WorldWideScience

Sample records for generic site safety

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. Prioritization of generic safety issues

    International Nuclear Information System (INIS)

    Emrit, R.; Minners, W.; VanderMolen, H.

    1983-12-01

    This report presents the priority rankings for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The report focuses on the prioritization of generic safety issues. Issues primarily concerned with the licensing process or environmental protection and not directly related to safety have been excluded from prioritization. The prioritized issues include: TMI Action Plan items under development; previously proposed issues covered by Task Action Plans, except issues designated at Unresolved Safety Issues (USIs) which had already been assigned high priority; and newly-proposed issues. Future supplements to this report will include the prioritization of additional issues. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolutions of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative

  8. 78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

    Science.gov (United States)

    2013-04-16

    ...] Generic Drug Facilities, Sites, and Organizations AGENCY: Food and Drug Administration, HHS. ACTION.... Generic drug facilities, certain sites, and organizations identified in a generic drug submission are... active pharmaceutical ingredients and certain other sites and organizations that support the manufacture...

  9. A prioritization of generic safety issues

    International Nuclear Information System (INIS)

    Emrit, R.; Riggs, R.; Milstead, W.; Pittman, J.

    1991-07-01

    This report presents the priority rankings for generic safety issues and related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The report focuses on the prioritization of generic safety issues. Issues primarily concerned with the licensing process or environmental protection and not directly related to safety have been excluded from prioritization. The prioritized issues include: TMI Action Plan items under development; previously proposed issues covered by Task Action Plans, except issues designated as Un-resolved Safety Issues (USIs) which had already been assigned high priority; and newly-proposed issues. Future supplements to this report will include the prioritization of additional issues. The safety priority rankings are High, Medium, Low, and Drop and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolutions of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. 1310 refs

  10. Central repository for low- and intermediate-level waste (ALMA) conceptual design, siting and safety study

    International Nuclear Information System (INIS)

    Kjellbert, N.; Haeggblom, H.; Cederstroem, M.; Lundgren, T.

    1980-07-01

    A generic design, siting and safety study of a proposed repository for low- and intermediate-level waste has been made. Special emphasis has been placed on safety characterostics. The conceptual design and the generic site, on which the study is based, are realistically chosen in accordance with present construction techniques and the existing geohydrological conditions in Sweden. (Auth.)

  11. 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.

  12. Effect of generic issues program on improving safety

    International Nuclear Information System (INIS)

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

    2010-01-01

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

  13. 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

  14. 77 FR 60125 - Generic Drug Facilities, Sites and Organizations

    Science.gov (United States)

    2012-10-02

    ...] Generic Drug Facilities, Sites and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice..., and certain sites and organizations identified in a generic drug submission, that they must provide... and Innovation Act (FDASIA). This notice is intended to help organizations ascertain if they need to...

  15. 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)

  16. 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

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

    International Nuclear Information System (INIS)

    1992-12-01

    This report is to provide a comprehensive description of the implementation and verification status of Three Mile Island (TMI) Action Plan requirements, safety issues designated as Unresolved Safety Issues (USIs), Generic Safety Issues(GSIs), and other Multiplant Actions (MPAs) that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. An additional 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 or until the NRC issues a request for action by licensees

  18. Method for assigning sites to projected generic nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Holter, G.M.; Purcell, W.L.; Shutz, M.E.; Young, J.R.

    1986-07-01

    Pacific Northwest Laboratory developed a method for forecasting potential locations and startup sequences of nuclear power plants that will be required in the future but have not yet been specifically identified by electric utilities. Use of the method results in numerical ratings for potential nuclear power plant sites located in each of the 10 federal energy regions. The rating for each potential site is obtained from numerical factors assigned to each of 5 primary siting characteristics: (1) cooling water availability, (2) site land area, (3) power transmission land area, (4) proximity to metropolitan areas, and (5) utility plans for the site. The sequence of plant startups in each federal energy region is obtained by use of the numerical ratings and the forecasts of generic nuclear power plant startups obtained from the EIA Middle Case electricity forecast. Sites are assigned to generic plants in chronological order according to startup date.

  19. Method for assigning sites to projected generic nuclear power plants

    International Nuclear Information System (INIS)

    Holter, G.M.; Purcell, W.L.; Shutz, M.E.; Young, J.R.

    1986-07-01

    Pacific Northwest Laboratory developed a method for forecasting potential locations and startup sequences of nuclear power plants that will be required in the future but have not yet been specifically identified by electric utilities. Use of the method results in numerical ratings for potential nuclear power plant sites located in each of the 10 federal energy regions. The rating for each potential site is obtained from numerical factors assigned to each of 5 primary siting characteristics: (1) cooling water availability, (2) site land area, (3) power transmission land area, (4) proximity to metropolitan areas, and (5) utility plans for the site. The sequence of plant startups in each federal energy region is obtained by use of the numerical ratings and the forecasts of generic nuclear power plant startups obtained from the EIA Middle Case electricity forecast. Sites are assigned to generic plants in chronological order according to startup date

  20. Generic Site Safety Report

    CERN Document Server

    International Atomic Energy Agency. Vienna. ITER Joint Central Team

    2001-01-01

    The ITER Engineering Design Activities (EDA) are being conducted jointly by Euratom, Japan, and the Russian Federation, as Parties to the ITER EDA Agreement signed on 21 July 1992 and subsequently extended until July 20th 2001. (The United States of America was an ITER Party until September 30th 1999). The activities are conducted under the auspices of the IAEA by the ITER Joint Central Team and by the Home Teams (HT). The JCT is composed of qualified persons made available by each of the Parties in approximately equal numbers. The JCT members are located at the ITER Joint Work Sites (JWS) in Naka (Japan), Garching (Germany), and formerly in San Diego (USA). The Home Teams are established and organized by each Party for performing the tasks of the work programme for the EDA, assigned to them in approximately equal shares. Home Teams in each of the Parties perform specific design tasks, and perform research and development in technology (physics R&D is contributed voluntarily). The Home Team Leaders (HTL) ...

  1. 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)

  2. 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.

  3. Draft report on compilation of generic safety issues for light water reactor nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-07-01

    A generally accepted approach to characterizing the safety concerns in nuclear power plants is to express them as safety issues which need to be resolved. When such safety issues are applicable to a generation of plants of a particular design or to a family of plants of similar design, they are termed generic safety issues. Examples of generic safety issues are those related to reactor vessel embrittlement, control rod insertion reliability or strainer clogging. The safety issues compiled in this document are based on broad international experience. This compilation is one element in the framework of IAEA activities to assist Member States in reassessing the safety of operating nuclear power plants. Refs.

  4. Draft report on compilation of generic safety issues for light water reactor nuclear power plants

    International Nuclear Information System (INIS)

    1997-07-01

    A generally accepted approach to characterizing the safety concerns in nuclear power plants is to express them as safety issues which need to be resolved. When such safety issues are applicable to a generation of plants of a particular design or to a family of plants of similar design, they are termed generic safety issues. Examples of generic safety issues are those related to reactor vessel embrittlement, control rod insertion reliability or strainer clogging. The safety issues compiled in this document are based on broad international experience. This compilation is one element in the framework of IAEA activities to assist Member States in reassessing the safety of operating nuclear power plants. Refs

  5. 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

  6. 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)

  7. 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.

  8. A program approach for site safety at oil spills

    International Nuclear Information System (INIS)

    Whipple, F.L.; Glenn, S.P.; Ocken, J.J.; Ott, G.L.

    1993-01-01

    When OSHA developed the hazardous waste operations (Hazwoper) regulations (29 CFR 1910.120) members of the response community envisioned a separation of oil and open-quotes hazmatclose quotes response operations. Organizations that deal with oil spills have had difficulty applying Hazwoper regulations to oil spill operations. This hinders meaningful implementation of the standard for their personnel. We should approach oil spills with the same degree of caution that is applied to hazmat response. Training frequently does not address the safety of oil spill response operations. Site-specific safety and health plans often are neglected or omitted. Certain oils expose workers to carcinogens, as well as chronic and acute hazards. Significant physical hazards are most important. In responding to oil spills, the hazards must be addressed. It is the authors' contention that a need exists for safety program at oil spill sites. Gone are the days of labor pool hires cleaning up spills in jeans and sneakers. The key to meaningful programs for oil spills requires application of controls focused on relevant safety risks rather than minimal chemical exposure hazards. Working with concerned reviewers from other agencies and organizations, the authors have developed a general safety and health program for oil spill response. It is intended to serve as the basis for organizations to customize their own written safety and health program (required by OSHA). It also provides a separate generic site safety plan for emergency phase oil spill operations (check-list) and long term post-emergency phase operations

  9. 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...

  10. 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

  11. Status of safety issues at licensed power plants: TMI action plan requirements, unresolved safety issues, generic safety issues

    International Nuclear Information System (INIS)

    1991-12-01

    As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, a program was established whereby an annual NUREG report would be published on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was compiled and reported in three NUREG volumes. Volume 1, published in March 1991, addressed the status of of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). This annual NUREG report combines these volumes into a single report and provides updated information as of September 30, 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. This report is to provide a comprehensive description of the implementation and verification status of TMI Action Plan Requirements, safety issues designated as USIs, and GSIs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. An additional 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 or until the NRC issues a request for action by licensees

  12. 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

  13. 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)

  14. Light Water Reactor Generic Safety Issues Database (LWRGSIDB). User's manual

    International Nuclear Information System (INIS)

    1999-01-01

    resolved in other plants and which can be used in reassessing the safety of individual operating plants. The IAEA-TECDOC-1044, Generic Safety Issues for Nuclear Power Plants with Light Water Reactors and Measures Taken for Their Resolution (September 1998), is a compilation of such safety issues which is based on broad international experience. This compilation is one element within the framework of IAEA activities to assist Member States in reassessing the safety of operating nuclear power plants. It is a compilation not only of the generic safety issues identified in nuclear power plants but also, in almost all cases, the measures taken to resolve these issues. The safety issues, which are generic in nature with regard to light water reactors (LWRs), and the measures taken for their resolution, are intended for use as a reference in the reassessment of the safety of operating plants.The information contained in the main body of the TECDOC has been used to establish a database. This database has search, query and report functions. This information is thus available in an electronic form which can be selectively queried and with which reports can be produced according to the requirements of the user. The database also enables the IAEA to update the data periodically on the basis of information made available by Member States

  15. Generic safety issues for nuclear power plants with light water reactors and measures taken for their resolution

    International Nuclear Information System (INIS)

    1998-09-01

    The IAEA Conference on 'The Safety of Nuclear Power: Strategy for the Future' in 1991 was a milestone in nuclear safety. Two of the important items addressed by this conference were ensuring and enhancing safety of operating plants and treatment of nuclear power plants built to earlier safety standards. A number of publications related to these two items issued subsequent to this conference were: A Common Basis for Judging the Safety of Nuclear Power Plants Built to Earlier Standards, INSAG-9 (1995), the IAEA Safety Guide 50-SG-O12, periodic Safety Review of Operational Nuclear Power Plants (1994) and an IAEA publication on the Safety Evaluation of Operating Nuclear Power Plants Built to Earlier Standards - A Common Basis for Judgement (1997). Some of the findings of the 1991 Conference have not yet been fully addressed. An IAEA Symposium on reviewing the Safety of Existing Nuclear Power Plants in 1996 showed that there is an urgent need for operating organizations and national authorities to review operating nuclear power plants which do not meet the high safety levels of the vast majority of plants and to undertake improvements with assistance from the international community if required. Safety reviews of operating nuclear power plants take on added importance in the context of the Convention on Nuclear safety and its implementation. The purpose of this TECDOC compilation based on broad international experience, is to assist the Member States in the reassessment of operating plants by providing a list of generic safety issues identified in nuclear power plants together with measures taken to resolve these issues. These safety issues are generic in nature with regard to light water reactors and the measures for their resolution are for use as a reference for the safety reassessment of operating plants. The TECDOC covers issues thought to be significant to Member States based on consensus process. It provides an introduction to the use of generic safety issues for

  16. A prioritization of generic safety issues. Supplement 21, Revision insertion instructions

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    1996-12-31

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative.

  17. A prioritization of generic safety issues. Supplement 21, Revision insertion instructions

    International Nuclear Information System (INIS)

    1996-01-01

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative.

  18. A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

    International Nuclear Information System (INIS)

    1995-11-01

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report

  19. A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

    Energy Technology Data Exchange (ETDEWEB)

    None

    1995-11-01

    The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors. To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.

  20. Resolution of Generic Safety Issue 29: Bolting degradation or failure in nuclear power plants

    International Nuclear Information System (INIS)

    Johnson, R.E.

