control (HISIC) that includes seven principles: definitions and requirements, hazard identification, safety insurance control, safety critical limits, monitoring and control, verification and validation, system log and documentation. HISIC was implemented in the development of a robot for urological applications that was known as URObot. The URObot is a universal robot with different modules adaptable for 3D ultrasound image-guided interstitial laser coagulation, radiation seed implantation, laser resection, and electrical resection of the prostate. Safety was always the key issue in the building of the robot. The HISIC strategies were adopted for safety enhancement in mechanical, electrical and software design. The initial test on URObot showed that HISIC had the potential ability to improve the safety of the system. Further safety experiments are being conducted in our laboratory.

The safety issues of medical robotics

International Nuclear Information System (INIS)

Fei Baowei; Ng, W.S.; Chauhan, Sunita; Kwoh, Chee Keong

2001-01-01

In this paper, we put forward a systematic method to analyze, control and evaluate the safety issues of medical robotics. We created a safety model that consists of three axes to analyze safety factors. Software and hardware are the two material axes. The third axis is the policy that controls all phases of design, production, testing and application of the robot system. The policy was defined as hazard identification and safety insurance control (HISIC) that includes seven principles: definitions and requirements, hazard identification, safety insurance control, safety critical limits, monitoring and control, verification and validation, system log and documentation. HISIC was implemented in the development of a robot for urological applications that was known as URObot. The URObot is a universal robot with different modules adaptable for 3D ultrasound image-guided interstitial laser coagulation, radiation seed implantation, laser resection, and electrical resection of the prostate. Safety was always the key issue in the building of the robot. The HISIC strategies were adopted for safety enhancement in mechanical, electrical and software design. The initial test on URObot showed that HISIC had the potential ability to improve the safety of the system. Further safety experiments are being conducted in our laboratory

Generic safety evaluation report regarding integrity of BWR scram system piping

International Nuclear Information System (INIS)

1981-08-01

Safety concerns associated with postulated pipe breaks in the boiling water reactor (BWR) scram system were identified during the staff's continuing investigation of the Browns Ferry Unit 3 control rod partial insertion failure on June 28, 1980. This report includes an evaluation of the licensing basis for the BWR scram discharge volume (SDV) piping and an assessment of the potential for the SDV piping to fail while in service. A discussion of the means available for mitigation an unlikely SDV system failure is provided. Generic recommendations are made to improve mitigation capability and ensure that system integrity is maintained in service

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...

Status of safety issues at licensed power plants

International Nuclear Information System (INIS)

1991-03-01

As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, a program has been established whereby an annual NUREG series report will be published on the status of licensee implementation and NRC verification of safety issues in major NRC requirement areas. The data contained in this report are a product of the NRC's Safety Issues Management System database, which is maintained by the Project Management Staff in the Office of Nuclear Reactor Regulation and by personnel in the NRC regions. This report has been prepared in order to provide a comprehensive description of the implementation and verification status of all the TMI Action Plan requirements at licensed reactors, and to make this information available to other interested parties, including the public. A corollary purpose of this report is for it to serve as a follow-on to NUREG-0933, ''A Prioritization of Safety Issues,'' which tracks safety issues up until requirements are approved for imposition at licensed facilities

Safety issues on advanced fuel

International Nuclear Information System (INIS)

Gross, H.; Krebs, W.D.

1998-01-01

In the recent years a general discussion has started whether unsolved safety issues are related to advanced fuel. Advanced fuel is in this context a summary of features like high burnup, improved clad materials, low leakage loading pattern with high peaking factors etc. The design basis accidents RIA and Loca are of special interest for this discussion. From the Siemens point of view RIA is not a safety issue. There are sufficient margins between the enthalpy rise calculated by modern 3D methods and the fuel failures which occurred in RIA simulation tests when the effect of pulse width is taken into account. The evaluation of possible uncertainties for the established Loca criteria (17% equivalent corrosion, 1200 C clad temperature) for high burnup makes sense. But fuel with high burnup has significantly lower peaking factors than fuel with lower burnup. This gives sufficient margin counterbalancing possible uncertainties. In contrast to the above incomplete control rod insertion at higher burnup is potentially a real safety issue. Although Siemens fuel was not affected by the reported incidents they addressed the problem and checked that they have sufficient design margin for their fuel. (orig.) [de

The role of KURT and A-KRS in the development of generic safety cases in Korea

International Nuclear Information System (INIS)

Jeong, Jong-Tae; Choi, Heui-Joo; Koh, Yong-Kwon; Kim, Geon-Young; Kim, Kyung-Su

2014-01-01

According to the draft guidelines for a deep geological disposal system for high-level wastes in Korea, the total annual risk for the average person resulting from the radiation exposure should not exceed 1.0 x 10 -6 /yr and the expected radiation exposure to the average person for each scenario should not exceed 10 mSv/yr (NSSC, 2012). Regulatory compliance should be supported by multiple lines of reasoning such as probabilistic analysis of exposure dose and risk, uncertainty analysis, natural analogue, complementary safety indicators such as radionuclide concentration and release rates, secure of defence-in-depth. The integrated safety assessment should also be made and updated consistently based on up-to-date data and information for each stage of deep geological disposal of high-level waste (HLW) such as basic studies, site characterisation, design, construction, operation, closure, environmental monitoring after closure and so on. These are the bases for the development of a safety case in Korea. The Korea Atomic Energy Research Institute (KAERI) is now developing generic safety cases based on the Advanced Korean Reference Repository System (A-KRS) and the KAERI Underground Research Tunnel (KURT). The A-KRS is a geological disposal system for radioactive wastes from the pyro-processing of PWR spent nuclear fuels in Korea. KURT is a small-scale underground research laboratory constructed and operated to assess the feasibility, safety, appropriateness and stability of the disposal concept by making various in situ tests and experiments. In this paper, the concept and long-term safety assessment of the A-KRS design, the role of the KURT in the development of safety cases, and the development of complex scenarios to support the development of generic safety cases in Korea are described. (authors)

Unresolved Safety Issue A-46 - seismic qualification of equipment in operating plants

International Nuclear Information System (INIS)

Anderson, N.

1985-01-01

Seismic Qualification of Equipment in Operating Plants was designated as an Unresolved Safety Issue (USI) in December, 1980. The USI A-46 program was developed in early 1981 to investigate the adequacy of mechanical and electrical equipment in operating plants to withstand a safe shutdown earthquake. The approach taken was to develop viable, cost effective alternatives to current seismic qualification licensing requirements which could be applied to operating nuclear power plants. The tasks investigated include: (1) identification of seismic sensitive systems and equipment; (2) assessment of adequacy of existing seismic qualification methods; (3) development and assessment of in-situ test procedures to assist in qualification of equipment; (4) seismic qualification of equipment using seismic experience data; and (5) development of methods to generate generic floor response spectra. Progress to date and plans for completion of resolution are reported

Advanced CFD simulation for the assessment of nuclear safety issues at EDF. Some examples

International Nuclear Information System (INIS)

Vare, Christophe

2014-01-01

EDF R and D has computer power that puts it amongst the top industrial research centers in the world. Its supercomputers and in-house codes as well as its experts represent important capabilities to support EDF activities (safety analyses, support to the design of new reactors, analysis of accidental situations non reproducible by experiments, better understanding of physics or complex system response, effects of uncertainties and identification of prominent parameters, qualification and optimization of processes and materials...). Advanced numerical simulation is a powerful tool allowing EDF to increase its competitiveness, improve its performance and the safety of its plants. On this issue, EDF made the choice to develop its own in-house codes, instead of using commercial software, in order to be able to capitalize its expertise and methodologies. This choice allowed as well easier technological transfer to the concerned business units or engineering divisions, fast adaptation of our simulation tools to emerging needs and the development of specific physics or functionalities not addressed by the commercial offer. During the last ten years, EDF has decided to open its in-house codes, through the Open Source way. This is the case for Code – Aster (structure analysis), Code – Saturne (computational fluid dynamics, CFD), TELEMAC (flow calculations in aquatic environment), SALOME (generic platform for Pre and Post-Processing) and SYRTHES (heat transfer in complex geometries), among others. The 3 open source software: Code – Aster, Code – Saturne and TELEMAC, are certified by the French Nuclear Regulatory Authority for many «Important to Safety» studies. Advanced simulation, which treats complex, multi-field and multi-physics problems, is of great importance for the assessment of nuclear safety issues. This paper will present 2 examples of advanced simulation using Code – Saturne for safety issues of nuclear power plants in the fields of R and D and

76 FR 67461 - Cosmetic Microbiological Safety Issues; Public Meeting

Science.gov (United States)

2011-11-01

...] Cosmetic Microbiological Safety Issues; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION... Administration (FDA) is announcing a public meeting entitled ``Cosmetic Microbiological Safety Issues.'' The... cosmetic microbiological safety and to suggest areas for the possible development of FDA guidance documents...

Report of the review of the safety improvement programme for South Ukraine NPP units 1 and 2 and to identify the safety issues of ''small series'' WWER-1000 NPPs. South Ukraine Yuzhnoukrainsk, Nikolaev Region Ukraine, 8 to 19 July 1996. Draft

International Nuclear Information System (INIS)

Bastin, S.; Hoehn, J.; Lin, C.; Taylor, R.; Benitez, F.; Dale, H.; Mueller, B.; Rieg, C.Y.

1996-10-01

According to the Ukrainian request the purpose of the IAEA experts' mission was to review the safety improvement programme for South Ukraine NPP Units 1 and 2 in order to advise on the completeness and adequacy of safety improvements implemented and/or proposed. Another purpose of the mission was to identify major design and operational deficiencies as a basis to compile a consolidated list of generic safety issues for the units of the 'small series'' of WWER-1000 reactors (''Issue Book for ''small series'' WWER-1000 NPPs). Conclusions and recommendations from the IAEA mission are based on the combined expertise of the international group of experts who composed the team. They are intended to assist national authorities and plant operators who have the sole responsibilities for the regulation and safe operation. tabs

Safety reviews of next-generation light-water reactors

International Nuclear Information System (INIS)

Kudrick, J.A.; Wilson, J.N.

1997-01-01

The Nuclear Regulatory Commission (NRC) is reviewing three applications for design certification under its new licensing process. The U.S. Advanced Boiling Water Reactor (ABWR) and System 80+ designs have received final design approvals. The AP600 design review is continuing. The goals of design certification are to achieve early resolution of safety issues and to provide a more stable and predictable licensing process. NRC also reviewed the Utility Requirements Document (URD) of the Electric Power Research Institute (EPRI) and determined that its guidance does not conflict with NRC requirements. This review led to the identification and resolution of many generic safety issues. The NRC determined that next-generation reactor designs should achieve a higher level of safety for selected technical and severe accident issues. Accordingly, NRC developed new review standards for these designs based on (1) operating experience, including the accident at Three Mile Island, Unit 2; (2) the results of probabilistic risk assessments of current and next-generation reactor designs; (3) early efforts on severe accident rulemaking; and (4) research conducted to address previously identified generic safety issues. The additional standards were used during the individual design reviews and the resolutions are documented in the design certification rules. 12 refs

Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study.

Science.gov (United States)

Shraim, Naser Y; Al Taha, Tasneem A; Qawasmeh, Rawan F; Jarrar, Hiba N; Shtaya, Maram A N; Shayeb, Lama A; Sweileh, Waleed M

2017-12-28

Generic substitution in several countries has become a common practice. Besides, it is considered as a major cost minimizing strategy meant to contain pharmaceutical expenditure without compromising healthcare quality. However, the safety and quality issues of generic products are of top concerns of general practitioners and health work professionals. This study aimed to investigate community pharmacist's knowledge, attitudes and practices toward generic medicines in Palestine. This study was a cross-sectional observational study employing a self-administered questionnaire. The questionnaire was of four main sections: demographic and practice details of the participants, knowledge, attitudes and the influencing factors related to selection and dispensing of generic medicines. A convenience sampling technique was implemented in this study in which the data collection form was distributed in West Bank- Palestine among a set of practicing pharmacists. Mann-Whitney-U or Kruskal-Wallis tests were used to comparison of different issues as appropriate. P-values of marketing approval of generics, while 87.4% of participants agreed that they should be given the right to substitute generics and the majority (62.3%) support generic substitution for brand name drugs in all cases when a generic is available The main two factors affect pharmacists' selection and dispensing of generic medicines are personal faith in the product (86.1%) and cost effectiveness of generic medicines (84.1%). Generic medicines substitution among pharmacists is widespread and prevalent. Our data found that participant pharmacists in Palestine had basic knowledge with regards to generic medicine. However, their knowledge score pertaining the technical and regulatory aspects of bioequivalence and pharmacokinetic parameters in particular was insufficient.

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

Key issues for passive safety

International Nuclear Information System (INIS)

Hayns, M.R.

1996-01-01

The paper represents a summary of the introductory presentation made at this Advisory Group Meeting on the Technical Feasibility and Reliability of Passive Safety Systems. It was intended as an overview of our views on what are the key issues and what are the technical problems which might dominate any future developments of passive safety systems. It is, therefore, not a ''review paper'' as such and only record the highlights. (author)

Key issues for passive safety

Energy Technology Data Exchange (ETDEWEB)

Hayns, M R [AEA Technology, Harwell, Didcot (United Kingdom). European Institutions; Hicken, E F [Forschungszentrum Juelich GmbH (Germany)

1996-12-01

The paper represents a summary of the introductory presentation made at this Advisory Group Meeting on the Technical Feasibility and Reliability of Passive Safety Systems. It was intended as an overview of our views on what are the key issues and what are the technical problems which might dominate any future developments of passive safety systems. It is, therefore, not a ``review paper`` as such and only record the highlights. (author).

Generic medicines and generic substitution: contrasting perspectives of stakeholders in Ireland.

Science.gov (United States)

O'Leary, A; Usher, C; Lynch, M; Hall, M; Hemeryk, L; Spillane, S; Gallagher, P; Barry, M

2015-12-15

The Health (Pricing and Supply of Medical Goods) Act 2013 passed into law in July 2013 and legislated for generic substitution in Ireland. The aim of the study was to ascertain the knowledge and perceptions of stakeholders i.e. patients, pharmacists and prescribers, of generic medicines and to generic substitution with the passing of legislation. Three stakeholder specific questionnaires were developed to assess knowledge of and perceptions to generic medicines and generic substitution. Purposive samples of patients, prescribers and pharmacists were analysed. Descriptive quantitative and qualitative analyses were undertaken. A total of 762 healthcare professionals and 353 patients were recruited. The study highlighted that over 84% of patients were familiar with generic medicines and are supportive of the concept of generic substitution. Approximately 74% of prescribers and 84% of pharmacists were supportive of generic substitution in most cases. The main areas of concern highlighted by the healthcare professionals that might impact on the successful implementation of the policy, were the issue of bioequivalence with generic medicines, the computer software systems used at present in general practitioner (GP) surgeries and the availability of branded generics. The findings from this study identify a high baseline rate of acceptance to generic medicines and generic substitution among patients, prescribers and pharmacists in the Irish setting. The concerns of the main stakeholders provide a valuable insight into the potential difficulties that may arise in its implementation, and the need for on-going reassurance and proactive dissemination of the impact of the generic substitution policy. The existing positive attitude to generic medicines and generic substitution among key stakeholders in Ireland to generic substitution, combined with appropriate support and collaboration should result in the desired increase in rates of prescribing, dispensing and use of generic

Development of a Generic Environmental Safety Case for the Disposal of Higher Activity Wastes in the UK

International Nuclear Information System (INIS)

Bailey, Lucy; Hicks, Tim

2016-01-01

The UK generic ESC demonstrates safe disposal of higher activity wastes, by providing: • A demonstration of how environmental safety can be achieved by a variety of disposal concepts based on systems of multiple engineered and natural barriers, providing multiple safety functions; • An understanding of expected barrier performance and how conditions in a disposal system will evolve, based on research findings presented in RWM’s knowledge base; • An approach to safety assessment based on multiple lines of reasoning, involving both qualitative and quantitative analysis; • Complementary insight modelling and total system modelling used to develop understanding of how different components of the engineered and natural barrier system contribute to safety

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)

Relationship between regulatory issues and probabilistic risk assessments

International Nuclear Information System (INIS)

Ilberg, D.; Papazoglou, I.

1985-01-01

The objective of this study was to obtain some perspective on the characteristics and the relative number of regulatory issues that are PRA related, i.e., can be effectively addressed by plant specific PRA studies. It was also aimed at developing approaches to resolution of regulatory issues as part of plant specific PRAs. Several ongoing NRC programs include a number of safety-related issues which are applicable to operating plants. A number of these issues include aspects that strongly interact with items addressed in PRA studies. The resolution of several generic issues using PRA studies has already started. A review of over 335 issues included in three NRC programs was conducted: Generic Issue Program (GI); Systematic Evaluation Program (SEP); and TMI Action Plan (TMI). The review identifid 240 items related to PRA, 120 of which were judged to have significant effect on core damage frequency. It is believed that these items can be effectively treated in a PRA study that includes internal and external events

Practicing industrial safety - issues involved

International Nuclear Information System (INIS)

Gunasekaran, P.

2016-01-01

Industrial safety is all about measures or techniques implemented to reduce the risk of injury, loss to persons, property or the environment in any industrial facility. The issue of industrial safety evolved concurrently with industrial development as a shift from compensation to prevention as well. Today, industrial safety is widely regarded as one of the most important factors that any business, large or small, must consider in its operations, as prevention of loss is also a part of profit. Factories Act of Central government and Rules made under it by the state deals with the provisions on industrial safety legislation. There are many other acts related to safety of personnel, property and environment. Occupational health and safety is also of primary concern. The aim is to regulate health and safety conditions for all employers. It includes safety standards and health standards. These acts encourage employers and employees to reduce workplace hazards and to implement new or improve existing safety and health standards; and develop innovative ways to achieve them. Maintain a reporting and record keeping system to monitor job-related injuries and illnesses; establish training programs to increase the number and competence of occupational safety and health personnel

Safety Issues with Hydrogen as a Vehicle Fuel

Energy Technology Data Exchange (ETDEWEB)

L. C. Cadwallader; J. S. Herring

1999-09-01

This report is an initial effort to identify and evaluate safety issues associated with the use of hydrogen as a vehicle fuel in automobiles. Several forms of hydrogen have been considered: gas, liquid, slush, and hydrides. The safety issues have been discussed, beginning with properties of hydrogen and the phenomenology of hydrogen combustion. Safety-related operating experiences with hydrogen vehicles have been summarized to identify concerns that must be addressed in future design activities and to support probabilistic risk assessment. Also, applicable codes, standards, and regulations pertaining to hydrogen usage and refueling have been identified and are briefly discussed. This report serves as a safety foundation for any future hydrogen safety work, such as a safety analysis or a probabilistic risk assessment.

Safety Issues with Hydrogen as a Vehicle Fuel

Energy Technology Data Exchange (ETDEWEB)

Cadwallader, Lee Charles; Herring, James Stephen

1999-10-01

This report is an initial effort to identify and evaluate safety issues associated with the use of hydrogen as a vehicle fuel in automobiles. Several forms of hydrogen have been considered: gas, liquid, slush, and hydrides. The safety issues have been discussed, beginning with properties of hydrogen and the phenomenology of hydrogen combustion. Safety-related operating experiences with hydrogen vehicles have been summarized to identify concerns that must be addressed in future design activities and to support probabilistic risk assessment. Also, applicable codes, standards, and regulations pertaining to hydrogen usage and refueling have been identified and are briefly discussed. This report serves as a safety foundation for any future hydrogen safety work, such as a safety analysis or a probabilistic risk assessment.

Road safety issues for bus transport management.

Science.gov (United States)

Cafiso, Salvatore; Di Graziano, Alessandro; Pappalardo, Giuseppina

2013-11-01

Because of the low percentage of crashes involving buses and the assumption that public transport improves road safety by reducing vehicular traffic, public interest in bus safety is not as great as that in the safety of other types of vehicles. It is possible that less attention is paid to the significance of crashes involving buses because the safety level of bus systems is considered to be adequate. The purpose of this study was to evaluate the knowledge and perceptions of bus managers with respect to safety issues and the potential effectiveness of various technologies in achieving higher safety standards. Bus managers were asked to give their opinions on safety issues related to drivers (training, skills, performance evaluation and behaviour), vehicles (maintenance and advanced devices) and roads (road and traffic safety issues) in response to a research survey. Kendall's algorithm was used to evaluate the level of concordance. The results showed that the majority of the proposed items were considered to have great potential for improving bus safety. The data indicated that in the experience of the participants, passenger unloading and pedestrians crossing near bus stops are the most dangerous actions with respect to vulnerable users. The final results of the investigation showed that start inhibition, automatic door opening, and the materials and internal architecture of buses were considered the items most strongly related to bus passenger safety. Brake assistance and vehicle monitoring systems were also considered to be very effective. With the exception of driver assistance systems for passenger and pedestrian safety, the perceptions of the importance of other driver assistance systems for vehicle monitoring and bus safety were not unanimous among the bus company managers who participated in this survey. The study results showed that the introduction of new technologies is perceived as an important factor in improving bus safety, but a better understanding

International conference on topical issues in nuclear safety. Contributed papers

International Nuclear Information System (INIS)

2001-01-01

The objective of the Conference was to foster the exchange of information on topical issues in nuclear safety, with the aim of consolidating an international consensus on the present status of these issues, priorities for future work, and needs for strengthening international cooperation, including the IAEA recommendations for future activities. This book contains concise contributed papers submitted on issues falling within the thematic scope of the Conference: risk informed decision making, influence of external factors on safety, safety of fuel cycle facilities, safety of research reactors, and safety performance indicators

International conference on topical issues in nuclear safety. Contributed papers

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-07-01

The objective of the Conference was to foster the exchange of information on topical issues in nuclear safety, with the aim of consolidating an international consensus on the present status of these issues, priorities for future work, and needs for strengthening international cooperation, including the IAEA recommendations for future activities. This book contains concise contributed papers submitted on issues falling within the thematic scope of the Conference: risk informed decision making, influence of external factors on safety, safety of fuel cycle facilities, safety of research reactors, and safety performance indicators.

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

ALWR - regulatory stabilization through simplicity, margin, and improved safety

International Nuclear Information System (INIS)

Vine, G.; Gray, S.

1989-01-01

The Electric Power Research Institute Advanced Light Water Reactor (ALWR) program is discussed with respect to the following topics: fundamental acceptance criteria for the ALWR; program approach; utility steering committee technical guidance; safety principles; utility requirements document; design bases; generic safety issue resolution; reactor accidents prevention and mitigation; and programmatic plans

Safety and licensing issues for Indian PHWRs

International Nuclear Information System (INIS)

Srinivasan, G.R.; Das, M.

1997-01-01

India has achieved competency in design, construction, commissioning and operation of Pressurized Heavy Water Reactor based Nuclear Power Plants and has completed more than 120 reactor operating years with an extremely satisfactory safety record. In this paper, the safety management in NPCIL and operational safety aspects are discussed, licensing and regulatory approach is described and some of the main safety issues for Indian PHWRs are brought out. (author)

Characterization report for the ferrocyanide safety issue

International Nuclear Information System (INIS)

Pulsipher, B.A.; Burger, L.L.; Liebetrau, A.M.; Scheele, R.D.

1997-06-01

Recently PNNL was tasked by DOE to develop and demonstrate a risk-based strategic approach to characterizing Hanford's Nuclear Waste Tanks. This strategic approach was documented in a report entitled ''A Risk-Based Focused Decision-Management Approach for Justifying Characterization of Hanford Tank Waste''. In support of the general approach, a specific strategy for addressing each of the several safety issues associated with the tanks was developed. This report documents the approach for the Ferrocyanide Safety Issue. The purpose of this report is to describe a structured logic diagram (SLD) for determining the risk associated with the ferrocyanide tank safety issue and provide the supporting information for the SLD. The SLD addresses the resolution of risks resulting from the presence of ferrocyanide layers within the Hanford tanks. The informational requirements for determining risk from any reaction stemming from ferrocyanide are outlined in the SLD. This report will describe the potential paths to a successful resolution of the ferrocyanide safety issue. Complete development of the intervention pathway is outside the scope of this current activity. General descriptions of the approach, key components of the SLD, and conclusions are provided in the body of this report. The complete SLD, descriptions of each box shown in the SLD, a discussion on how to fill data needs, and a list of contributors is provided in the appendices

Mark II containment program load evaluation and acceptance criteria; Generic Technical Activity A-8

International Nuclear Information System (INIS)

Anderson, C.J.

1981-08-01

The report provides a discussion of LOCA-related suppression pool hydrodynamic loads in boiling water reactor (BWR) facilities with the Mark II pressure-suppression containment design. This report concludes NRC Generic Technical Activity A-8, 'Mark II Containment Pool Dynamic Loads,' which has been designated an 'Unresolved Safety Issue' pursuant to Section 210 of the Energy Reorganization Act of 1974

Strategy for resolution of the flammable gas safety issue

International Nuclear Information System (INIS)

Johnson, G.D.

1997-01-01

This document provides a strategy for resolution of the Flammable Gas Safety Issue. It defines the key elements required for the following: Closing the Flammable Gas Unreviewed Safety Question (USQ); Providing the administrative basis for resolving the safety issue; Defining the data needed to support these activities; and Providing the technical and administrative path for removing tanks from the Watch List

Strategy for resolution of the flammable gas safety issue

Energy Technology Data Exchange (ETDEWEB)

Johnson, G.D.

1997-05-23

This document provides a strategy for resolution of the Flammable Gas Safety Issue. It defines the key elements required for the following: Closing the Flammable Gas Unreviewed Safety Question (USQ); Providing the administrative basis for resolving the safety issue; Defining the data needed to support these activities; and Providing the technical and administrative path for removing tanks from the Watch List.

Generic test platform for representative tests of safety I/C systems - 15546

International Nuclear Information System (INIS)

Fourestie, B.; Kuck, H.; Richter, J.; Rieche, S.; Waitz, M.

2015-01-01

In compliance with the IEC 61513 safety Instrumentation and Control (I/C) systems must be successfully validated in their final configuration prior to installation on site and commissioning. However the contingent need for modifications during system validation activities or subsequently during the commissioning phase may entail long and costly re-engineering of the I/C systems. With the view to ease these possible modifications, a Generic Test Platform has been developed by AREVA which allows combining a real I/C system subpart with an emulation server. This platform provides a faithful representation of the I/C System allowing crediting the validation test results carried out on this platform. (authors)

Draft pilot report - Approaches to the resolution of safety issues

International Nuclear Information System (INIS)

2006-01-01

The purpose of this report is to present in a concise form how some safety matters associated with currently operating light water reactors have been addressed. The issues discussed in this report are common to member countries with currently operating LWRs (PWR, BWR, VVER) and, as such, have wide interest in the nuclear safety community. Accordingly, this report can serve as a reference for researchers, regulations and others (e.g., industry) interested in understanding the approach and status of issues. This report should also be useful for knowledge transfer by documenting what has been done or is planned regarding selected safety matters and as a source for identifying reference material containing additional detail. The issues addressed in this report should not be viewed as questioning the safety of operating reactors, which have reached very high operational safety record, but rather as areas where uncertainty in knowledge exists, where safety assessment has been based on conservative assumptions, and where regulatory decisions need, or will need to be confirmed. Thus, the development of sound technical bases through continuing research will improve the current knowledge and allow for more realistic safety assessment. The safety issues discussed in this initial version of the report are: - design basis accident spectrum; - severe accident issues; - reactor pressure vessel integrity; - hydrogen control; - containment integrity; - accident management; - station blackout; - high burnup fuel; - power up-rates; - ECCS strainer clogging; - boron dilution. For each issue, the scope of the issue is defined, its status discussed and planned work or research described, including schedule. This pilot version of the report is limited to input from nine countries (Belgium, Czech Republic, Finland, France, Germany, Japan, Korea, Sweden and the U.S.). An overview of this information for each issue by country is provided in the table. This document does not contain a

High-heat tank safety issue resolution program plan. Revision 2

International Nuclear Information System (INIS)

Wang, O.S.

1994-12-01

The purpose of this program plan is to provide a guide for selecting corrective actions that will mitigate and/or remediate the high-heat waste tank safety issue for single-shell tank 241-C-106. The heat source of approximately 110,000 Btu/hr is the radioactive decay of the stored waste material (primarily 90 Sr) inadvertently transferred into the tank in the later 1960s. Currently, forced ventilation, with added water to promote thermal conductivity and evaporation cooling, is used for heat removal. The method is very effective and economical. At this time, the only viable solution identified to permanently resolve this safety issue is the removal of heat-generating waste in the tank. This solution is being aggressively pursued as the only remediation method to this safety issue, and tank 241-C-106 has been selected as the first single-shell tank for retrieval. The current cooling method and other alternatives are addressed in this program as means to mitigate this safety issue before retrieval. This program plan has three parts. The first part establishes program objectives and defines safety issue, drivers, and resolution criteria and strategy. The second part evaluates the high-heat safety issue and its mitigation and remediation methods and other alternatives according to resolution logic. The third part identifies major tasks and alternatives for mitigation and resolution of the safety issue. A table of best-estimate schedules for the key tasks is also included in this program plan

ATLAS program for advanced thermal-hydraulic safety research

International Nuclear Information System (INIS)

Song, Chul-Hwa; Choi, Ki-Yong; Kang, Kyoung-Ho

2015-01-01

Highlights: • Major achievements of the ATLAS program are highlighted in conjunction with both developing advanced light water reactor technologies and enhancing the nuclear safety. • The ATLAS data was shown to be useful for the development and licensing of new reactors and safety analysis codes, and also for nuclear safety enhancement through domestic and international cooperative programs. • A future plan for the ATLAS testing is introduced, covering recently emerging safety issues and some generic thermal-hydraulic concerns. - Abstract: This paper highlights the major achievements of the ATLAS program, which is an integral effect test program for both developing advanced light water reactor technologies and contributing to enhancing nuclear safety. The ATLAS program is closely related with the development of the APR1400 and APR"+ reactors, and the SPACE code, which is a best-estimate system-scale code for a safety analysis of nuclear reactors. The multiple roles of ATLAS testing are emphasized in very close conjunction with the development, licensing, and commercial deployment of these reactors and their safety analysis codes. The role of ATLAS for nuclear safety enhancement is also introduced by taking some examples of its contributions to voluntarily lead to multi-body cooperative programs such as domestic and international standard problems. Finally, a future plan for the utilization of ATLAS testing is introduced, which aims at tackling recently emerging safety issues such as a prolonged station blackout accident and medium-size break LOCA, and some generic thermal-hydraulic concerns as to how to figure out multi-dimensional phenomena and the scaling issue.