    1990-06-01

    This report describes the US Nuclear Regulatory Commission's (NRC's) Generic Safety Issue 29, ''Bolting Degradation or Failure in Nuclear Power Plants,'' including the bases for establishing the issue and its historical highlights. The report also describes the activities of the Atomic Industrial Forum (AIF) relevant to this issue, including its cooperation with the Materials Properties Council (MPC) to organize a task group to help resolve the issue. The Electric Power Research Institute, supported by the AIF/MPC task group, prepared and issued a two-volume document that provides, in part, the technical basis for resolving Generic Safety Issue 29. This report presents the NRC's review and evaluation of the two-volume document and NRC's conclusion that this document, in conjunction with other information from both industry and NRC, provides the bases for resolving this issue

  1. 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...

  2. Nuclear installations sites safety

    International Nuclear Information System (INIS)

    Barber, P.; Candes, P.; Duclos, P.; Doumenc, A.; Faure, J.; Hugon, J.; Mohammadioun, B.

    1988-11-01

    This report is divided into ten parts bearing: 1 Safety analysis procedures for Basis Nuclear Installations sites (BNI) in France 2 Site safety for BNI in France 3 Industrial and transport activities risks for BNI in France 4 Demographic characteristics near BNI sites in France 5 Meteorologic characteristics of BNI sites in France 6 Geological aspects near the BNI sites in France 7 Seismic studies for BNI sites in France 8 Hydrogeological aspects near BNI sites in France 9 Hydrological aspects near BNI sites in France 10 Ecological and radioecological studies of BNI sites in France [fr

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

    International Nuclear Information System (INIS)

    1993-12-01

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

  4. Biosphere models for safety assesment of radioactive waste disposal

    Energy Technology Data Exchange (ETDEWEB)

    Proehl, G; Olyslaegers, G; Zeevaert, T [SCK/CEN, Mol (Belgium); Kanyar, B [University of Veszprem (Hungary). Dept. of Radiochemistry; Pinedo, P; Simon, I [Centro de Investigaciones Energeticas Medioambientales y Tecnologicas (CIEMAT), Madrid (Spain); Bergstroem, U; Hallberg, B [Studsvik Ecosafe, Nykoeping (Sweden); Mobbs, S; Chen, Q; Kowe, R [NRPB, Chilton, Didcot (United Kingdom)

    2004-07-01

    The aim of the BioMoSA project has been to contribute in the confidence building of biosphere models, for application in performance assessments of radioactive waste disposal. The detailed objectives of this project are: development and test of practical biosphere models for application in long-term safety studies of radioactive waste disposal to different European locations, identification of features, events and processes that need to be modelled on a site-specific rather than on a generic base, comparison of the results and quantification of the variability of site-specific models developed according to the reference biosphere methodology, development of a generic biosphere tool for application in long term safety studies, comparison of results from site-specific models to those from generic one, Identification of possibilities and limitations for the application of the generic biosphere model. (orig.)

  5. Biosphere models for safety assessment of radioactive waste disposal

    International Nuclear Information System (INIS)

    Proehl, G.; Olyslaegers, G.; Zeevaert, T.; Kanyar, B.; Bergstroem, U.; Hallberg, B.; Mobbs, S.; Chen, Q.; Kowe, R.

    2004-01-01

    The aim of the BioMoSA project has been to contribute in the confidence building of biosphere models, for application in performance assessments of radioactive waste disposal. The detailed objectives of this project are: development and test of practical biosphere models for application in long-term safety studies of radioactive waste disposal to different European locations, identification of features, events and processes that need to be modelled on a site-specific rather than on a generic base, comparison of the results and quantification of the variability of site-specific models developed according to the reference biosphere methodology, development of a generic biosphere tool for application in long term safety studies, comparison of results from site-specific models to those from generic one, Identification of possibilities and limitations for the application of the generic biosphere model. (orig.)

  6. 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

  7. Nuclear power: Siting and safety

    International Nuclear Information System (INIS)

    Openshaw, S.

    1986-01-01

    By 2030, half, or even two-thirds, of all electricity may be generated by nuclear power. Major reactor accidents are still expected to be rare occurrences, but nuclear safety is largely a matter of faith. Terrorist attacks, sabotage, and human error could cause a significant accident. Reactor siting can offer an additional, design-independent margin of safety. Remote geographical sites for new plants would minimize health risks, protect the industry from negative changes in public opinion concerning nuclear energy, and improve long-term public acceptance of nuclear power. U.K. siting practices usually do not consider the contribution to safety that could be obtained from remote sites. This book discusses the present trends of siting policies of nuclear power and their design-independent margin of safety

  8. 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.

  9. 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.

  10. Preliminary safety evaluation for the Simpevarp subarea. Based on data and site descriptions after the initial site investigation stage

    International Nuclear Information System (INIS)

    2005-04-01

    elucidate the importance of these uncertainties. The migration properties of the rock matrix (porosity, formation factor and K d ) meet the preferred values. However, the values are based on few samples only and evaluation of more samples would thus enhance this conclusion. The assessments made for the PSE also suggest some implications for design, some of which are of a generic character to be considered also for the other sites. The most important such feedbacks are: Compared to the actual safety requirement, the design rules for discarding canister positions due to potential intersection with too large fractures or deformation zones are overly restrictive. The percentage of deposition holes to be discarded would substantially decrease if the design rules were better harmonised with the actual safety requirements. However, it is important to note that current design rules overestimate the number of discarded deposition holes. The spatial variability of the thermal conductivity may be too large to be consistent with the currently adopted design rules, which only consider mean values and a margin to handle spatial variability. The additional temperature analyses conducted here and the predicted spatial variability of thermal conductivity imply that the canister spacing currently suggested by design may be insufficient at some canister locations. The temperature margin for the gaps between canister/buffer and buffer/rock and for the uncertainty/variability in rock thermal conductivity applied in the design work should be revisited, since the present rules seem to leave too little margin for these factors. Finally, this PSE also highlights issues that would have to be considered if the Simpevarp subarea was to be assessed in a full safety assessment. Most of the issues are rather generic in nature and thus also warrant consideration in future safety assessments of other sites

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

    International Nuclear Information System (INIS)

    Serkiz, A.W.

    1988-04-01

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

  12. Region-scale groundwater flow modelling of generic high level waste disposal sites

    International Nuclear Information System (INIS)

    Metcalfe, D.

    1996-02-01

    Regional-scale groundwater flow modelling analyses are performed on generic high level waste (HLW) disposal sites to assess the extent to which a large crystalline rock mass such as a pluton or batholith can be expected to contain and isolate HLW in terms of hydraulic considerations, for a variety of geologic and hydrogeologic conditions. The two-dimensional cross-sectional conceptual models of generic HLW disposal sites are evaluated using SWIFT III, which is a finite-difference flow and transport code. All steps leading to the final results and conclusions are incorporated in this report. The available data and information on geological and hydrogeologic conditions in plutons and batholiths are summarized. The generic conceptual models developed from this information are defined in terms of the finite difference grid, the geologic and hydrogeologic properties and the hydrologic boundary conditions used. The modelled results are described with contour maps showing the modelled head fields, groundwater flow paths and travel times and groundwater flux rates within the modelled systems. The results of the modelling analyses are used to develop general conclusions on the scales and patterns of groundwater flow in granitic plutons and batholiths. The conclusions focus on geologic and hydrogeologic characteristics that can result in favourable conditions, in terms of hydraulic considerations, for a HLW repository. (author) 43 refs., 9 tabs., 40 figs

  13. Status of safety issues at licensed power plants: TMI Action Plan requirements, unresolved safety issues, generic safety issues, other multiplant action issues. Supplement 4

    International Nuclear Information System (INIS)

    1994-12-01

    As part of ongoing US Nuclear Regulatory Commission (NRC) efforts to ensure the quality and accountability of safety issue information, the NRC established a program for publishing an annual report on the status of licensee implementation and NRC verification of safety issues in major NRC requirements areas. This information was initially compiled and reported in three NUREG-series volumes. Volume 1, published in March 1991, addressed the status of Three Mile Island (TMI) Action Plan Requirements. Volume 2, published in May 1991, addressed the status of unresolved safety issues (USIs). Volume 3, published in June 1991, addressed the implementation and verification status of generic safety issues (GSIs). The first annual supplement, which combined these volumes into a single report and presented updated information as of September 30, 1991, was published in December 1991. The second annual supplement, which provided updated information as of September 30, 1992, was published in December 1992. Supplement 2 also provided the status of licensee implementation and NRC verification of other multiplant action (MPA) issues not related to TMI Action Plan requirements, USIs, or GSIs. Supplement 3 gives status as of September 30, 1993. This annual report, Supplement 4, presents updated information as of September 30, 1994. This report gives a comprehensive description of the implementation and verification status of TMI Action Plan requirements, safety issues designated as USIs, GSIs, and other MPAs that have been resolved and involve implementation of an action or actions by licensees. This report makes the information available to other interested parties, including the public. Additionally, this report serves as a follow-on to NUREG-0933, ''A Prioritization of Generic Safety Issues,'' which tracks safety issues until requirements are approved for imposition at licensed plants or until the NRC issues a request for action by licensees

  14. Site evaluation for nuclear installations. Safety requirements

    International Nuclear Information System (INIS)

    2003-01-01

    This Safety Requirements publication supersedes the Code on the Safety of Nuclear Power Plants: Siting, which was issued in 1988 as Safety Series No. 50-C-S (Rev. 1). It takes account of developments relating to site evaluations for nuclear installations since the Code on Siting was last revised. These developments include the issuing of the Safety Fundamentals publication on The Safety of Nuclear Installations, and the revision of various safety standards and other publications relating to safety. Requirements for site evaluation are intended to ensure adequate protection of site personnel, the public and the environment from the effects of ionizing radiation arising from nuclear installations. It is recognized that there are steady advances in technology and scientific knowledge, in nuclear safety and in what is considered adequate protection. Safety requirements change with these advances and this publication reflects the present consensus among States. This Safety Requirements publication was prepared under the IAEA programme on safety standards for nuclear installations. It establishes requirements and provides criteria for ensuring safety in site evaluation for nuclear installations. The Safety Guides on site evaluation listed in the references provide recommendations on how to meet the requirements established in this Safety Requirements publication. The objective of this publication is to establish the requirements for the elements of a site evaluation for a nuclear installation so as to characterize fully the site specific conditions pertinent to the safety of a nuclear installation. The purpose is to establish requirements for criteria, to be applied as appropriate to site and site-installation interaction in operational states and accident conditions, including those that could lead to emergency measures for: (a) Defining the extent of information on a proposed site to be presented by the applicant; (b) Evaluating a proposed site to ensure that the site

  15. 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.

  16. Improving construction site safety through leader-based verbal safety communication.

    Science.gov (United States)

    Kines, Pete; Andersen, Lars P S; Spangenberg, Soren; Mikkelsen, Kim L; Dyreborg, Johnny; Zohar, Dov

    2010-10-01

    The construction industry is one of the most injury-prone industries, in which production is usually prioritized over safety in daily on-site communication. Workers have an informal and oral culture of risk, in which safety is rarely openly expressed. This paper tests the effect of increasing leader-based on-site verbal safety communication on the level of safety and safety climate at construction sites. A pre-post intervention-control design with five construction work gangs is carried out. Foremen in two intervention groups are coached and given bi-weekly feedback about their daily verbal safety communications with their workers. Foremen-worker verbal safety exchanges (experience sampling method, n=1,693 interviews), construction site safety level (correct vs. incorrect, n=22,077 single observations), and safety climate (seven dimensions, n=105 questionnaires) are measured over a period of up to 42 weeks. Baseline measurements in the two intervention and three control groups reveal that foremen speak with their workers several times a day. Workers perceive safety as part of their verbal communication with their foremen in only 6-16% of exchanges, and the levels of safety at the sites range from 70-87% (correct observations). Measurements from baseline to follow-up in the two intervention groups reveal that safety communication between foremen and workers increases significantly in one of the groups (factor 7.1 increase), and a significant yet smaller increase is found when the two intervention groups are combined (factor 4.6). Significant increases in the level of safety are seen in both intervention groups (7% and 12% increases, respectively), particularly in regards to 'access ways' and 'railings and coverings' (39% and 84% increases, respectively). Increases in safety climate are seen in only one of the intervention groups with respect to their 'attention to safety.' No significant trend changes are seen in the three control groups on any of the three measures

  17. National Ignition Facility Project Site Safety Program

    International Nuclear Information System (INIS)

    Dun, C

    2003-01-01

    This Safety Program for the National Ignition Facility (NIF) presents safety protocols and requirements that management and workers shall follow to assure a safe and healthful work environment during activities performed on the NIF Project site. The NIF Project Site Safety Program (NPSSP) requires that activities at the NIF Project site be performed in accordance with the ''LLNL ES and H Manual'' and the augmented set of controls and processes described in this NIF Project Site Safety Program. Specifically, this document: (1) Defines the fundamental NIF site safety philosophy. (2) Defines the areas covered by this safety program (see Appendix B). (3) Identifies management roles and responsibilities. (4) Defines core safety management processes. (5) Identifies NIF site-specific safety requirements. This NPSSP sets forth the responsibilities, requirements, rules, policies, and regulations for workers involved in work activities performed on the NIF Project site. Workers are required to implement measures to create a universal awareness that promotes safe practice at the work site and will achieve NIF management objectives in preventing accidents and illnesses. ES and H requirements are consistent with the ''LLNL ES and H Manual''. This NPSSP and implementing procedures (e.g., Management Walkabout, special work procedures, etc.,) are a comprehensive safety program that applies to NIF workers on the NIF Project site. The NIF Project site includes the B581/B681 site and support areas shown in Appendix B

  18. Deep Borehole Disposal Safety Analysis.

    Energy Technology Data Exchange (ETDEWEB)

    Freeze, Geoffrey A. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Stein, Emily [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Price, Laura L. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); MacKinnon, Robert J. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Tillman, Jack Bruce [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2016-10-01

    This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept. It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.

  19. The role of safety analyses in site selection. Some personal observations based on the experience from the Swiss site selection process

    Energy Technology Data Exchange (ETDEWEB)

    Zuidema, Piet [Nagra, Wettingen (Switzerland)

    2015-07-01

    In Switzerland, the site selection process according to the ''Sectoral Plan for Deep Geological Repositories'' (BFE 2008) is underway since 2008. This process takes place in three stages. In stage 1 geological siting regions (six for the L/ILW repository and three for the HLW repository) have been identified, in stage 2 sites for the surface facilities have been identified for all siting regions in close co-operation with the sting regions and a narrowing down of the number of siting regions based on geological criteria will take place. In stage 3 the sites for a general license application are selected and the general license applications will be submitted which eventually will lead to the siting decision for both repository types. In the Swiss site selection process, safety has the highest priority. Many factors affect safety and thus a whole range of safety-related issues are considered in the identification and screening of siting possibilities. Besides dose calculations a range of quantitative and qualitative issues are considered. Dose calculations are performed in all three stages of the site selection process. In stage 1 generic safety calculations were made to develop criteria to be used for the identification of potential siting regions. In stage 2, dose calculations are made for comparing the different siting regions according to a procedure prescribed in detail by the regulator. Combined with qualitative evaluations this will lead to a narrowing down of the number of siting regions to at least two siting regions for each repository type. In stage 3 full safety cases will be prepared as part of the documentation for the general license applications. Besides the dose calculations, many other issues related to safety are analyzed in a quantitative and qualitative manner. These consider the 13 criteria defined in the Sectoral Plan and the corresponding indicators. The features analyzed cover the following broad themes: efficiency of

  20. The role of safety analyses in site selection. Some personal observations based on the experience from the Swiss site selection process

    International Nuclear Information System (INIS)

    Zuidema, Piet

    2015-01-01

    In Switzerland, the site selection process according to the ''Sectoral Plan for Deep Geological Repositories'' (BFE 2008) is underway since 2008. This process takes place in three stages. In stage 1 geological siting regions (six for the L/ILW repository and three for the HLW repository) have been identified, in stage 2 sites for the surface facilities have been identified for all siting regions in close co-operation with the sting regions and a narrowing down of the number of siting regions based on geological criteria will take place. In stage 3 the sites for a general license application are selected and the general license applications will be submitted which eventually will lead to the siting decision for both repository types. In the Swiss site selection process, safety has the highest priority. Many factors affect safety and thus a whole range of safety-related issues are considered in the identification and screening of siting possibilities. Besides dose calculations a range of quantitative and qualitative issues are considered. Dose calculations are performed in all three stages of the site selection process. In stage 1 generic safety calculations were made to develop criteria to be used for the identification of potential siting regions. In stage 2, dose calculations are made for comparing the different siting regions according to a procedure prescribed in detail by the regulator. Combined with qualitative evaluations this will lead to a narrowing down of the number of siting regions to at least two siting regions for each repository type. In stage 3 full safety cases will be prepared as part of the documentation for the general license applications. Besides the dose calculations, many other issues related to safety are analyzed in a quantitative and qualitative manner. These consider the 13 criteria defined in the Sectoral Plan and the corresponding indicators. The features analyzed cover the following broad themes: efficiency of

  1. Development of NUMO safety case for geological disposal

    International Nuclear Information System (INIS)

    Suzuki, Satoru; Deguchi, Akira

    2016-01-01

    NUMO has developed a generic safety ease based on the latest knowledge to show the feasibility and safety of geological disposal in Japan. The NUMO safety case has been developed to provide a basic structure for subsequent safety cases that would be applied to any selected site, emphasising practical approaches and methodology, which will be applicable for the conditions/constraints during an actual siting process. This paper will provide a brief overview of the NUMO safety case. (author)

  2. 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.

  3. Probabilistic safety assessment for a generic deep geological repository for high-level waste and long-lived intermediate-level waste in clay

    International Nuclear Information System (INIS)

    Resele, G.; Holocher, J.; Mayer, G.; Hubschwerlen, N.; Niemeyer, M.; Beushausen, M.; Wollrath, J.

    2010-01-01

    Document available in extended abstract form only. In the selection procedure for the search of a final site location for the disposal of radioactive wastes, the comparison and evaluation of different potentially suitable repository systems in different types of host rocks will be an essential and crucial step. Since internationally accepted guidelines on how to perform such quantitative comparisons between repository systems with regard to their long-term safety behaviour are still lacking, in 2007 the German Federal Office for Radiation Protection launched the project 'VerSi' (Vergleichende Sicherheitsanalysen - Comparing Safety Assessments) that aims at the development of a methodology for the comparison of long-term safety assessments. A vital part of the VerSi project is the performance of long-term safety assessments for the comparison of two repository systems. The comparison focuses on a future repository for heat-generating, i.e. high-level and long-lived intermediate-level radioactive wastes in Germany. Rock salt is considered as a potential host rock for such a repository, and one repository system in VerSi is defined similarly to the potential site located in the Gorleben salt dome. Another suitable host rock formation may be clay. A generic location within the lower Cretaceous clays in Northern Germany is therefore chosen for the comparison of safety assessments within the VerSi project. The long-term safety assessment of a repository system for heat-generating radioactive waste at the generic clay location comprises different steps, amongst others: - Identifying the relevant processes in the near-field, in the geosphere and in the biosphere which are relevant for the long-term safety behaviour. - Development of a safety concept for the repository system. - Deduction of scenarios of the long-term evolution of the repository system. - Definition of statistic weights, i. e. the likelihood of occurrence of the scenarios. - Performance of a

  4. 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

  5. Comparative analysis of safety related site characteristics

    International Nuclear Information System (INIS)

    Andersson, Johan

    2010-12-01

    This document presents a comparative analysis of site characteristics related to long-term safety for the two candidate sites for a final repository for spent nuclear fuel in Forsmark (municipality of Oesthammar) and in Laxemar (municipality of Oskarshamn) from the point of view of site selection. The analyses are based on the updated site descriptions of Forsmark /SKB 2008a/ and Laxemar /SKB 2009a/, together with associated updated repository layouts and designs /SKB 2008b and SKB 2009b/. The basis for the comparison is thus two equally and thoroughly assessed sites. However, the analyses presented here are focussed on differences between the sites rather than evaluating them in absolute terms. The document serves as a basis for the site selection, from the perspective of long-term safety, in SKB's application for a final repository. A full evaluation of safety is made for a repository at the selected site in the safety assessment SR-Site /SKB 2011/, referred to as SR-Site main report in the following

  6. Comparative analysis of safety related site characteristics

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan (ed.)

    2010-12-15

    This document presents a comparative analysis of site characteristics related to long-term safety for the two candidate sites for a final repository for spent nuclear fuel in Forsmark (municipality of Oesthammar) and in Laxemar (municipality of Oskarshamn) from the point of view of site selection. The analyses are based on the updated site descriptions of Forsmark /SKB 2008a/ and Laxemar /SKB 2009a/, together with associated updated repository layouts and designs /SKB 2008b and SKB 2009b/. The basis for the comparison is thus two equally and thoroughly assessed sites. However, the analyses presented here are focussed on differences between the sites rather than evaluating them in absolute terms. The document serves as a basis for the site selection, from the perspective of long-term safety, in SKB's application for a final repository. A full evaluation of safety is made for a repository at the selected site in the safety assessment SR-Site /SKB 2011/, referred to as SR-Site main report in the following

  7. PHWR safety: design, siting and construction

    International Nuclear Information System (INIS)

    Sharma, V.K.

    2002-01-01

    In all activities associated with NPPs viz. siting, design, construction, commissioning and operation, safety is given overriding importance. The safety design principles of PHWRs are based on defence-in-depth approach, physical and functional separation between process and safety systems and also among various safety systems, redundancy to meet single failure criteria and postulation of a number of design basis events for which the plant must be designed. Apart from engineered safety systems, PHWRs have inherent characteristics which contribute to safety. In siting of a NPP, it is required to ensure that the given site does not pose undue radiological hazard to public and the environment both during normal operation as well as during and following an accident condition. For this purpose, all site related external events, both natural and man induced, are assessed for their effect on the plant and are considered as part of the design basis. Possible radiological impact of the NPP on environment and surrounding population is assessed and ensured to be within acceptable limits. During construction phase, it is essential that the NPP be built in accordance with design intent and with required quality of workmanship to ensure that the NPP will remain safe during all states of operation. This is achieved through careful execution and QA activities encompassing all aspects of component fabrication at manufacturer works, civil construction, site erection, assembly, and commissioning. Future trends in nuclear safety will continue to be based on existing principles which have proved to be sound. These will be further strengthened by features such as increasing use of passive means of performing safety functions and a more explicit treatment of severe accidents. (author)

  8. 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

  9. Eighth ITER technical meeting on safety and environment

    International Nuclear Information System (INIS)

    Gordon, C.; Raeder, J.

    2000-01-01

    From November 27 to 30, 2000 the Eighth ITER Technical Meeting on Safety and Environment was held by the ITER Joint Central Team (JCT) at the Garching Joint Work Site, which also hosts the ITER Safety, Environment and Health Group (SEHG). At this meeting, safety experts from the Home Teams (HT) worked together with the SEHG members towards the following main objectives: review of Generic Site Safety Report (GSSR) results and drafts; review of the Plant Design Description (PDD) summary of safety; update on the status of the R and D tasks contributing to GSSR

  10. Mitigative techniques and analysis of generic site conditions for ground-water contamination associated with severe accidents

    Energy Technology Data Exchange (ETDEWEB)

    Shafer, J.M.; Oberlander, P.L.; Skaggs, R.L.

    1984-04-01

    The purpose of this study is to evaluate the feasibility of using ground-water contaminant mitigation techniques to control radionuclide migration following a severe commercial nuclear power reactor accident. The two types of severe commercial reactor accidents investigated are: (1) containment basemat penetration of core melt debris which slowly cools and leaches radionuclides to the subsurface environment, and (2) containment basemat penetration of sump water without full penetration of the core mass. Six generic hydrogeologic site classifications are developed from an evaluation of reported data pertaining to the hydrogeologic properties of all existing and proposed commercial reactor sites. One-dimensional radionuclide transport analyses are conducted on each of the individual reactor sites to determine the generic characteristics of a radionuclide discharge to an accessible environment. Ground-water contaminant mitigation techniques that may be suitable, depending on specific site and accident conditions, for severe power plant accidents are identified and evaluated. Feasible mitigative techniques and associated constraints on feasibility are determined for each of the six hydrogeologic site classifications. The first of three case studies is conducted on a site located on the Texas Gulf Coastal Plain. Mitigative strategies are evaluated for their impact on contaminant transport and results show that the techniques evaluated significantly increased ground-water travel times. 31 references, 118 figures, 62 tables.

  11. Mitigative techniques and analysis of generic site conditions for ground-water contamination associated with severe accidents

    International Nuclear Information System (INIS)

    Shafer, J.M.; Oberlander, P.L.; Skaggs, R.L.