Advanced nuclear reactor safety issues and research needs

International Nuclear Information System (INIS)

2002-01-01

On 18-20 February 2002, the OECD Nuclear Energy Agency (NEA) organised, with the co-sponsorship of the International Atomic Energy Agency (IAEA) and in collaboration with the European Commission (EC), a Workshop on Advanced Nuclear Reactor Safety Issues and Research Needs. Currently, advanced nuclear reactor projects range from the development of evolutionary and advanced light water reactor (LWR) designs to initial work to develop even further advanced designs which go beyond LWR technology (e.g. high-temperature gas-cooled reactors and liquid metal-cooled reactors). These advanced designs include a greater use of advanced technology and safety features than those employed in currently operating plants or approved designs. The objectives of the workshop were to: - facilitate early identification and resolution of safety issues by developing a consensus among participating countries on the identification of safety issues, the scope of research needed to address these issues and a potential approach to their resolution; - promote the preservation of knowledge and expertise on advanced reactor technology; - provide input to the Generation IV International Forum Technology Road-map. In addition, the workshop tried to link advancement of knowledge and understanding of advanced designs to the regulatory process, with emphasis on building public confidence. It also helped to document current views on advanced reactor safety and technology, thereby contributing to preserving knowledge and expertise before it is lost. (author)

Investigations of possibilities to dispose of spent nuclear fuel in Lithuania: a model case. Volume 3, Generic Safety Assessment of Repository in Crystalline Rocks

International Nuclear Information System (INIS)

Motiejunas, S.; Poskas, P.

2005-01-01

In this Volume a generic safety assessment of the repository for spent nuclear fuel in crystalline rock in Lithuania is presented. Modeling of safety relevant radionuclide release from the defected canister and their transport through the near field and far field was performed. Doses to humans due to released radionuclides in the well water were calculated and compared with the dose restrictions existing in Lithuania. For this stage of generic safety assessment only two scenarios were chosen: base scenario and canister defect scenario. KBS-3 concept developed by SKB for disposal of spent nuclear fuel in Sweden was chosen as prototype for repository in crystalline basement in Lithuania. The KBS-3H design with horizontal canister emplacement is proposed as a reference design for Lithuania

Assessment of basic safety issues

International Nuclear Information System (INIS)

Queniart, D.

1996-01-01

Work on the French-German common safety approach for future nuclear power plants continued in 1994 to allow for more detailed discussion of some major issues, taking into account the options provided by the industry for the EPR (European Pressurized water Reactor) project, as described in the document entitled 'Conceptual Safety Features Review File'. Seven meetings of a GPR/RSK advisory experts subgroup, six GPR/RSK plenary sessions and six meetings of the safety authorities (DFD) dealt with the following topics: design of the systems and use of probabilistic approaches, application of a 'break preclusion' approach to the main primary pipings, protection against external hazards (aircraft crashes, explosions, earthquakes), provisions with respect to accidents involving core melt and to containment design, radiological consequences of reference accidents and accidents involving core melt at low pressure. The important aspects of the joint policy are recalled in the presentation. The whole set of GPR/RSK recommendations were agreed by the French and German safety authorities during the DFD meetings of 1994 and early 1995. The utilities decided to begin the basic design phase in February, 1995. Work is now continuing to develop the common French-German approach for future nuclear power plants, in the same way as before. In 1995, this mainly covers the design of the containment and of the systems, but also new issues such as the protection against secondary side overpressurization, radiological protection of workers and radioactive wastes. (J.S.). 3 figs., 1 tab

Decision making under uncertainty: An investigation into the application of formal decision-making methods to safety issue decisions

International Nuclear Information System (INIS)

Bohn, M.P.

1992-12-01

As part of the NRC-sponsored program to study the implications of Generic Issue 57, ''Effects of Fire Protection System Actuation on Safety-Related Equipment,'' a subtask was performed to evaluate the applicability of formal decision analysis methods to generic issues cost/benefit-type decisions and to apply these methods to the GI-57 results. In this report, the numerical results obtained from the analysis of three plants (two PWRs and one BWR) as developed in the technical resolution program for GI-57 were studied. For each plant, these results included a calculation of the person-REM averted due to various accident scenarios and various proposed modifications to mitigate the accident scenarios identified. These results were recomputed to break out the benefit in terms of contributions due to random event scenarios, fire event scenarios, and seismic event scenarios. Furthermore, the benefits associated with risk (in terms of person-REM) averted from earthquakes at three different seismic ground motion levels were separately considered. Given this data, formal decision methodologies involving decision trees, value functions, and utility functions were applied to this basic data. It is shown that the formal decision methodology can be applied at several different levels. Examples are given in which the decision between several retrofits is changed from that resulting from a simple cost/benefit-ratio criterion by virtue of the decision-makinger's expressed (and assumed) preferences

Exploring the Knowledge and Perception of Generic Medicines among Final Year Undergraduate Medical, Pharmacy, and Nursing Students in Sierra Leone: A Comparative Cross-Sectional Approach

Directory of Open Access Journals (Sweden)

Peter Bai James

2018-01-01

Full Text Available Most low-income nations have national medicine policy that emphasized the use of generic medicines in the public health sector. However, the use of generics is often debatable as there are concerns over its efficacy, quality, and safety compared to their branded counterparts. This study was conducted to compare the knowledge and perception of generic medicines among final year undergraduate medical, pharmacy, and nursing students in Sierra Leone. We conducted a questionnaire-based cross-sectional study among these students at the College of Medicine and Allied Health Sciences University of Sierra Leone. Out of the 62 students, only two (2/62, 3.2% knew about the acceptable bioequivalence limit. At least half of respondents in all three groups agreed that all generics are therapeutically equivalent to their innovator brand. At least half of the medicine (21/42, 50% and nursing (6/9, 66.6% students, compared to pharmacy students (5/11, 45.5%, believed that higher safety standards are required for proprietary medicines than for generic medicines. Most of them agreed that they need more information on the safety, quality, and efficacy aspects of generics (59/62, 95.2%. All three groups of healthcare students, despite variations in their responses, demonstrated a deficiency in knowledge and misconception regarding generic medicines. Training on issues surrounding generic drugs in healthcare training institutions is highly needed among future healthcare providers in Sierra Leone.

Safety issue resolution strategy plan for inactive miscellaneous underground storage tanks

International Nuclear Information System (INIS)

Wang, O.S.; Powers, T.B.

1994-09-01

The purpose of this strategy plan is to identify, confirm, and resolve safely issues associated with inactive miscellaneous underground storage tanks (MUSTs) using a risk-based priority approach. Assumptions and processes to assess potential risks and operational concerns are documented in this report. Safety issue priorities are ranked based on a number of considerations including risk ranking and cost effectiveness. This plan specifies work scope and recommends schedules for activities related to resolving safety issues, such as collecting historical data, searching for authorization documents, performing Unreviewed Safety Question (USQ) screening and evaluation, identifying safety issues, imposing operational controls and monitoring, characterizing waste contents, mitigating and resolving safety issues, and fulfilling other remediation requirements consistent with the overall Tank Waste Remediation System strategy. Recommendations for characterization and remediation are also recommended according to the order of importance and practical programmatic consideration

Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia.

Science.gov (United States)

Kumar, Rohit; Hassali, Mohamed Azmi; Saleem, Fahad; Alrasheedy, Alian A; Kaur, Navneet; Wong, Zhi Yen; Kader, Muhamad Ali Sk Abdul

2015-01-01

Generic medicine prescribing has become a common practice in public hospitals. However, the trend in private medical centres seems to be different. The objective of this study was to investigate knowledge, perceptions and behavior of physicians from private medical centres in Malaysia regarding generic medicines. This study was a cross-sectional nationwide survey targeting physicians from private medical centres in Malaysia. The survey was conducted using questionnaire having (i) background and demographic data of the physicians, volume of prescription in a day, stock of generic medicines in their hospital pharmacy etc. (ii) their knowledge about bioequivalence (iii) prescribing behavior (iv) physicians' knowledge of quality, safety and efficacy of generic medicines, and their cost (v) perceptions of physicians towards issues pertaining to generic medicines utilization. A total of 263 questionnaires out of 735 were received, giving a response rate of 35.8%. Of the respondents, 214 (81.4%) were male and 49 (18.6%) were females. The majority of the participants were in the age range of 41-50 years and comprised 49.0% of the respondents. Only 2.3% of physicians were aware of the regulatory limits of bioequivalence standards in Malaysia. Of the respondents, 23.2% agreed that they 'always' write their prescriptions using originator product name whereas 50.2% do it 'usually'. A number of significant associations were found between their knowledge, perceptions about generic medicines and their demographic characteristics. The majority of the physicians from private medical centres in Malaysia had negative perceptions about safety, quality and the efficacy of generic medicines. These negative perceptions could be the cause of the limited use of generic medicines in the private medical centres. Therefore, in order to facilitate their use, it is recommended that the physicians need to be reassured and educated about the drug regulatory authority approval system of generic

A PLC generic requirements and specification for safety-related applications in nuclear power plants

International Nuclear Information System (INIS)

Han, Jea Bok; Lee, C. K.; Lee, D. Y.

2001-12-01

This report presents the requirements and specification to be applied to the generic qualification of programmable Logic Controller(PLC), which is being developed as part of the KNICS project, 'Development of the Digital Reactor Safety Systems' of which purpose is the application to safety-related instrumentation and control systems in nuclear power plants. This report defines the essential and critical characteristics that shall be included as part of a PLC design for safety-related application. The characteristics include performance, reliability, accuracy, the overall response time from an input to the PLC exceeding it trip condition to the resulting outputs, and the specification of processors and memories in digital controller. It also specifies the quality assurance process for software development, dealing with executive software, firmware, application software tools for developing the application software, and human machine interface(HMI). In addition, this report reviews the published standards and guidelines that are required for the PLC development and the quality assurance processes such as environment requirements, seismic withstand requirements, EMI/RFI withstand requirements, and isolation test

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

Guidelines for nuclear-power-plant safety-issue-prioritization information development

International Nuclear Information System (INIS)

Andrews, W.B.; Gallucci, R.H.V.; Heaberlin, S.W.; Bickford, W.E.; Konzek, G.J.; Strenge, D.L.; Smith, R.I.; Weakley, S.A.

1983-02-01

Pacific Northwest Laboratory has developed a methodology, with examples, to calculate - to an approximation serviceable for prioritization purposes - the risk, dose and cost impacts of implementing resolutions to reactor safety issues. This report is an applications guide to issue-specific calculations. A description of the approach, mathematical models, worksheets and step-by-step examples are provided. Analysis using this method is intended to provide comparable results for many issues at a cost of two staff-weeks per issue. Results will be used by the NRC to support decisions related to issue priorities in allocation of resources to complete safety issue resolutions

Safety-related parameters for the MAPLE research reactor and a comparison with the IAEA generic 10-MW research reactor

International Nuclear Information System (INIS)

Carlson, P.A.; Lee, A.G.; Smith, H.J.; Ellis, R.J.

1989-07-01

A summary is presented of some of the principle safety-related physics parameters for the MAPLE Research Reactor, and a comparison with the IAEA Generic 10-MW Reactor is given. This provides a means to assess the operating conditions and fuelling requirements for safe operation of the MAPLE Research Reactor under accepted standards

Issues of Safety and Security: New Challenging to Malaysia Tourism Industry

OpenAIRE

Mohd Ayob Norizawati; Masron Tarmiji

2014-01-01

The safety and security issues nowadays become one of the forces causing changes in tourism industry in era of millennium. The main concern of this issues more focus on crime rates, terrorism, food safety, health issues and natural disaster. This topic gained the popularity in tourism research after 9/11 tragedy and since then the academicians and practitioners started seeking the best solution in ways to mitigate these negative impacts. For Malaysia, the image as safety and secure destinatio...

Integrated safety assessment report, Haddam Neck Plant (Docket No. 50-213): Integrated Safety Assessment Program: Draft report

International Nuclear Information System (INIS)

1987-07-01

The integrated assessment is conducted on a plant-specific basis to evaluate all licensing actions, licensee initiated plant improvements and selected unresolved generic/safety issues to establish implementation schedules for each item. Procedures allow for a periodic updating of the schedules to account for licensing issues that arise in the future. The Haddam Neck Plant is one of two plants being reviewed under the pilot program. This report indicates how 82 topics selected for review were addressed, and presents the staff's recommendations regarding the corrective actions to resolve the 82 topics and other actions to enhance plant safety. 135 refs., 4 figs., 5 tabs

Guidelines for nuclear-power-plant safety-issue prioritization information development

International Nuclear Information System (INIS)

Andrews, W.B.; Gallucci, R.H.V.; Konzek, G.J.

1983-05-01

This is the second in a series of reports to document the use of a methodology developed by the Pacific Northwest Laboratory to calculate, for prioritization purposes, the risk, dose and cost impacts of implementing resolutions to reactor safety issues. This report contains results of issue-specific analyses for 15 issues. Each issue was considered within the contraints of available information as of September 1982 and two staff-weeks of labor. The results will be referenced, as one consideration in setting priorities for reactor safety issues, in an NRC prioritization report to be published at a future date

Topical issues in nuclear, radiation and radioactive waste safety. Contributed papers

Energy Technology Data Exchange (ETDEWEB)

NONE

1998-08-01

The IAEA International Conference on Topical Issues in Nuclear, Radiation and Radioactive Waste Safety was held in Vienna, Austria, 30 August - 4 September 1998 with the objective to foster the exchange of information on topical issues in nuclear, radiation and radioactive waste safety, with the aim of consolidating an international consensus on: the present status of these issues; priorities for future work; and needs for strengthening international co-operation, including recommendations for the IAEA`s future activities. The document includes 43 papers presented at the Conference dealing with the following topical issues: Safety Management; Backfitting, Upgrading and Modernization of NPPs; Regulatory Strategies; Occupational Radiation Protection: Trends and Developments; Situations of Chronic Exposure to Residual Radioactive Materials: Decommissioning and Rehabilitation and Reclamation of Land; Radiation Safety in the Far Future: The Issue of Long Term Waste Disposal. A separate abstract and indexing were provided for each paper. Refs, figs, tabs

Topical issues in nuclear, radiation and radioactive waste safety. Contributed papers

International Nuclear Information System (INIS)

1998-08-01

The IAEA International Conference on Topical Issues in Nuclear, Radiation and Radioactive Waste Safety was held in Vienna, Austria, 30 August - 4 September 1998 with the objective to foster the exchange of information on topical issues in nuclear, radiation and radioactive waste safety, with the aim of consolidating an international consensus on: the present status of these issues; priorities for future work; and needs for strengthening international co-operation, including recommendations for the IAEA's future activities. The document includes 43 papers presented at the Conference dealing with the following topical issues: Safety Management; Backfitting, Upgrading and Modernization of NPPs; Regulatory Strategies; Occupational Radiation Protection: Trends and Developments; Situations of Chronic Exposure to Residual Radioactive Materials: Decommissioning and Rehabilitation and Reclamation of Land; Radiation Safety in the Far Future: The Issue of Long Term Waste Disposal. A separate abstract and indexing were provided for each paper

Innovation strategies for generic drug companies: moving into supergenerics.

Science.gov (United States)

Ross, Malcolm S F

2010-04-01

Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

Generic medicines: Perceptions of Physicians in Basrah, Iraq

Directory of Open Access Journals (Sweden)

Adheed Khalid Sharrad

2009-08-01

Full Text Available BackgroundThe use of cheaper generic medicines is a strategy promotedin many countries to reduce rising health care costs. The aimof this study was to explore factors affecting generic medicineprescribing by physicians in Basrah, Iraq.MethodologyA purposive sample of ten physicians practicing in Basrahwas interviewed using a semi-structured interview guide.ResultsAnalysis of the interviews identified seven major themes:medicine prescribing practice, knowledge of therapeuticequivalency of generic medicine, patients’ acceptance ofgeneric medicine, counterfeit medicine, drug informationsource and effect of drug advertising on medicines choice,brand substitution practice by community pharmacists, and,finally strategies to improve generic medicine usefulness.Participants identified helpful strategies to increase genericprescribing including; physician and patient education ongeneric medicine; persuading physicians about the safety andefficacy of generic medicines; and finally educating seniormedical students on generic prescribing.ConclusionThe data suggest that participants were enthusiasticabout prescribing generic medicines. However physiciansinsist that pharmacists should not be allowed tosubstitute generic drugs without prior approval ofdoctors.

An interagency space nuclear propulsion safety policy for SEI - Issues and discussion

Science.gov (United States)

Marshall, A. C.; Sawyer, J. C., Jr.

1991-01-01

An interagency Nuclear Safety Policy Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative nuclear propulsion program to facilitate the implementation of mission planning and conceptual design studies. The NSPWG developed a top level policy to provide the guiding principles for the development and implementation of the nuclear propulsion safety program and the development of Safety Functional Requirements. In addition, the NSPWG reviewed safety issues for nuclear propulsion and recommended top level safety requirements and guidelines to address these issues. Safety topics include reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations. In this paper the emphasis is placed on the safety policy and the issues and considerations that are addressed by the NSPWG recommendations.

Keeping nurse researchers safe: workplace health and safety issues.

Science.gov (United States)

Barr, Jennieffer; Welch, Anthony

2012-07-01

This article is a report of a qualitative study of workplace health and safety issues in nursing research. Researcher health and safety have become increasing concerns as there is an increased amount of research undertaken in the community and yet there is a lack of appropriate guidelines on how to keep researchers safe when undertaking fieldwork. This study employed a descriptive qualitative approach, using different sources of data to find any references to researcher health and safety issues. A simple descriptive approach to inquiry was used for this study. Three approaches to data collection were used: interviews with 15 researchers, audits of 18 ethics applications, and exploration of the literature between 1992 and 2010 for examples of researcher safety issues. Data analysis from the three approaches identified participant comments, narrative descriptions or statements focused on researcher health and safety. Nurse researchers' health and safety may be at risk when conducting research in the community. Particular concern involves conducting sensitive research where researchers are physically at risk of being harmed, or being exposed to the development of somatic symptoms. Nurse researchers may perceive the level of risk of harm as lower than the actual or potential harm present in research. Nurse researchers do not consistently implement risk assessment before and during research. Researcher health and safety should be carefully considered at all stages of the research process. Research focusing on sensitive data and vulnerable populations need to consider risk minimization through strategies such as appropriate researcher preparation, safety during data collection, and debriefing if required. © 2012 Blackwell Publishing Ltd.

Integrated Safety in ''SARAF'

International Nuclear Information System (INIS)

Dickstein, P.; Grof, Y.; Machlev, M.; Pernick, A.

2004-01-01

As of the very early stages of the accelerator project at the Soreq Nuclear Research Center ''SARAF'' a safety group was established which has been an inseparable participant in the planning and design of the new facility. The safety group comprises of teams responsible for the shielding, radiation protection and general industrial safety aspects of ''SARAF''. The safety group prepared and documented the safety envelope for the accelerator, dealing with the safety requirements and guidelines for the first, pre-operational, stages of the project. The safety envelope, though based upon generic principles, took into account the accelerator features and the expected modes of operation. The safety envelope was prepared in a hierarchical structure, containing Basic Principles, Basic Guidelines, General Principles for Safety Implementation, Safety Requirements and Safety Underlining Issues. The above safety envelope applies to the entire facility, which entails the accelerator itself and the experimental areas and associated plant and equipment utilizing and supporting the production of the accelerated particle beams

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Science.gov (United States)

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

2017-12-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

Questionnaire responses concerning safety issues in MR examination

International Nuclear Information System (INIS)

Yamaguchi-Sekino, Sachiko; Nakai, Toshiharu; Muranaka, Hiroyuki

2011-01-01

Recently, the rising numbers of medical implants and scanners with higher static magnetic field have increased safety concerns for magnetic resonance (MR) examination. To determine future safety focus, we distributed anonymous questionnaires to 3250 members of the Japanese Society for Magnetic Resonance in Medicine (JSMRM) and received 978 responses. Safety issues on the questionnaire concentrated on the handling of patients with implants (Q7-18, appendix), acoustic trauma due to scanning (Q19-21, appendix), and MR compatibility within the scanner room (Q22-25, appendix). Ninety-three percent of respondents indicated they had encountered cases with implants or medical materials of unknown MR compatibility; 21.7% reported heating problems and 15.0%, nerve stimulation problems, in patients with implants during MR examination. Although 88.7% of respondents recognized the term ''MR compatibility'', 68.2% indicated limited detailed understanding of the term. Eleven percent had had cases with suspected acoustic injury from MR scanner noise. Scanner noise levels were not clarified in any way in 37.4% cases, but 69.5% applied ear protection to patients. Labeling of ''MR compatibility'' of equipment brought into the MR scanner room was reported by 71.9%. More than 50% experienced MR compatibility issues related to equipment brought into the MR scanner room. With regard to safety issues on metallic objects which are implanted in MR workers, 88.1% indicated they would continue current operations even the implant is inside the body. Respondents identified lectures and seminars by professional societies, safety training by manufacturers, and information from the Internet and literature as the 3 main sources for up-dating safety information for MR examination. (author)

Characterization strategy report for the organic safety issues

International Nuclear Information System (INIS)

Goheen, S.C.; Campbell, J.A.; Fryxell, G.E.

1997-08-01

This report describes a logical approach to resolving potential safety issues resulting from the presence of organic components in hanford tank wastes. The approach uses a structured logic diagram (SLD) to provide a pathway for quantifying organic safety issue risk. The scope of the report is limited to selected organics (i.e., solvents and complexants) that were added to the tanks and their degradation products. The greatest concern is the potential exothermic reactions that can occur between these components and oxidants, such as sodium nitrate, that are present in the waste tanks. The organic safety issue is described in a conceptual model that depicts key modes of failure-event reaction processes in tank systems and phase domains (domains are regions of the tank that have similar contents) that are depicted with the SLD. Applying this approach to quantify risk requires knowing the composition and distribution of the organic and inorganic components to determine (1) how much energy the waste would release in the various domains, (2) the toxicity of the region associated with a disruptive event, and (3) the probability of an initiating reaction. Five different characterization options are described, each providing a different level of quality in calculating the risks involved with organic safety issues. Recommendations include processing existing data through the SLD to estimate risk, developing models needed to link more complex characterization information for the purpose of estimating risk, and examining correlations between the characterization approaches for optimizing information quality while minimizing cost in estimating risk

Consideration of social scientific issues in a safety case. Final report

International Nuclear Information System (INIS)

Sailer, Michael; Kallenbach-Herbert, Beate; Brohmann, Bettina; Spieth-Achtnich, Angelika

2010-01-01

The research outcome presented here - a model for identifying and describing safety-relevant social scientific issues - provides a scientific basis for addressing these issues in a safety case. In order for them to be implemented in a repository process, it would be necessary to elaborate in greater detail the initial conceptual foundations that have been laid in this research project in line with the project's terms of reference. The requisite elaboration relates to binding rules for designing the repository process, particularly with regard to the stages in which the safety case is to be developed during planning, approval, construction and operation through to repository closure. Such detailed elaboration also needs to involve specifying the extent to which each social scientific issue and sub-issue is to be addressed in the different stages. Consideration would need to be given not only to the relevance of the issue for a given stage but also to the various options and methods for providing proof of safety. It would be possible to draw on experiences with handling safety management in nuclear power plants - a sphere in which over the last ten years efforts have been ongoing to develop methods for presentation by the operator and review by the authorities. Furthermore, it is likely that the social scientific issues relevant to a safety case cannot be defined once and for all in a single process, but that the need for continual revision and adaptation will arise due to both the increasing knowledge acquired during the course of the repository process and the experiences and expectations of stakeholders (similarly to experiences in the sphere of scientific-technological requirements). Appropriate conditions need to be defined for such a process. This process could be supported by implementing the option mentioned above whereby a regulatory definition of safety management for geological disposal is formulated which encompasses all safety-relevant social scientific

Generic nuclear power plant component failure data bank

International Nuclear Information System (INIS)

Araujo Goes, A.G. de; Gibelli, S.M.O.

1988-11-01

This report consist in the development of a generic nuclear power plant component failure data bank. This data bank was implemented in a PC-XT microcomputer, IBM compatible, using the Open Access II program. Generic failure data tables for Westinghouse nuclear power plants and for general PWR power plants are presented. They are the final product of a research which included a preselection and a selection of data collected from the available sources in the library of CNEN (National Nuclear Energy Commission) and from the CIN/CNEN (Neclear Information Center). Futhermore, a proposal of evaluating models of average failure rates of pumps and valves are also presented. Through the electronic data bank one can easily have a generic view of failure rate ranges as well as failure models foe a certain component. It is very importante to develop procedures to collect and store generic failure data that can be quickly accessed, in order to update the Probabilistic Safety Study of Angra-1 and to used in studies which may have component failures of nuclear power plant safety systems. In the future, data specialization can be achieved by means of statistical calculations involving specific data collected from the operational experience of Angra-1 nuclear power plant and the generic data bank. (author) [pt

The efficacy and safety of on-demand Elonza; a generic product of sildenafil in Thai men with erectile dysfunction.

Science.gov (United States)

Wijitsettakul, Udomsak; Pempongkosol, Sompol

2013-06-01

To evaluate the efficacy and safety of Elonza (generic product of sildenafil) 100 mg, a phosphodiesterase type 5 (PDE5) inhibitor, in Thai men with erectile dysfunction (ED). This prospective, Cohort study was conducted for eight weeks. Two hundred ten male patients, older than 20 years of age with ED were enrolled to receive generic product of sildenafil 100 mg taken as needed. Efficacy is evaluated through the International Index of Erectile Function (IIEF) scores for the five separate response domains, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction domain. After sildenafil administration, erectile function domain scores were significantly increased from baseline, 5.02 (p product of sildenafil, was an effective and well-tolerated treatment for ED in Thai men.

NRC integrated program for the resolution of Unresolved Safety Issues A-3, A-4 and A-5 regarding steam generator tube integrity: Final report

International Nuclear Information System (INIS)

1988-09-01

This report presents the results of the NRC integrated program for the resolution of Unresolved Safety Issues (USIs) A-3, A-4, and A-5 regarding steam generator tube integrity. A generic risk assessment is provided and indicates that risk from steam generator tube rupture (SGTR) events is not a significant contributor to total risk at a given site, nor to the total risk to which the general public is routinely exposed. This finding is considered to be indicative of the effectiveness of licensee programs and regulatory requirements for ensuring steam generator tube integrity in accordance with 10 CFR 50, Appendices A and B. This report also identifies a number of staff-recommended actions that the staff finds can further improve the effectiveness of licensee programs in ensuring the integrity of steam generator tubes and in mitigating the consequences of an SGTR. As part of the integrated program, the staff issued Generic Letter 85-02 encouraging licensees of pressurized water reactors (PWRs) to upgrade their programs, as necessary, to meet the intent of the staff-recommended actions; however, such actions do not constitute NRC requirements. In addition, this report describes a number of ongoing staff actions and studies involving steam generator issues which are being pursued to provide added assurance that risk from SGTR events will continue to be small. 146 refs., 5 figs., 11 tabs

Verification and validation issues for digitally-based NPP safety systems

International Nuclear Information System (INIS)

Ets, A.R.

1993-01-01

The trend toward standardization, integration and reduced costs has led to increasing use of digital systems in reactor protection systems. While digital systems provide maintenance and performance advantages, their use also introduces new safety issues, in particular with regard to software. Current practice relies on verification and validation (V and V) to ensure the quality of safety software. However, effective V and V must be done in conjunction with a structured software development process and must consider the context of the safety system application. This paper present some of the issues and concerns that impact on the V and V process. These include documentation of systems requirements, common mode failures, hazards analysis and independence. These issues and concerns arose during evaluations of NPP safety systems for advanced reactor designs and digital I and C retrofits for existing nuclear plants in the United States. The pragmatic lessons from actual systems reviews can provide a basis for further refinement and development of guidelines for applying V and V to NPP safety systems. (author). 14 refs

Critical safety issues in the design of fusion machines

International Nuclear Information System (INIS)

Kramer, W.

1991-01-01

In the course of developing fusion machines both general safety considerations and safety assessments for the various components and systems of actual machines increase in number and become more and more coherent. This is particularly true for the NET/ITER projects where safety analysis plays an increasing role for the design of the machine. Since in a D/T tokamak the radiological hazards will be dominant basic radiological safety objectives are discussed. Critical safety issues as identified in particular by the NET/ITER community are reviewed. Subsequently, issues of major concern are considered both for normal operation and for conceivable accidents. The following accidents are considered to be crucial: Loss of cooling in plasma facing components, loss of vacuum, tritium system failure, and magnet system failure. To mitigate accident consequences a confinement concept based on passive features and multiple barriers including detritiation and filtering has to be applied. The reactor building as final barrier needs special attention to cope with both internal and external hazards. (orig.)

Health, safety and environmental research program

International Nuclear Information System (INIS)

Dinner, P.J.

1983-01-01

This report outlines the Health, Safety and Environmental Research Program being undertaken by the CFFTP. The Program objectives, relationship to other CFFTP programs, implementation plans and expected outputs are stated. Opportunities to build upon the knowledge and experience gained in safely managing tritium in the CANDU program, by addressing generic questions pertinent to tritium safety for fusion facilities, are identified. These opportunities exist across a broad spectrum of issues covering the anticipated behaviour of tritium in fusion facilities, the surrounding environment and in man

A Generic Safety Assessment Model for a Trench Type LILW Repository

International Nuclear Information System (INIS)

Lee, Youn-Myoung; Choi, Hee-Joo

2015-01-01

This program is ready for a total system performance assessment and is able to deterministically and probabilistically evaluate the nuclide release from a repository and farther transport into the geosphere and biosphere under various normal circumstances, disruptive events, and scenarios that can occur after a failure of waste packages with associated uncertainty. Despite the conceptual design of a trench type LILW repository system, all parameter values associated with the repository system were assumed for the time being, and the generic model developed through this study should be helpful because the evaluation of such releases is very important. A simple and effective model for a safety assessment of a conceptual trench repository system, in which an LILW that arises from a nuclear power plant and other sources, has been developed. The computer program based on this model has also been developed as a GoldSim template using the commercial GoldSim development tool

A Generic Safety Assessment Model for a Trench Type LILW Repository

Energy Technology Data Exchange (ETDEWEB)

Lee, Youn-Myoung; Choi, Hee-Joo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2015-05-15

This program is ready for a total system performance assessment and is able to deterministically and probabilistically evaluate the nuclide release from a repository and farther transport into the geosphere and biosphere under various normal circumstances, disruptive events, and scenarios that can occur after a failure of waste packages with associated uncertainty. Despite the conceptual design of a trench type LILW repository system, all parameter values associated with the repository system were assumed for the time being, and the generic model developed through this study should be helpful because the evaluation of such releases is very important. A simple and effective model for a safety assessment of a conceptual trench repository system, in which an LILW that arises from a nuclear power plant and other sources, has been developed. The computer program based on this model has also been developed as a GoldSim template using the commercial GoldSim development tool.

Trial evaluations in comparison with the 1983 safety goals

International Nuclear Information System (INIS)

Riggs, R.; Sege, G.

1985-06-01

This report provides retrospective comparisons of selected generic regulatory actions to the 1983 NRC safety goals, which had been issued for evaluation during a two-year period. The issues covered are those analyzed by the Office of Nuclear Reactor Regulation (NRR) (assisted in some cases by the Battelle Pacific Northwest Laboratory). The issues include auxiliary feedwater reliability, pressurized thermal shock, power-operated relief valve isolation, asymmetric blowdown loads on PWR primary systems, pool dynamic loads for BWR containments, and steam generator tube rupture. Calculated core-melt frequencies, mortality risks, and cost-benefit ratios are compared with the corresponding safety-goal quantitative design objectives. Considerations that should influence interpretation of the comparisons are discussed. Comments are included on whether and how the safety goals may have helped in the regulatory decision process and on problems encountered

Evaluation and proposed improvements to effectiveness of US Nuclear Regulatory Commission generic communications

International Nuclear Information System (INIS)

Thurber, J.A.; Melber, B.D.; Geisendorfer, C.L.; Vallario, R.W.

1988-01-01

This report describes an evaluation of NRC generic communications with industry concerning safety related issues of commercial nuclear power plandts. The analysis builds on the findings presented in the 1986 Office of Analysis and Evaluation of Operational Data (AEOD) Special Study Report, ''An Overview of Nuclear Power Plant Operating Experience Feedback Programs'' (AEOD/S602). The primary objective of the report is to present practical recommendations for improving NRC's documents and generic communications system. The report is based upon a systematic review and evaluation of NRC and industry operating experience documents. It also includes an analysis of interviews with licensee personnel at five utilities and their nuclear power plants. NRC regional and headquarters managers and staff were also interviewed for the study. NRC and licensee personnel interviewed are generally satisfied with the current NRC-industry communications system; however, several problems and potential solutions to those problems are identified in this study. The report makes seven major recommendations for improvement in the effectiveness of NRC-industry generic communications about nuclear power plant operating experience

Nuclear power systems: Their safety. Current issue review

International Nuclear Information System (INIS)

Myers, L.C.

1994-04-01

Human beings utilize energy in many forms and from a variety of sources. A number of countries have chosen nuclear-electric generation as a component of their energy system. At the end of 1992, there were 419 power reactors operating in 29 countries, accounting for more than 15% of the world's production of electricity. In 1992, 13 countries derived at least 25% of their electricity from nuclear units, with Lithuania leading at just over 78%, followed closely by France at 72%. In the same year, Canada produced about 16% of its electricity from nuclear units. Some 53 power reactors are under construction in 14 countries outside the former USSR. Within the ex-USSR countries, six new reactors are currently under construction. No human endeavour carries the guarantee of perfect safety and the question of whether of not nuclear-electric generation represents an 'acceptable' risk to society has long been vigorously debated. Until the events of late April 1986 in the then Soviet Union, nuclear safety had indeed been an issue for discussion, for some concern, but not for alarm. The accident at the Chernobyl reactor irrevocably changed all that. This disaster brought the matter of nuclear safety into the public mind in a dramatic fashion. Subsequent opening of the ex-Soviet nuclear power program to outside scrutiny has done little to calm people's concerns about the safety of nuclear power in that part of the world. This paper discusses the issue of safety in complex energy systems and provides brief accounts of some of the most serious reactor accidents that have occurred to date, as well as more recent, less dramatic events touching on the safety issue. (author). 7 refs

Trend analysis of incidents involving setpoint drift in safety or safety/relief valves at U.S. LWRs

International Nuclear Information System (INIS)

Watanabe, Norio

2008-01-01

Since the beginning of the 1980's, in the United States, there have been many licensee event reports (LERs) involving setpoint drift in safety or safety/relief valves. The United States Nuclear Regulatory Commission (NRC) has issued a lot of generic communications on this issue and the industry has made efforts to resolve the issue. However, the NRC staff recently highlighted that over 70 LERs involved instances where safety or safety/relief valves failed to meet the allowed setpoint tolerance from 2001 through August 2006. In the present study, we analyzed the U.S. experience with setpoint drift in safety/relief valves (SRVs) at BWRs, pressurizer safety valves (PSVs), and main steam safety valves (MSSVs) at PWRs by reviewing approximately 90 LERs from 2000 to 2006 and examined the trend focusing on causes and setpoint deviation ranges. This study indicates that for SRVs and MSSVs, disc-seat bonding is a dominant cause of the setpoint drifting high and has a tendency to result in a relatively large deviation of the setpoint. This means that disc-seat bonding might be a safety concern from the view point of overpressure protection. For PSVs, the deviation of setpoints is generally small, although its causes are not specified in many instances. (author)

Safety considerations in next step fusion design and beyond

International Nuclear Information System (INIS)

Holland, D.F.

1990-01-01

Recent U.S. and international design studies provide insights into the potential safety and environmental advantages of fusion as well as the development needed to realize this potential. We in the Fusion Safety Program at EG ampersand G Idaho have analyzed the Compact Ignition Tokamak (CIT), the International Thermonuclear Engineering Reactor (ITER), and the Advanced Reactor Innovative Engineering Study (ARIES). I have reviewed these three designs to determine issues related to meeting the safety and the environmental goals that guide fusion development in the U.S. The paper lists safety and environmental issues that are generic to fusion and approaches to favorably resolve each issue. The technical developments that have the highest potential of contributing to improving the safety and environmental attractiveness of fusion are identified and discussed. These developments are in the areas of low-activation materials, plasma- facing components, and plasma physics relating to off-normal plasma events and tritium burn-up. 8 refs., 7 tabs

A summary of the conclusions of generic issue 113: Dynamic qualification and testing of large bore hydraulic snubbers

International Nuclear Information System (INIS)

Ware, A.G.; Nitzel, M.E.

1993-01-01

The Nuclear Regulatory Commission (NRC) developed Generic Issue 113, Dynamic Qualification and Testing of Large Bore Hydraulic Snubbers (LBHSs), with the objective of evaluating the reliability of LBHSs in operating commercial nuclear power plants. For the purposes of this research, LBHSs were defined as those hydraulic snubbers with rated load capacities ≥50 kips. Relatively high LBHS failure rates were common during the early 1980s; however, industry actions taken during the last several years in response to increased inspection and testing requirements have resulted in lower LBHS failure rates. To address the issue of LBHS adequacy, the NRC developed Generic Issue 113 (GI-113). This paper provides a summary of the important findings of the GI-113 research program and a discussion of the recommendations that were made in NUREG/CR-5416. Fifteen potential improvements in LBHS reliability were identified, covering the areas of design, environmental (including dynamic) qualification, functional testing, visual inspection, and personnel training. Probabilistic risk assessment studies were used to perform a cost/benefit analysis for each. There were five potential improvements in functional testing and visual inspections with low cost/benefit ratios for both existing and future nuclear plants, and an additional six potential improvements that were determined to be cost beneficial only for future plants. Further investigations of the single failure of snubbers that could damage critical components or systems were recommended in NUREG/CR-5416

Safety issues at the defense production reactors

International Nuclear Information System (INIS)

1987-01-01

The United States produces plutonium and tritium for use in nuclear weapons at the defense production reactors - the N Reactor in Washington and the Savannah River reactors in South Carolina. This report reaches general conclusions about the management of those reactors and highlights a number of safety and technical issues that should be resolved. The report provides an assessment of the safety management, safety review, and safety methodology employed by the Department of Energy and the private contractors who operate the reactors for the federal government. This report examines the safety objective established by the Department of Energy for the production reactors and the process the Department of its contractors use to implement the objective; focuses on a variety of uncertainties concerning the production reactors, particularly those related to potential vulnerabilities to severe accidents; and identifies ways in which the DOE approach to management of the safety of the production reactors can be improved

Safety Culture in Pre-operational Phases of Nuclear Power Plant Projects

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-09-15

An abundance of information exists on safety culture related to the operational phases of nuclear power plants; however, pre-operational phases present unique challenges. This publication focuses on safety culture during pre-operational phases that span the interval from before a decision to launch a nuclear power programme to first fuel load. It provides safety culture insights and focuses on eight generic issues: safety culture understanding; multicultural aspects; leadership; competencies and resource competition; management systems; learning and feedback; cultural assessments; and communication. Each issue is discussed in terms of: specific challenges; desired state; approaches and methods; and examples and resources. This publication will be of interest to newcomers and experienced individuals faced with the opportunities and challenges inherent in safety culture programmes aimed at pre-operational activities.

Safety Culture in Pre-operational Phases of Nuclear Power Plant Projects

International Nuclear Information System (INIS)

2012-01-01

An abundance of information exists on safety culture related to the operational phases of nuclear power plants; however, pre-operational phases present unique challenges. This publication focuses on safety culture during pre-operational phases that span the interval from before a decision to launch a nuclear power programme to first fuel load. It provides safety culture insights and focuses on eight generic issues: safety culture understanding; multicultural aspects; leadership; competencies and resource competition; management systems; learning and feedback; cultural assessments; and communication. Each issue is discussed in terms of: specific challenges; desired state; approaches and methods; and examples and resources. This publication will be of interest to newcomers and experienced individuals faced with the opportunities and challenges inherent in safety culture programmes aimed at pre-operational activities.

Generic clearance values

International Nuclear Information System (INIS)

Bossio, M.C.; Muniz, C.C.

2009-01-01

This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document 'Safety Reports Series Nr 44' of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (author)

Generic Clearance Values

International Nuclear Information System (INIS)

Bossio, M.C.; Muniz, C.C.

2010-01-01

This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on the one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document Safety Reports Series 44 of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (authors) [es

Current safety issues related to research reactor operation

International Nuclear Information System (INIS)

Alcala-Ruiz, F.

2000-01-01

The Agency has included activities on research reactor safety in its Programme and Budget (P and B) since its inception in 1957. Since then, these activities have traditionally been oriented to fulfil the Agency's functions and obligations. At the end of the decade of the eighties, the Agency's Research Reactor Safety Programme (RRSP) consisted of a limited number of tasks related to the preparation of safety related publications and the conduct of safety missions to research reactor facilities. It was at the beginning of the nineties when the RRSP was upgraded and expanded as a subprogramme of the Agency's P and B. This subprogramme continued including activities related to the above subjects and started addressing an increasing number of issues related to the current situation of research reactors (in operation and shut down) around the world such as reactor ageing, modifications and decommissioning. The present paper discusses some of the above issues as recognised by various external review or advisory groups (e.g., Peer Review Groups under the Agency's Performance Programme Appraisal System (PPAS) or the standing International Nuclear Safety Advisory Group (INSAG)) and the impact of their recommendations on the preparation and implementation of the part of the Agency's P and B relating to the above subject. (author)

Health, safety and environmental issues in thin film manufacturing

NARCIS (Netherlands)

Alsema, E.A.; Baumann, A.E.; Hill, R.; Patterson, M.H.

1997-01-01

An investigation is made of Health, Safety and Environmental (HSE) aspects for the manufacturing, use and decommissioning of CdTe, CIS and a-Si modules. Issues regarding energy requirements, resource availability, emissions of toxic materials, occupational health and safety and module waste

Relevant safety issues in designing the HTR-10 reactor

International Nuclear Information System (INIS)

Sun Yuliang; Xu Yuanghui

2001-01-01

The HTR-10 is a 10 MWth pebble bed high temperature gas cooled reactor being constructed as a research facility at the Institute of Nuclear Energy Technology. This paper discusses design issues of the HTR-10 which are related to safety. It addresses the safety criteria used in the development and assessment of the design, the safety important systems, and the safety classification of components. It also summarises the results of safety analysis, including the approach used for the radioactive source term, as well as the approach to containment design. (author)

Analysis of high burnup fuel safety issues

Energy Technology Data Exchange (ETDEWEB)

Lee, Chan Bock; Kim, D. H.; Bang, J. G.; Kim, Y. M.; Yang, Y. S.; Jung, Y. H.; Jeong, Y. H.; Nam, C.; Baik, J. H.; Song, K. W.; Kim, K. S

2000-12-01

Safety issues in steady state and transient behavior of high burnup LWR fuel above 50 - 60 MWD/kgU were analyzed. Effects of burnup extension upon fuel performance parameters was reviewed, and validity of both the fuel safety criteria and the performance analysis models which were based upon the lower burnup fuel test results was analyzed. It was found that further tests would be necessary in such areas as fuel failure and dispersion for RIA, and high temperature cladding corrosion and mechanical deformation for LOCA. Since domestic fuels have been irradiated in PWR up to burnup higher than 55 MWD/kgU-rod. avg., it can be said that Korea is in the same situation as the other countries in the high burnup fuel safety issues. Therefore, necessary research areas to be performed in Korea were derived. Considering that post-irradiation examination(PIE) for the domestic fuel of burnup higher than 30 MWD/kgU has not been done so far at all, it is primarily necessary to perform PIE for high burnup fuel, and then simulation tests for RIA and LOCA could be performed by using high burnup fuel specimens. For the areas which can not be performed in Korea, international cooperation will be helpful to obtain the test results. With those data base, safety of high burnup domestic fuels will be confirmed, current fuel safety criteria will be re-evaluated, and finally transient high burnup fuel behavior analysis technology will be developed through the fuel performance analysis code development.

Analysis of high burnup fuel safety issues

International Nuclear Information System (INIS)

Lee, Chan Bock; Kim, D. H.; Bang, J. G.; Kim, Y. M.; Yang, Y. S.; Jung, Y. H.; Jeong, Y. H.; Nam, C.; Baik, J. H.; Song, K. W.; Kim, K. S

2000-12-01

Safety issues in steady state and transient behavior of high burnup LWR fuel above 50 - 60 MWD/kgU were analyzed. Effects of burnup extension upon fuel performance parameters was reviewed, and validity of both the fuel safety criteria and the performance analysis models which were based upon the lower burnup fuel test results was analyzed. It was found that further tests would be necessary in such areas as fuel failure and dispersion for RIA, and high temperature cladding corrosion and mechanical deformation for LOCA. Since domestic fuels have been irradiated in PWR up to burnup higher than 55 MWD/kgU-rod. avg., it can be said that Korea is in the same situation as the other countries in the high burnup fuel safety issues. Therefore, necessary research areas to be performed in Korea were derived. Considering that post-irradiation examination(PIE) for the domestic fuel of burnup higher than 30 MWD/kgU has not been done so far at all, it is primarily necessary to perform PIE for high burnup fuel, and then simulation tests for RIA and LOCA could be performed by using high burnup fuel specimens. For the areas which can not be performed in Korea, international cooperation will be helpful to obtain the test results. With those data base, safety of high burnup domestic fuels will be confirmed, current fuel safety criteria will be re-evaluated, and finally transient high burnup fuel behavior analysis technology will be developed through the fuel performance analysis code development

Commercial truck parking and other safety issues.

Science.gov (United States)

2015-10-01

Commercial truck parking is a safety issue, since trucks are involved in approximately 10% of all fatal accidents on interstates and : parkways in Kentucky. Drivers experience schedule demands and long hours on the road, yet they cannot easily determ...

Status report on resolution of Waste Tank Safety Issues at the Hanford Site. Revision 1

International Nuclear Information System (INIS)

Dukelow, G.T.; Hanson, G.A.

1995-05-01

The purpose of this report is to provide and update the status of activities supporting the resolution of waste tank safety issues and system deficiencies at the Hanford Site. This report provides: (1) background information on safety issues and system deficiencies; (2) a description of the Tank Waste Remediation System and the process for managing safety issues and system deficiencies; (3) changes in safety issue description, prioritization, and schedules; and (4) a summary of the status, plans, order of magnitude, cost, and schedule for resolving safety issues and system deficiencies

Safety issues with bisphosphonate therapy for osteoporosis

DEFF Research Database (Denmark)

Suresh, Ernest; Pazianas, Michael; Abrahamsen, Bo

2014-01-01

Randomized controlled trials have demonstrated the efficacy of bisphosphonates (BP) in improving BMD and reducing fracture risk. Various safety issues that were not noted in clinical trials have, however, now emerged with post-marketing surveillance and increasing clinical experience. The risk...

Development of a stand-alone microcomputer based DOE contractor generic radiation worker safety course

International Nuclear Information System (INIS)

Klos, D.B.; Gardner, P.R.

1985-01-01

Westinghouse Hanford Company (WHC) has developed Computer Based Training (CBT) materials for radiation and industrial safety. First released for general Fast Flux Test Facility in November, 1984. This course has now been taken by nearly 350 people. Completion times for new personnel average around eight hours. The next project undertaken was construction of a Radiation Worker Safety course generic enough for use by all contractors at the Hanford site. The design process of the Hanford site course indicated that the quantity of ''DOE common material'' may be sufficient to warrant consideration of a larger target population. Specifically, the course will be designed to run on an IBM-PC or compatible computer having 256K RAM, a standard IBM color graphics card or equivalent, a color graphics monitor, and two floppy disk drives or one hard disk. The target student population includes those who routinely work in Radiation Areas, especially crafts people. We are not targeting Health Physics personnel, except, possibly, for introductory training, nor are we directing the course toward ''casual'' or escorted workers

Safety issues on advanced fuel

Energy Technology Data Exchange (ETDEWEB)

Gross, H.; Krebs, W.D. [Siemens AG, Bereich Energieerzeugug (KWU), Erlangen (Germany). Geschaeftsgebiet Nukleare Energieerzeugung

1998-05-01

In the recent years a general discussion has started whether unsolved safety issues are related to advanced fuel. Advanced fuel is in this context a summary of features like high burnup, improved clad materials, low leakage loading pattern with high peaking factors etc. The design basis accidents RIA and Loca are of special interest for this discussion. From the Siemens point of view RIA is not a safety issue. There are sufficient margins between the enthalpy rise calculated by modern 3D methods and the fuel failures which occurred in RIA simulation tests when the effect of pulse width is taken into account. The evaluation of possible uncertainties for the established Loca criteria (17% equivalent corrosion, 1200 C clad temperature) for high burnup makes sense. But fuel with high burnup has significantly lower peaking factors than fuel with lower burnup. This gives sufficient margin counterbalancing possible uncertainties. In contrast to the above incomplete control rod insertion at higher burnup is potentially a real safety issue. Although Siemens fuel was not affected by the reported incidents they addressed the problem and checked that they have sufficient design margin for their fuel. (orig.) [Deutsch] In den letzten Jahren hat eine allgemeine Diskussion begonnen, ob mit fortgeschrittenen Brennelementen (BE) ungeklaerte Sicherheitsprobleme verbunden sind. Dabei ist `Fortgeschrittene Brennelemente` ein Sammelbegriff fuer hohe Abbraende, verbesserte Huellrohrmaterialien, Low-leakage-Einsatzplanungen mit hohen Heissstellenfaktoren usw. Die Auslegungsstoerfaelle RIA und Loca sind in dieser Diskussion von besonderer Bedeutung. Aus der Sicht von Siemens ist der RIA kein Sicherheitsproblem. Zwischen den mit modernen 3D-Methoden berechneten Enthalpieerhoehungen und den in RIA-Experimenten aufgetretenen Brennstabdefekten bestehen ausreichende Abstaende, wenn der Einfluss der Pulsbreite beruecksichtigt wird. Die Untersuchung eventueller Unsicherheiten bei hohen

GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

OpenAIRE

Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

2017-01-01

Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

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

Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs

Science.gov (United States)

Hansen, Richard A.; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K.; Raofi, Saeid; Page, C. David; Peissig, Peggy

2018-01-01

Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for

Safety Issues Concerning the Medical Use of Cannabis and Cannabinoids

Directory of Open Access Journals (Sweden)

Mark A Ware

2005-01-01

Full Text Available Safety issues are a major barrier to the use of cannabis and cannabinoid medications for clinical purposes. Information on the safety of herbal cannabis may be derived from studies of recreational cannabis use, but cannabis exposure and effects may differ widely between medical and recreational cannabis users. Standardized, quality-controlled cannabinoid products are available in Canada, and safety profiles of approved medications are available through the Canadian formulary. In the present article, the evidence behind major safety issues related to cannabis use is summarized, with the aim of promoting informed dialogue between physicians and patients in whom cannabinoid therapy is being considered. Caution is advised in interpreting these data, because clinical experience with cannabinoid use is in the early stages. There is a need for long-term safety monitoring of patients using cannabinoids for a wide variety of conditions, to further guide therapeutic decisions and public policy.

Associations between generic substitution and patients' attitudes, beliefs and experience

DEFF Research Database (Denmark)

Østergaard Rathe, Jette; Larsen, Pia Veldt; Andersen, Morten

2013-01-01

Abstract Background Generic substitution has been implemented in many countries, but knowledge about patients’ attitudes, beliefs and experiences is still sparse. Aim To assess associations between generic switching and patients’ attitudes, beliefs and experiences with previous generic switching...... on generic medicine and confidence in the healthcare system. Only prescriptions issued by the general practitioners were included. For each patient we focused on one purchase of a generically substitutable drug (index drug). Patients were identified by means of a dispensing database. Results Earlier generic...... switches within the index ATC code were statistically significantly associated with experience of a generic switch (adjusted OR 5.93 95% CI 4.70; 7.49). Having had more than 5 earlier switches within other ATC codes and having negative views on generic medicines reduced the odds of experiencing a generic...

Climate and climate-related issues for the safety assessment SR-Can

International Nuclear Information System (INIS)

Naeslund, Jens-Ove

2006-11-01

The purpose of this report is to document current scientific knowledge of the climate-related conditions and processes relevant to the long-term safety of a KBS-3 repository to a level required for an adequate treatment in the safety assessment SR-Can. The report also includes a concise background description of the climate system. The report includes three main chapters: A description of the climate system (Chapter 2); Identification and discussion of climate-related issues (Chapter 3); and, A description of the evolution of climate-related conditions for the safety assessment (Chapter 4). Chapter 2 includes an overview of present knowledge of the Earth climate system and the climate conditions that can be expected to occur in Sweden on a 100,000 year time perspective. Based on this, climate-related issues relevant for the long-term safety of a KBS-3 repository are identified. These are documented in Chapter 3 'Climate-related issues' to a level required for an adequate treatment in the safety assessment. Finally, in Chapter 4, 'Evolution of climate-related conditions for the safety assessment' an evolution for a 120,000 year period is presented, including discussions of identified climate-related issues of importance for repository safety. The documentation is from a scientific point of view not exhaustive, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of a safety assessment. As further described in the SR-Can Main Report and in the Features Events and Processes report, the content of the present report has been audited by comparison with FEP databases compiled in other assessment projects. This report follows as far as possible the template for documentation of processes regarded as internal to the repository system. However, the term processes is not used in this report, instead the term issue has been used. Each issue includes a set of processes together resulting in the behaviour of a

Climate and climate-related issues for the safety assessment SR-Can

Energy Technology Data Exchange (ETDEWEB)

Naeslund, Jens-Ove (comp.)

2006-11-15

The purpose of this report is to document current scientific knowledge of the climate-related conditions and processes relevant to the long-term safety of a KBS-3 repository to a level required for an adequate treatment in the safety assessment SR-Can. The report also includes a concise background description of the climate system. The report includes three main chapters: A description of the climate system (Chapter 2); Identification and discussion of climate-related issues (Chapter 3); and, A description of the evolution of climate-related conditions for the safety assessment (Chapter 4). Chapter 2 includes an overview of present knowledge of the Earth climate system and the climate conditions that can be expected to occur in Sweden on a 100,000 year time perspective. Based on this, climate-related issues relevant for the long-term safety of a KBS-3 repository are identified. These are documented in Chapter 3 'Climate-related issues' to a level required for an adequate treatment in the safety assessment. Finally, in Chapter 4, 'Evolution of climate-related conditions for the safety assessment' an evolution for a 120,000 year period is presented, including discussions of identified climate-related issues of importance for repository safety. The documentation is from a scientific point of view not exhaustive, since such a treatment is neither necessary for the purposes of the safety assessment nor possible within the scope of a safety assessment. As further described in the SR-Can Main Report and in the Features Events and Processes report, the content of the present report has been audited by comparison with FEP databases compiled in other assessment projects. This report follows as far as possible the template for documentation of processes regarded as internal to the repository system. However, the term processes is not used in this report, instead the term issue has been used. Each issue includes a set of processes together resulting in the

The Norwegian Plan of Action for nuclear safety issues

International Nuclear Information System (INIS)

1997-07-01

The Plan of Action underlies Norwegian activities in the field of international co-operation to enhance nuclear safety and prevent radioactive contamination from activities in Eastern Europe and the former Soviet Union. Geographically the highest priority has been given to support for safety measures in north-west Russia. This information brochure outlines the main content of the Plan of Action for nuclear safety issues and lists a number of associated measures and projects

The Norwegian Plan of Action for nuclear safety issues

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-07-01

The Plan of Action underlies Norwegian activities in the field of international co-operation to enhance nuclear safety and prevent radioactive contamination from activities in Eastern Europe and the former Soviet Union. Geographically the highest priority has been given to support for safety measures in north-west Russia. This information brochure outlines the main content of the Plan of Action for nuclear safety issues and lists a number of associated measures and projects.

Key practical issues in strengthening safety culture. INSAG-15. A report by the International Safety Advisory Group

International Nuclear Information System (INIS)

2002-01-01

This report describes the essential practical issues to be considered by organizations aiming to strengthen safety culture. It is intended for senior executives, managers and first line supervisors in operating organizations. Although safety culture cannot be directly regulated, it is important that members of regulatory bodies understand how their actions affect the development of attempts to strengthen safety culture and are sympathetic to the need to improve the less formal human related aspects of safety. The report is therefore of relevance to regulators, although not intended primarily for them. The International Nuclear Safety Advisory Group (INSAG) introduced the concept of safety culture in its INSAG-4 report in 1991. Since then, many papers have been written on safety culture, as it relates to organizations and individuals, its improvement and its underpinning prerequisites. Variations in national cultures mean that what constitutes a good approach to enhancing safety culture in one country may not be the best approach in another. However, INSAG seeks to provide pragmatic and practical advice of wide applicability in the principles and issues presented in this report. Nuclear and radiological safety are the prime concerns of this report, but the topics discussed are so general that successful application of the principles should lead to improvements in other important areas, such as industrial safety, environmental performance and, in some respects, wider business performance. This is because many of the attitudes and practices necessary to achieve good performance in nuclear safety, including visible commitment by management, openness, care and thoroughness in completing tasks, good communication and clarity in recognizing major issues and dealing with them as a priority, have wide applicability

Dungeness 'A' Nuclear Power Station. The findings of NII's assessment of Nuclear Electric's long term safety review

International Nuclear Information System (INIS)

1994-01-01

The assessment is reported of Nuclear Electrics' Long Term Safety Reviews (LTSR) of the Dungeness A magnox reactors. The assessment was undertaken by the Health and Safety Executive's Nuclear Installations Inspectorate (NII) which is responsible for regulating the safety of nuclear installations in the United Kingdom. This was one of a programme of LTSRs for all the UK magnox reactors. The LTSR for each plant was proceeded by a Generic Issues programme. The results of both the LTSR and the Generic Issues programme have been used by NII in forming the conclusions of this assessment. Overall the safety case for Dungeness A is satisfactory for continued operation. A programme of additional modifications and inspections has been put in place which further enhances the safety justification. Reactor operations will continue to be monitored and regulated in accordance with the inspections required under the licensing arrangements. Provided these requirements and the agreed further analysis, improvements and inspections give satisfactory results it is expected that the station will be able to operate safely till each reactor is at least 30 years old. Beyond this point a further Periodic Safety Review will be required. (UK)

NASA Aerospace Flight Battery Program: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries; Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries; Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop). Volume 1, Part 1

Science.gov (United States)

Manzo, Michelle A.; Brewer, Jeffrey C.; Bugga, Ratnakumar V.; Darcy, Eric C.; Jeevarajan, Judith A.; McKissock, Barbara I.; Schmitz, Paul C.