    1984-04-01

    The purpose of this study is to evaluate the feasibility of using ground-water contaminant mitigation techniques to control radionuclide migration following a severe commercial nuclear power reactor accident. The two types of severe commercial reactor accidents investigated are: (1) containment basemat penetration of core melt debris which slowly cools and leaches radionuclides to the subsurface environment, and (2) containment basemat penetration of sump water without full penetration of the core mass. Six generic hydrogeologic site classifications are developed from an evaluation of reported data pertaining to the hydrogeologic properties of all existing and proposed commercial reactor sites. One-dimensional radionuclide transport analyses are conducted on each of the individual reactor sites to determine the generic characteristics of a radionuclide discharge to an accessible environment. Ground-water contaminant mitigation techniques that may be suitable, depending on specific site and accident conditions, for severe power plant accidents are identified and evaluated. Feasible mitigative techniques and associated constraints on feasibility are determined for each of the six hydrogeologic site classifications. The first of three case studies is conducted on a site located on the Texas Gulf Coastal Plain. Mitigative strategies are evaluated for their impact on contaminant transport and results show that the techniques evaluated significantly increased ground-water travel times. 31 references, 118 figures, 62 tables

  12. 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

  13. ITER-FEAT safety

    International Nuclear Information System (INIS)

    Gordon, C.W.; Bartels, H.-W.; Honda, T.; Raeder, J.; Topilski, L.; Iseli, M.; Moshonas, K.; Taylor, N.; Gulden, W.; Kolbasov, B.; Inabe, T.; Tada, E.

    2001-01-01

    Safety has been an integral part of the design process for ITER since the Conceptual Design Activities of the project. The safety approach adopted in the ITER-FEAT design and the complementary assessments underway, to be documented in the Generic Site Safety Report (GSSR), are expected to help demonstrate the attractiveness of fusion and thereby set a good precedent for future fusion power reactors. The assessments address ITER's radiological hazards taking into account fusion's favourable safety characteristics. The expectation that ITER will need regulatory approval has influenced the entire safety design and assessment approach. This paper summarises the ITER-FEAT safety approach and assessments underway. (author)

  14. SafetyAnalyst : software tools for safety management of specific highway sites

    Science.gov (United States)

    2010-07-01

    SafetyAnalyst provides a set of software tools for use by state and local highway agencies for highway safety management. SafetyAnalyst can be used by highway agencies to improve their programming of site-specific highway safety improvements. SafetyA...

  15. 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)

  16. 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

  17. Safety Review Services, Site Review Services and IRRS

    International Nuclear Information System (INIS)

    Yllera, Javier

    2010-01-01

    The selection and the evaluation of the site for a nuclear power plant are crucial parts of establishing a nuclear power programme and can be significantly affected by costs, public acceptance and safety considerations. Siting is the process of selecting a suitable site for a facility. This is area containing the plant, defined by a boundary and under effective control of the Plant Management. For safety related issues comparison within topics is generally quite straightforward. For example, sites with relatively higher seismic hazard would be penalized in comparison with those in more stable areas. The site for the NPP is generally chosen at a relatively ‘aseismic’ part of the country. This generally means that well known seismogenic sources are more than at least 50 kms from the site. The proposed sites for nuclear installations shall be examined with respect to the frequency and the severity of natural and human induced events and phenomena that could affect the safety of the installation. The Events unconnected with the operation of a facility or activity which could have an effect on the safety of the facility or activity. The relationship between the site and the design for the nuclear installation shall be examined to ensure that the radiological risk to the public and the environment arising from releases defined by the source terms is acceptably low. The Nuclear Regulatory Authority should issue a document that sets out the technical safety and security criteria against which the Site Permit Application for a new NPP will be reviewed. The objective of the Site Safety Review Services (SSRS) is provided upon request from a Member State. An independent review and assessment of the site and nuclear installation safety in relation to external natural and man induced hazards. This is to make recommendations on additional analysis or plant modifications to be carried out in order to comply with the IAEA Safety Standards and to enhance safety

  18. U.S. NRC's generic issues program

    International Nuclear Information System (INIS)

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

    2008-01-01

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

  19. Application of a safety assessment methodology to a hypothetical surface disposal at Serpong site, Indonesia

    International Nuclear Information System (INIS)

    Lubis, E.; Mallants, D.; Volckaert, G.; Marivoet, J.; Neerdael, B.

    2000-01-01

    A preliminary and generic safety assessment of a candidate shallow land burial (SLB) repository at Serpong site, Indonesia, has been performed. The step-by-step safety assessment methodology included an analysis of features, events, and processes (FEPs), and mathematical modelling of radionuclide migration in the near field, geosphere and biosphere. On the basis of an extensive FEP catalogue the most relevant scenarios to be considered in the consequence analysis were selected. Both the normal evolution scenario (NES) and the alternative scenarios were identified. On the basis of these scenarios a conceptual model that included all the important physical-chemical processes was built for the near field and geosphere. A two-dimensional numerical model was then used to solve the governing flow and transport equations for appropriate initial and boundary conditions. The calculations were performed using a repository-specific value for the total disposed activity in combination with hypothetical values for radionuclide composition based on a typical radionuclide content of low level waste in Belgium. Site-specific data on hydrogeological properties were used for the geosphere calculations. Typical results of the consequence analysis in terms of radionuclide fluxes to the geosphere and radionuclide concentrations in the groundwater are discussed. (author)

  20. Safety aspects of siting

    International Nuclear Information System (INIS)

    Rosen, M.

    1976-01-01

    Outline of parameters to be considered in site selection, radiation safety, and mechanisms of radiation release. Radiation doses in tablular form for areas at various distances from the plant. (HP) [de

  1. Site safety requirements for high level waste disposal

    International Nuclear Information System (INIS)

    Chen Weiming; Wang Ju

    2006-01-01

    This paper outlines the content, status and trend of site safety requirements of International Atomic Energy Agency, America, France, Sweden, Finland and Japan. Site safety requirements are usually represented as advantageous vis-a-vis disadvantagous conditions, and potential advantage vis-a-vis disadvantage conditions, respectively in aspects of geohydrology, geochemistry, lithology, climate and human intrusion etc. Study framework and steps of site safety requirements for China are discussed under the view of systems science. (authors)

  2. Safety Oversight of Decommissioning Activities at DOE Nuclear Sites

    International Nuclear Information System (INIS)

    Zull, Lawrence M.; Yeniscavich, William

    2008-01-01

    The Defense Nuclear Facilities Safety Board (Board) is an independent federal agency established by Congress in 1988 to provide nuclear safety oversight of activities at U.S. Department of Energy (DOE) defense nuclear facilities. The activities under the Board's jurisdiction include the design, construction, startup, operation, and decommissioning of defense nuclear facilities at DOE sites. This paper reviews the Board's safety oversight of decommissioning activities at DOE sites, identifies the safety problems observed, and discusses Board initiatives to improve the safety of decommissioning activities at DOE sites. The decommissioning of former defense nuclear facilities has reduced the risk of radioactive material contamination and exposure to the public and site workers. In general, efforts to perform decommissioning work at DOE defense nuclear sites have been successful, and contractors performing decommissioning work have a good safety record. Decommissioning activities have recently been completed at sites identified for closure, including the Rocky Flats Environmental Technology Site, the Fernald Closure Project, and the Miamisburg Closure Project (the Mound site). The Rocky Flats and Fernald sites, which produced plutonium parts and uranium materials for defense needs (respectively), have been turned into wildlife refuges. The Mound site, which performed R and D activities on nuclear materials, has been converted into an industrial and technology park called the Mound Advanced Technology Center. The DOE Office of Legacy Management is responsible for the long term stewardship of these former EM sites. The Board has reviewed many decommissioning activities, and noted that there are valuable lessons learned that can benefit both DOE and the contractor. As part of its ongoing safety oversight responsibilities, the Board and its staff will continue to review the safety of DOE and contractor decommissioning activities at DOE defense nuclear sites

  3. 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

  4. Site safety plan for Lawrence Livermore National Laboratory CERCLA investigations at site 300. Revision 2

    Energy Technology Data Exchange (ETDEWEB)

    Kilmer, J.

    1997-08-01

    Various Department of Energy Orders incorporate by reference, health and safety regulations promulgated by the Occupational Safety and Health Administration (OSHA). One of the OSHA regulations, 29 CFR 1910.120, Hazardous Waste Operations and Emergency Response, requires that site safety plans are written for activities such as those covered by work plans for Site 300 environmental investigations. Based upon available data, this Site Safety Plan (Plan) for environmental restoration has been prepared specifically for the Lawrence Livermore National Laboratory Site 300, located approximately 15 miles east of Livermore, California. As additional facts, monitoring data, or analytical data on hazards are provided, this Plan may need to be modified. It is the responsibility of the Environmental Restoration Program and Division (ERD) Site Safety Officer (SSO), with the assistance of Hazards Control, to evaluate data which may impact health and safety during these activities and to modify the Plan as appropriate. This Plan is not `cast-in-concrete.` The SSO shall have the authority, with the concurrence of Hazards Control, to institute any change to maintain health and safety protection for workers at Site 300.

  5. 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

  6. 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

  7. Visualization of Safety Assessment Result Using GIS in SITES

    International Nuclear Information System (INIS)

    Yun, Bong-Yo; Park, Joo Wan; Park, Se-Moon; Kim, Chang-Lak

    2006-01-01

    Site Information and Total Environmental database management System (SITES) is an integrated program for overall data analysis, environmental monitoring, and safety analysis that are produced from the site investigation and environmental assessment of the relevant nuclear facility. SITES is composed of three main modules such as Site Environment Characterization database for Unified and Reliable Evaluation system (SECURE), Safety Assessment INTegration system (SAINT) and Site Useful Data Analysis and ALarm system (SUDAL). The visualization function of safety assessment and environmental monitoring results is designed. This paper is to introduce the visualization design method using Geographic Information System (GIS) for SITES

  8. Use of site specific data from Aespoe - preliminary results from the on-going safety analysis SR 97

    International Nuclear Information System (INIS)

    Stroem, A.; Selroos, J.O.; Andersson, Johan

    1998-01-01

    This paper discusses an on-going safety assessment study of SKB as well as the use of field data from Aespoe for obtaining input parameters for flow and radionuclide transport modelling in the geosphere. In the on-going Safety Assessment study SR 97, three individual sites in Sweden are used for exemplifying site specific conditions on overall repository performance. Thus, models capable of reproducing site specific characteristics are utilised. This is primarily obtained by implementing the geologic structural models in suitable conceptual models for groundwater flow on both regional and local scales. The models for flow incorporate observed and/or inferred water conducting features as well as other site-specific characteristics necessary for realistic descriptions of flow at the sites. The flow modelling thus aims at realism; the results obtained for present day conditions should not in any serious aspect conflict with observations at the site. Agreement between observed and modelled entities provides confidence in that a sound understanding of the site is obtained. Aespoe is one of the three sites providing site-specific conditions in SR 97. Transport is subsequently modelled using a stream tube approach where the 'travel times', for non-sorbing species, and discharge locations of a set of one-dimensional stream tubes are obtained from particle tracking in the flow model. The resulting distribution of 'travel times' in a single model realisation reflects the spatial variability and spatial extent of the repository, whereas the ensemble travel time distribution (over several realisations) for a given canister location reflects the uncertainty in travel time. The actual transport paths used in the transport modelling are thus dependent on site specific information such as e.g. existence of water conductive features. Other input parameters to the transport model are based on more generic and/or conservative arguments. However, the goal in a safety assessment

  9. Evolution of Safety Basis Documentation for the Fernald Site

    International Nuclear Information System (INIS)

    Brown, T.; Kohler, S.; Fisk, P.; Krach, F.; Klein, B.

    2004-01-01

    The objective of the Department of Energy's (DOE) Fernald Closure Project (FCP), in suburban Cincinnati, Ohio, is to safely complete the environmental restoration of the Fernald site by 2006. Over 200 out of 220 total structures, at this DOE plant site which processed uranium ore concentrates into high-purity uranium metal products, have been safely demolished, including eight of the nine major production plants. Documented Safety Analyses (DSAs) for these facilities have gone through a process of simplification, from individual operating Safety Analysis Reports (SARs) to a single site-wide Authorization Basis containing nuclear facility Bases for Interim Operations (BIOs) to individual project Auditable Safety Records (ASRs). The final stage in DSA simplification consists of project-specific Integrated Health and Safety Plans (I-HASPs) and Nuclear Health and Safety Plans (N-HASPs) that address all aspects of safety, from the worker in the field to the safety basis requirements preserving the facility/activity hazard categorization. This paper addresses the evolution of Safety Basis Documentation (SBD), as DSAs, from production through site closure

  10. Analysis of safety culture components based on site interviews

    International Nuclear Information System (INIS)

    Ueno, Akira; Nagano, Yuko; Matsuura, Shojiro

    2002-01-01

    Safety culture of an organization is influenced by many factors such as employee's moral, safety policy of top management and questioning attitude among site staff. First this paper analyzes key factors of safety culture on the basis of site interviews. Then the paper presents a safety culture composite model and its applicability in various contexts. (author)

  11. 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

  12. 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

  13. The generics in transplantation and the rules on their use.

    Science.gov (United States)

    Masri, Marwan

    2003-06-01

    agents MMF and Rapamycin. Currently there are 5 FDA approved Cyclosporine generics with a 20% market share in the USA and a mere 0% in Europe. Alternatives formulations to both Rapa and for MMF would be available soon. These forms are not by definition generics and are considered by the FDA to be new brand names act on the same site as Cell Cept and Rapaimmune. Their introduction would be a great welcome and would definitely results in cost saving in transplantation cost. In conclusion, generics efficacy and safety is similar to that of the brand name and their use is cost effective.