2010-01-01

This NASA Aerospace Flight Battery Systems Working Group was chartered within the NASA Engineering and Safety Center (NESC). The Battery Working Group was tasked to complete tasks and to propose proactive work to address battery related, agency-wide issues on an annual basis. In its first year of operation, this proactive program addressed various aspects of the validation and verification of aerospace battery systems for NASA missions. Studies were performed, issues were discussed and in many cases, test programs were executed to generate recommendations and guidelines to reduce risk associated with various aspects of implementing battery technology in the aerospace industry. This document contains Part 1 - Volume I: Generic Safety, Handling and Qualification Guidelines for Lithium-Ion (Li-Ion) Batteries, Availability of Source Materials for Lithium-Ion (Li-Ion) Batteries, and Maintaining Technical Communications Related to Aerospace Batteries (NASA Aerospace Battery Workshop).

Safety Culture and Issue in the Malaysian Manufacturing Sector

OpenAIRE

Ali Danish; Yusof Yusri; Adam Anbia

2017-01-01

. This paper highlights the Safety culture and issue in the Malaysian Manufacturing Sector and emphasis the high occupational accidents due to lack of safety culture and non-compliance of the requirements of Occupational Safety and Health Act 1994. The aim of this study is to review the occupational accidents occurrence in the Malaysia workplace since 2012-2016. Malaysia aimed to reduce the occupational accidents, the results show by DOSH increase that Occupational Noise Induced Hearing Loss ...

Key issues of the common French-German safety approach for future PWRs

International Nuclear Information System (INIS)

Frisch, W.; Rohde, J.; Gros, G.; Queniart, D.

1996-01-01

The general common safety approach issued in May 1993 contains safety objectives, general principles and already some technical principles. Based on general safety approach, detailed recommendations have been developed in 1994 on key issues such as: system design and use of PSA; integrity of the primary circuit; external hazards; severe accidents and containment design; radiological consequences of reference accidents and low pressure core melt accidents. A selection of the detailed recommendations is presented in the full paper. (author)

Environmental safety issues for semiconductors (research on scarce materials recycling)

International Nuclear Information System (INIS)

Izumi, Shigekazu

2004-01-01

In the 21st century, in the fabrication of various industrial parts, particularly, current and future electronics devices in the semiconductor industry, environmental safety issues should be carefully considered. We coined a new term, environmental safety issues for semiconductors, considering our semiconductor research and technology which include environmental and ecological factors. The main object of this analysis is to address the present situation of environmental safety problems in the semiconductor industry; some of which are: (1) the generation and use of hazardous toxic gases in the crystal growth procedure such as molecular beam epitaxy (MBE) and metalorganic chemical vapor deposition (MOCVD), (2) the generation of industrial toxic wastes in the semiconductor process and (3) scarce materials recycling from wastes in the MBE and MOCVD growth procedure

The importance of being first: evidence from Canadian generic pharmaceuticals.

Science.gov (United States)

Hollis, Aidan

2002-12-01

This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors. Copyright 2002 John Wiley & Sons, Ltd.

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

Analysis of safety issues in household meat consumption in Odeda ...

African Journals Online (AJOL)

The study analyzed the safety problems with household meat consumption in Odeda Local Government Area, Ogun state, Nigeria. The objectives were to describe the socioeconomic characteristics of the respondents; assess the level of awareness of safety issues in households' meat consumption; and evaluate the ...

Definition of containment issues

International Nuclear Information System (INIS)

Walker, D.H.

1982-01-01

Public Law 96-567 Nuclear Safety Research, Development and Demonstration Act of 1980, directed the US Department of Energy (DOE) to provide an accelerated and coordinated program for developing practical generic improvements that would enhance the capability for safe, reliable and economical operation of Light Water Nuclear Reactor Power Stations. The DOE approach to defining such a program will consist of two phases, (1) definition of program requirements and (2) implementation of the program plan. This paper summarizes the results of the program definition phase for the containment integrity function. The definition phase effort was carried out by two groups of knowledgeable technical experts from the nuclear industry, one of which addressed containment integrity. Tabulated in the paper are the issues identified by the working groups and their associated priorities. Also tabulated are those high priority issues for which ongoing programs do not appear to provide sufficient information to resolve the issue. The results of this review show that existing programs to a great extent address existing issues in a manner such that the issues should be resolved by the programs

Generic Sensor Failure Modeling for Cooperative Systems

Science.gov (United States)

Jäger, Georg; Zug, Sebastian

2018-01-01

The advent of cooperative systems entails a dynamic composition of their components. As this contrasts current, statically composed systems, new approaches for maintaining their safety are required. In that endeavor, we propose an integration step that evaluates the failure model of shared information in relation to an application’s fault tolerance and thereby promises maintainability of such system’s safety. However, it also poses new requirements on failure models, which are not fulfilled by state-of-the-art approaches. Consequently, this work presents a mathematically defined generic failure model as well as a processing chain for automatically extracting such failure models from empirical data. By examining data of an Sharp GP2D12 distance sensor, we show that the generic failure model not only fulfills the predefined requirements, but also models failure characteristics appropriately when compared to traditional techniques. PMID:29558435

Safety issues of nuclear production of hydrogen

International Nuclear Information System (INIS)

Piera, Mireia; Martinez-Val, Jose M.; Jose Montes, Ma

2006-01-01

Hydrogen is not an uncommon issue in Nuclear Safety analysis, particularly in relation to severe accidents. On the other hand, hydrogen is a household name in the chemical industry, particularly in oil refineries, and is also a well known chemical element currently produced by steam reforming of natural gas, and other methods (such as coal gasification). In the not-too-distant future, hydrogen will have to be produced (by chemical reduction of water) using renewable and nuclear energy sources. In particular, nuclear fission seems to offer the cheapest way to provide the primary energy in the medium-term. Safety principles are fundamental guidelines in the design, construction and operation both of hydrogen facilities and nuclear power plants. When these two technologies are integrated, a complete safety analysis must consider not only the safety practices of each industry, but any interaction that could be established between them. In particular, any accident involving a sudden energy release from one of the facilities can affect the other. Release of dangerous substances (chemicals, radiotoxic effluents) can also pose safety problems. Although nuclear-produced hydrogen facilities will need specific approaches and detailed analysis on their safety features, a preliminary approach is presented in this paper. No significant roadblocks are identified that could hamper the deployment of this new industry, but some of the hydrogen production methods will involve very demanding safety standards

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

Science.gov (United States)

Hansen, Richard A; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K; Raofi, Saeid; Page, C David; Peissig, Peggy

2017-04-01

Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar

Safety issues at the defense production reactors

International Nuclear Information System (INIS)

1987-01-01

The United States produces plutonium and tritium for use in nuclear weapons at the defense production reactors endash the N Reactor in Washington and the Savannah River reactors in South Carolina. This report reaches general conclusions about the management of those reactors and highlights a number of safety and technical issues that should be resolved. The report provides an assessment of the safety management, safety review, and safety methodology employed by the Department of Energy and the private contractors who operate the reactors for the federal government. The report is necessarily based on a limited review of the defense production reactors. It does not address whether any of the reactors are ''safe,'' because such an analysis would involve a determination of acceptable risk endash a matter of obvious importance, but one that was beyond the purview of the committee. It also does not address whether the safety of the production reactors is comparable to that of commercial nuclear power stations, because even this narrower question extended beyond the charge to the committee and would have involved detailed analyses that the committee could not undertake

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

Energy Technology Data Exchange (ETDEWEB)

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

2009-07-01

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

Contribution of safety issues to public perceptions of energy systems

International Nuclear Information System (INIS)

Otway, H.J.; Thomas, K.

1978-01-01

Public opposition is an important consideration for those responsible for energy planning; however, the formulation of socially viable policies requires an understanding of the reasons for this opposition. An attitude model was applied to identify the underlying determinants of public perceptions of five energy systems: nuclear, coal, oil, solar and hydro. Empirical results (heterogeneous sample of the general public, N = 224) are reported in which these energy systems were found to be perceived in terms of four basic dimensions: psychological aspects; economic benefits; socio-political implications; environmental and physical safety issues. For the total sample, safety issues made an appreciable contribution to attitudes toward all of the systems except nuclear energy, where it was not significant. A differential analysis of two sub-samples, those respondents PRO and CON nuclear energy, showed that benefits and safety issues were important determinants of PRO attitudes while CON attitudes were primarily due to psychological aspects and concerns about personal and political power. The role of technical information in the formation of public attitudes toward technological policies is discussed

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

International Nuclear Information System (INIS)

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

2009-01-01

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

IAEA's experience in compiling a generic component reliability data base

International Nuclear Information System (INIS)

Tomic, B.; Lederman, L.

1991-01-01

Reliability data are essential in probabilistic safety assessment, with component reliability parameters being particularly important. Component failure data which is plant specific would be most appropriate but this is rather limited. However, similar components are used in different designs. Generic data, that is all data that is not plant specific to the plant being analyzed but which relates to components more generally, is important. The International Atomic Energy Agency has compiled the Generic Component Reliability Data Base from data available in the open literature. It is part of the IAEA computer code package for fault/event tree analysis. The Data Base contains 1010 different records including most of the components used in probabilistic safety analyses of nuclear power plants. The data base input was quality controlled and data sources noted. The data compilation procedure and problems associated with using generic data are explained. (UK)

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

The contribution of safety issues to public perceptions of energy systems

International Nuclear Information System (INIS)

Otway, H.J.; Thomas, Kerry

1978-01-01

Public opposition is an important consideration for those responsible for energy planning. An attitude model was applied to identify the underlying determinants of public perceptions of five energy systems: nuclear, coal, oil, solar and hydro. Empirical results are reported in which these energy systems were found to be perceived in terms of four basic dimensions: psychological aspects; economics benefits; socio-political implications; environmental and physical safety issues. For the total sample, safety issues made an appreciable contribution to attitudes toward all of the systems except nuclear energy, where it was not significant. A differential analysis of two sub-samples, those respondents PRO and CON nuclear energy, showed that benefits and safety issues were important determinants of PRO attitudes while CON attitudes were primarily due to psychological aspects and concerns about personal and political power. The role of technical information in the formation of public attitudes toward technological policies is discussed [fr

ISSUES OF FETUS DRUG SAFETY

Directory of Open Access Journals (Sweden)

A.V. Ostrovskaya

2010-01-01

Full Text Available The article is focused on the issue of fetus drug safety. Development of a child’s health depends both on hereditary information and environment factors. The reason for deviation from the process of normal prenatal development could be any xenobiotics, physical factors and some medications having a pathogenic effect during pregnancy on the embryo and fetus. Due to that, the physician’s preventive work based on the knowledge of embryogenesis processes and critical development periods. Key words: teratogenic action, medications, prenatal development, congenital malformation, newborns, children.(Pediatric Pharmacology. – 2010; 7(1:25-28

Experimental facility for containment sump reliability studies (Generic Task A-43)

International Nuclear Information System (INIS)

Durgin, W.W.; Padmanabhan, M.; Janik, C.R.

1980-12-01

On July 3, 1979, Sandia National Laboratories (Sandia) contracted the Alden Research Laboratory (ARL) to conduct tests on unresolved safety issues associated with containment sump performance during the recirculation mode (Generic Task A-43). This report describes the test facility constructed and completed under Phase I, Task III of the contract. Sump performance is determined through the observation of vortex formation in the main tank and the measurement of swirl, pressure gradient, and entrained air in the suction pipes. The use of electrically operated valves and a sophisticated data acquisition system, with computer interface, allows the test flow parameters to be set and test data to be taken (with the exception of vortex observations) from a single central office

Brand and generic medications: Are they interchangeable

International Nuclear Information System (INIS)

Al-Jazairi, Abdulrazak S.; Blhareth, S.; Eqtefan, Iyad S.; Al-Suwayeh, Saleh A.

2008-01-01

Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety and the Food and Drug Administration (FDA) standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch. Articles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE (1966-2006). References from the extracted articles and additional data sources, including the Code of Federal Regulations and Regulatory Guidelines from the FDA Center for Drug Evaluation and research were also reviewed. Foe most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products can not be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit. Performing the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed. (author)

Nuclear safety in EU candidate countries

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-10-01

Nuclear safety in the candidate countries to the European Union is a major issue that needs to be addressed in the framework of the enlargement process. Therefore WENRA members considered it was their duty to offer their technical assistance to their Governments and the European Union Institutions. They decided to express their collective opinion on nuclear safety in those candidate countries having at least one nuclear power plant: Bulgaria, the Czech Republic, Hungary, Lithuania, Romania, Slovakia and Slovenia. The report is structured as follows: A foreword including background information, structure of the report and the methodology used, General conclusions of WENRA members reflecting their collective opinion, For each candidate country, an executive summary, a chapter on the status of the regulatory regime and regulatory body, and a chapter on the nuclear power plant safety status. Two annexes are added to address the generic safety characteristics and safety issues for RBMK and VVER plants. The report does not cover radiation protection and decommissioning issues, while safety aspects of spent fuel and radioactive waste management are only covered as regards on-site provisions. In order to produce this report, WENRA used different means: For the chapters on the regulatory regimes and regulatory bodies, experts from WENRA did the work. For the chapters on nuclear power plant safety status, experts from WENRA and from French and German technical support organisations did the work. Taking into account the contents of these chapters, WENRA has formulated its general conclusions in this report.

Nuclear safety in EU candidate countries

International Nuclear Information System (INIS)

2000-10-01

Nuclear safety in the candidate countries to the European Union is a major issue that needs to be addressed in the framework of the enlargement process. Therefore WENRA members considered it was their duty to offer their technical assistance to their Governments and the European Union Institutions. They decided to express their collective opinion on nuclear safety in those candidate countries having at least one nuclear power plant: Bulgaria, the Czech Republic, Hungary, Lithuania, Romania, Slovakia and Slovenia. The report is structured as follows: A foreword including background information, structure of the report and the methodology used, General conclusions of WENRA members reflecting their collective opinion, For each candidate country, an executive summary, a chapter on the status of the regulatory regime and regulatory body, and a chapter on the nuclear power plant safety status. Two annexes are added to address the generic safety characteristics and safety issues for RBMK and VVER plants. The report does not cover radiation protection and decommissioning issues, while safety aspects of spent fuel and radioactive waste management are only covered as regards on-site provisions. In order to produce this report, WENRA used different means: For the chapters on the regulatory regimes and regulatory bodies, experts from WENRA did the work. For the chapters on nuclear power plant safety status, experts from WENRA and from French and German technical support organisations did the work. Taking into account the contents of these chapters, WENRA has formulated its general conclusions in this report

Generic communications index. Listings of communications 1971-1989

Energy Technology Data Exchange (ETDEWEB)

Hagemeyer, D; Towle, H

1991-05-01

As part of its program to feed back information on operating experience to industry, the U.S. Nuclear Regulatory Commission (NRC) issues generic communications called bulletins (about 5/yr), circulars (now discontinued), generic letters (about 20/yr), and information notices (about 100/yr). The report presents an updated Generic Communications Index (GCI; previously published in NUREG/CR-4690, Vol. 1, December 1987) of all such communications from 1971, when such documentation started, to 1989. The GCI consists of records, one for each communication, containing fields for identification number, title, NRC technical contact, general system or topic, specific component or topic, cause or defect, potential effect, remarks, and vendors involved. To facilitate information retrieval, the report also contains topical listings of generic communications numbers. (author)

Generic task problem descriptions: Category B, C, and D tasks

International Nuclear Information System (INIS)

1978-06-01

This document contains information relating to Category B, C, and D generic technical activities. The specific information provided for each task includes the reactor type to which the generic issue applies, the NRC division with lead responsibility and a description of the problem to be addressed by the task. Also provided in this document is a listing of Category A generic technical activities and definitions of Priority Categories A, B, C, and D

Does educational intervention improve doctors’ knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia

Science.gov (United States)

Wong, Zhi Yen; Alrasheedy, Alian A.; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

2014-01-01

Objectives: To investigate the impact of an educational intervention on doctors’ knowledge and perceptions towards generic medicines and their generic (international non-proprietary name) prescribing practice. Methods: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors’ knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. Results: The intervention was effective in improving doctors’ knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively). In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05). Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05). Conclusion: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors’ knowledge of generic medicines. PMID:26770747

Non-technical issues in safety assessments for nuclear disposal facilities

International Nuclear Information System (INIS)

Kallenbach-Herbert, Beate; Brohmann, Bettina

2010-09-01

The paper highlights that a comprehensive approach to safety affords the consideration of technology, organisation, personnel and social environment. In several safety relevant contexts of nuclear waste disposal these fields are closely interrelated. The approach for the consideration of socio-scientific aspects which is sketched in this paper supports the systematic treatment of safety relevant non-technical issues in the safety case or in safety assessments for a disposal project. Furthermore it may foster the dialogue among specialists from the technical, the natural- and the socio-scientific field on questions of disposal safety. In this way it may contribute to a better understanding among the affected scientific disciplines in nuclear waste disposal.

Ethical and Safety Issues of Stem Cell-Based Therapy.

Science.gov (United States)

Volarevic, Vladislav; Markovic, Bojana Simovic; Gazdic, Marina; Volarevic, Ana; Jovicic, Nemanja; Arsenijevic, Nebojsa; Armstrong, Lyle; Djonov, Valentin; Lako, Majlinda; Stojkovic, Miodrag

2018-01-01

Results obtained from completed and on-going clinical studies indicate huge therapeutic potential of stem cell-based therapy in the treatment of degenerative, autoimmune and genetic disorders. However, clinical application of stem cells raises numerous ethical and safety concerns. In this review, we provide an overview of the most important ethical issues in stem cell therapy, as a contribution to the controversial debate about their clinical usage in regenerative and transplantation medicine. We describe ethical challenges regarding human embryonic stem cell (hESC) research, emphasizing that ethical dilemma involving the destruction of a human embryo is a major factor that may have limited the development of hESC-based clinical therapies. With previous derivation of induced pluripotent stem cells (iPSCs) this problem has been overcome, however current perspectives regarding clinical translation of iPSCs still remain. Unlimited differentiation potential of iPSCs which can be used in human reproductive cloning, as a risk for generation of genetically engineered human embryos and human-animal chimeras, is major ethical issue, while undesired differentiation and malignant transformation are major safety issues. Although clinical application of mesenchymal stem cells (MSCs) has shown beneficial effects in the therapy of autoimmune and chronic inflammatory diseases, the ability to promote tumor growth and metastasis and overestimated therapeutic potential of MSCs still provide concerns for the field of regenerative medicine. This review offers stem cell scientists, clinicians and patient's useful information and could be used as a starting point for more in-depth analysis of ethical and safety issues related to clinical application of stem cells.

Issue on NPP-I and C important to safety-Data Communication

International Nuclear Information System (INIS)

Koo, I. S.; Hong, S. B.; Cho, J. W.; Choi, Y. S.; Lee, J. C.

2010-01-01

1. Issue on CDV and FDIS of IEC61500 - Nuclear Power Plants - Instrumentation and control important to safety -Data communication - Activities on IEC TC45, SC45A/WGA3. 2. As issue the requirements for safety data communication which is essential part of digital I and C systems, the fundamental technology for IT based nuclear I and C is established. 3. Approval and circulation of IED61500 CDV and FDIS - Issue of the international standard, IEC 61500. 4. Issue one IEC61500, three interim documents, three presentations and five technical support to industry, and participation in IEC TC45 and SC45A plenary meeting and intermediate meeting on SC45A/WGA3. 5. Based on IEC61500, an new project on wireless technologyes application to NPP will be proceeded

Safety issues and updates under MR environments

Energy Technology Data Exchange (ETDEWEB)

Kim, Soo Jung; Kim, Kyung Ah, E-mail: bellenina@daum.net

2017-04-15

Highlights: • Unexpected biological effects can occur within stronger magnetic fields. • MR safety for MR conditional items is not guaranteed beyond the tested conditions. • Updated knowledge about MR-related safety is important for a safe MR environment. - Abstract: Magnetic resonance (MR) imaging is a useful imaging tool with superior soft tissue contrast for diagnostic evaluation. The MR environments poses unique risks to patients and employees differently from ionizing radiation exposure originated from computed tomography and plain x-ray films. The technology associated with MR system has evolved continuously since its introduction in the late 1970s. MR systems have advanced with static magnetic fields, faster and stronger gradient magnetic fields and more powerful radiofrequency transmission coils. Higher field strengths of MR offers greater signal to noise capability and better spatial resolution, resulting in better visualization of anatomic detail, with a reduction in scan time. With the rapid evolution of technology associated with MR, we encounter new MR-related circumstances and unexpected dangerous conditions. A comprehensive update of our knowledge about MR safety is necessary to prevent MR-related accidents and to ensure safety for patients and staff associated with MR. This review presents an overview about MR-related safety issues and updates.

Key practical issues in strengthening safety culture. INSAG-15. A report by the International Safety Advisory Group [Russian Edition

International Nuclear Information System (INIS)

2015-01-01

This report describes the essential practical issues to be considered by organizations aiming to strengthen safety culture. It is intended for senior executives, managers and first line supervisors in operating organizations. Although safety culture cannot be directly regulated, it is important that members of regulatory bodies understand how their actions affect the development of attempts to strengthen safety culture and are sympathetic to the need to improve the less formal human related aspects of safety. The report is therefore of relevance to regulators, although not intended primarily for them. The International Nuclear Safety Advisory Group (INSAG) introduced the concept of safety culture in its INSAG-4 report in 1991. Since then, many papers have been written on safety culture, as it relates to organizations and individuals, its improvement and its underpinning prerequisites. Variations in national cultures mean that what constitutes a good approach to enhancing safety culture in one country may not be the best approach in another. However, INSAG seeks to provide pragmatic and practical advice of wide applicability in the principles and issues presented in this report. Nuclear and radiological safety are the prime concerns of this report, but the topics discussed are so general that successful application of the principles should lead to improvements in other important areas, such as industrial safety, environmental performance and, in some respects, wider business performance. This is because many of the attitudes and practices necessary to achieve good performance in nuclear safety, including visible commitment by management, openness, care and thoroughness in completing tasks, good communication and clarity in recognizing major issues and dealing with them as a priority, have wide applicability

Phytosanitary irradiation of fresh tropical commodities in Hawaii: Generic treatments, commercial adoption, and current issues

International Nuclear Information System (INIS)

Follett, Peter A.; Weinert, Eric D.

2012-01-01

Hawaii is a pioneer in the use of phytosanitary irradiation. The commercial X-ray irradiation facility, Hawaii Pride LLC, has been shipping papaya and other tropical fruits and vegetables to the United States mainland using irradiation for 11 years. Irradiation is an approved treatment to control quarantine pests in 17 fruits and 7 vegetables for export from Hawaii to the US mainland. Hawaiian purple sweet potato is the highest volume product with annual exports of more than 12 million lbs (5500 t). The advent of generic radiation treatments for tephritid fruit flies (150 Gy) and other insects (400 Gy) will accelerate commodity export approvals and facilitate worldwide adoption. Lowering doses for specific pests and commodities can lower treatment costs and increase capacity owing to shorter treatment times, and will minimize any quality problems. Current impediments to wider adoption include the 1 kGy limit for fresh horticultural products, the labeling requirement, and non-acceptance of phytosanitary irradiation in Japan, the European Union, and elsewhere. Irradiation has potential as a treatment for unregulated imports to prevent new pest incursions. - Highlights: ► Irradiation is used to control quarantine insects in exported fresh commodities. ► Hawaii exported 5.7 t of tropical produce using irradiation in 2010. ► Generic radiation treatments will accelerate commodity export approvals. ► Lowering the dose for specific commodities will reduce costs/maintain quality. ► Current issues include the 1 kGy dose limit and labeling requirements.

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

Safety and sensitivity analyses of a generic geologic disposal system for high-level radioactive waste

International Nuclear Information System (INIS)

Kimura, Hideo; Takahashi, Tomoyuki; Shima, Shigeki; Matsuzuru, Hideo

1994-11-01

This report describes safety and sensitivity analyses of a generic geologic disposal system for HLW, using a GSRW code and an automated sensitivity analysis methodology based on the Differential Algebra. An exposure scenario considered here is based on a normal evolution scenario which excludes events attributable to probabilistic alterations in the environment. The results of sensitivity analyses indicate that parameters related to a homogeneous rock surrounding a disposal facility have higher sensitivities to the output analyzed here than those of a fractured zone and engineered barriers. The sensitivity analysis methodology provides technical information which might be bases for the optimization of design of the disposal facility. Safety analyses were performed on the reference disposal system which involve HLW in amounts corresponding to 16,000 MTU of spent fuels. The individual dose equivalent due to the exposure pathway ingesting drinking water was calculated using both the conservative and realistic values of geochemical parameters. In both cases, the committed dose equivalent evaluated here is the order of 10 -7 Sv, and thus geologic disposal of HLW may be feasible if the disposal conditions assumed here remain unchanged throughout the periods assessed here. (author)

Opinion of the IRSN on the instruction on the continuation of the GPR assessment of the safety re-examination VD3-900 - Examination of the conclusive report of the safety re-examination of the nr 1 reactor of the Fessenheim plant after the third decennial inspection

International Nuclear Information System (INIS)

2011-02-01

This report first describes the context of the safety re-examination of the nr 1 reactor of the Fessenheim nuclear power station (CNPE) and assesses the generic aspects of this re-examination, assesses additional information transmitted by EDF and concerning these generic aspects (external and internal stresses, accidents and their radiological consequences, design of systems and civil engineering works), states recommendations on various topics and issues to be considered (internal explosions, probabilistic studies, severe accidents, confinement in post-accidental situation, behaviour of containment enclosures, and son on). It assesses the content of the conclusive report of the safety re-examination

U.S. Food System Working Conditions as an Issue of Food Safety.

Science.gov (United States)

Clayton, Megan L; Smith, Katherine C; Pollack, Keshia M; Neff, Roni A; Rutkow, Lainie

2017-02-01

Food workers' health and hygiene are common pathways to foodborne disease outbreaks. Improving food system jobs is important to food safety because working conditions impact workers' health, hygiene, and safe food handling. Stakeholders from key industries have advanced working conditions as an issue of public safety in the United States. Yet, for the food industry, stakeholder engagement with this topic is seemingly limited. To understand this lack of action, we interviewed key informants from organizations recognized for their agenda-setting role on food-worker issues. Findings suggest that participants recognize the work standards/food safety connection, yet perceived barriers limit adoption of a food safety frame, including more pressing priorities (e.g., occupational safety); poor fit with organizational strategies and mission; and questionable utility, including potential negative consequences. Using these findings, we consider how public health advocates may connect food working conditions to food and public safety and elevate it to the public policy agenda.

14 CFR 414.35 - Public notification of the criteria by which a safety approval was issued.

Science.gov (United States)

2010-01-01

... issued. For each grant of a safety approval, the FAA will publish in the Federal Register a notice of the... which a safety approval was issued. 414.35 Section 414.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety...

Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

Energy Technology Data Exchange (ETDEWEB)

Szebeni, Janos, E-mail: jszebeni2@gmail.com [Nanomedicine Research and Education Center, Semmelweis University, Budapest & SeroScience Ltd, Budapest (Hungary); Storm, Gert [Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht (Netherlands)

2015-12-18

Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

Complement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugs

International Nuclear Information System (INIS)

Szebeni, Janos; Storm, Gert

2015-01-01

Liposomes are known to activate the complement (C) system, which can lead in vivo to a hypersensitivity syndrome called C activation-related pseudoallergy (CARPA). CARPA has been getting increasing attention as a safety risk of i.v. therapy with liposomes, whose testing is now recommended in bioequivalence evaluations of generic liposomal drug candidates. This review highlights the adverse consequences of C activation, the unique symptoms of CARPA triggered by essentially all i.v. administered liposomal drugs, and the various features of vesicles influencing this adverse immune effect. For the case of Doxil, we also address the mechanism of C activation and the opsonization vs. long circulation (stealth) paradox. In reviewing the methods of assessing C activation and CARPA, we delineate the most sensitive porcine model and an algorithm for stepwise evaluation of the CARPA risk of i.v. liposomes, which are proposed for standardization for preclinical toxicology evaluation of liposomal and other nanoparticulate drug candidates. - Highlights: • Outlining of difficulties in generic development of liposomal drugs. • New regulatory requirements to evaluate CARPA in preclinical studies. • Review of complement activation by liposomes and its adverse consequences (CARPA). • Assays of C activation in vitro and CARPA in vivo, with the porcine test in focus. • Decision tree how to handle the risk of CARPA assessed by a battery of tests.

Ethical issues in patient safety: Implications for nursing management.

Science.gov (United States)

Kangasniemi, Mari; Vaismoradi, Mojtaba; Jasper, Melanie; Turunen, Hannele

2013-12-01

The purpose of this article is to discuss the ethical issues impacting the phenomenon of patient safety and to present implications for nursing management. Previous knowledge of this perspective is fragmented. In this discussion, the main drivers are identified and formulated in 'the ethical imperative' of patient safety. Underlying values and principles are considered, with the aim of increasing their visibility for nurse managers' decision-making. The contradictory nature of individual and utilitarian safety is identified as a challenge in nurse management practice, together with the context of shared responsibility and identification of future challenges. As a conclusion, nurse managers play a strategic role in patient safety. Their role is to incorporate ethical values of patient safety into decision-making at all levels in an organization, and also to encourage clinical nurses to consider values in the provision of care to patients. Patient safety that is sensitive to ethics provides sustainable practice where the humanity and dignity of all stakeholders are respected.

Nuclear reactors safety issues

International Nuclear Information System (INIS)

Barre, Francois; Seiler, Nathalie

2008-01-01

Full text of publication follows: Since the seventies, economic incentives have led the utilities to drive a permanent evolution of the light water reactor (LWR). The evolution deals with the reactor designs as well as the way to operate them in a more flexible manner. It is for instance related to the fuel technologies and management. On the one hand, the technologies are in continuous evolution, such as the fuel pellets (MOX, Gd fuel, or Cr doped fuels..) as well as advanced cladding materials (M5 TM , MDA or ZIRLO). On the other hand, the fuel management is also subject to continuous evolution in particular in terms of increasing the level of burn-up, the reactor (core) power, the enrichment, as well as the duration of reactor cycles. For instance, in a few years in France, the burn-up has raised beyond the value of 39 GWj/t, initially authorized up to 52 GWj/t for the UO 2 fuel. In the near future, utilities foreseen to reach fuel burn-up of 60 GWj/t for MOX fuel and 70 GWj/t for UO 2 fuel. Furthermore, the future reactor of fourth generation will use new fuels of advanced conception. Furthermore with the objective of improving the safety margins, methods and calculation tools used by the utilities in the elaboration of their safety demonstrations submitted to the Safety Authority, are in movement. The margin evaluation methodologies often consist of a calculation chain of best-estimate multi-field simulations (e.g. various codes being coupled to simulate in a realistic way the evolution of the thermohydraulic, neutronic and mechanic state of the reactor). The statistical methods are more and more sophisticated and the computer codes are integrating ever-complex physical models (e.g. three-dimensional at fine scale). Following this evolution, the Institute of Radioprotection and Nuclear Safety (IRSN), whose one of the roles is to examine the safety records and to rend a technical expertise, considers the necessity of reevaluating the safety issues for advanced

Safety culture issues and perspectives

International Nuclear Information System (INIS)

Dahlgren Persson, K.

1999-01-01

indicators, the symptoms and significance of shortcomings and degradation in the safety management processes and safety culture and hence failed to take effective corrective actions at an early stage. Key performance issues such as critical oversight, self assessment processes and effective corrective action programmes were not fully appreciated by senior management even after performance deficiencies were identified by the regulator and other external agencies. The seeming inability of the regulator to influence this senior management level, especially at the early stages of safety performance degradation was a major contributing factor in the continuation of the performance decline to the point that regulatory intervention became a necessity. Recovery processes commonly used a new utility senior management team to kick-start the change process and corresponding regulatory resource increases focused on monitoring the recovery. A comprehensive recovery plan and an interactive relationship with the regulator were deemed essential for a successful recovery. A review of the developing safety culture was a factor considered necessary to ensure sustainability. Public involvement in the regulatory monitoring process helped restore their confidence in the regulator, utility and plant management. The group recommended IAEA continue work to develop guidance for senior corporate management and regulators in this area (author) (ml)

Legislation for the countermeasures on special issues of nuclear safety regulations

International Nuclear Information System (INIS)

Cho, Byung Sun; Lee, Mo Sung; Chung, Gum Chun; Kim, Heon Jin; Oh, Ho Chul

2004-02-01

Since the present nuclear safety regulation has some legal problems that refer to special issues and contents of regulatory provisions, this report has preformed research on the legal basic theory of nuclear safety regulation to solve the problems. In addition, this report analyzed the problems of each provisions and suggested the revision drafts on the basis of analyzing problems and the undergoing theory of nuclear safety regulation

Legislation for the countermeasures on special issues of nuclear safety regulations

Energy Technology Data Exchange (ETDEWEB)

Cho, Byung Sun; Lee, Mo Sung; Chung, Gum Chun; Kim, Heon Jin; Oh, Ho Chul [Chongju Univ., Cheongju (Korea, Republic of)

2004-02-15

Since the present nuclear safety regulation has some legal problems that refer to special issues and contents of regulatory provisions, this report has preformed research on the legal basic theory of nuclear safety regulation to solve the problems. In addition, this report analyzed the problems of each provisions and suggested the revision drafts on the basis of analyzing problems and the undergoing theory of nuclear safety regulation.

Technical Issues and Proposes on the Legislation of Probabilistic Safety Assessment in Periodic Safety Review

International Nuclear Information System (INIS)

Hwang, Seok-Won; Jeon, Ho-Jun; Na, Jang-Hwan

2015-01-01

Korean Nuclear Power Plants have performed a comprehensive safety assessment reflecting design and procedure changes and using the latest technology every 10 years. In Korea, safety factors of PSR are revised to 14 by revision of IAEA Safety Guidelines in 2003. In the revised safety guidelines, safety analysis field was subdivided into deterministic safety analysis, PSA (Probabilistic safety analysis), and hazard analysis. The purpose to examine PSA as a safety factor on PSR is to make sure that PSA results and assumptions reflect the latest state of NPPs, validate the level of computer codes and analytical models, and evaluate the adequacy of PSA instructions. In addition, its purpose is to derive the plant design change, operating experience of other plants and safety enhancement items as well. In Korea, PSA is introduced as a new factor. Thus, the overall guideline development and long-term implementation strategy are needed. Today in Korea, full-power PSA model revision and low-power and shutdown (LPSD) PSA model development is being performed as a part of the post Fukushima action items for operating plants. The scope of the full-power PSA is internal/external level 1, 2 PSA. But in case of fire PSA, the scope is level 1 PSA using new method, NUREG/CR-6850. In case of LPSD PSA, level 1 PSA for all operating plants, and level 2 PSA for 2 demonstration plants are under development. The result of the LPSD PSA will be used as major input data for plant specific SAMG (Severe Accident Management Guideline). The scope of PSA currently being developed in Korea cannot fulfill 'All Mode, All Scope' requirements recommended in the IAEA Safety Guidelines. Besides the legislation of PSA, step-by-step development strategy for non-performed scopes such as level 3 PSA and new fire PSA is one of the urgent issues in Korea. This paper suggests technical issues and development strategies for each PSA technical elements.

Dust Combustion Safety Issues for Fusion Applications

Energy Technology Data Exchange (ETDEWEB)

L. C. Cadwallader

2003-05-01

This report summarizes the results of a safety research task to identify the safety issues and phenomenology of metallic dust fires and explosions that are postulated for fusion experiments. There are a variety of metal dusts that are created by plasma erosion and disruptions within the plasma chamber, as well as normal industrial dusts generated in the more conventional equipment in the balance of plant. For fusion, in-vessel dusts are generally mixtures of several elements; that is, the constituent elements in alloys and the variety of elements used for in-vessel materials. For example, in-vessel dust could be composed of beryllium from a first wall coating, tungsten from a divertor plate, copper from a plasma heating antenna or diagnostic, and perhaps some iron and chromium from the steel vessel wall or titanium and vanadium from the vessel wall. Each of these elements has its own unique combustion characteristics, and mixtures of elements must be evaluated for the mixture’s combustion properties. Issues of particle size, dust temperature, and presence of other combustible materials (i.e., deuterium and tritium) also affect combustion in air. Combustion in other gases has also been investigated to determine if there are safety concerns with “inert” atmospheres, such as nitrogen. Several coolants have also been reviewed to determine if coolant breach into the plasma chamber would enhance the combustion threat; for example, in-vessel steam from a water coolant breach will react with metal dust. The results of this review are presented here.

Containment Emergency Sump Performance. Technical findings related to Unresolved Safety Issue A-43. Revision 1

International Nuclear Information System (INIS)

1985-10-01

This report summarizes key technical findings related to Unresolved Safety Issue (USI) A-43, Containment Emergency Sump Performance. Both BWRs and PWRs are considered in this report. Emergency core cooling systems require a clean, reliable water source to maintain long-term recirculation following a loss-of-coolant accident (LOCA). PWRs rely on the containment emergency sump to provide such a water supply to residual heat removal pumps and containment spray pumps. BWRs rely on pump suction intakes in the suppression pool or wet well to provide water to residual heat removal and core spray systems. Thus, the technical findings in this report provide information on post-LOCA recirculation. These findings have been derived from extensive experimental studies, generic plant studies, and assessments of sumps used for long-term cooling. Results of hydraulic tests have shown that the potential for air ingestion is less severe than previously hypothesized. The effects of debris blockage on NPSH margin must be dealt with on a plant-specific basis. These findings have been used to develop revisions to Regulatory Guide 1.82 and Standard Review Plan Section 6.2.2 (NUREG-0800)

Application of the risk-based strategy to the Hanford tank waste organic-nitrate safety issue

International Nuclear Information System (INIS)

Hunter, V.L.; Colson, S.D.; Ferryman, T.; Gephart, R.E.; Heasler, P.; Scheele, R.D.

1997-12-01

This report describes the results from application of the Risk-Based Decision Management Approach for Justifying Characterization of Hanford Tank Waste to the organic-nitrate safety issue in Hanford single-shell tanks (SSTs). Existing chemical and physical models were used, taking advantage of the most current (mid-1997) sampling and analysis data. The purpose of this study is to make specific recommendations for planning characterization to help ensure the safety of each SST as it relates to the organic-nitrate safety issue. An additional objective is to demonstrate the viability of the Risk-Based Strategy for addressing Hanford tank waste safety issues

Application of the risk-based strategy to the Hanford tank waste organic-nitrate safety issue

Energy Technology Data Exchange (ETDEWEB)

Hunter, V.L.; Colson, S.D.; Ferryman, T.; Gephart, R.E.; Heasler, P.; Scheele, R.D.

1997-12-01

This report describes the results from application of the Risk-Based Decision Management Approach for Justifying Characterization of Hanford Tank Waste to the organic-nitrate safety issue in Hanford single-shell tanks (SSTs). Existing chemical and physical models were used, taking advantage of the most current (mid-1997) sampling and analysis data. The purpose of this study is to make specific recommendations for planning characterization to help ensure the safety of each SST as it relates to the organic-nitrate safety issue. An additional objective is to demonstrate the viability of the Risk-Based Strategy for addressing Hanford tank waste safety issues.

Ecological Issues Related to Children's Health and Safety

Science.gov (United States)

Aldridge, Jerry; Kohler, Maxie

2009-01-01

Issues concerning the health and safety of children and youth occur at multiple levels. Bronfenbrenner (1995) proposed an ecological systems approach in which multiple systems interact to enhance or diminish children's development. The same systems are at work in health promotion. The authors present and review articles that reflect the multiple…

Issues of Safety and Security: New Challenging to Malaysia Tourism Industry

Directory of Open Access Journals (Sweden)

Mohd Ayob Norizawati

2014-01-01

Full Text Available The safety and security issues nowadays become one of the forces causing changes in tourism industry in era of millennium. The main concern of this issues more focus on crime rates, terrorism, food safety, health issues and natural disaster. This topic gained the popularity in tourism research after 9/11 tragedy and since then the academicians and practitioners started seeking the best solution in ways to mitigate these negative impacts. For Malaysia, the image as safety and secure destination was tarnished a few years lately and new unfortunates incident in this year bring more damage to Malaysia image. Healthy issues, terrorism, Lahad Datu intrusion, repeated kidnapping and shooting in Sabah, twin airlines incident, riot and illegal demonstration and false reporting by international media brings new challenging to Malaysia. Although some incident may be had short-term impact to Malaysia tourism industry, but it’s still gave the big impact to Malaysia branding process. Many travellers and Malaysian itself still believe that Malaysia is a one of safer destination and country to visit and stayed in, but more outstanding efforts was require to make sure Malaysia tourism industry was capable to recover from this negative impact as soon as possible.

Resolution of the Hanford site ferrocyanide safety issue

International Nuclear Information System (INIS)

Cash, R.J.; Lilga, M.A.; Babad, H.

1997-01-01

The Ferrocyanide Safety Issue at the Hanford Site was officially resolved in December 1996. This paper summarizes the key activities that led to final resolution of this safety hazard, a process that began in 1990 after it and other safety concerns were identified for the underground high-level waste storage tanks at the Hanford Site. At the time little was known about ferrocyanide-nitrate/nitrite reactions and their potential to cause offsite releases of radioactivity. The ferrocyanide hazard was a perceived problem, but it took six years of intense studies and analyses of tank samples to prove that the problem no longer exists. The issue revolved around the fact that ferrocyanide and nitrate mixtures can be made to explode violently if concentrated, dry, and heated to temperatures of at least 250 degrees C. The studies conducted over the last six years have shown that the combined effects of temperature, radiation, and pH during 40 or more years of storage have destroyed almost all of the ferrocyanide originally added to tanks. This was shown in laboratory experiments using simulant wastes and confirmed by actual samples taken from the ferrocyanide tanks. The tank waste sludges are now too dilute to support a sustained exothermic reaction, even if dried out and heated to high temperatures. 2 tabs., 18 refs

Generic medications for you, but brand-name medications for me.

Science.gov (United States)

Keenum, Amy J; Devoe, Jennifer E; Chisolm, Deena J; Wallace, Lorraine S

2012-01-01

Because generic medications are less expensive than brand-name medications, government and private insurers have encouraged and/or mandated the use of generics. This study aimed at evaluating perceptions about generic medications among English-speaking women of childbearing age currently enrolled in U.S. TennCare (Medicaid). We recruited a convenience sample of patients from the waiting room of a primary care/gynecology health clinic, with 80% recruitment rate among those approached. We orally administered a 25-item questionnaire to gather sociodemographic information and to assess beliefs regarding the efficacy, safety, cost, and preferences for personal use of generic medications. The average age of the women (n=172) was 28.8 ± 6.4 years, and most were white (82.0%) and currently married (58.1%). Nearly one-fifth (19.2%) had not completed high school. Most women believed that generic medications were less expensive (97.6%) and better value (60.5%) than brand-name medications, but only 45.3% preferred to take generics themselves. About a quarter (23.3%) believed that brand-name medications were more effective than generics, whereas 13.4% believed that generics caused more side effects. Few women reported that their doctor (29.7%) and/or pharmacist (35.5%) had ever talked to them about taking generics. Awareness of the benefits of generics did not equal preferences for personal use of generics among this sample of women enrolled in U.S. TennCare. Furthermore, women reported that providers-both physicians and pharmacists-infrequently discussed generic substitution with them. Copyright © 2012 Elsevier Inc. All rights reserved.

NS [Nuclear Safety] update. Current safety and security activities and developments taking place in the Department of Nuclear Safety and Security, Issue no. 11, June 2009

International Nuclear Information System (INIS)

2009-06-01

The current issue presents information about the following topics: Nuclear Safety Review for the Year 2008; Feedback from IRS Topical Studies and Events Applied to Safety Standards; Education and Training Programmes at the IAEA Department of Nuclear Safety and Security; Peer Review of Operational Safety Performance (PROSPER)

Containment-emergency-sump performance. Technical findings related to Unresolved Safety Issue A-43

International Nuclear Information System (INIS)

1983-04-01

This report summarizes key technical findings related to the Unresolved Safety Issue A-43, Containment Emergency Sump Performance, and provides recommendations for resolution of attendant safety issues. The key safety questions relate to: (a) effects of insulation debris on sump performance; (b) sump hydraulic performance as determined by design features, submergence, and plant induced effects, and (c) recirculation pump performance wherein air and/or particulate ingestion can occur. The technical findings presented in this report provide information relevant to the design and performance evaluation of the containment emergency sump

Collegiate Aviation Research and Education Solutions to Critical Safety Issues

Science.gov (United States)

Bowen, Brent (Editor)

2002-01-01

This Conference Proceedings is a collection of 6 abstracts and 3 papers presented April 19-20, 2001 in Denver, CO. The conference focus was "Best Practices and Benchmarking in Collegiate and Industry Programs". Topics covered include: satellite-based aviation navigation; weather safety training; human-behavior and aircraft maintenance issues; disaster preparedness; the collegiate aviation emergency response checklist; aviation safety research; and regulatory status of maintenance resource management.

[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

Science.gov (United States)

Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

2017-04-01

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands

Emerging issues in occupational safety and health.

Science.gov (United States)

Schulte, Paul A

2006-01-01

In developed countries, changes in the nature of work and the workforce may necessitate recalibrating the vision of occupational safety and health (OSH) researchers, practitioners, and policymakers to increase the focus on the most important issues. New methods of organizing the workplace, extensive labor contracting, expansion of service and knowledge sectors, increase in small business, aging and immigrant workers, and the continued existence of traditional hazards in high-risk sectors such as construction, mining, agriculture, health care, and transportation support the need to address: 1) broader consideration of the role and impact of work, 2) relationship between work and psychological dysfunction, 3) increased surveillance basis for research and intervention, 4) overcoming barriers to the conduct and use of epidemiologic research, 5) information and knowledge transfer and application, 6) economic issues in prevention, and 7) the global interconnectedness of OSH. These issues are offered to spur thinking as new national research agendas for OSH are considered for developed countries.

Collegiate Aviation Research and Education Solutions to Critical Safety Issues. UNO Aviation Monograph Series. UNOAI Report.

Science.gov (United States)

Bowen, Brent, Ed.

This document contains four papers concerning collegiate aviation research and education solutions to critical safety issues. "Panel Proposal Titled Collegiate Aviation Research and Education Solutions to Critical Safety Issues for the Tim Forte Collegiate Aviation Safety Symposium" (Brent Bowen) presents proposals for panels on the…

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 in GPR prospecting: a rarely-considered issue

Science.gov (United States)

Persico, Raffaele; Pajewski, Lara; Trela, Christiane; Carrick Utsi, Erica

2016-04-01

Safety issues (of people first of all, but also of the equipment and environment) are rarely considered in Ground-Penetrating Radar (GPR) prospecting and, more in general, in near-surface geophysical prospecting. As is right and fully understandable, the scientific community devotes greatest attention first of all to the theoretical and practical aspects of GPR technique, affecting the quality of attainable results, secondly to the efforts and costs needed to achieve them [1-2]. However, the (luckily) growing GPR market and range of applications make it worth giving serious consideration to safety issues, too. The existing manuals dealing with safety in geophysics are mainly concerned with applications requiring "deep" geophysical prospecting, for example the search for oilfields and other hydrocarbon resources [3]. Near-surface geophysics involves less dangers than deep geophysics, of course. Nevertheless, several accidents have already happened during GPR experimental campaigns. We have personally had critical experiences and collected reliable testimonies concerning occurred problems as mountain sicks, fractures of legs, stomach problems, allergic reactions, encounters with potentially-dangerous animals, and more. We have also noticed that much more attention is usually paid to safety issues during indoor experimental activities (in laboratory), rather than during outdoor fieldworks. For example, the Italian National research Council is conventioned with safety experts who hold periodical seminaries about safety aspects. Having taken part to some of them, to our experience we have never heard a "lecture" devoted to outdoor prospecting. Nowadays, any aspects associated to the use of the technologies should be considered. The increasing sensibility and sense of responsibility towards environmental matters impose GPR end-users to be careful not to damage the environment and also the cultural heritage. Near-surface prospecting should not compromise the flora and

Current status of environmental, health, and safety issues of nickel metal-hydride batteries for electric vehicles

Energy Technology Data Exchange (ETDEWEB)

Corbus, D; Hammel, C J; Mark, J

1993-08-01

This report identifies important environment, health, and safety issues associated with nickel metal-hydride (Ni-MH) batteries and assesses the need for further testing and analysis. Among the issues discussed are cell and battery safety, workplace health and safety, shipping requirements, and in-vehicle safety. The manufacture and recycling of Ni-MH batteries are also examined. This report also overviews the ``FH&S`` issues associated with other nickel-based electric vehicle batteries; it examines venting characteristics, toxicity of battery materials, and the status of spent batteries as a hazardous waste.

Current status of environmental, health, and safety issues of nickel metal-hydride batteries for electric vehicles

International Nuclear Information System (INIS)

Corbus, D.; Hammel, C.J.; Mark, J.

1993-08-01

This report identifies important environment, health, and safety issues associated with nickel metal-hydride (Ni-MH) batteries and assesses the need for further testing and analysis. Among the issues discussed are cell and battery safety, workplace health and safety, shipping requirements, and in-vehicle safety. The manufacture and recycling of Ni-MH batteries are also examined. This report also overviews the ''FH ampersand S'' issues associated with other nickel-based electric vehicle batteries; it examines venting characteristics, toxicity of battery materials, and the status of spent batteries as a hazardous waste

Safety issues and their ranking for WWER-1000 model 320 nuclear power plants. A publication of the extrabudgetary programme on the safety of WWER and RBMK nuclear power plants

International Nuclear Information System (INIS)

1996-03-01

The objective of this report is to present a consolidated list of safety deficiencies, called safety issues, ranked according to their safety significance and the corrective measures to improve overall safety. It is intended for use as a reference to facilitate the development of plant specific safety improvement programmes and to serve as a basis for reviewing their implementation. To the extent that information was made available to the IAEA, the country/plant specific status with respect to each safety issue is described. Section 2 provides an overview of the impact of the relevant issues on the main safety functions in different operational conditions and other aspects important to overall plant safety. A summary of the safety issues and their respective ranking is given in Tables 1 and 2 at the end of Section 2. Section 3 deals with individual safety issues identified in the design which are presented according to the structure below. Section 4 presents the safety issues related to operational safety according to a similar structure but without the ranking. 73 refs, 3 tabs

Safety issues and their ranking for WWER-1000 model 320 nuclear power plants. A publication of the extrabudgetary programme on the safety of WWER and RBMK nuclear power plants

International Nuclear Information System (INIS)

1997-04-01

The objective of this report is to present a consolidated list of safety deficiencies, called safety issues, ranked according to their safety significance and the corrective measures to improve overall safety. It is intended for use as a reference to facilitate the development of plant specific safety improvement programmes and to serve as a basis for reviewing their implementation. To the extent that information was made available to the IAEA, the country/plant specific status with respect to each safety issue is described. Section 2 provides an overview of the impact of the relevant issues on the main safety functions in different operational conditions and other aspects important to overall plant safety. A summary of the safety issues and their respective ranking is given in Tables 1 and 2 at the end of Section 2. Section 3 deals with individual safety issues identified in the design which are presented according to the structure below. Section 4 presents the safety issues related to operational safety according to a similar structure but without the ranking

Occupational safety and health issues associated with green building

NARCIS (Netherlands)

Terwoert, J.; Ustailieva, E.

2013-01-01

This e-fact provides information on the work-related risk factors and the occupational safety and health (OSH) issues associated the planning and construction of green buildings, their maintenance, renovation (retrofitting), demolition, on-site waste collection. Some of these OSH risks are new

Mixed WTO ruling on generic drug development.

Science.gov (United States)

Elliott, R

2000-01-01

On 17 March 2000, the World Trade Organization upheld the provision in Canada's patent laws that allows generic drug manufacturers to develop (but not sell) their cheaper versions of patented medicines before the 20-year patients expire. The decision prevents pharmaceutical companies from enjoying market monopolies beyond their patent terms, avoiding what would otherwise be even lengthier delays in the sale of cheaper, generic drugs in Canada. This decision is of significance not only to Canada, but also to other WTO member countries and to all individuals who use pharmaceutical products. However, the decision is not all positive: the WTO also ruled that Canada is violating international agreements by letting generic manufacturers stockpile their versions of patented drugs before patents expire. This article explains the issues, the arguments, and the decision.

Ferrocyanide Safety Program: Data requirements for the ferrocyanide safety issue developed through the data quality objectives (DQO) process

International Nuclear Information System (INIS)

Buck, J.W.; Anderson, C.M.; Pulsipher, B.A.; Toth, J.J.; Turner, P.J.; Cash, R.J.; Dukelow, G.T.; Meacham, J.E.

1993-12-01

This document records the data quality objectives (DQO) process applied to the Ferrocyanide Waste Tank Safety Issue at the Hanford Site by the Pacific Northwest Laboratory and Westinghouse Hanford Company. Specifically, the major recommendations and findings from this Ferrocyanide DQO process are presented so that decision makers can determine the type, quantity, and quality of data required for addressing tank safety issues. The decision logic diagrams and error tolerance equations also are provided. Finally, the document includes the DQO sample-size formulas for determining specific tank sampling requirements

The future of nuclear power after Sizewell B. 3 v.: v. 1 Economic issues; v. 2 Environmental and safety issues; v. 3 Public perception issues

International Nuclear Information System (INIS)

1987-01-01

The three days of conference proceedings are published in three separate volumes. The first includes 7 papers relating to economic issues - those presented at the Sizewell-B public inquiry and the changes in the economic situation since the inquiry ended. The electricity demand, how this demand is to be met by nuclear and other fuel sources and how energy conservation might be an economic alternative to simply building more generating capacity are all issues discussed. The possible privatisation of the industry is also touched on. Volume two has 8 papers concerned with environmental and safety issues. These include the influence of the Sizewell-B decision on nuclear licensing and reactor safety, the technical and safety aspects of pressurized water reactors (PWR), the roles of British Nuclear Fuels and the United Kingdom Atomic Energy Authority, and radiation protection and effluent discharge control. The six papers in volume 3 look at public perception issues - not only towards nuclear power but towards the public inquiry process. The local authority view, the Friends of the Earth case against the PWR, and technical expertise in the decision process are also topics covered. All the papers are indexed separately. (UK)

Integrated safety assessment report: Integrated Safety Assessment Program: Millstone Nuclear Power Station, Unit 1 (Docket No. 50-245): Draft report

International Nuclear Information System (INIS)

1987-04-01

The Integrated Safety Assessment Program (ISAP) was initiated in November 1984, by the US Nuclear Regulatory Commission to conduct integrated assessments for operating nuclear power reactors. The integrated assessment is conducted in a plant-specific basis to evaluate all licensing actions, licensee initiated plant improvements and selected unresolved generic/safety issues to establish implementation schedules for each item. In addition, procedures will be established to allow for a periodic updating of the schedules to account for licensing issues that arise in the future. This report documents the review of Millstone Nuclear Power Station, Unit No. 1, operated by Northeast Nuclear Energy Company (located in Waterford, Connecticut). Millstone Nuclear Power Station, Unit No. 1, is one of two plants being reviewed under the pilot program for ISAP. This report indicates how 85 topics selected for review were addressed. This report presents the staff's recommendations regarding the corrective actions to resolve the 85 topics and other actions to enhance plant safety. The report is being issued in draft form to obtain comments from the licensee, nuclear safety experts, and the Advisory Committee for Reactor Safeguards (ACRS). Once those comments have been resolved, the staff will present its positions, along with a long-term implementation schedule from the licensee, in the final version of this report

Safety issues and their ranking for 'small series' WWER-1000 nuclear power plants. A publication of the extrabudgetary programme on the safety of WWER and RBMK nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-09-01

This report presents the safety issues in 'small series' WWER-1000 nuclear power plants (NPPs). Safety issues are deviations from current recognized safety practices in design and operation judged to be safety significant by their impact on the plants' defence in depth. This report is intended to serve as reference for the development of plant specific safety improvement programmes and for the evaluation of measures proposed and/or implemented. The identification of safety issues is based on safety studies conducted by the operators of 'small series' WWER-1000 units and by organizations dealing with these reactors, on findings of IAEA safety missions to 'small series' WWER-1000 plants in South Ukraine, at Novovoronezh and Kalinin, and on information obtained from specialists from various countries during an IAEA consultants meeting, 8-12 September 1997 in Vienna, within the framework of the Extra budgetary Programme on the Safety of WWER and RBMK NPPs. Safety issues are first presented according to their impact on the main safety functions and are then described individually. The safety issues are characterized by issue title and specified by issue clarification. Safety issues connected with plant design are followed by the ranking of the issue and ranking justification. Altogether 85 safety issues have been identified, 12 of which are in Category III (defence in depth is insufficient, immediate corrective action is necessary), 38 in Category 11 (defence in depth is degraded, action is needed to resolve the issue) and 22 in Category I (departure from international practices, to be addressed as part of actions to resolve higher priority issues). In the case of operational safety issues (13 safety issues) no ranking is provided as the available material was considered insufficient. For each safety issue, comments and recommendations are made by the IAEA; the status of corresponding measures to improve safety implemented or planned at each site are presented in the

Safety issues and their ranking for 'small series' WWER-1000 nuclear power plants. A publication of the extrabudgetary programme on the safety of WWER and RBMK nuclear power plants

International Nuclear Information System (INIS)

2000-09-01

This report presents the safety issues in 'small series' WWER-1000 nuclear power plants (NPPs). Safety issues are deviations from current recognized safety practices in design and operation judged to be safety significant by their impact on the plants' defence in depth. This report is intended to serve as reference for the development of plant specific safety improvement programmes and for the evaluation of measures proposed and/or implemented. The identification of safety issues is based on safety studies conducted by the operators of 'small series' WWER-1000 units and by organizations dealing with these reactors, on findings of IAEA safety missions to 'small series' WWER-1000 plants in South Ukraine, at Novovoronezh and Kalinin, and on information obtained from specialists from various countries during an IAEA consultants meeting, 8-12 September 1997 in Vienna, within the framework of the Extra budgetary Programme on the Safety of WWER and RBMK NPPs. Safety issues are first presented according to their impact on the main safety functions and are then described individually. The safety issues are characterized by issue title and specified by issue clarification. Safety issues connected with plant design are followed by the ranking of the issue and ranking justification. Altogether 85 safety issues have been identified, 12 of which are in Category III (defence in depth is insufficient, immediate corrective action is necessary), 38 in Category 11 (defence in depth is degraded, action is needed to resolve the issue) and 22 in Category I (departure from international practices, to be addressed as part of actions to resolve higher priority issues). In the case of operational safety issues (13 safety issues) no ranking is provided as the available material was considered insufficient. For each safety issue, comments and recommendations are made by the IAEA; the status of corresponding measures to improve safety implemented or planned at each site are presented in the

Multimegawatt Space Reactor Safety

International Nuclear Information System (INIS)

Stanley, M.L.