  14. Development of the NUMO pre-selection, site-specific safety case

    International Nuclear Information System (INIS)

    Fujiyama, Tetsuo; Suzuki, Satoru; Deguchi, Akira; Umeki, Hiroyuki

    2016-01-01

    Key conclusions: ◆ “The NUMO pre-selection, site-specific safety case” provides the basic structure for subsequent safety cases that will be applied to any selected site, emphasising practical approaches and methodology which will be applicable for the conditions/constraints during an actual siting process. ◆ The preliminary results of the design and safety assessment would underpin the feasibility and safety of geological disposal in Japan.

  15. 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

  16. Safety cases and siting processes

    International Nuclear Information System (INIS)

    Metlay, Daniel; Ewing, Rodney

    2014-01-01

    Central to any process for building a deep-mined geologic repository for high-activity radioactive waste is the development of a safety case. To date, such cases, in various forms have been elaborated for a variety of concepts for geologic disposal, including in salt, clay, argillite, crystalline rock (granite and gneiss) and volcanic tuff formations. In addition to the technical effort required to develop a safety case, increasingly nations have come to believe that it is also critical to obtain the consent of the region or community where the facility might be located. The purpose of this paper is to explore issues associated with just one aspect of consent-based siting: How can such a process be designed so that willingness to accept a site for a repository continues to be meaningful even as new technical knowledge and insights emerge during site characterisation? In short, what is the meaning of 'informed consent' in the context of repository development? (authors)

  17. 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

  18. Application of biosphere models in the Biomosa project: a comparative assessment of five European radioactive waste disposal sites

    International Nuclear Information System (INIS)

    Kowe, R.; Mobbs, S.; Proehl, G.; Bergstrom, U.; Kanyar, B.; Olyslaegers, G.; Zeevaert, T.; Simon, I.

    2004-01-01

    The BIOMOSA (Biosphere Models for Safety Assessment of Radioactive Waste Disposal) project is a part of the EC fifth framework research programme. The main goal of this project is the improvement of the scientific basis for the application of biosphere models in the framework of long-term safety studies of radioactive waste disposal facilities. Furthermore, the outcome of the project will provide operators and regulatory bodies with guidelines for performance assessments of repository systems. The study focuses on the development and application of site-specific models and a generic biosphere tool BIOGEM (Biosphere Generic Model), using the experience from the national programmes and the IAEA BIOMASS reference biosphere methodology. The models were applied to 5 typical locations in the EU, resulting in estimates of the annual individual doses to the critical groups and the ranking of the importance of the pathways for each of the sites. The results of the site-specific and generic models were then compared. In all cases the doses calculated by the generic model were less than the doses obtained from the site-specific models. Uncertainty in the results was estimated by means of stochastic calculations which allow a comparison of the overall model uncertainty with the variability across the different sites considered. (author)

  19. 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

  20. Preliminary safety analysis of the Gorleben site

    International Nuclear Information System (INIS)

    Bracke, G.; Fischer-Appelt, K.

    2014-01-01

    The safety requirements governing the final disposal of heat-generating radioactive waste in Germany were implemented by the Federal Ministry of Environment, Natural Conservation and Nuclear Safety (BMU) in 2010. The Ministry considers as a fundamental objective the protection of man and the environment against the hazards of radioactive waste. Unreasonable burdens and obligation for future generations shall be avoided. The main safety principles are concentration and inclusion of radioactive and other pollutants in a containment-providing rock zone. Any release of radioactive nuclides may increase the risk for men and the environment only negligibly compared to natural radiation exposure. No intervention or maintenance work shall be necessary in the post-closure phase. Retrieval/recovery of the waste shall be possible up to 500 years after closure. The Gorleben salt dome has been discussed since the 1970's as a possible repository site for heat-generating radioactive waste in Germany. The objective of the project preliminary safety analysis of the Gorleben site (VSG) was to assess if repository concepts at the Gorleben site or other sites with a comparable geology could comply with these requirements based on currently available knowledge (Fischer-Appelt, 2013; Bracke, 2013). In addition to this it was assessed if methodological approaches can be used for a future site selection procedure and which technological and conceptual considerations can be transferred to other geological situations. The objective included the compilation and review of the available exploration data of the Gorleben site and on disposal in salt rock, the development of repository designs, and the identification of the needs for future R and D work and further site investigations. (authors)

  1. 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.

  2. Behavior-based safety on construction sites: a case study.

    Science.gov (United States)

    Choudhry, Rafiq M

    2014-09-01

    This work presents the results of a case study and describes an important area within the field of construction safety management, namely behavior-based safety (BBS). This paper adopts and develops a management approach for safety improvements in construction site environments. A rigorous behavioral safety system and its intervention program was implemented and deployed on target construction sites. After taking a few weeks of safety behavior measurements, the project management team implemented the designed intervention and measurements were taken. Goal-setting sessions were arranged on-site with workers' participation to set realistic and attainable targets of performance. Safety performance measurements continued and the levels of performance and the targets were presented on feedback charts. Supervisors were asked to give workers recognition and praise when they acted safely or improved critical behaviors. Observers were requested to have discussions with workers, visit the site, distribute training materials to workers, and provide feedback to crews and display charts. They were required to talk to operatives in the presence of line managers. It was necessary to develop awareness and understanding of what was being measured. In the process, operatives learned how to act safely when conducting site tasks using the designed checklists. Current weekly scores were discussed in the weekly safety meetings and other operational site meetings with emphasis on how to achieve set targets. The reliability of the safety performance measures taken by the company's observers was monitored. A clear increase in safety performance level was achieved across all categories: personal protective equipment; housekeeping; access to heights; plant and equipment, and scaffolding. The research reveals that scores of safety performance at one project improved from 86% (at the end of 3rd week) to 92.9% during the 9th week. The results of intervention demonstrated large decreases in

  3. 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.’

  4. 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.

  5. 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)

  6. 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.

  7. Radiation safety for site radiography

    International Nuclear Information System (INIS)

    1986-01-01

    This guidance is an update of the 1975 Code of Practice for Site Radiography and is for the use of employers and their radiographers who carry out site work. The subject is discussed under the following headings: Administrative organization, Personnel requirements, Equipment (x-ray and gamma-ray equipment, security, pipeline crawler equipment and safety equipment) Work methods and monitoring, Carriage of sources, Contingency plans, Legal considerations. (U.K.)

  8. 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.

  9. Ninth ITER technical meeting on safety and environment

    International Nuclear Information System (INIS)

    Raeder, J.; Gordon, C.

    2001-01-01

    The ninth ITER Technical Meeting on safety and environment, the last in the course of the ITER Engineering Design Activities (EDA), was held at the ITER Garching Joint Work site, 8 to 10 May 2001. At this Meeting, safety experts from the House Teams worked together with the members of the Safety, Environment and Health Groups (SEHG) of the ITER Joint Central Team (JCT) in the following areas: finalization of the Generic Site Safety report (GSSR) which is considered to be the most important objective of the present work; summary of the safety related R and D work done by the Home Teams for ITER during EDA; review of verification and validation work done on computer codes being applied for Safety and Environment (S and E) analyses; outline of work considered necessary for improving the S and E database, quantifying uncertainties of the code results and preparing the adaptation of ITER to a specific site

  10. Studies on Labour Safety in Construction Sites

    Directory of Open Access Journals (Sweden)

    S. Kanchana

    2015-01-01

    Full Text Available Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites.

  11. Studies on Labour Safety in Construction Sites

    Science.gov (United States)

    Kanchana, S.; Sivaprakash, P.; Joseph, Sebastian

    2015-01-01

    Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites. PMID:26839916

  12. UMTRA Project environmental, health, and safety plan

    International Nuclear Information System (INIS)

    1989-02-01

    The basic health and safety requirements established in this plan are designed to provide guidelines to be applied at all Uranium Mill Tailings Remedial Action (UMTRA) Project sites. Specific restrictions are given where necessary. However, an attempt has been made to provide guidelines which are generic in nature, and will allow for evaluation of site-specific conditions. Health and safety personnel are expected to exercise professional judgment when interpreting these guidelines to ensure the health and safety of project personnel and the general population. This UMTRA Project Environmental, Health, and Safety (EH ampersand S) Plan specifies the basic Federal health and safety standards and special DOE requirements applicable to this program. In addition, responsibilities in carrying out this plan are delineated. Some guidance on program requirements and radiation control and monitoring is also included. An Environmental, Health, and Safety Plan shall be developed as part of the remedial action plan for each mill site and associated disposal site. Special conditions at the site which may present potential health hazards will be described, and special areas that should should be addressed by the Remedial Action Contractor (RAC) will be indicated. Site-specific EH ampersand S concerns will be addressed by special contract conditions in RAC subcontracts. 2 tabs

  13. 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

  14. 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.

  15. General aspects of siting and safety considerations

    International Nuclear Information System (INIS)

    Rutgers, E.

    1980-01-01

    The siting process from site selection to the different stages of review by the regulatory body is described. Special attention is payed to the role and responsibilities of the licensing authority. Next, the basic considerations involved in the siting process are reviewed. They include system planning, engineering, safety, environmental impact (including land use) and economics. Case studies illustrating different aspects of the siting process (e.g. site selection) are presented. (orig.)

  16. 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

  17. 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.

  18. A Generic Multi-Compartmental CNS Distribution Model Structure for 9 Drugs Allows Prediction of Human Brain Target Site Concentrations

    NARCIS (Netherlands)

    Yamamoto, Yumi; Valitalo, Pyry A.; van den Berg, Dirk-Jan; Hartman, Robin; van den Brink, Willem; Wong, Yin Cheong; Huntjens, Dymphy R.; Proost, Johannes H.; Vermeulen, An; Krauwinkel, Walter; Bakshi, Suruchi; Aranzana-Climent, Vincent; Marchand, Sandrine; Dahyot-Fizelier, Claire; Couet, William; Danhof, Meindert; van Hasselt, Johan G. C.; de lange, Elizabeth C. M.

    Purpose Predicting target site drug concentration in the brain is of key importance for the successful development of drugs acting on the central nervous system. We propose a generic mathematical model to describe the pharmacokinetics in brain compartments, and apply this model to predict human

  19. 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)

  20. 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

  1. Preliminary safety evaluation for the Forsmark area. Based on data and site descriptions after the initial site investigation stage

    International Nuclear Information System (INIS)

    Andersson, Johan

    2005-08-01

    effects of channelling on radionuclide migration. However, this can only partly be achieved by new measurement approaches. The assessed migration properties of the rock matrix comply with the preferred values. However, the values are based on few samples only and evaluation of more samples would thus further substantiate this conclusion. Better feedback on this issue will be available in relation to the full migration analysis made within the on-going full safety assessment SR-Can. The assessments made for the PSE also suggest some implications for design, some of which are of a generic character to be considered also for the other sites. The most important such feedbacks are: Compared with the actual safety requirement for long-term mechanical stability of deposition holes, the design rules for discarding canister positions due to potential intersections with large fractures or deformation zones seem to be too restrictive. For this reason SKB has now started a project aiming at estimating the probability of actually finding the deposition holes intersected by large fractures. This assessment will also produce more realistic estimates of the degree-of-utilisation. The 6 m spacing of canister deposition holes, suggested in the repository design, appears sufficient. At least locally, it may be possible to use even shorter canister spacing, or to reduce the spacing between the deposition tunnels, but this would require a more detailed understanding of the spatial variability of the thermal properties. Finally, this PSE also highlights issues that would have to be considered if the Forsmark area were to be assessed in a full safety assessment. Important such issues are assessing the probability of identifying large fractures intersecting potential deposition holes, assessing likelihood and the consequences of thermal spalling of deposition holes, and assessing the consequences of the very low permeability of the rock mass

  2. Preliminary safety evaluation for the Forsmark area. Based on data and site descriptions after the initial site investigation stage

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden)

    2005-08-01

    the effects of channelling on radionuclide migration. However, this can only partly be achieved by new measurement approaches. The assessed migration properties of the rock matrix comply with the preferred values. However, the values are based on few samples only and evaluation of more samples would thus further substantiate this conclusion. Better feedback on this issue will be available in relation to the full migration analysis made within the on-going full safety assessment SR-Can. The assessments made for the PSE also suggest some implications for design, some of which are of a generic character to be considered also for the other sites. The most important such feedbacks are: Compared with the actual safety requirement for long-term mechanical stability of deposition holes, the design rules for discarding canister positions due to potential intersections with large fractures or deformation zones seem to be too restrictive. For this reason SKB has now started a project aiming at estimating the probability of actually finding the deposition holes intersected by large fractures. This assessment will also produce more realistic estimates of the degree-of-utilisation. The 6 m spacing of canister deposition holes, suggested in the repository design, appears sufficient. At least locally, it may be possible to use even shorter canister spacing, or to reduce the spacing between the deposition tunnels, but this would require a more detailed understanding of the spatial variability of the thermal properties. Finally, this PSE also highlights issues that would have to be considered if the Forsmark area were to be assessed in a full safety assessment. Important such issues are assessing the probability of identifying large fractures intersecting potential deposition holes, assessing likelihood and the consequences of thermal spalling of deposition holes, and assessing the consequences of the very low permeability of the rock mass.

  3. Safety culture aspects of managing for safety. Experience of a large nuclear reprocessing site

    International Nuclear Information System (INIS)

    Rycraft, H.S.

    1996-01-01

    The Nuclear Industry is going through turbulent times both in terms of public acceptance and business issues. Safety is one area which impacts on whether the business is allowed to continue, and how an organisation organizes itself. The need to cut costs to make nuclear power a viable energy resource, has forced the nuclear utilities to review manning policies, and management style, and in particular how to maintain safety standards during a period of change, and ultimately support continuing improvement of standards. The shrinking workforce requires a new style of management, one that depends more on the people of the organisation taking responsibility for safety at all levels of the organisation. Not only personal safety but the safety of their colleagues, general public and the environment. The safety culture of an organisation is indivisible from the company culture, each aspect of a culture influences the whole and so the balance between business, safety and quality, has to be managed. BNFL provides a full fuel cycle service to nuclear power plants, and associated services to many national and international organisations. The following notes are taken from the work carried out in the company, and mostly at the Nuclear Reprocessing and Waste storage Site at Sellafield, based in the North West of England. Following the recent re-organisation, the site now employs 6200 people and has a further 1500 contractors working on construction activities on the site. Activities on the site range from remote handling to hands on tasks, involving highly active materials to low level waste. (author)

  4. CANDU safety under severe accidents

    International Nuclear Information System (INIS)

    Snell, V.G.; Howieson, J.Q.; Frescura, G.M.; King, F.; Rogers, J.T.; Tamm, H.

    1988-01-01

    The characteristics of the CANDU reactor relevant to severe accidents are set first by the inherent properties of the design, and second by the Canadian safety/licensing approach. Probabilistic safety assessment studies have been performed on operating CANDU plants, and on the 4 x 880 MW(e) Darlington station now under construction; furthermore a scoping risk assessment has been done for a CANDU 600 plant. They indicate that the summed severe core damage frequency is of the order of 5 x 10 -6 /year. CANDU nuclear plant designers and owner/operators share information and operational experience nationally and internationally through the CANDU Owners' Group (COG). The research program generally emphasizes the unique aspects of the CANDU concept, such as heat removal through the moderator, but it has also contributed significantly to areas generic to most power reactors such as hydrogen combustion, containment failure modes, fission product chemistry, and high temperature fuel behaviour. Abnormal plant operating procedures are aimed at first using event-specific emergency operating procedures, in cases where the event can be diagnosed. If this is not possible, generic procedures are followed to control Critical Safety Parameters and manage the accident. Similarly, the on-site contingency plans include a generic plan covering overall plant response strategy, and a specific plan covering each category of contingency

  5. Safety leadership: application in construction site.

    Science.gov (United States)

    Cooper, Dominic

    2010-01-01

    The extant safety literature suggests that managerial Safety Leadership is vital to the success and maintenance of a behavioral safety process. The current paper explores the role of Managerial Safety Leadership behaviors in the success of a behavioral safety intervention in the Middle-East with 47,000 workers from multiple nationalities employed by fourteen sub-contractors and one main contractor. A quasi-experimental repeating ABABAB, within groups design was used. Measurement focused on managerial Safety Leadership and employee safety behaviors as well as Corrective Actions. Data was collected over 104 weeks. During this time, results show safety behavior improved by 30 percentage points from an average of 65% during baseline to an average of 95%. The site achieved 121 million man-hours free of lost-time injuries on the longest run. Stepwise multiple regression analyses indicated 86% of the variation in employee safety behavior was associated with senior, middle and front-line manager's Safety Leadership behaviors and the Corrective Action Rate. Approximately 38% of the variation in the Total Recordable Incident Rate (TRIR) was associated with the Observation rate, Corrective Action Rate and Observers Records of managerial safety leaders (Visible Ongoing Support). The results strongly suggest manager's Safety Leadership influences the success of Behavioral Safety processes.

  6. Prospective safety performance evaluation on construction sites.

    Science.gov (United States)

    Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

    2015-05-01

    This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. Beyond design basis external flooding. Generic design assessment and lessons learned from the Fukushima Dai-ichi accident

    International Nuclear Information System (INIS)

    MacLeod, Tanya; Smith, Leslie; Allmark, Tim; Ford, Peter

    2017-01-01

    New reactors intended for construction in GB undergo the Office for Nuclear Regulation's (ONR's) Generic Design Assessment (GDA). GDA is a pre-licensing process that provides requesting parties with the opportunity to demonstrate at an early stage that the design is capable of meeting the legal requirements of Great Britain. During GDA, the intended reactor site may not yet be known. Therefore, requesting parties usually define a 'Generic Site' with characteristics typical for Great Britain. These characteristics should, as far as possible, bound the characteristics of known potential sites so that reactors of the proposed type could potentially be built at various suitable locations. This paper critically reviews ONR's approach to ensuring that external flooding is appropriately addressed at the GDA stage and covers: An overview of ONR's approach to post-Fukushima assessment. Changes to ONR's SAPs (Safety Assessment Principles) related to External Flooding. Two examples of post-Fukushima GDA approaches to External Flooding. Uncertainty and the provision of adequate safety measures. The paper concludes that the identification of potential vulnerabilities in the design to external flooding combined with a consideration of post-Fukushima resilience enhancements has led to increased regulatory confidence in the robustness of new reactor designs in GB against external flooding. (author)

  8. Safety assessment input for site selection - the Swedish example - 59031

    International Nuclear Information System (INIS)

    Andersson, Johan

    2012-01-01

    Svensk Kaernbraenslehantering AB (SKB) has performed comprehensive investigations of two candidate sites for a final repository for Sweden's spent nuclear fuel. In March 2011 SKB decided to submit licence applications for a final repository at Forsmark. Before selection, SKB stated that the site that offers the best prospects for achieving long-term safety in practice would be selected. Based on experiences previous safety assessments, a number of issues related to long-term safety need to be considered in the context of site comparison. The factors include sensitivity to climate change such as periods of permafrost and glaciations, rock mechanics evolution including the potential for thermally induced spalling and sensitivity to potential future earthquakes, current and future groundwater flow, evolution of groundwater composition and proximity to mineral resources. Each of these factors related to long-term safety for the two candidate sites is assessed in a comparative analysis of site characteristics. The assessment also considers differences in biosphere conditions and in the confidence of the site descriptions. The comparison is concluded by an assessment on how the identified differences would affect the estimated radiological risk from a repository located at either of the sites. The assessment concludes that there are a number of safety related site characteristics for which the analyses do not show any decisive differences in terms of implications on safety, between the sites Forsmark and Laxemar. However, the frequency of water conducting fractures at repository depth is much smaller at Forsmark than at Laxemar. This difference, in turn, affects the future stability of the current favourable groundwater composition, which combined with the much higher flows at Laxemar would, for the current repository design, lead to a breach in the safety functions for the buffer and the canister for many more deposition positions at Laxemar than at Forsmark. Thereby

  9. Early Site Permit Demonstration Program: Plant parameters envelope report

    International Nuclear Information System (INIS)

    1993-03-01

    The Early Site Permit (ESP) Demonstration Program is the nuclear industry's initiative for piloting the early resolution of siting-related issues before the detailed design proceedings of the combined operating license review. The ESP Demonstration Program consists of three phases. The plant parameters envelopes task is part of Phase 1, which addresses the generic review of applicable federal regulations and develops criteria for safety and environmental assessment of potential sites. The plant parameters envelopes identify parameters that characterize the interface between an ALWR design and a potential site, and quantify the interface through values selected from the Utility Requirements Documents, vendor design information, or engineering assessments. When augmented with site-specific information, the plant parameters envelopes provide sufficient information to allow ESPs to be granted based on individual ALWR design information or enveloping design information for the evolutionary, passive, or generic ALWR plants. This document is expected to become a living document when used by future applicants

  10. 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...

  11. Preliminary safety evaluation for the Laxemar subarea. Based on data and site descriptions after the initial site investigation stage

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden)

    2006-03-15

    The main objectives of this Preliminary Safety Evaluation (PSE) of the Laxemar subarea have been to determine, with limited efforts, whether the feasibility study's judgement of the suitability of the candidate area with respect to long-term safety holds up in the light of the actual site investigation data; to provide feedback to continued site investigations and site-specific repository design and to identify site-specific scenarios and geoscientific issues for further analyses. The PSE focuses on comparing the attained knowledge of the sites with the suitability criteria as set out by SKB in 2000. These criteria both concern properties of the site judged to be necessary for safety and engineering (requirements) and properties judged to be beneficial (preferences). The findings are then evaluated in order to provide feedback to continued investigations and design work. The PSE does not aim at comparing sites and does not assess compliance with safety and radiation protection criteria. The latter is eventually done in coming Safety Assessments. This preliminary safety evaluation shows that, according to existing data, the Laxemar subarea meets all safety requirements. The evaluation also shows that the Laxemar subarea meets most of the safety preferences, but for some aspects of the site description further reduction of the uncertainties would enhance the safety case. Despite the stated concerns, there is no reason, from a safety point of view, not to continue the Site Investigations at the Laxemar subarea. There are uncertainties to resolve and the safety would eventually need to be verified through a proper safety assessment. Only some of the uncertainties noted in the Site Descriptive Model have safety implications and need further resolution for this reason. Furthermore, uncertainties may need resolving for other reasons, such as giving an adequate assurance of site understanding or assisting in optimising design. Notably, there are questions about the

  12. Preliminary safety evaluation for the Laxemar subarea. Based on data and site descriptions after the initial site investigation stage

    International Nuclear Information System (INIS)

    Andersson, Johan

    2006-03-01

    The main objectives of this Preliminary Safety Evaluation (PSE) of the Laxemar subarea have been to determine, with limited efforts, whether the feasibility study's judgement of the suitability of the candidate area with respect to long-term safety holds up in the light of the actual site investigation data; to provide feedback to continued site investigations and site-specific repository design and to identify site-specific scenarios and geoscientific issues for further analyses. The PSE focuses on comparing the attained knowledge of the sites with the suitability criteria as set out by SKB in 2000. These criteria both concern properties of the site judged to be necessary for safety and engineering (requirements) and properties judged to be beneficial (preferences). The findings are then evaluated in order to provide feedback to continued investigations and design work. The PSE does not aim at comparing sites and does not assess compliance with safety and radiation protection criteria. The latter is eventually done in coming Safety Assessments. This preliminary safety evaluation shows that, according to existing data, the Laxemar subarea meets all safety requirements. The evaluation also shows that the Laxemar subarea meets most of the safety preferences, but for some aspects of the site description further reduction of the uncertainties would enhance the safety case. Despite the stated concerns, there is no reason, from a safety point of view, not to continue the Site Investigations at the Laxemar subarea. There are uncertainties to resolve and the safety would eventually need to be verified through a proper safety assessment. Only some of the uncertainties noted in the Site Descriptive Model have safety implications and need further resolution for this reason. Furthermore, uncertainties may need resolving for other reasons, such as giving an adequate assurance of site understanding or assisting in optimising design. Notably, there are questions about the

  13. Geosphere process report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    Skagius, Kristina

    2010-11-01

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  14. Geosphere process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Skagius, Kristina (ed.) (Kemakta Konsult AB, Stockholm (Sweden))

    2010-11-15

    This report documents geosphere processes identified as relevant to the long-term safety of a KBS-3 repository, and forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  15. 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

  16. Lessons learned in the implementation of Integrated Safety Management at DOE Order Compliance Sites vs Necessary and Sufficient Sites

    International Nuclear Information System (INIS)

    Hill, R.L.

    2000-01-01

    This paper summarizes the development and implementation of Integrated Safety Management (ISM) at an Order Compliance Site (Savannah River Site) and a Necessary and Sufficient Site (Nevada Test Site). A discussion of each core safety function of ISM is followed by an example from an Order Compliance Site and a Necessary and Sufficient Site. The Savannah River Site was the first DOE site to have a DOE Headquarters-validated and approved ISM System. The NTS is beginning the process of verification and validation. This paper defines successful strategies for integrating Environment, Safety, and Health management into work under various scenarios

  17. Post-closure Safety of the Borehole Disposal Concept

    International Nuclear Information System (INIS)

    Little, R.