1989-01-01

The Multimegawatt (MMW) Space Reactor Project supports the Strategic Defense Initiative Office requirement to provide reliable, safe, cost-effective, electrical power in the MMW range. Specifically, power may be used for neutral particle beams, free electron lasers, electromagnetic launchers, and orbital transfer vehicles. This power plant technology may also apply to the electrical power required for other uses such as deep-space probes and planetary exploration. The Multimegawatt Space Reactor Project, the Thermionic Fuel Element Verification Program, and Centaurus Program all support the Multimegawatt Space Nuclear Power Program and form an important part of the US Department of Energy's (DOE's) space and defense power systems activities. A major objective of the MMW project is the development of a reference flight system design that provides the desired levels of public safety, health protection, and special nuclear material (SNM) protection when used during its designated missions. The safety requirements for the MMW project are a hierarchy of requirements that consist of safety requirements/regulations, a safety policy, general safety criteria, safety technical specifications, safety design specifications, and the system design. This paper describes the strategy and philosophy behind the development of the safety requirements imposed upon the MMW concept developers. The safety organization, safety policy, generic safety issues, general safety criteria, and the safety technical specifications are discussed

ISSUES AND RECENT TRENDS IN VEHICLE SAFETY COMMUNICATION SYSTEMS

Directory of Open Access Journals (Sweden)

Sadayuki TSUGAWA

2005-01-01

Full Text Available This paper surveys the research on the applications of inter-vehicle communications, the issues of the deployment and technology, and the current status of inter-vehicle communications projects in Europe, the United States and Japan. The inter-vehicle communications, defined here as communications between on-board ITS computers, improve road traffic safety and efficiency by expanding the horizon of the drivers and on-board sensors. One of the earliest studies on inter-vehicle communications began in Japan in the early 1980s. The inter-vehicle communications play an essential role in automated platooning and cooperative driving systems developed since the 1990's by enabling vehicles to obtain data that would be difficult or impossible to measure with on-board sensors. During these years, interest in applications for inter-vehicle communications increased in the EU, the US and Japan, resulting in many national vehicle safety communications projects such as CarTALK2000 in the EU and VSCC in the US. The technological issues include protocol and communications media. Experiments employ various kinds of protocols and typically use infrared, microwave or millimeter wave media. The situation is ready for standardization. The deployment strategy is another issue. To be feasible, deployment should begin with multiple rather than single services that would work even at a low penetration rate of the communication equipment. In addition, non-technological, legal and institutional issues remained unsolved. Although inter-vehicle communications involve many issues, such applications should be promoted because they will lead to safer and more efficient automobile traffic.

NS [Nuclear Safety] update. Current safety and security activities and developments taking place in the Department of Nuclear Safety and Security, Issue no. 12, September 2009

International Nuclear Information System (INIS)

2009-09-01

The current issue presents information about the following topics: Nuclear Security Report 2009; G8 Nuclear Safety and Security Group (NSSG); Uranium Production Site Appraisal Team (UPSAT); New Entrant Nuclear Power Programmes Safety Guide on the Establishment of the Safety Infrastructure (DS424)

Specific issues, exact locations: case study of a community mapping project to improve safety in a disadvantaged community.

Science.gov (United States)

Qummouh, Rana; Rose, Vanessa; Hall, Pat

2012-12-01

Safety is a health issue and a significant concern in disadvantaged communities. This paper describes an example of community-initiated action to address perceptions of fear and safety in a suburb in south-west Sydney which led to the development of a local, community-driven research project. As a first step in developing community capacity to take action on issues of safety, a joint resident-agency group implemented a community safety mapping project to identify the extent of safety issues in the community and their exact geographical location. Two aerial maps of the suburb, measuring one metre by two metres, were placed on display at different locations for four months. Residents used coloured stickers to identify specific issues and exact locations where crime and safety were a concern. Residents identified 294 specific safety issues in the suburb, 41.9% (n=123) associated with public infrastructure, such as poor lighting and pathways, and 31.9% (n=94) associated with drug-related issues such as drug activity and discarded syringes. Good health promotion practice reflects community need. In a very practical sense, this project responded to community calls for action by mapping resident knowledge on specific safety issues and exact locations and presenting these maps to local decision makers for further action.

Savannah River Site generic data base development

International Nuclear Information System (INIS)

Blanchard, A.

2000-01-01

This report describes the results of a project to improve the generic component failure database for the Savannah River Site (SRS). Additionally, guidelines were developed further for more advanced applications of database values. A representative list of components and failure modes for SRS risk models was generated by reviewing existing safety analyses and component failure data bases and from suggestions from SRS safety analysts. Then sources of data or failure rate estimates were identified and reviewed for applicability. A major source of information was the Nuclear Computerized Library for Assessing Reactor Reliability, or NUCLARR. This source includes an extensive collection of failure data and failure rate estimates for commercial nuclear power plants. A recent Idaho National Engineering Laboratory report on failure data from the Idaho Chemical Processing Plant was also reviewed. From these and other recent sources, failure data and failure rate estimates were collected for the components and failure modes of interest. For each component failure mode, this information was aggregated to obtain a recommended generic failure rate distribution (mean and error factor based on a lognormal distribution). Results are presented in a table in this report. A major difference between generic database and previous efforts is that this effort estimates failure rates based on actual data (failure events) rather than on existing failure rate estimates. This effort was successful in that over 75% of the results are now based on actual data. Also included is a section on guidelines for more advanced applications of failure rate data. This report describes the results of a project to improve the generic component failure database for the Savannah River site (SRS). Additionally, guidelines were developed further for more advanced applications of database values

Opinion of the IRSN on French electronuclear stock safety and radioprotection in 2009

International Nuclear Information System (INIS)

2010-01-01

In its first part, this annual report presents the main trends which emerge after a global examination of nuclear safety and radioprotection of the operated nuclear power plants in France during 2009. The second part reports, comments and discusses events which occurred in 2009 and are considered as important as far as safety is concerned. The third part deals with generic anomalies, i.e. those affecting several nuclear plants. The fourth part discusses significant evolutions implemented or planned by EDF, whether they are modifications or arrangements in plant operation aimed at treating safety issues, but also economic constraints

Hydrogen peroxide safety issues

International Nuclear Information System (INIS)

Conner, W.V.

1993-01-01

A literature survey was conducted to review the safety issues involved in handling hydrogen peroxide solutions. Most of the information found in the literature is not directly applicable to conditions at the Rocky Flats Plant, but one report describes experimental work conducted previously at Rocky Flats to determine decomposition reaction-rate constants for hydrogen peroxide solutions. Data from this report were used to calculate decomposition half-life times for hydrogen peroxide in solutions containing several decomposition catalysts. The information developed from this survey indicates that hydrogen peroxide will undergo both homogeneous and heterogeneous decomposition. The rate of decomposition is affected by temperature and the presence of catalytic agents. Decomposition of hydrogen peroxide is catalyzed by alkalies, strong acids, platinum group and transition metals, and dissolved salts of transition metals. Depending upon conditions, the consequence of a hydrogen peroxide decomposition can range from slow evolution of oxygen gas to a vapor, phase detonation of hydrogen peroxide vapors

Estimation of average hazardous-event-frequency for allocation of safety-integrity levels

International Nuclear Information System (INIS)

Misumi, Y.; Sato, Y.

1999-01-01

One of the fundamental concepts of the draft international standard, IEC 61508, is target failure measures to be allocated to Electric/Electronic/Programmable Electronic Safety-Related Systems, i.e. Safety Integrity Levels. The Safety Integrity Levels consist of four discrete probabilistic levels for specifying the safety integrity requirements or the safety functions to be allocated to Electric/Electronic/Programmable Electronic Safety-Related Systems. In order to select the Safety Integrity Levels the draft standard classifies Electric/Electronic/Programmable Electronic Safety-Related Systems into two modes of operation using demand frequencies only. It is not clear which modes of operation should be applied to Electric/Electronic/Programmable Electronic Safety-Related Systems taking into account the demand-state probability and the spurious demand frequency. It is essential for the allocation of Safety Integrity Levels that generic algorithms be derived by involving possible parameters, which make it possible to model the actuality of real systems. The present paper addresses this issue. First of all, the overall system including Electric/Electronic/programmable Electronic Safety-Related Systems is described using a simplified fault-tree. Then, the relationships among demands, demand-states and proof-tests are studied. Overall systems are classified into two groups: a non-demand-state-at-proof-test system which includes both repairable and non-repairable demand states and a constant-demand-frequency system. The new ideas such as a demand-state, spurious demand-state, mean time between detections, rates of d-failure and h-failure, and an h/d ratio are introduced in order to make the Safety Integrity Levels and modes of operation generic and comprehensive. Finally, the overall system is simplified and modeled by fault-trees using Priority-AND gates. At the same time the assumptions for modeling are described. Generic algorithms to estimate hazardous

IAEA activities on communication of nuclear safety issues

International Nuclear Information System (INIS)

Wieland, P.

2001-01-01

The regulatory authorities in several countries have taken the initiative to overcome the renowned difficulties of communicating nuclear safety issues. They communicate with segments of the public specially in case of nuclear/radiological accidents, waste disposal, transport of radioactive material or food irradiation. This reflects the full recognition of the importance of the topic. However it is also recognized that there is hitherto a need of international assistance in order to develop a regulatory communication strategy that could be harmonized and at the same time customized to the different needs. Communications on nuclear, radiation, transport and radioactive waste safety are needed to: disseminate information on safety to the public in both routine and emergency situations ; be attentive to public concerns, and address them; maintain social trust and confidence by keeping society informed on the established safety standards and how they are enforced; facilitate the decision-making process on nuclear matters by promptly presenting factual information in a clear manner; integrate and maintain an information network at both the national and international levels; improve co-operation with other countries and international organizations; encourage the dissemination of factual information on nuclear issues in schools. A major factor in addressing all of these questions is understanding the audience(s). A two way communication process is needed to establish what particular audiences want to know and in what form they prefer to receive information. This will differ depending on the audience and circumstances. For example, the information on a routine day-to-day basis will be different from what might be needed at the time of an accident. Communication with the news media is a matter of particular importance, as they are both an audience in themselves and a channel for communicating with wider audiences. (author)

Planning exercise for the resolution of high level waste tank safety issues

International Nuclear Information System (INIS)

Bunting, J.; Saveland, J.

1992-01-01

Several conditions have been found to exist within high level radioactive waste storage tanks at the Hanford site which could lead to uncontrolled exothermic reactions and/or to the release of tank contents into the environment. These conditions have led to the establishment of four priority 1 safety issues for the Hanford tanks. Resolution of these safety issues will require the coordinated efforts of professionals in chemical, nuclear, operations, safety, and other technical areas. A coordinated and integrated approach is necessary in order to achieve resolution in the shortest possible time, while ensuring that the steps taken do not complicate the later jobs of vitrification and ultimate disposal. This paper describes the purpose, process, and results of an effort to develop a suggested approach. (author)

Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.

Science.gov (United States)

Kesselheim, Aaron S; Misono, Alexander S; Lee, Joy L; Stedman, Margaret R; Brookhart, M Alan; Choudhry, Niteesh K; Shrank, William H

2008-12-03

Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs. To summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral. We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of beta-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of alpha-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was -0.03 (95% confidence interval, -0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution. Whereas evidence does not

A framework for elaborating a geological disposal safety case: Main issues to be addressed

International Nuclear Information System (INIS)

Besnus, F.; Gay, D.

2002-01-01

International guidance on safety standards for the geological disposal of radioactive waste is being elaborated by IAEA. A comparison of experiences acquired in developing deep repository projects shows that many important issues related to the progressive building of confidence in the safety demonstration of such facilities are commonly addressed by the various organisations involved in radioactive waste management. However, there is still some discrepancies in defining the steps that form the staged elaboration of a safety case. This paper intends to propose a framework for defining the safety case in describing the main issues to be addressed and highlighting questions of consistency between former steps. (author)

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

NS [Nuclear Safety] update. Current safety and security activities and developments taking place in the Department of Nuclear Safety and Security, Issue no. 6, March 2008

International Nuclear Information System (INIS)

2008-03-01

The current issue presents information about the following activities: 1) International Conference on Illicit Nuclear Trafficking which took place in November 2007 in Edinburgh. The principal aim of the conference was to examine the threat and context of illicit nuclear trafficking of radioactive material, specifically, what is being done to combat such trafficking and where more needs to be done. The conference was also to consider how the obligations and commitments of the legally binding and non-binding international instruments could be and are being implemented by various States. 2) INSAG Message on Nuclear Safety Infrastructure in which the INSAG Chairman Richard Meserve addressed nuclear safety in the current context and various issues that warrant special attention. 3) approved for publication the Safety Requirements publication on Safety of Nuclear Fuel Cycle Facilities. 4) The Asian Nuclear Safety Network (ANSN)

Consumer confidence in the safety of food in Canada and the Netherlands: The validation of a generic framework

NARCIS (Netherlands)

Jonge, de J.; Trijp, van J.C.M.; Goddard, E.; Frewer, L.J.

2008-01-01

A thorough understanding of consumer confidence in the safety of food and the factors by which this is influenced is necessary for the development of adequate and effective risk management and communication regarding food safety issues. As food chains become globalized, risk management and

NS [Nuclear Safety] update. Current safety and security activities and developments taking place in the Department of Nuclear Safety and Security, Issue no. 10, March 2009

International Nuclear Information System (INIS)

2009-03-01

The current issue contains information about the following meetings: Application of the Code of Conduct on the Safety of Research Reactors (the 'Code'). Environmental Modelling for Radiation Safety (EMRAS II); Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management (the Joint Convention). The document also gives an overview on International Nuclear Security Advisory Service (INSServ)

Regulatory Oversight of Safety Culture in Finland: A Systemic Approach to Safety

International Nuclear Information System (INIS)

Oedewald, P.; Väisäsvaara, J.

2016-01-01

In Finland the Radiation and Nuclear Safety Authority STUK specifies detailed regulatory requirements for good safety culture. Both the requirements and the practical safety culture oversight activities reflect a systemic approach to safety: the interconnections between the technical, human and organizational factors receive special attention. The conference paper aims to show how the oversight of safety culture can be integrated into everyday oversight activities. The paper also emphasises that the scope of the safety culture oversight is not specific safety culture activities of the licencees, but rather the overall functioning of the licence holder or the new build project organization from safety point of view. The regulatory approach towards human and organizational factors and safety culture has evolved throughout the years of nuclear energy production in Finland. Especially the recent new build projects have highlighted the need to systematically pay attention to the non-technical aspects of safety as it has become obvious how the HOF issues can affect the design processes and quality of construction work. Current regulatory guides include a set of safety culture related requirements. The requirements are binding to the licence holders and they set both generic and specific demands on the licencee to understand, monitor and to develop safety culture of their own organization but also that of their supplier network. The requirements set for the licence holders has facilitated the need to develop the regulator’s safety culture oversight practices towards a proactive and systemic approach.

Component reliability data for use in probabilistic safety assessment

International Nuclear Information System (INIS)

1988-10-01

Generic component reliability data is indispensable in any probabilistic safety analysis. It is not realistic to assume that all possible component failures and failure modes modeled in a PSA would be available from the operating experience of a specific plant in a statistically meaningful way. The degree that generic data is used in PSAs varies from case to case. Some studies are totally based on generic data while others use generic data as prior information to be specialized by plant specific data. Most studies, however, finally use a combination where data for certain components come from generic data sources and others from Bayesian updating. The IAEA effort to compile a generic component reliability data base aimed at facilitating the use of data available in the literature and at highlighting pitfalls which deserve special consideration. It was also intended to complement the fault tree and event tree package (PSAPACK) and to facilitate its use. Moreover, it should be noted, that the IAEA has recently initiated a Coordinated Research Program in Reliability Data Collection, Retrieval and Analysis. In this framework the issues identified as most affecting the quality of existing data bases would be addressed. This report presents the results of a compilation made from the specialized literature and includes reliability data for components usually considered in PSA

Contrast media. Safety issues and ESUR guidelines

Energy Technology Data Exchange (ETDEWEB)

Thomsen, H.S. (ed.) [Copenhagen Univ. Hospital, Herlev (Denmark). Dept. of Diagnostic Radiology 54E2

2006-07-01

In 1994 the European Society of Urogenital Radiology (ESUR) set up a committee to consider the safety of the contrast media used in radiology departments. Since then, the committee has questioned members, reviewed the literature, proposed guidelines, and discussed these proposals with participants at the annual symposia on urogenital radiology. This book represents the end result of this hard work. It contains all of the agreed guidelines, updated when necessary, and thereby comprehensively covers the many different safety issues relating to the diverse contrast media: barium contrast media, iodinated contrast media, MR contrast media (both gadolinium-based extracellular and organ-specific) and ultrasound contrast media. The prevention and treatment of both acute and delayed non-renal adverse reactions as well as the renal adverse reactions are covered in detail. The inclusion of all the ESUR guidelines within one book will offer an invaluable, unique and unparalleled resource. (orig.)

Contrast media. Safety issues and ESUR guidelines

International Nuclear Information System (INIS)

Thomsen, H.S.

2006-01-01

In 1994 the European Society of Urogenital Radiology (ESUR) set up a committee to consider the safety of the contrast media used in radiology departments. Since then, the committee has questioned members, reviewed the literature, proposed guidelines, and discussed these proposals with participants at the annual symposia on urogenital radiology. This book represents the end result of this hard work. It contains all of the agreed guidelines, updated when necessary, and thereby comprehensively covers the many different safety issues relating to the diverse contrast media: barium contrast media, iodinated contrast media, MR contrast media (both gadolinium-based extracellular and organ-specific) and ultrasound contrast media. The prevention and treatment of both acute and delayed non-renal adverse reactions as well as the renal adverse reactions are covered in detail. The inclusion of all the ESUR guidelines within one book will offer an invaluable, unique and unparalleled resource. (orig.)

Addressing the fundamental issues in reliability evaluation of passive safety of AP1000 for a comparison with active safety of PWR

International Nuclear Information System (INIS)

Hashim Muhammad; Yoshikawa, Hidekazu; Yang Ming

2013-01-01

Passive safety systems adopted in advanced Pressurized Water Reactor (PWR), such as AP1000 and EPR, should attain higher reliability than the existing active safety systems of the conventional PWR. The objective of this study is to discuss the fundamental issues relating to the reliability evaluation of AP1000 passive safety systems for a comparison with the active safety systems of conventional PWR, based on several aspects. First, comparisons between conventional PWR and AP1000 are made from the both aspects of safety design and cost reduction. The main differences between these PWR plants exist in the configurations of safety systems: AP1000 employs the passive safety system while reducing the number of active systems. Second, the safety of AP1000 is discussed from the aspect of severe accident prevention in the event of large break loss of coolant accidents (LOCA). Third, detailed fundamental issues on reliability evaluation of AP1000 passive safety systems are discussed qualitatively by using single loop models of safety systems of both PWRs plants. Lastly, methodology to conduct quantitative estimation of dynamic reliability for AP1000 passive safety systems in LOCA condition is discussed, in order to evaluate the reliability of AP1000 in future by a success-path-based reliability analysis method (i.e., GO-FLOW). (author)

Safety issues relating to the design of fusion power facilities

International Nuclear Information System (INIS)

Stasko, R.R.; Wong, K.Y.; Russell, S.B.

1986-06-01

In order to make fusion power a viable future source of energy, it will be necessary to ensure that the cost of power for fusion electric generation is competitive with advanced fission concepts. In addition, fusion power will have to live up to its original promise of being a more radiologically benign technology than fission, and be able to demonstrate excellent operational safety performance. These two requirements are interrelated, since the selection of an appropriate safety philosophy early in the design phase could greatly reduce or eliminate the capital costs of elaborate safety related and protective sytems. This paper will briefly overview a few of the key safety issues presently recognized as critical to the ultimate achievement of licensable, environmentally safe and socially acceptable fusion power facilities. 12 refs

Safety aspects in life extension of NPPs. Working material

International Nuclear Information System (INIS)

2002-01-01

Due to current social and economical framework, in last years many Member States (MS) started a process of Plant Life Extension (PLEX) for their older nuclear facilities. The process followed many different approaches, being intrinsically dependent on the national regulatory framework and technical tradition. This process has many nuclear safety implications, other than strategic and political ones, and therefore a need for tailoring the available safety assessment tools to such applications has become urgent in recent years. Typical safety assessment processes such as the Periodic Safety Review has been used already and can be used in the future as a framework for a PLEX. Also the review of regular maintenance and ageing management programs and the continuous upgrading of the Safety Analysis Report are tools widely used in a life extension context in many MS. However, recently some MS highlighted the need to identify in a clear way the technical aspects more directly affecting the decision for a long-term operation of a nuclear facility. Many Technical Cooperation projects have been requested for the year 2003-2004 on this subject and a generic task in Nuclear Safety proved necessary as a background activity. Therefore, on May 6-10, 2002, a Consultant Meeting dealing with Safety Aspects of life extension for NPPs was convened at the Nuclear Safety Dept. of the IAEA. It was attended by representatives of Regulatory Bodies and Utilities, both from countries with experience of life extension of NPPs and countries where the process is at the beginning. The main application problems were identified and discussed and a first attempt was carried out to define the key elements of the life extension process, isolating peculiar technical items, LTO related, from generic safety related tasks. The result was a preliminary technical document with a collection of basic experience and information for the implementation of a PLEX program. Therefore the draft document was thought

Japan's regulatory and safety issues regarding nuclear materials transport

International Nuclear Information System (INIS)

Saito, T.; Yamanaka, T.

2004-01-01

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

Campus Safety and Student Privacy Issues in Higher Education

Science.gov (United States)

Burnett, Kristen Slater

2010-01-01

The purpose of this study is to delve into, and further understand, the perceptions of higher education administrators when they experience having to simultaneously balance the issues of campus safety and student privacy. The research surveyed approximately 900 (with 147 returns) administrators who self-identified as having a role in incidents of…

Assessment of policy issues in nuclear safety regulation according to circumstantial changes

Energy Technology Data Exchange (ETDEWEB)

Chang, Soon Heung; Lee, Byong Ho; Baek, Won Pil; Lee, Kwang Gu; Huh, Gyun Young; Hahn, Young Tae [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

2000-03-15

The objective of the work is to assess various issues in nuclear safety regulation in consideration of circumstantial changes. Emphasis is given to the safety of operating NPPs. It is concluded that the Periodic Safety Review (PSR) should be implemented in Korea as soon as possible, in harmonization with the regulation for life extension of NPPs. The IAEA guidelines, including 10 year intervals and 11 safety factors, should be used as the basic guidelines. The approach to improve regulatory effectiveness is also reviewed and a transition to 'knowledge-based regulation' is suggested.

Assessment of policy issues in nuclear safety regulation according to circumstantial changes

Energy Technology Data Exchange (ETDEWEB)

Chang, Soon Heung; Chang, Soon Heung; Lee, Byong Ho; Baek, Won Pil; Roh, Chang Hyun; Lee, Kwang Gu; Kim, Hong Chae; Lee, Yong Ho [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

1999-03-15

The objective of the work is to assess various issues in nuclear safety regulation in consideration of circumstantial changes. Emphasis is given to the safety of operating NPPs. It is concluded that the Periodic Safety Review (PSR) should be implemented in Korea as soon as possible, in harmonization with the regulation for life extension of NPPs. The IAEA guidelines, including 10 year intervals and 11 safety factors, should be used as the basic guidelines. Efforts are also required to cope with other circumstantial changes such as the establishment of International Nuclear Regulators Association (INRA)

A survey exploring the knowledge and perceptions of senior medical students in Nepal toward generic medicines

Directory of Open Access Journals (Sweden)

Sudesh Gyawali

2016-08-01

Full Text Available Background: The accurate knowledge of generic medicine issues among future prescribers will enhance the prescribing of cost-effective medicines. This study aimed to explore the knowledge and perception of senior medical students about the generic medicines. Methodology: A cross-sectional study was conducted among 237 senior medical students (final year students and interns using a validated self-administered questionnaire. The collected data were analyzed using Statistical Package for the Social Sciences version 20 for windows and comparison of difference was done using linear by linear association. A p value of less than 0.05 was taken as statistically significant. Results: The average age (standard deviation of the respondents was 23.54 (1.39 years. Almost 5% of respondents correctly answered the question regarding the regulatory limits for bioequivalence. Almost two-thirds of respondents correctly agreed that generic medicine is bioequivalent to a brand-name medicine, and 79.3% and 72.5% of respondents correctly agreed that the medicine should be present in the same dosage form and same dose, respectively, as the brand-name medicines. However, almost half of the respondents had impression that brand-name medicines are required to meet higher safety standard than generic medicines. Almost 90% of respondents felt that advertisement by the drug companies would influence the use of brand-name medicine and they need more information about generic medicine. Conclusion: This study highlights the negative perception and knowledge deficit among the respondents. The students’ responses to almost all the statements were almost similar to the respondents’ academic year (final year students and interns, gender and nationality.

The Impact of Information on Doctors’ Attitudes Toward Generic Drugs

Directory of Open Access Journals (Sweden)

Aggeliki V. Tsaprantzi MD

2016-03-01

Full Text Available The objective of this study is to assess the impact of information on doctors’ attitudes and perceptions toward generics. A cross-sectional survey based on a specially designed 21-item questionnaire was conducted. The survey involved doctors of different specialties working in a public hospital in Greece. The analysis includes descriptive and inferential statistics, reliability and validity tests, as well as structural equation modeling to evaluate the causal model. Statistical analysis was accomplished by using SPSS 20 and Amos 20. A total of 134 questionnaires out of 162 were received, providing a response rate of 82.71%. A number of significant associations were found between information and perceptions about generic medicines with demographic characteristics. It seems that the provision of quality information on generic drugs influences doctors’ attitudes and prescription practices toward generic drugs. This is not a static process but a rather dynamic issue involving information provision policies for strengthening the proper doctors’ attitudes toward generic drugs.

Review of the generic aging lessons learned (GALL) report for U.S. NPPs

International Nuclear Information System (INIS)

Gong Yi; Dou Yikang

2014-01-01

Generic aging lessons learned (GALL) report is a technical basis document issued by U.S. nuclear regulatory commission (NRC) for guiding the review of license renewal application (LRA) of its domestic nuclear power plants (NPPs). By form of tabulations, GALL report addresses the correlation among materials, environments, aging effects/mechanisms, and aging management programs (AMPs) from the level of specific structures and/or components. Based on literature investigation and analysis, the essential information of GALL report in the aspects of background, development history, content framework, and application was reviewed in this paper, which should be the first time in China and would have reference value for establishment of both the AMPs and the nuclear safety regulations of extending the lifetime of its NPPs. (authors)

Safety issues related to the intermediate heat storage for the EU DEMO

Energy Technology Data Exchange (ETDEWEB)

Carpignano, Andrea [NEMO group, Dipartimento Energia, Politecnico di Torino, C.so Duca degli Abruzzi 24, 10129 Torino (Italy); Pinna, Tonio [ENEA, 00044 Frascati (Italy); Savoldi, Laura; Sobrero, Giulia; Uggenti, Anna Chiara [NEMO group, Dipartimento Energia, Politecnico di Torino, C.so Duca degli Abruzzi 24, 10129 Torino (Italy); Zanino, Roberto, E-mail: roberto.zanino@polito.it [NEMO group, Dipartimento Energia, Politecnico di Torino, C.so Duca degli Abruzzi 24, 10129 Torino (Italy)

2016-11-01

Highlights: • IHS affects only the PHTS and the BoP (Balance of Plant). • PIEs list does not change but IHS influences PIEs evolution. • Additional issues to be addressed in PIEs study due to the implementation of HIS. • No safety/operational major obstacles were found for IHS concept. - Abstract: The functional deviations able to compromise system safety in the EU DEMO Primary Heat Transfer System (PHTS) with intermediate heat storage (IHS) based on molten salts are identified and compared to the deviations identified with PHTS without IHS. The resulting safety issues for the Balance of Plant (BoP) have been taken into account. Functional Failure Mode and Effects Analysis (FFMEA) is used to highlight the Postulated Initiating Events (PIE) of incident/accident sequences and to provide some safety insights during the preliminary design. The architecture of the system with IHS does not introduce new PIE with respect to the case without IHS, but it modifies some of them. In particular the two Postulated Initiating Events that are affected by the presence of IHS are the LOCA in the tubes of the HX between primary and intermediate circuit and the loss of heat sink for the first wall or the breeding zone. In fact the IHS introduces some advantages concerning the stability of the secondary circuit, but some weaknesses are associated to the physical-chemical nature of molten salts, especially oxidizing power, corrosive nature and risk of solidification. These issues can be managed in the design by the introduction of new safety functions.