    2016-01-01

    Conclusion: • BDC post-closure safety assessments have been undertaken over last 15-20 years. • Consistent with best international practice and IAEA guidance: – used structure assessment approach; – peer reviewed; – iterative. • Built confidence in BDC as a safe long-term management option for DSRSs at both a generic and site-specific level

  18. Perspective on safety case to support a possible site recommendation decision

    International Nuclear Information System (INIS)

    Gil, A.V.; Gamble, R.P.

    2002-01-01

    The mission of the US Department of Energy (DOE) is to provide the basis for a national decision regarding the development of a geological repository for spent nuclear fuel and high-level radioactive waste at the Yucca Mountain site in Nevada. There are a number of steps in the decision process defined by US law that must be completed prior to development of a repository at this site. The DOE's focus is currently on the first two steps in this process: characterization of the site to support a determination by the DOE on whether the site is suitable for a geologic repository and a decision by the Secretary of Energy (the Secretary) on whether to recommend to the President that the site be approved for a repository. To enhance the confidence of multiple audiences in the basis for these actions, and to provide a basis for subsequent action by the President and the US Congress, information supporting the decision process must include the elements of a safety case consistent with the statutory and regulatory framework for these decisions. The idea of a safety case is to broaden the basis for confidence by decision-makers and the public in conclusions about safety. A safety case should cite multiple lines of evidence, or reasoning, beyond the results of a safety assessment to support the demonstration of safety, which includes compliance with applicable safety criteria. The multiple lines of evidence should show the basis for confidence in safety. To be most effective, such evidence requires information not directly used in the safety assessment. (author)

  19. Meteorological events in site evaluation for nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2005-01-01

    This Safety Guide provides recommendations and guidance on conducting hazard assessments of extreme and rare meteorological phenomena. It is of interest to safety assessors and regulators involved in the licensing process as well as to designers of nuclear power plants. This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. It supplements the IAEA Safety Requirements publication on Site Evaluation for Nuclear Facilities which is to supersede the Code on the Safety of Nuclear Power Plants: Siting, Safety Series No. 50-C-S (Rev. 1), IAEA, Vienna (1988). The present Safety Guide supersedes two earlier Safety Guides: Safety Series No. 50-SG-S11A (1981) on Extreme Meteorological Events in Nuclear Power Plant Siting, Excluding Tropical Cyclones and Safety Series No. 50-SG-S11B (1984) on Design Basis Tropical Cyclone for Nuclear Power Plants. The purpose of this Safety Guide is to provide recommendations and guidance on conducting hazard assessments of extreme and rare meteorological phenomena. This Safety Guide provides interpretation of the Safety Requirements publication on Site Evaluation for Nuclear Facilities and guidance on how to fulfil these requirements. It is aimed at safety assessors or regulators involved in the licensing process as well as designers of nuclear power plants, and provides them with guidance on the methods and procedures for analyses that support the assessment of the hazards associated with extreme and rare meteorological events. This Safety Guide discusses the extreme values of meteorological variables and rare meteorological phenomena, as well as their rates of occurrence, according to the following definitions: (a) Extreme values of meteorological variables such as air temperature and wind speed characterize the meteorological or climatological environment. And (b) Rare meteorological phenomena

  20. Preliminary safety evaluation, based on initial site investigation data. Planning document

    International Nuclear Information System (INIS)

    Hedin, Allan

    2002-12-01

    This report is a planning document for the preliminary safety evaluations (PSE) to be carried out at the end of the initial stage of SKBs ongoing site investigations for a deep repository for spent nuclear fuel. The main purposes of the evaluations are to determine whether earlier judgements of the suitability of the candidate area for a deep repository with respect to long-term safety holds up in the light of borehole data and to provide feed-back to continued site investigations and site specific repository design. The preliminary safety evaluations will be carried out by a safety assessment group, based on a site model, being part of a site description, provided by a site modelling group and a repository layout within that model suggested by a repository engineering group. The site model contains the geometric features of the site as well as properties of the host rock. Several alternative interpretations of the site data will likely be suggested. Also the biosphere is included in the site model. A first task for the PSE will be to compare the rock properties described in the site model to previously established criteria for a suitable host rock. This report gives an example of such a comparison. In order to provide more detailed feedback, a number of thermal, hydrological, mechanical and chemical analyses of the site will also be included in the evaluation. The selection of analyses is derived from the set of geosphere and biosphere analyses preliminarily planned for the comprehensive safety assessment named SR-SITE, which will be based on a complete site investigation. The selection is dictated primarily by the expected feedback to continued site investigations and by the availability of data after the PSE. The repository engineering group will consider several safety related factors in suggesting a repository layout: Thermal calculations will be made to determine a minimum distance between canisters avoiding canister surface temperatures above 100 deg C

  1. 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.

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

    International Nuclear Information System (INIS)

    Vander Molen, Harold J.

    2001-01-01

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

  3. Contribution from Belgium - Belgian contribution to the PWG1 Generic Study on Undetected Failures of Safety systems

    International Nuclear Information System (INIS)

    Vincke, Marc

    1997-01-01

    In the frame of its participation to the PWG 1 generic study on 'Undetected Failures of Safety Systems', AVN performed a search of such cases among the Belgian plants, using the proposed criterion: to find significant events where equipment remained inoperable, or would have been unable to fulfil correctly its safety function for an extended period of time until their condition was discovered. An extended period of time means one cycle duration or several test interval periods at least; if unknown, it has to be estimated w.r.t. plant lifetime. Note that non safety systems preventing safety systems to perform their function are to be included. As a first information source, a screening of AVN's DIANE (Domestic Information about Nuclear Events) database, for undetected failures of safety systems was performed. This database is used to store and retrieve information on a selection of events which have occurred in the Belgian NPPs since 1985. The sources of information are the incident reports which AVN receives from the utilities, completed with the reports of our inspectors on site. The coding system used within this database is based on the IRS Coding Manual. This coding system does not always allow for an easy retrieval of events related to a specific subject. In addition the DIANE-coding system does not allow for direct retrieval of undetected failures. In a first step, the following systems were scanned: reactor coolant system, reactor heat removal system, emergency core cooling system, chemical and volume control, containment spray, main and auxiliary feedwater, component cooling water, control rod drives. For each system, records were selected by examining their title. Careful reading of the 64 reports selected this way finally led to two cases compatible with the criteria. The decennial revision studies formed a second set of information sources. An inquiry to AVN's engineers responsible for the decennial revision projects allowed to

  4. Early Site Permit Demonstration Program: Plant parameters envelope report. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-01

    The Early Site Permit (ESP) Demonstration Program is the nuclear industry`s initiative for piloting the early resolution of siting-related issues before the detailed design proceedings of the combined operating license review. The ESP Demonstration Program consists of three phases. The plant parameters envelopes task is part of Phase 1, which addresses the generic review of applicable federal regulations and develops criteria for safety and environmental assessment of potential sites. The plant parameters envelopes identify parameters that characterize the interface between an ALWR design and a potential site, and quantify the interface through values selected from the Utility Requirements Documents, vendor design information, or engineering assessments. When augmented with site-specific information, the plant parameters envelopes provide sufficient information to allow ESPs to be granted based on individual ALWR design information or enveloping design information for the evolutionary, passive, or generic ALWR plants. This document is expected to become a living document when used by future applicants.

  5. 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

  6. 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

  7. Alternative off-site power supply improves nuclear power plant safety

    International Nuclear Information System (INIS)

    Gjorgiev, Blaže; Volkanovski, Andrija; Kančev, Duško; Čepin, Marko

    2014-01-01

    Highlights: • Additional power supply for mitigation of the station blackout event in NPP is used. • A hydro power plant is considered as an off-site alternative power supply. • An upgrade of the probabilistic safety assessment from its traditional use is made. • The obtained results show improvement of nuclear power plant safety. - Abstract: A reliable power system is important for safe operation of the nuclear power plants. The station blackout event is of great importance for nuclear power plant safety. This event is caused by the loss of all alternating current power supply to the safety and non-safety buses of the nuclear power plant. In this study an independent electrical connection between a pumped-storage hydro power plant and a nuclear power plant is assumed as a standpoint for safety and reliability analysis. The pumped-storage hydro power plant is considered as an alternative power supply. The connection with conventional accumulation type of hydro power plant is analysed in addition. The objective of this paper is to investigate the improvement of nuclear power plant safety resulting from the consideration of the alternative power supplies. The safety of the nuclear power plant is analysed through the core damage frequency, a risk measure assess by the probabilistic safety assessment. The presented method upgrades the probabilistic safety assessment from its common traditional use in sense that it considers non-plant sited systems. The obtained results show significant decrease of the core damage frequency, indicating improvement of nuclear safety if hydro power plant is introduced as an alternative off-site power source

  8. Siting of nuclear facilities. Selections from Nuclear Safety

    Energy Technology Data Exchange (ETDEWEB)

    Buchanan, J.R.

    1976-07-01

    The report presented siting policy and practice for nuclear power plants as developed in the U.S. and abroad. Twenty-two articles from Nuclear Safety on this general topic are reprinted since they provide a valuable reference source. The appendices also include reprints of some relevant regulatory rules and guides on siting. Advantages and disadvantages of novel siting concepts such as underground containment, offshore siting, and nuclear energy parks are addressed. Other topics include site criteria, risk criteria, and nuclear ship criteria.

  9. Siting of nuclear facilities. Selections from Nuclear Safety

    International Nuclear Information System (INIS)

    Buchanan, J.R.

    1976-07-01

    The report presented siting policy and practice for nuclear power plants as developed in the U.S. and abroad. Twenty-two articles from Nuclear Safety on this general topic are reprinted since they provide a valuable reference source. The appendices also include reprints of some relevant regulatory rules and guides on siting. Advantages and disadvantages of novel siting concepts such as underground containment, offshore siting, and nuclear energy parks are addressed. Other topics include site criteria, risk criteria, and nuclear ship criteria

  10. 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

  11. 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)

  12. Patient Safety in Spine Surgery: Regarding the Wrong-Site Surgery

    OpenAIRE

    Lee, Seung-Hwan; Kim, Ji-Sup; Jeong, Yoo-Chul; Kwak, Dae-Kyung; Chun, Ja-Hae; Lee, Hwan-Mo

    2013-01-01

    Patient safety regarding wrong site surgery has been one of the priority issues in surgical fields including that of spine care. Since the wrong-side surgery in the DM foot patient was reported on a public mass media in 1996, the wrong-site surgery issue has attracted wide public interest as regarding patient safety. Despite the many wrong-site surgery prevention campaigns in spine care such as the operate through your initial program by the Canadian Orthopaedic Association, the sign your sit...

  13. Climate and climate-related issues for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    2010-12-01

    The purpose of this report is to document current scientific knowledge on climate and climate-related conditions, relevant to the long-term safety of a KBS-3 repository, to a level required for an adequate treatment in the safety assessment SR-Site. The report also presents a number of dedicated studies on climate and selected climate-related processes of relevance for the assessment of long term repository safety. Based on this information, the report presents a number of possible future climate developments for Forsmark, the site selected for building a repository for spent nuclear fuel in Sweden (Figure 1-1). The presented climate developments are used as basis for the selection and analysis of SR-Site safety assessment scenarios in the SR-Site main report /SKB 2011/. The present report is based on research conducted and published by SKB as well as on research reported in the general scientific literature

  14. Climate and climate-related issues for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    The purpose of this report is to document current scientific knowledge on climate and climate-related conditions, relevant to the long-term safety of a KBS-3 repository, to a level required for an adequate treatment in the safety assessment SR-Site. The report also presents a number of dedicated studies on climate and selected climate-related processes of relevance for the assessment of long term repository safety. Based on this information, the report presents a number of possible future climate developments for Forsmark, the site selected for building a repository for spent nuclear fuel in Sweden (Figure 1-1). The presented climate developments are used as basis for the selection and analysis of SR-Site safety assessment scenarios in the SR-Site main report /SKB 2011/. The present report is based on research conducted and published by SKB as well as on research reported in the general scientific literature

  15. Radionuclide transport report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This document compiles radionuclide transport calculations of a KBS-3 repository for the safety assessment SR-Site. The SR-Site assessment supports the licence application for a final repository at Forsmark, Sweden

  16. Code on the safety of nuclear power plants: Siting

    International Nuclear Information System (INIS)

    1988-01-01

    This Code provides criteria and procedures that are recommended for safety in nuclear power plant siting. It forms part of the Agency's programme for establishing Codes and Safety Guides relating to land based stationary thermal neutron power plants

  17. 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)

  18. 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.

  19. 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.