Safety analysis of autonomous excavator functionality

International Nuclear Information System (INIS)

Seward, D.; Pace, C.; Morrey, R.; Sommerville, I.

2000-01-01

This paper presents an account of carrying out a hazard analysis to define the safety requirements for an autonomous robotic excavator. The work is also relevant to the growing generic class of heavy automated mobile machinery. An overview of the excavator design is provided and the concept of a safety manager is introduced. The safety manager is an autonomous module responsible for all aspects of system operational safety, and is central to the control system's architecture. Each stage of the hazard analysis is described, i.e. system model creation, hazard definition and hazard analysis. Analysis at an early stage of the design process, and on a system that interfaces directly to an unstructured environment, exposes certain issues relevant to the application of current hazard analysis methods. The approach taken in the analysis is described. Finally, it is explained how the results of the hazard analysis have influenced system design, in particular, safety manager specifications. Conclusions are then drawn about the applicability of hazard analysis of requirements in general, and suggestions are made as to how the approach can be taken further

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

Eminent radiological safety issues confronting the State of Hawaii

International Nuclear Information System (INIS)

Hashimoto, H.H.

1984-01-01

The State of Hawaii currently has over one hundred radioactive material use licenses. Nuclear Regulatory Commission licenses are primarily held by hospitals, industrial radiographers, and academic institutions. Complementing this, the State Department of Health regulates x-ray machines, radium, and has an emergency response role for accidents involving radioactive materials. The existing radiation protection program was created by piecemeal legislation. As a result, regulatory surveillance and actual control vary widely among the agencies. The State Legislature, in 1980, decided that action must be taken to set a clear state policy towards the use and disposal of nuclear materials. It was therefore recommended that the State of Hawaii Radiation Safety Advisory Committee be convened to assist the state in the evaluation of the issues. This report contains issue papers on radiation related topics addressed by the Radiation Safety Advisory Committe. Topics discussed include transportation, environmental monitoring, emergency response, and waste disposal. A survey of various radioactive sources identified medical applications as a category requiring stricter control. Selected chapters of the Hawaii Revised Statutes are also examined

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)

A survey exploring knowledge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia.

Science.gov (United States)

Chua, Gin Nie; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Awaisu, Ahmed

2010-05-01

The objective of this study was to evaluate the general practitioners' (GPs') knowledge and perceptions towards generic medicines in a northern state of Malaysia. A postal cross-sectional survey involving registered GPs in Penang, Malaysia was undertaken. A 23-item questionnaire was developed, validated and administered on the GPs. Eighty-seven GPs responded to the survey (response rate 26.8%). The majority of the respondents (85.1%) claimed that they actively prescribed generic medicines in their practice. On the other hand, only 4.6% of the respondents correctly identified the Malaysia's National Pharmaceutical Control Bureau's bioequivalence standard for generic products. There were misconceptions among the respondents about the concepts of "bioequivalence", "efficacy", "safety", and "manufacturing standards" of generic medicines. GPs in this survey believed that a standard guideline on brand substitution process, collaboration with pharmacists, patient education and information on safety and efficacy of generic medicines were necessary to ensure quality use of generics. Furthermore, advertisements and product bonuses offered by pharmaceutical companies, patient's socio-economic factors as well as credibility of manufacturers were factors reported to influence their choice of medicine. Although it appeared that GPs have largely accepted the use of generic medicines, they still have concerns regarding the reliability and quality of such products. GPs need to be educated and reassured about generic products approval system in Malaysia concerning bioequivalence, quality, and safety. The current findings have important implications in establishing generic medicines policy in Malaysia. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

Materials-related issues in the safety and licensing of nuclear fusion facilities

Science.gov (United States)

Taylor, N.; Merrill, B.; Cadwallader, L.; Di Pace, L.; El-Guebaly, L.; Humrickhouse, P.; Panayotov, D.; Pinna, T.; Porfiri, M.-T.; Reyes, S.; Shimada, M.; Willms, S.

2017-09-01

Fusion power holds the promise of electricity production with a high degree of safety and low environmental impact. Favourable characteristics of fusion as an energy source provide the potential for this very good safety and environmental performance. But to fully realize the potential, attention must be paid in the design of a demonstration fusion power plant (DEMO) or a commercial power plant to minimize the radiological hazards. These hazards arise principally from the inventory of tritium and from materials that become activated by neutrons from the plasma. The confinement of these radioactive substances, and prevention of radiation exposure, are the primary goals of the safety approach for fusion, in order to minimize the potential for harm to personnel, the public, and the environment. The safety functions that are implemented in the design to achieve these goals are dependent on the performance of a range of materials. Degradation of the properties of materials can lead to challenges to key safety functions such as confinement. In this paper the principal types of material that have some role in safety are recalled. These either represent a potential source of hazard or contribute to the amelioration of hazards; in each case the related issues are reviewed. The resolution of these issues lead, in some instances, to requirements on materials specifications or to limits on their performance.

Safety performance indicators. Topical issues paper no. 5

International Nuclear Information System (INIS)

Dahlgren, K.; Lederman, L.; Szikszai, T.; Palomo, J.

2001-01-01

performance, they are just one of a larger set of tools including probabilistic safety assessment (PSA), regulatory inspection, quality assurance, external reviews and self-assessment needed to assess operational safety performance. The integration of information compiled from such evaluation tools yields the best results. Two areas of increasingly common interest are 'risk based' indicators, and 'safety culture' indicators. The key to managing the nuclear business today is to establish a high quality safety management system as well as developing a strong safety culture within the entire organization. 'The safety management system comprises those arrangements made by the organization for the management of safety in order to promote a strong safety culture and achieve good safety performance'. This definition, presented in INSAG-13, illustrates the close connection between 'safety management systems' and 'safety culture' and that they are in fact inseparable. To manage safety effectively you need a systematic approach and at the same time be aware of the effects of the approach on individual and collective human behaviour. This issue covers the following: development of safety performance indicators, indicator selection and use, recommended indicators, indicators collected from nuclear power plant initiatives, management of safety and safety culture, need and feasibility of an international system, plant management needs, regulatory use of safety performance indicators, public communication, and recommendations for priorities in future work

Development of a health and safety manual for emergency response operations

International Nuclear Information System (INIS)

Riland, C.A.; Junio, S.S.

2000-01-01

The Federal Radiological Monitoring and Assessment Center (FRMAC) Health and Safety Manual, which has been under development by a multi-agency group, is nearing completion and publication. The manual applies to offsite monitoring during a radiological accident or incident. Though written for multi-agency offsite monitoring activities (FRMAC), the manual is generic in nature and should be readily adaptable for other emergency response operations. Health and safety issues for emergency response situations often differ from those of normal operations. Examples of these differences and methodologies to address these issues are discussed. Challenges in manual development, including lack of regulatory and guidance documentation, are also discussed. One overriding principle in the Health and Safety Manual development is the overall reduction of risk, not just dose. The manual is broken into several chapters, which include Overview of Responsibities, Health Physics, Industrial Hygiene and Safey, Medical, and Environmental Compliance and Records. Included is a series of appendices, which presents additional information on forms and plans for default scenarios

Generic patch inference

DEFF Research Database (Denmark)

Andersen, Jesper; Lawall, Julia

2010-01-01

A key issue in maintaining Linux device drivers is the need to keep them up to date with respect to evolutions in Linux internal libraries. Currently, there is little tool support for performing and documenting such changes. In this paper we present a tool, spdiff, that identifies common changes...... developers can use it to extract an abstract representation of the set of changes that others have made. Our experiments on recent changes in Linux show that the inferred generic patches are more concise than the corresponding patches found in commits to the Linux source tree while being safe with respect...

Review of EU-APR Design for Selected Safety Issues of WERNA RHWG 2013

Energy Technology Data Exchange (ETDEWEB)

Kim, Yong Soo; Kim, Ji Hwan [KHNP CRI, Daejeon (Korea, Republic of)

2016-10-15

Western European Nuclear Regulators' Association (WENRA) was established in 1999 to develop a harmonized approach to nuclear safety and radiation protection and their regulation. In 2013, the Reactor Harmonization Working Group (RHWG) of WENRA sets out the common positions on the seven selected key safety issues. This paper is to introduce the regulatory positions of WENRA RHWG 2013 and to review the compliance of the EU-APR with them. In this paper, we reviewed the compliance of the EUAPR regarding seven safety issues for new NPPs presented by WERNA RHWG in 2013. The EU-APR design fully complies with all WERNA RHWG safety issues since the following measures have been incorporated in it: - Successive five levels of DiD maintaining independence between different levels of DiD - Diverse design against multiple failure events such as ATWS, SBO, Loss of Ultimate Heat Sink, and Loss of Spent Fuel Pool Cooling - SAs dedicated mitigation systems to ensure the containment integrity during the SAs. - Practically eliminates accident sequences with a large or early release of radiological materials by diverse designs for multiple failure events, SAs dedicated mitigation system, and double containment design - Standard site parameters not lead to core melt accidents due to natural or man-made external hazards.

Implementation of Safety and Security Issues in the Transport of Radioactive Material in Argentina

International Nuclear Information System (INIS)

López Vietri, J.; Elechosa, C.; Gerez Miranda, C.; Menossi, S.; Rodríguez Roldán, M.S.; Fernández, A.

2016-01-01

This paper is intended to describe implementation of safety and security issues in the transport of radioactive material by the Nuclear Regulatory Authority (in Spanish Autoridad Regulatoria Nuclear, ARN), which is the Competent Authority of Argentina in Safety, Security and Safeguards of radioactive and nuclear material. There are depicted main regulatory activities dealing with the mentioned issues, and relevant milestones of national regulatory standards and guidance applied, that are based on requirements and guides from IAEA. Interfaces between Safety and Security sections are most of the times complementary but sometimes conflictive, therefore the resolution of such conflicts and goals achieved during their implementation are also commented; as well as future joint planned activities between both sections of ARN as a way to provide safety and security without compromising one or the other. (author)

RBMK safety issues

International Nuclear Information System (INIS)

Weber, J.P.; Reichenbach, D.; Tscherkashow, J.M.

1995-01-01

On the basis of information and documents from the RBMK operation countries, the Western consortium mainly examined the two most modern plants, Ignalin-2 and Smolensk-3. The identification of numerous shortcomings, some of which had already been recongized by the participating Eastern organizations, resulted in some 300 specific recommendations to reactor designers, operators and licensing authorities. These recommendations are to be acted upon at once; only a small number did not meet with the approval of the Eastern partners. The safety review provided the Western consotrium with a profound insight into the design and safety of third-generation RBMK reactors; the Eastern partners were able to accumulate experience in working with Western safety philosophy. (orig.) [de

Generic drugs: Review and experiences from South India

Directory of Open Access Journals (Sweden)

Philip Mathew

2015-01-01

Full Text Available The cost of pharmaceuticals, as a percentage of total healthcare spending, has been rising worldwide. This has resulted in strained national budgets and a high proportion of people without access to essential medications. Though India has become a global hub of generic drug manufacturing, the expected benefits of cheaper drugs are not translating into savings for ordinary people. This is in part due to the rise of branded generics, which are marketed at a price point close to the innovator brands. Unbranded generic medicines are not finding their way into prescriptions due to issues of confidence and perception, though they are proven to be much cheaper and comparable in efficacy to branded medicines. The drug inventory of unbranded generic manufacturers fares reasonably when reviewed using the World Health Organization-Health Action International (WHO-HAI tool for analysing drug availability. Also, unbranded generic medicines are much cheaper when compared to the most selling brands and they can bring down the treatment costs in primary care and family practice. We share our experience in running a community pharmacy for an urban health center in the Pathanamthitta district of Kerala State, which is run solely on generic medicines. The drug availability at the community pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final consumers were up to 93.1%, when compared with most-selling brand of the same formulation.

GOoDA: The Generic Optimization Data Analyzer

CERN Multimedia

CERN. Geneva

2012-01-01

To address this issue, a generic decomposition of how a microprocessor is using the consumed cycles allows code developers to quickly understand which of the myriad of microarchitectural complexities they are battling, without requiring a detailed knowledge of the microarchitecture. When this approach is intrinsically integrated into a performance data analysis tool,...

Application of a generic biosphere model for dose assessments to five European sites

International Nuclear Information System (INIS)

Chen, Q; Kowe, R; Mobbs, S F; Proehl, G; Olyslaegers, G; Zeevaert, T; Kanyar, B; Pinedo, P; Simon, I; Bergstroem, U; Hallberg, B; Jones, J A; Oatway, W B; Watson, S J

2006-01-01

The BIOMOSA (BIOsphere MOdels for Safety Assessment of radioactive waste disposal) project was part of the EC fifth framework research programme. The main goal of this project was to improve the scientific basis for the application of biosphere models in the framework of long-term safety studies of radioactive waste disposal facilities and to enhance the confidence in using biosphere models for performance assessments. The study focused on the development and application of a generic biosphere tool BIOGEM (BIOsphere GEneric Model) using the IAEA BIOMASS reference biosphere methodology, and the comparison between BIOGEM and five site-specific biosphere models. The site-specific models and the generic model were applied to five typical locations in Europe, resulting in estimates of the annual effective individual doses to the critical groups and the ranking of the importance of the exposure pathways for each of the sites. Uncertainty in the results was also estimated by means of stochastic calculations based on variation of the site-specific parameter values. This paper describes the generic model and the deterministic and stochastic results obtained when it was applied to the five sites. Details of the site-specific models and the corresponding results are described in two companion papers. This paper also presents a comparison of the results between the generic model and site-specific models. In general, there was an acceptable agreement of the BIOGEM for both the deterministic and stochastic results with the results from the site-specific models

Health and safety plan for operations performed for the Environmental Restoration Program

Energy Technology Data Exchange (ETDEWEB)

Trippet, W.A. II (IT Corp., (United States)); Reneau, M.; Morton, S.L. (EG and G Idaho, Inc., Idaho Falls, ID (United States))

1992-04-01

This document constitutes the generic health and safety plan for the Environmental Restoration Program (ERP). It addresses the health and safety requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA); Occupational Safety and Health Administration (OSHA) 29 CFR 1910.120 standard; and EG G Idaho, Inc. This plan is a guide to individuals who must complete a health and safety plan for a task performed for the EPR. It contains a task specific addendum that, when completed, specifically addresses task specific health and safety issues. This health and safety plan reduces the time it takes to write a task specific health and safety plan by providing discussions of requirements, guidance on where specific information is located, and specific topics in the Addendum that must be discussed at a task level. This format encourages a complete task specific health and safety plan and a standard for all health and safety plans written for ERP.

Health and safety plan for operations performed for the Environmental Restoration Program

International Nuclear Information System (INIS)

Trippet, W.A. II; Reneau, M.; Morton, S.L.

1992-04-01

This document constitutes the generic health and safety plan for the Environmental Restoration Program (ERP). It addresses the health and safety requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA); Occupational Safety and Health Administration (OSHA) 29 CFR 1910.120 standard; and EG ampersand G Idaho, Inc. This plan is a guide to individuals who must complete a health and safety plan for a task performed for the EPR. It contains a task specific addendum that, when completed, specifically addresses task specific health and safety issues. This health and safety plan reduces the time it takes to write a task specific health and safety plan by providing discussions of requirements, guidance on where specific information is located, and specific topics in the Addendum that must be discussed at a task level. This format encourages a complete task specific health and safety plan and a standard for all health and safety plans written for ERP

Modeling issues associated with production reactor safety assessment

International Nuclear Information System (INIS)

Stack, D.W.; Thomas, W.R.

1990-01-01

This paper describes several Probabilistic Safety Assessment (PSA) modeling issues that are related to the unique design and operation of the production reactors. The identification of initiating events and determination of a set of success criteria for the production reactors is of concern because of their unique design. The modeling of accident recovery must take into account the unique operation of these reactors. Finally, a more thorough search and evaluation of common-cause events is required to account for combinations of unique design features and operation that might otherwise not be included in the PSA. It is expected that most of these modeling issues also would be encountered when modeling some of the other more unique reactor and nonreactor facilities that are part of the DOE nuclear materials production complex. 9 refs., 2 figs

Key issues on safety design basis selection and safety assessment

International Nuclear Information System (INIS)

An, S.; Togo, Y.

1976-01-01

In current fast reactor design in Japan, four design accident conditions and four design seismic conditions are adopted as the design base classifications. These are classified by the considerations on both likelihood of occurrence and the severeness of the consequences. There are several major problem areas in safety design consideration such as core accident problems which include fuel sodium interaction, fuel failure propagation and residual decay heat removal, and decay heat removal systems problems which is more or less the problem of selection of appropriate system and of assurance of high reliability of the system. In view of licensing, two kinds of accidents are postulated in evaluating the adequacy of a reactor site. The one is the ''major accident'' which is the accident to give most severe radiation hazard to the public from technical point of view. The other is the ''hypothetical accident'', induced public accident of which is severer than that of major accident. While the concept of the former is rather unique to Japanese licensing, the latter is almost equivalent to design base hypothetical accident of the US practice. In this paper, design bases selections, key safety issues and some of the licensing considerations in Japan are described

Occupational health and safety issues among nurses in the Philippines.

Science.gov (United States)

de Castro, A B; Cabrera, Suzanne L; Gee, Gilbert C; Fujishiro, Kaori; Tagalog, Eularito A

2009-04-01

Nursing is a hazardous occupation in the United States, but little is known about workplace health and safety issues facing the nursing work force in the Philippines. In this article, work-related problems among a sample of nurses in the Philippines are described. Cross-sectional data were collected through a self-administered survey during the Philippine Nurses Association 2007 convention. Measures included four categories: work-related demographics, occupational injury/illness, reporting behavior, and safety concerns. Approximately 40% of nurses had experienced at least one injury or illness in the past year, and 80% had experienced back pain. Most who had an injury did not report it. The top ranking concerns were stress and overwork. Filipino nurses encounter considerable health and safety concerns that are similar to those encountered by nurses in other countries. Future research should examine the work organization factors that contribute to these concerns and strengthen policies to promote health and safety.

Occupational Health and Safety Issues Among Nurses in the Philippines

Science.gov (United States)

de Castro, A. B.; Cabrera, Suzanne L.; Gee, Gilbert C.; Fujishiro, Kaori; Tagalog, Eularito A.

2009-01-01

Nursing is a hazardous occupation in the United States, but little is known about workplace health and safety issues facing the nursing work force in the Philippines. In this article, work-related problems among a sample of nurses in the Philippines are described. Cross-sectional data were collected through a self-administered survey during the Philippine Nurses Association 2007 convention. Measures included four categories: work-related demographics, occupational injury/illness, reporting behavior, and safety concerns. Approximately 40% of nurses had experienced at least one injury or illness in the past year, and 80% had experienced back pain. Most who had an injury did not report it. The top ranking concerns were stress and overwork. Filipino nurses encounter considerable health and safety concerns that are similar to those encountered by nurses in other countries. Future research should examine the work organization factors that contribute to these concerns and strengthen policies to promote health and safety. PMID:19438081

Perception of the value of generic drugs in São Paulo, Brazil

Directory of Open Access Journals (Sweden)

Elene Paltrinieri Nardi

2016-01-01

Full Text Available Abstract The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%, and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

Perception of the value of generic drugs in São Paulo, Brazil.

Science.gov (United States)

Nardi, Elene Paltrinieri; Ferraz, Marcos Bosi

2016-02-01

The objective of this study was to assess the perceptions of opinion-leaders, patients and their accompanying family members or carers about generic drugs. Three groups of participants were surveyed: (i) 50 customers while they were visiting commercial pharmacies located in São Paulo city, Brazil, (ii) 25 patients and 25 companions while they were waiting at the university outpatient clinic, and (iii) 50 healthcare opinion-leaders from government, hospitals, health plans, academia, and pharmaceutical companies. The questions explored socio-demographic characteristics and perceptions regarding value attributes of generic drugs compared to brand name drugs. Respondents had an average age of 52 years and 53% were women. Respondents believed generic drugs to be cheaper than brand name drugs (97%), and 31% thought generic drugs to be less effective than brand name drugs. Also, generic drugs were perceived by 54% of respondents to be as safe as brand name drugs and 74% would prefer brand name drugs if there was no price difference. In conclusion, multiple factors may contribute to the decision to buy generic drugs; among these, perceived effectiveness, safety and price appear to be the most important factors.

Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.

Science.gov (United States)

Wouters, Olivier J; Kanavos, Panos G; McKEE, Martin

2017-09-01

solutions to address issues in Europe and the United States, such as streamlining the generic drug approval process and requiring generic prescribing and substitution where such policies are not yet in place. The history of substitution laws in the United States provides insights into the economic, political, and cultural issues influencing the adoption of generic drug policies. Governments should apply coherent supply- and demand-side policies in generic drug markets. An immediate priority is to convince more physicians, pharmacists, and patients that generic drugs are bioequivalent to branded products. Special-interest groups continue to obstruct reform in Europe and the United States. © 2017 The Authors The Milbank Quarterly published by Wiley Periodicals, Inc. on behalf of The Millbank Memorial Fund.

Generic Certificates. Agricultural Economic Report Number 594.

Science.gov (United States)

Glauber, Joseph W.

The Food Security Act of 1985 authorizes the U.S. Department of Agriculture to issue generic certificates in lieu of cash payments due to program participants and merchants of agricultural products under provisions of several programs. The certificates may be used to acquire stocks held as collateral on government loans or owned by the Commodity…

Research of beryllium safety issues

International Nuclear Information System (INIS)

Longhurst, G.R.; Anderl, R.A.; Dolan, T.J.; Hankins, M.R.; Pawelko, R.J.

1993-01-01

Beryllium has been identified as a leading contender for the plasma-facing material in ITER. Its use has some obvious advantages, but there are also a number of safety concerns associated with it. The Idaho National Engineering Laboratory (INEL) has undertaken a number of studies to help resolve some of these issues. One issue is the response of beryllium to neutron irradiation. We have tested samples irradiated in the Advanced Test Reactor (ATR) and are currently preparing to make measurements of the change in mechanical properties of beryllium samples irradiated at elevated temperatures in the Fast Flux Test Facility (FFTF) and the Experimental Breeder Reactor II (EBR-II) at the INEL. Mechanical tests will be conducted at the irradiation temperatures of 375-550 C. Other experiments address permeation and retention of implanted tritium in plasma-sprayed beryllium. In one test the porosity of the material allowed 0.12% of implanted ions and 0.17% of atoms from background gas pressure to pass through the foil with essentially no delay. For comparison, similar tests on fully dense hot-rolled, vacuum melted or sintered powder foils of high purity beryllium showed only 0.001% of implanting ions to pass through the foil, and then only after a delay of several hours. None of the molecular gas appeared to permeate these latter targets. An implication is that plasma-sprayed beryllium may substantially enhance recycling of tritium to the plasma provided it is affixed to a relatively impermeable substrate. (orig.)

Generic implications of ATWS events at the Salem Nuclear Power Plant: generic implications. Vol. 1

International Nuclear Information System (INIS)

1983-04-01

This report is the first of two volumes. It documents the work of an interoffice, interdisciplinary NRC Task Force established to determine the generic implications of two anticipated transients without scram (ATWS) at the Salem Nuclear Power Plant, Unit 1 on February 22 and 25, 1983. A second report will document the NRC actions to be taken based on the work of the Task Force. The Task Force was established to address three questions: (1) Is there a need for prompt action for similar equipment in other facilities. (2) Are NRC and its licensees learning the sefety-management lessons, and, (3) How should the priority and content of the ATWS rule be adjusted. A number of short-term actions were taken through Bulletins and an Information Notice. Intermediate-term actions to address the generic issues will be addressed in the separate report and implemented through appropriate regulatory mechanisms

AADL Fault Modeling and Analysis Within an ARP4761 Safety Assessment

Science.gov (United States)

2014-10-01

Analysis Generator 27 3.2.3 Mapping to OpenFTA Format File 27 3.2.4 Mapping to Generic XML Format 28 3.2.5 AADL and FTA Mapping Rules 28 3.2.6 Issues...PSSA), System Safety Assessment (SSA), Common Cause Analysis (CCA), Fault Tree Analysis ( FTA ), Failure Modes and Effects Analysis (FMEA), Failure...Modes and Effects Summary, Mar - kov Analysis (MA), and Dependence Diagrams (DDs), also referred to as Reliability Block Dia- grams (RBDs). The

Program plan for evaluation of the Ferrocyanide Waste Tank safety issue at the Hanford Site

International Nuclear Information System (INIS)

Borsheim, G.L.; Meacham, J.E.; Cash, R.J.; Dukelow, G.T.

1994-03-01

This document describes the background, priorities, strategy and logic, and task descriptions for the Ferrocyanide Waste Tank Safety Program. The Ferrocyanide Safety Program was established in 1990 to provide resolution of a major safety issue identified for 24 high-level radioactive waste tanks at the Hanford Site

Confined Site Construction: A qualitative investigation of critical issues affecting management of Health and Safety

OpenAIRE

Spillane, John P.; Oyedele, Lukumon O.; Von Meding, Jason; Konanahalli, Ashwini; Jaiyeoba, Babatunde E.; Tijani, Iyabo K.

2011-01-01

The construction industry is inherently risky, with a significant number of accidents and disasters occurring, particularly on confined construction sites. This research investigates and identifies the various issues affecting successful management of health and safety in confined construction sites. The rationale is that identifying the issues would assist the management of health and safety particularly in inner city centres which are mostly confined sites. Using empiricism epistemology, th...

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

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system.

Science.gov (United States)

Zhao, Wenle; Pauls, Keith

2016-04-01

Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented. A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2 days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial

Editorial: emerging issues in sociotechnical systems thinking and workplace safety.

Science.gov (United States)

Noy, Y Ian; Hettinger, Lawrence J; Dainoff, Marvin J; Carayon, Pascale; Leveson, Nancy G; Robertson, Michelle M; Courtney, Theodore K

2015-01-01

The burden of on-the-job accidents and fatalities and the harm of associated human suffering continue to present an important challenge for safety researchers and practitioners. While significant improvements have been achieved in recent decades, the workplace accident rate remains unacceptably high. This has spurred interest in the development of novel research approaches, with particular interest in the systemic influences of social/organisational and technological factors. In response, the Hopkinton Conference on Sociotechnical Systems and Safety was organised to assess the current state of knowledge in the area and to identify research priorities. Over the course of several months prior to the conference, leading international experts drafted collaborative, state-of-the-art reviews covering various aspects of sociotechnical systems and safety. These papers, presented in this special issue, cover topics ranging from the identification of key concepts and definitions to sociotechnical characteristics of safe and unsafe organisations. This paper provides an overview of the conference and introduces key themes and topics. Sociotechnical approaches to workplace safety are intended to draw practitioners' attention to the critical influence that systemic social/organisational and technological factors exert on safety-relevant outcomes. This paper introduces major themes addressed in the Hopkinton Conference within the context of current workplace safety research and practice challenges.

The crisis in access to essential medicines in India: key issues which call for action.

Science.gov (United States)

Bhargava, Anurag; Kalantri, S P

2013-01-01

The government is planning to introduce free generic and essential medicines in public health facilities. Most people in India buy healthcare from the private sector, a compulsion that accounts for a high proportion of healthcare-related expenditure. To reduce the burden of healthcare costs, the government must improve availability and affordability of generic and essential medicines in the market. It can do so because India's large pharmaceutical industry is a major source of generic medicines worldwide. In this article, we discuss three factors that have impeded access to generic and essential medicines: (1) mistaken notions among policymakers, prescribers and patients about branded drugs and generic drugs in India; (2) high prices of medicines due to the progressive dismantling of the system of regulation of medicine prices, and (3) a drug approval and regulatory system that allows medicines (including fixed dose combinations) of doubtful efficacy, rationale, safety and public health relevance to dominate the market at the cost of access to affordable generic and essential medicines. The consequences of ill-health and wasted expenditure on drugs raise issues of public health ethics.Improving access to essential medicines in India is an urgent public health and ethical imperative. This should include improved public provisioning, a system of regulation of drug prices, and an evidence-based drug approval process.

Promotion of good safety culture at a Swedish BWR

Energy Technology Data Exchange (ETDEWEB)

Ingmarsson, K F [Forsmark NPP (Sweden)

1997-12-31

Within the nuclear industry there are two events which have had a significant impact on the way of thinking and attitudes to safety, although in different ways. The TMI accident at Harrisburg, USA put the focus on Man-Machine interface, the way of working and attitudes to safety. The accident at Chernobyl focused on Safety Management and Safety Culture. Before the TMI accident, technology was believed to be the solutions to all kinds of problems. Technical solutions should compensate for human behaviour. After the TMI accident the focus was put on Man-Machine issues and a lot of the resources within the Nuclear Industry was allocated to Man-Machine-Interfaces, Procedures, Training, etc. After the Chernobyl accident, safety culture (IAEA INSAG-4) became a commonly used concept which included an overall perspective on safety and an understanding of the interaction between Man, Technology and Organizational matters (MTO). The Safety Culture within an organization is the sum of all attitudes, qualities and experiences influencing safety. Safety Culture is consequently not only a single quality or a single property but a generic term representing the promotion of safety in many areas.

Promotion of good safety culture at a Swedish BWR

International Nuclear Information System (INIS)

Ingmarsson, K.F.

1996-01-01

Within the nuclear industry there are two events which have had a significant impact on the way of thinking and attitudes to safety, although in different ways. The TMI accident at Harrisburg, USA put the focus on Man-Machine interface, the way of working and attitudes to safety. The accident at Chernobyl focused on Safety Management and Safety Culture. Before the TMI accident, technology was believed to be the solutions to all kinds of problems. Technical solutions should compensate for human behaviour. After the TMI accident the focus was put on Man-Machine issues and a lot of the resources within the Nuclear Industry was allocated to Man-Machine-Interfaces, Procedures, Training, etc. After the Chernobyl accident, safety culture (IAEA INSAG-4) became a commonly used concept which included an overall perspective on safety and an understanding of the interaction between Man, Technology and Organizational matters (MTO). The Safety Culture within an organization is the sum of all attitudes, qualities and experiences influencing safety. Safety Culture is consequently not only a single quality or a single property but a generic term representing the promotion of safety in many areas

Issues regarding Risk Effect Analysis of Digitalized Safety Systems and Main Risk Contributors

International Nuclear Information System (INIS)

Kang, Hyun Gook; Jang, Seung-Cheol

2008-01-01

Risk factors of safety-critical digital systems affect overall plant risk. In order to assess this risk effect, a risk model of a digitalized safety system is required. This article aims to provide an overview of the issues when developing a risk model and demonstrate their effect on plant risk quantitatively. Research activities in Korea for addressing these various issues, such as the software failure probability and the fault coverage of self monitoring mechanism are also described. The main risk contributors related to the digitalized safety system were determined in a quantitative manner. Reactor protection system and engineered safety feature component control system designed as part of the Korean Nuclear I and C System project are used as example systems. Fault-tree models were developed to assess the failure probability of a system function which is designed to generate an automated signal for actuating both of the reactor trip and the complicated accident-mitigation actions. The developed fault trees were combined with a plant risk model to evaluate the effect of a digitalized system's failure on the plant risk. (authors)

A Generic Software Safety Document Generator

Science.gov (United States)

Denney, Ewen; Venkatesan, Ram Prasad

2004-01-01

Formal certification is based on the idea that a mathematical proof of some property of a piece of software can be regarded as a certificate of correctness which, in principle, can be subjected to external scrutiny. In practice, however, proofs themselves are unlikely to be of much interest to engineers. Nevertheless, it is possible to use the information obtained from a mathematical analysis of software to produce a detailed textual justification of correctness. In this paper, we describe an approach to generating textual explanations from automatically generated proofs of program safety, where the proofs are of compliance with an explicit safety policy that can be varied. Key to this is tracing proof obligations back to the program, and we describe a tool which implements this to certify code auto-generated by AutoBayes and AutoFilter, program synthesis systems under development at the NASA Ames Research Center. Our approach is a step towards combining formal certification with traditional certification methods.

Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

Directory of Open Access Journals (Sweden)

M Venkatesh

2011-01-01

Full Text Available Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20 th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.

Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

Science.gov (United States)

Venkatesh, M.; Bairavi, V. G.; Sasikumar, K. C.

2011-01-01

Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. PMID:21430959

Nordic perspectives on safety management in high reliability organizations: Theory and applications

International Nuclear Information System (INIS)

Svenson, Ola; Salo, I.; Sjerve, A.B.; Reiman, T.; Oedewald, P.

2006-04-01

The chapters in this volume are written on a stand-alone basis meaning that the chapters can be read in any order. The first 4 chapters focus on theory and method in general with some applied examples illustrating the methods and theories. Chapters 5 and 6 are about safety management in the aviation industry with some additional information about incident reporting in the aviation industry and the health care sector. Chapters 7 through 9 cover safety management with applied examples from the nuclear power industry and with considerable validity for safety management in any industry. Chapters 10 through 12 cover generic safety issues with examples from the oil industry and chapter 13 presents issues related to organizations with different internal organizational structures. Although the many of the chapters use a specific industry to illustrate safety management, the messages in all the chapters are of importance for safety management in any high reliability industry or risky activity. The interested reader is also referred to, e.g., a document by an international NEA group (SEGHOF), who is about to publish a state of the art report on Systematic Approaches to Safety Management (cf., CSNI/NEA/SEGHOF, home page: www.nea.fr). (au)

Nordic perspectives on safety management in high reliability organizations: Theory and applications

Energy Technology Data Exchange (ETDEWEB)

Svenson, Ola; Salo, I; Sjerve, A B; Reiman, T; Oedewald, P [Stockholm Univ. (Sweden)

2006-04-15

The chapters in this volume are written on a stand-alone basis meaning that the chapters can be read in any order. The first 4 chapters focus on theory and method in general with some applied examples illustrating the methods and theories. Chapters 5 and 6 are about safety management in the aviation industry with some additional information about incident reporting in the aviation industry and the health care sector. Chapters 7 through 9 cover safety management with applied examples from the nuclear power industry and with considerable validity for safety management in any industry. Chapters 10 through 12 cover generic safety issues with examples from the oil industry and chapter 13 presents issues related to organizations with different internal organizational structures. Although the many of the chapters use a specific industry to illustrate safety management, the messages in all the chapters are of importance for safety management in any high reliability industry or risky activity. The interested reader is also referred to, e.g., a document by an international NEA group (SEGHOF), who is about to publish a state of the art report on Systematic Approaches to Safety Management (cf., CSNI/NEA/SEGHOF, home page: www.nea.fr). (au)

Integrated plant safety assessment. Systematic evaluation program, Big Rock Point Plant (Docket No. 50-155). Final report

International Nuclear Information System (INIS)

1984-05-01

The Systematic Evaluation Program was initiated in February 1977 by the U.S. Nuclear Regulatory Commission to review the designs of older operating nuclear reactor plants to reconfirm and document their safety. The review provides (1) an assessment of how these plants compare with current licensing safety requirements relating to selected issues, (2) a basis for deciding how these differences should be resolved in an integrated plant review, and (3) a documented evaluation of plant safety when the supplement to the Final Integrated Plant Safety Assessment Report has been issued. This report documents the review of the Big Rock Point Plant, which is one of ten plants reviewed under Phase II of this program. This report indicates how 137 topics selected for review under Phase I of the program were addressed. It also addresses a majority of the pending licensing actions for Big Rock Point, which include TMI Action Plan requirements and implementation criteria for resolved generic issues. Equipment and procedural changes have been identified as a result of the review

An Evaluation Methodology Development and Application Process for Severe Accident Safety Issue Resolution

Directory of Open Access Journals (Sweden)

Robert P. Martin

2012-01-01

Full Text Available A general evaluation methodology development and application process (EMDAP paradigm is described for the resolution of severe accident safety issues. For the broader objective of complete and comprehensive design validation, severe accident safety issues are resolved by demonstrating comprehensive severe-accident-related engineering through applicable testing programs, process studies demonstrating certain deterministic elements, probabilistic risk assessment, and severe accident management guidelines. The basic framework described in this paper extends the top-down, bottom-up strategy described in the U.S Nuclear Regulatory Commission Regulatory Guide 1.203 to severe accident evaluations addressing U.S. NRC expectation for plant design certification applications.

High level issues in reliability quantification of safety-critical software

International Nuclear Information System (INIS)

Kim, Man Cheol

2012-01-01

For the purpose of developing a consensus method for the reliability assessment of safety-critical digital instrumentation and control systems in nuclear power plants, several high level issues in reliability assessment of the safety-critical software based on Bayesian belief network modeling and statistical testing are discussed. Related to the Bayesian belief network modeling, the relation between the assessment approach and the sources of evidence, the relation between qualitative evidence and quantitative evidence, how to consider qualitative evidence, and the cause-consequence relation are discussed. Related to the statistical testing, the need of the consideration of context-specific software failure probabilities and the inability to perform a huge number of tests in the real world are discussed. The discussions in this paper are expected to provide a common basis for future discussions on the reliability assessment of safety-critical software. (author)

Review of criticality safety and shielding analysis issues for transportation packages

International Nuclear Information System (INIS)

Parks, C.V.; Broadhead, B.L.

1995-01-01

The staff of the Nuclear Engineering Applications Section (NEAS) at Oak Ridge National Laboratory (ORNL) have been involved for over 25 years with the development and application of computational tools for use in analyzing the criticality safety and shielding features of transportation packages carrying radioactive material (RAM). The majority of the computational tools developed by ORNL/NEAS have been included within the SCALE modular code system (SCALE 1995). This code system has been used throughout the world for the evaluation of nuclear facility and package designs. With this development and application experience as a basis, this paper highlights a number of criticality safety and shielding analysis issues that confront the designer and reviewer of a new RAM package. Changes in the types and quantities of material that need to be shipped will keep these issues before the technical community and provide challenges to future package design and certification

IAEA's experience in compiling a generic component reliability data base

International Nuclear Information System (INIS)

Tomic, B.; Lederman, L.

1988-01-01

Reliability data are an essential part of probabilistic safety assessment. The quality of data can determine the quality of the study as a whole. It is obvious that component failure data originated from the plant being analyzed would be most appropriate. However, in few cases complete reliance on plant experience is possible, mainly because of the rather limited operating experience. Nuclear plants, although of different design, often use fairly similar components, so some of the experience could be combined and transferred from one plant to another. In addition information about component failures is available also from experts with knowledge on component design, manufacturing and operation. That bring us to the importance of assessing generic data. (Generic is meant to be everything that is not plant specific regarding the plant being analyzed). The generic data available in the open literature, can be divided in three broad categories. The first one includes data base used in previous analysis. These can be plant specific or updated from generic with plant specific information (latter case deserve special attention). The second one is based on compilation of plants' operating experience usually based on some kind of event reporting system. The third category includes data sources based on expert opinions (single or aggregate) or combination of expert opinions and other nuclear and non-nuclear experience. This paper reflects insights gained in compiling data from generic data sources and highlights advantages and pitfalls of using generic component reliability data in PSAs

Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.

Science.gov (United States)

Vial, Jérôme; Cohen, Mélanie; Sassiat, Patrick; Thiébaut, Didier

2008-07-01

The aim of this study was to evaluate the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH versus those of the proprietary product Taxotere (Tx). Generic formulations were purchased in 14 countries in Asia, Africa, the Middle East and Latin America. Levels of docetaxel and impurities (chromatographic peaks above 0.05%) were obtained for each sample using reverse-phase liquid chromatography with ultraviolet detection. The pH of aqueous solutions of generic docetaxel formulations and Tx was also measured. A global evaluation of quality was conducted on each product using a multicriteria desirability analysis based on standards defined by the International Conference on Harmonisation guidelines and the US Pharmacopeia paclitaxel injection monograph. Most generic formulations contained a lower than expected amount of docetaxel and/or a high level of impurities: 21 generic docetaxel formulations had an average mass of docetaxel that was generic docetaxel formulations had a total impurity content of >3.0%, almost twice the level of impurities in Tx 20 mg. In total, 33 impurities not present in Tx were detected in the generic samples. Desirability analysis demonstrated that none of the generic docetaxel formulations had composition characteristics similar to those of Tx. This study demonstrated that from an analytical point of view, 90% of the generic docetaxel formulations evaluated contained insufficient active drug, high levels of impurities or both. This has the potential to affect both efficacy and safety of the drug.

The generic article

NARCIS (Netherlands)

Farkas, D.F.; Swart, Henriëtte de

2005-01-01

We take a fresh look at the connection between genericity and (in)definiteness by reconsidering a long-standing puzzle concerning the relation between definiteness and genericity. We contrast English on the one hand and Romance languages and Hungarian on the other, focusing on generic sentences

Safety issues of tooth whitening using peroxide-based materials.

Science.gov (United States)

Li, Y; Greenwall, L

2013-07-01

In-office tooth whitening using hydrogen peroxide (H₂O₂) has been practised in dentistry without significant safety concerns for more than a century. While few disputes exist regarding the efficacy of peroxide-based at-home whitening since its first introduction in 1989, its safety has been the cause of controversy and concern. This article reviews and discusses safety issues of tooth whitening using peroxide-based materials, including biological properties and toxicology of H₂O₂, use of chlorine dioxide, safety studies on tooth whitening, and clinical considerations of its use. Data accumulated during the last two decades demonstrate that, when used properly, peroxide-based tooth whitening is safe and effective. The most commonly seen side effects are tooth sensitivity and gingival irritation, which are usually mild to moderate and transient. So far there is no evidence of significant health risks associated with tooth whitening; however, potential adverse effects can occur with inappropriate application, abuse, or the use of inappropriate whitening products. With the knowledge on peroxide-based whitening materials and the recognition of potential adverse effects associated with the procedure, dental professionals are able to formulate an effective and safe tooth whitening regimen for individual patients to achieve maximal benefits while minimising potential risks.

Safety Culture and Issue in the Malaysian Manufacturing Sector

Directory of Open Access Journals (Sweden)

Ali Danish

2017-01-01

Full Text Available . This paper highlights the Safety culture and issue in the Malaysian Manufacturing Sector and emphasis the high occupational accidents due to lack of safety culture and non-compliance of the requirements of Occupational Safety and Health Act 1994. The aim of this study is to review the occupational accidents occurrence in the Malaysia workplace since 2012-2016. Malaysia aimed to reduce the occupational accidents, the results show by DOSH increase that Occupational Noise Induced Hearing Loss 83.7%, occupational musculoskeletal diseases, 4.4% and occupational lung diseases 2.3%. But the as per the record from DOSH that in last 5-Years, the increment in the fatal accidents by Average 26%, Permanent Disability by Average 71% and Non-Permanent Disability by 64 % are investigated only in Manufacturing Industries. The government must show their high interest on such a vulnerable employees to accomplish the above aim. This step will be helpful for planning to reduce the accidents in workplaces and it will also detect the prevention for the future accidents.

Contrast media. Safety issues and ESUR guidelines. 3. ed.

International Nuclear Information System (INIS)

Thomsen, Henrik S.; Webb, Judith A.W.

2014-01-01

Fully updates the previous edition and includes new chapters on various complex topics. Represents a unique and unparalleled source of information on the many safety issues relating to different contrast media. Includes chapters on acute and delayed non-renal adverse reactions and on renal adverse reactions. Presented in a handy, easy-to-use format. In 1994 the European Society of Urogenital Radiology (ESUR) set up a committee to consider the safety of contrast media used for diagnostic imaging. Subsequently the committee questioned ESUR members, reviewed the literature, proposed guidelines, and discussed these proposals with participants at the annual symposia of the society. The end result of this work was the successful first edition of this book, published in 2006, which was followed by an equally successful second edition in 2009. This third edition not only fully updates the previous edition, but also includes new chapters on complex topics such as use of contrast media in children and practical aspects of off-label contrast media use. The authorship includes members, past members, and non-members of the Contrast Media Safety Committee.

Special Issue. 5th Meeting on Technology and Safety

International Nuclear Information System (INIS)

Kusakabe, Masashi; Kumagaya, Tadafusa; Minohara, Shinichi

2010-01-01

The documents in this Special Issue are the representative reports of achievements presented in the National Institute of Radiological Sciences (NIRS) 5th Meeting on Technology and Safety held on March 17, 2010. Personnel and investigators of NIRS and related companies gave their achievements by 19 oral and 31 poster presentations in fields of [IAR] irradiation (2 topics), accelerator/radiometry (9 topics), [EA] experimental animals (25 topics), [SM] safety management of facilities (5 topics), computer network system (4 topics), experimental instrument (1 topic), molecular imaging (2 topics) and others (2 topics). The Issue contains, as well as introductory and ending remarks, following 12 topics: [IAR] Working report of patient positioning system for radiotherapy with use of X-ray flat panel detector; Status of maintenance and management of facilities and equipments in Research center for Radiation Emergency Medicine; [EA] Past, present and future of mouse breeding in NIRS; Breeding of marmoset in NIRS/How can we have a bouncing marmoset baby?; Establishment of a genotyping method of transformed genes in transgenic mouse/genome walking method; Genetic monitoring system of mice by micro-satellite marker and its application in NIRS; Verification of sorting precision of FACSAria (Becton Dickinson and Co.), a highly sensitive, rapid sorting apparatus of cells/for precise sorting; Proposal of a task-solution workflow to determine the animal features for molecular imaging studies; [SM] Toward the introduction of Occupational Safety and Health Management System in NIRS; Use of unsealed radioisotopes less than the lower limit outside the legal control area; Arrangement of managing and supporting system for clinical studies; and Rearrangement of working system of personnel affairs. (T.T.)

Patient safety challenges in a case study hospital--of relevance for transfusion processes?

Science.gov (United States)

Aase, Karina; Høyland, Sindre; Olsen, Espen; Wiig, Siri; Nilsen, Stein Tore

2008-10-01

The paper reports results from a research project with the objective of studying patient safety, and relates the finding to safety issues within transfusion medicine. The background is an increased focus on undesired events related to diagnosis, medication, and patient treatment in general in the healthcare sector. The study is designed as a case study within a regional Norwegian hospital conducting specialised health care services. The study includes multiple methods such as interviews, document analysis, analysis of error reports, and a questionnaire survey. Results show that the challenges for improved patient safety, based on employees' perceptions, are hospital management support, reporting of accidents/incidents, and collaboration across hospital units. Several of these generic safety challenges are also found to be of relevance for a hospital's transfusion service. Positive patient safety factors are identified as teamwork within hospital units, a non-punitive response to errors, and unit manager's actions promoting safety.

The generic drug user fee amendments: an economic perspective

Science.gov (United States)

Berndt, Ernst R; Murphy, Stephen J

2018-01-01

Abstract Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes. PMID:29707218

Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

Science.gov (United States)

Rostron, Allen

2011-02-01

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

An approach to maintenance optimization where safety issues are important

International Nuclear Information System (INIS)

Vatn, Jorn; Aven, Terje

2010-01-01

The starting point for this paper is a traditional approach to maintenance optimization where an object function is used for optimizing maintenance intervals. The object function reflects maintenance cost, cost of loss of production/services, as well as safety costs, and is based on a classical cost-benefit analysis approach where a value of prevented fatality (VPF) is used to weight the importance of safety. However, the rationale for such an approach could be questioned. What is the meaning of such a VPF figure, and is it sufficient to reflect the importance of safety by calculating the expected fatality loss VPF and potential loss of lives (PLL) as being done in the cost-benefit analyses? Should the VPF be the same number for all type of accidents, or should it be increased in case of multiple fatality accidents to reflect gross accident aversion? In this paper, these issues are discussed. We conclude that we have to see beyond the expected values in situations with high safety impacts. A framework is presented which opens up for a broader decision basis, covering considerations on the potential for gross accidents, the type of uncertainties and lack of knowledge of important risk influencing factors. Decisions with a high safety impact are moved from the maintenance department to the 'Safety Board' for a broader discussion. In this way, we avoid that the object function is used in a mechanical way to optimize the maintenance and important safety-related decisions are made implicit and outside the normal arena for safety decisions, e.g. outside the traditional 'Safety Board'. A case study from the Norwegian railways is used to illustrate the discussions.

An approach to maintenance optimization where safety issues are important

Energy Technology Data Exchange (ETDEWEB)

Vatn, Jorn, E-mail: jorn.vatn@ntnu.n [NTNU, Production and Quality Engineering, 7491 Trondheim (Norway); Aven, Terje [University of Stavanger (Norway)

2010-01-15

The starting point for this paper is a traditional approach to maintenance optimization where an object function is used for optimizing maintenance intervals. The object function reflects maintenance cost, cost of loss of production/services, as well as safety costs, and is based on a classical cost-benefit analysis approach where a value of prevented fatality (VPF) is used to weight the importance of safety. However, the rationale for such an approach could be questioned. What is the meaning of such a VPF figure, and is it sufficient to reflect the importance of safety by calculating the expected fatality loss VPF and potential loss of lives (PLL) as being done in the cost-benefit analyses? Should the VPF be the same number for all type of accidents, or should it be increased in case of multiple fatality accidents to reflect gross accident aversion? In this paper, these issues are discussed. We conclude that we have to see beyond the expected values in situations with high safety impacts. A framework is presented which opens up for a broader decision basis, covering considerations on the potential for gross accidents, the type of uncertainties and lack of knowledge of important risk influencing factors. Decisions with a high safety impact are moved from the maintenance department to the 'Safety Board' for a broader discussion. In this way, we avoid that the object function is used in a mechanical way to optimize the maintenance and important safety-related decisions are made implicit and outside the normal arena for safety decisions, e.g. outside the traditional 'Safety Board'. A case study from the Norwegian railways is used to illustrate the discussions.

Defining safety culture and the nexus between safety goals and safety culture. 4. Enhancing Safety Culture Through the Establishment of Safety Goals

International Nuclear Information System (INIS)

Tateiwa, Kenji; Miyata, Koichi; Yahagi, Kimitoshi

2001-01-01

efficient management. To seek compatibility between safety culture and efficient management, and to build an agreeable common perception among the utility, regulatory body, and the public on rationalizing the safety level to the extent acceptable, two issues must be considered: (a) establishing safety goals and (b) quantifying the safety culture. As for the first issue, currently no generic safety goal for the nuclear industry is available in Japan. This causes difficulty in deciding whether or not a specific action that takes place in a plant leading to a certain amount of risk increment is acceptable. Therefore, it is important for us to have a safety goal established. By establishing the safety goal, we could utilize it for the following usage: 1. to enable prompt response in case a safety level has entered an unacceptable level; 2. to sustain and enhance the safety culture centered by risk information (sustaining safety culture and achieving rational management simultaneously); 3. to use public relations for plant activities, where condemnation for overlooking safety culture might arrive for a minor risk increasing activity. As for the second issue, we must devise a method to quantify the level of safety culture. This could be done based on the safety culture indicators listed in the appendix of IAEA INSAG-4 (Ref. 1). By quantifying the level of safety culture, a comprehensive safety level of a plant can be evaluated by integrating with the safety level based on PSA. For example, when considering on-line maintenance for specific equipment, it is important not only to assess the safety level in terms of PSA but also to assess the level of safety culture in order to have a comprehensive view of the safety level and to compare it with the safety goal. By both establishing safety goals and quantifying the level of safety culture in a nuclear power plant, the ability to assess the comprehensive safety level of a plant and acknowledge the quantitative margin from the safety

[The patents game. Generic and biosimilar drugs].

Science.gov (United States)

Villamañán, E; González, D; Armada, E; Ruano, M; Álvarez-Sala, R; Herrero, A

2016-01-01

The protection provided by patents on medicines has a limited duration. The expiry of patents expiration allows copies of the drugs to be released, competing with original. At first, they were identical to the original, known as generic drugs, but in recent years, due to the marketing of biological therapies and the expiry of many of their patents, biosimilar drugs have also emerged. These are not exact copies of the original, but, like generic drugs, biosimilar drugs have to demonstrate equivalence to the reference drugs in quality, safety and efficacy. Nevertheless, despite their importance and contribution to sustainability of health system, doctors are sometimes unaware of differences between them, and their impact in terms of clinical and economic effects. An attempt is made to review and clarify certain aspects often unknown by physicians, despite their involvement in their use. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

International conference on topical issues in nuclear installation safety: Continuous improvement of nuclear safety in a changing world. Book of contributed papers

Energy Technology Data Exchange (ETDEWEB)

NONE

2004-07-01

Papers presented at this conference where devoted to the following NPP safety related topical issues: Changing environments - coping with diversity and globalisation; Operating experience - managing changes effectively; Regulatory management systems - adapting to changes in the environment; Long term operations - maintaining safety margins while extending plant lifetime.

Safety and Regulatory Issues of the Thorium Fuel Cycle

Energy Technology Data Exchange (ETDEWEB)

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

2014-02-01

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

Assessment of policy issues in nuclear safety regulation according to circumstantial changes

Energy Technology Data Exchange (ETDEWEB)

Chang, Soon Heung; Lee, Byong Ho; Baek, Woon Pil; Lee, Seong Wook; Choi, Seong Soo; Roh, Chang Hyun; Lee, Kwang Gu [Korea Advanced Institute of Scienc and Technology, Taejon (Korea, Republic of)

1998-03-15

The objective of the work is to assess various issues in nuclear safety regulation in consideration of circumstantial changes. Emphasis is given to the safety of operating NPPs. The derivation of an effective regulation system considering 'Rhodic Safety Review (PSR)', 'operating License Renewal (LR)', 'backfitting' and 'maintenance rule' is the main objective of the first two years. It is found that those approaches should be introduced in Korea as soon as possible, with cross lingkage to maximize the effectiveness of regulation. In particular, the approaches for PSR are discussed with consultation of IAEA document and foreign practices.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics

Science.gov (United States)

Straka, Robert J.; Keohane, Denis J.; Liu, Larry Z.

2017-01-01

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003–2013 using key words of “generic switching” or “substitution” was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases. PMID:26099048

Thermal overload protection for electric motors on safety-related motor-operated valves: Generic Issue II.E.6.1

International Nuclear Information System (INIS)

Rothberg, O.

1988-06-01

NRC regulatory positions, as stated in Regulatory Guide 1.106, Revision 1, have been identified by the Office for Analysis and Evaluation of Operational Data (AEOD) as potential contributors to valve motor burnout. AEOD is particularly concerned about the allowed policy of bypassing thermal overload devices during normal or accident conditions. Regulatory Guide 1.106 favors compromising the function of thermal overload devices in favor of completing the safety-related action of valves. The purpose of this study was to determine if the guidance contained in Regulatory Guide 1.106 is appropriate and, if not, to recommend the necessary changes. This report describes thermal overload devices commonly used to protect safety-related valve operator motors. The regulatory guidelines stated in Regulatory Guide 1.106 along with the limitations of thermal overload protection are discussed. Supplements and alternatives to thermal overload protection are also described. Findings and conclusions of several AEOD reports are discussed. Information obtained from the standard review plan, standard technical specifications, technical specifications from representative plants, and several papers are cited

[Generic drugs: good or bad? Physician's knowledge of generic drugs and prescribing habits].

Science.gov (United States)

García, A J; Martos, F; Leiva, F; Sánchez de la Cuesta, F

2003-01-01

In this article we analyze the responses of 1220 Spanish physicians who participated in a survery about generic drugs. A previously validated questionnaire was sent to physicians through the Spanish Medical Councils of the different provinces. Four items were analyzed: what doctors know about generic drugs (knowledge); physicians' prescribing habits concerning these drugs (attitude and professional competence); how prescription of generic drugs effects pharmaceutical costs amd, finally, what doctors believe a generic drug should be. The influence of physician-related variables (age, type of contract, specialty, workload, etc.) on prescribing of generic drugs was also analyzed. In view of the results, we believe that to rationalize expenditure through and appropriate policy on generic drugs Spanish health authorities should offer more and better training and information (clear and independent) about what generic drugs are.

Deeply discounted medications: Implications of generic prescription drug wars.

Science.gov (United States)

Czechowski, Jessica L; Tjia, Jennifer; Triller, Darren M

2010-01-01

To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. Publicly available generic prescription discount program drug lists as of May 1, 2009. Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.

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)

Development of safety analysis technology for integral reactor

International Nuclear Information System (INIS)

Kim, Hee Cheol; Kim, K. K.; Kim, S. H.

2002-04-01

The state-of-the-arts for the integral reactor was performed to investigate the safety features. The safety and performance of SMART were assessed using the technologies developed during the study. For this purpose, the computer code system and the analysis methodology were developed and the safety and performance analyses on SMART basic design were carried out for the design basis event and accident. The experimental facilities were designed for the core flow distribution test and the self-pressurizing pressurizer performance test. The tests on the 2-phase critical flow with non-condensable gas were completed and the results were used to assess the critical flow model. Probabilistic Safety Assessment(PSA) was carried out to evaluate the safety level and to optimize the design by identifying and remedying any weakness in the design. A joint study with KINS was carried out to promote licensing environment. The generic safety issues of integral reactors were identified and the solutions were formulated. The economic evaluation of the SMART desalination plant and the activities related to the process control were carried out in the scope of the study

Comparing recurrent antibiotic prescriptions in children treated with a brand name or a generic formulation.

Science.gov (United States)

Piovani, Daniele; Clavenna, Antonio; Cartabia, Massimo; Bortolotti, Angela; Fortino, Ida; Merlino, Luca; Bonati, Maurizio

2015-02-01

The aim of this study was to investigate the rate of recurrent prescriptions and hospital admissions in children receiving a brand name or generic antibiotic prescription. The data source was a database of reimbursed prescriptions. Outpatient children/adolescents brand name formulations and for each age strata (0-5, 6-11, and 12-17 years old) for four antibiotics: amoxicillin, amoxicillin clavulanate, clarithromycin, and cefaclor. The percentage of therapy switches was calculated. Cochran-Mantel-Haenszel test was used to compare the age-adjusted outcomes. In all, 17.5% (57 346) of children received at least one recurrent prescription. The rate of recurrent prescriptions was slightly lower in children receiving any generic (OR 0.96; 95%CI 0.93-0.98), compared with any brand name, antibiotic. The percentage of hospital admissions occurring in children initially treated with a brand name (1.01%; 95%CI 0.98-1.08) or generic (1.03%; 0.96-1.06) antibiotic was not different (p = 0.43). For children receiving amoxicillin clavulanate, the hospital admission rate was slightly higher in the brand name group (p = 0.002), while no differences were found for the other active substances. Children treated with generic antibiotics had no worse safety and effectiveness outcomes when compared with those receiving brand name ones. These results provide additional evidence on the safety of generic antibiotics. Copyright © 2014 John Wiley & Sons, Ltd.