  20. 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

  1. 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

  2. Seismic Hazards in Site Evaluation for Nuclear Installations. Specific Safety Guide

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-08-15

    This Safety Guide was prepared under the IAEA programme for safety standards for nuclear installations. It supplements the Safety Requirements publication on Site Evaluation for Nuclear Installations. The present publication provides guidance and recommends procedures for the evaluation of seismic hazards for nuclear power plants and other nuclear installations. It supersedes Evaluation of Seismic Hazards for Nuclear Power Plants, IAEA Safety Standards Series No. NS-G-3.3 (2002). In this publication, the following was taken into account: the need for seismic hazard curves and ground motion spectra for the probabilistic safety assessment of external events for new and existing nuclear installations; feedback of information from IAEA reviews of seismic safety studies for nuclear installations performed over the previous decade; collective knowledge gained from recent significant earthquakes; and new approaches in methods of analysis, particularly in the areas of probabilistic seismic hazard analysis and strong motion simulation. In the evaluation of a site for a nuclear installation, engineering solutions will generally be available to mitigate, by means of certain design features, the potential vibratory effects of earthquakes. However, such solutions cannot always be demonstrated to be adequate for mitigating the effects of phenomena of significant permanent ground displacement such as surface faulting, subsidence, ground collapse or fault creep. The objective of this Safety Guide is to provide recommendations and guidance on evaluating seismic hazards at a nuclear installation site and, in particular, on how to determine: (a) the vibratory ground motion hazards, in order to establish the design basis ground motions and other relevant parameters for both new and existing nuclear installations; and (b) the potential for fault displacement and the rate of fault displacement that could affect the feasibility of the site or the safe operation of the installation at

  3. Transient analysis for resolving safety issues

    International Nuclear Information System (INIS)

    Chao, J.; Layman, W.

    1987-01-01

    The Nuclear Safety Analysis Center (NSAC) has a Generic Safety Analysis Program to help resolve high priority generic safety issues. This paper describes several high priority safety issues considered at NSAC and how they were resolved by transient analysis using thermal hydraulics and neutronics codes. These issues are pressurized thermal shock (PTS), anticipated transients without scram (ATWS), steam generator tube rupture (SGTR), and reactivity transients in light of the Chernobyl accident

  4. Reassessment of selected factors affecting siting of Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    Davis, R.E.; Hanson, A.L.; Mubayi, V.; Nourbakhsh, H.P.

    1997-02-01

    Brookhaven National Laboratory has performed a series of probabilistic consequence assessment calculations for nuclear reactor siting. This study takes into account recent insights into severe accident source terms and examines consequences in a risk based format consistent with the quantitative health objectives (QHOs) of the NRC`s Safety Goal Policy. Simplified severe accident source terms developed in this study are based on the risk insights of NUREG-1150. The results of the study indicate that both the quantity of radioactivity released in a severe accident as well as the likelihood of a release are lower than those predicted in earlier studies. The accident risks using the simplified source terms are examined at a series of generic plant sites, that vary in population distribution, meteorological conditions, and exclusion area boundary distances. Sensitivity calculations are performed to evaluate the effects of emergency protective action assumptions on the risk of prompt fatality and latent cancers fatality, and population relocation. The study finds that based on the new source terms the prompt and latent fatality risks at all generic sites meet the QHOs of the NRC`s Safety Goal Policy by margins ranging from one to more than three orders of magnitude. 4 refs., 17 figs., 24 tabs.

  5. 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)

  6. Decommissioning of commercial shallow-land burial sites

    International Nuclear Information System (INIS)

    Murphy, E.S.; Holter, G.M.

    1979-01-01

    Estimated costs and safety considerations for decommissioning LLW burial grounds have been evaluated. Calculations are based on a generic burial ground assumed to be located at a western and an eastern site. Decommissioning modes include: (1) site stabilization followed by long-term care of the site; and (2) waste relocation. Site stabilization is estimated to cost from $0.4 million to $7.5 million, depending on the site and the stabilization option chosen. Long-term care is estimated to cost about $100,000 annually, with somewhat higher costs during early years because of increased site maintenance and environmental monitoring requirements. Long-term care is required until the site is released for unrestricted public use. Occupational and public safety impacts of site stabilization and long-term care are estimated to be small. Relocation of all the waste from a reference burial ground is estimated to cost more than $1.4 billion and to require more than 20 years for completion. Over 90% of the cost is associated with packaging, transportation, and offsite disposal of the exhumed waste. Waste relocation results in significant radiation exposure to decommissioning workers

  7. Safety- and performance indicators for a generic deep geological repository in clay

    International Nuclear Information System (INIS)

    Resele, G.; Niemeyer, M.; Wilhelm, St.; Heimer, St.; Mohlfeld, M.; Eilers, G.; Preuss, J.; Wollrath, J.

    2010-01-01

    Document available in extended abstract form only. As a first step of an impartial survey for an optimal site selection for a deep geological repository in Germany, potentially suitable regions shall be identified and localised according to their suitability. During the early phases of such a site selection procedure the information about the properties of the host rock and the geological situation at the potential sites is not very precise. As site investigation procedures are both expensive and time-consuming, it is essential to identify those properties of the geological barrier system that are most relevant for long-term safety. Furthermore, adequate indicators have to be chosen that allow a simple but efficient assessment of the suitability of the potential regions. Definition and application of 'exclusion criteria' based on single parameter values, e.g. the hydraulic conductivity of the host rock, is inadequate because the long-term safety depends on the interaction of many features and properties of the barrier system. In a research project, indicators have been developed which depend on the most relevant properties of the geological barriers and estimate the overall performance of a repository system. The application of these indicators on the barrier properties which have been found during the investigations of potential repository sites in clay located in Germany, Switzerland and France demonstrates how, for instance, an unfavourably high hydraulic permeability of the clay can be compensated by a large vertical extension of the clay layer and small hydraulic gradients. Other indicators evaluate the importance of hydraulic discontinuities and define the minimal requirements on technical barriers like seals and backfill of emplacement tunnels. When the information of the radionuclide inventory and the biosphere, especially the diluting aquifer is included, the indicators allow the estimation of the resulting dose which matches the result of a

  8. WAG 2 remedial investigation and site investigation site-specific work plan/health and safety checklist for the sediment transport modeling task

    International Nuclear Information System (INIS)

    Holt, V.L.; Baron, L.A.

    1994-05-01

    This site-specific Work Plan/Health and Safety Checklist (WP/HSC) is a supplement to the general health and safety plan (HASP) for Waste Area Grouping (WAG) 2 remedial investigation and site investigation (WAG 2 RI ampersand SI) activities [Health and Safety Plan for the Remedial Investigation and Site Investigation of Waste Area Grouping 2 at the Oak Ridge National Laboratory, Oak Ridge, Tennessee (ORNL/ER-169)] and provides specific details and requirements for the WAG 2 RI ampersand SI Sediment Transport Modeling Task. This WP/HSC identifies specific site operations, site hazards, and any recommendations by Oak Ridge National Laboratory (ORNL) health and safety organizations [i.e., Industrial Hygiene (IH), Health Physics (HP), and/or Industrial Safety] that would contribute to the safe completion of the WAG 2 RI ampersand SI. Together, the general HASP for the WAG 2 RI ampersand SI (ORNL/ER-169) and the completed site-specific WP/HSC meet the health and safety planning requirements specified by 29 CFR 1910.120 and the ORNL Hazardous Waste Operations and Emergency Response (HAZWOPER) Program Manual. In addition to the health and safety information provided in the general HASP for the WAG 2 RI ampersand SI, details concerning the site-specific task are elaborated in this site-specific WP/HSC, and both documents, as well as all pertinent procedures referenced therein, will be reviewed by all field personnel prior to beginning operations

  9. 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

  10. Seismic safety margins research program. Phase I final report - Plant/site selection and data collection (Project I)

    International Nuclear Information System (INIS)

    Chuang, T.Y.

    1981-07-01

    Project I of Phase I of the Seismic Safety Margins Research Program (SSMRP) comprised two parts: the selection of a representative nuclear power plant/site for study in Phase I and the collection of data needed by the other SSMRP projects. Unit 1 of the Zion Nuclear Power Plant in Zion, Illinois, was selected for the SSMRP Phase I studies. Unit 1 of the Zion plant has been validated as a good choice for the Phase I study plant. Although no single nuclear power plant can represent all such plants equally well, selection criteria were developed to maximize the generic implications of Phase I of the SSMRP. On the basis of the selection criteria, the Zion plant and its site were found to be reasonably representative of operating and future plants with regard to its nuclear steam supply system; the type of containment structure (prestressed concrete); its electrical capacity (1100 MWe); its location (the Midwest); the peak seismic acceleration used for design (0.17g); and the properties of the underlying soil (the low-strain shear-wave velocity is 1650 ft/s in a 50- to 100-ft-thick layer of soil overlying sedimentary bedrock). (author)

  11. 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.

  12. WAG 2 remedial investigation and site investigation site-specific work plan/health and safety checklist for the soil and sediment task

    International Nuclear Information System (INIS)

    Holt, V.L.; Burgoa, B.B.

    1993-12-01

    This document is a site-specific work plan/health and safety checklist (WP/HSC) for a task of the Waste Area Grouping 2 Remedial Investigation and Site Investigation (WAG 2 RI ampersand SI). Title 29 CFR Part 1910.120 requires that a health and safety program plan that includes site- and task-specific information be completed to ensure conformance with health- and safety-related requirements. To meet this requirement, the health and safety program plan for each WAG 2 RI ampersand SI field task must include (1) the general health and safety program plan for all WAG 2 RI ampersand SI field activities and (2) a WP/HSC for that particular field task. These two components, along with all applicable referenced procedures, must be kept together at the work site and distributed to field personnel as required. The general health and safety program plan is the Health and Safety Plan for the Remedial Investigation and Site Investigation of Waste Area Grouping 2 at the Oak Ridge National Laboratory, Oak Ridge, Tennessee (ORNL/ER-169). The WP/HSCs are being issued as supplements to ORNL/ER-169

  13. Fuel and canister process report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    Werme, Lars; Lilja, Christina

    2010-12-01

    This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  14. Fuel and canister process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Werme, Lars; Lilja, Christina (eds.)

    2010-12-15

    This report documents fuel and canister processes identified as relevant to the long-term safety of a KBS-3 repository. It forms an important part of the reporting of the safety assessment SR-Site. The detailed assessment methodology, including the role of the process reports in the assessment, is described in the SR-Site Main report /SKB 2011/

  15. Use of safety analysis to site comfirmation procedure in case of hard rock repository

    International Nuclear Information System (INIS)

    Peltonen, E.K.

    1984-02-01

    The role of safety analysis in a confirmation procedure of a candidate disposal site of radioactive wastes is discussed. Items dealt with include principle reasons and practical goals of the use of safety analysis, methodology of safety analysis and assessment, as well as usefulness and adequacy of the present safety analysis. Safety analysis is a tool, which enables one to estimate quantitatively the possible radiological impacts from the disposal. The results can be compared with the criteria and the suitability conclusions drawn. Because of its systems analytical nature safety analysis is an effective method to reveal, what are the most important factors of the disposal system and the most critical site characteristics inside the lumped parameters often provided by the experimental site investigation methods. Furthermore it gives information on the accuracy needs of different site properties. This can be utilized to judge whether the quality and quantity of the measurements for the characterization are sufficient as well as to guide the further site investigations. A more practical discussion regarding the applicability of the use of safety analysis is presented by an example concerning the assessment of a Finnish candidate site for low- and intermediate-level radioactive waste repository. (author)

  16. Safety assessment of multi-unit NPP sites subject to external events

    International Nuclear Information System (INIS)

    Samaddar, Sujit; Hibino, Kenta; Coman, Ovidiu

    2014-01-01

    This paper presents a framework for conducting a probabilistic safety assessment of multi-unit sites against external events. The treatment of multiple hazard on a unit, interaction between units, implementation of severe accident measures, human reliability, environmental conditions, metric of risk for both reactor and non-reactor sources, integration of risk and responses and many such important factors need to be addressed within the context of this framework. The framework facilitates the establishment of a comprehensive methodology that can be applied internationally to the peer review of safety assessment of multi-unit sites under the impact of multiple external hazards. In summary, it can be said that the site safety assessment for a multi-unit site will be quite complex and need to start with individual unit risk assessments, these need to be combined considering the interactions between units and their responses, and the fragilities of the installations established considering the combined demands from all interactions. Using newly established risk metric the risk can then be integrated for the overall site. Fig. 2 shows schematically such a proposal. Much work has to done and the IAEA has established a working group that is systematically establishing the structure and process to incorporate the many issues that are a part of a multi-unit site safety assessment. (authors)

  17. 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

  18. Underground siting of nuclear power plants: potential benefits and penalties

    International Nuclear Information System (INIS)

    Allensworth, J.A.; Finger, J.T.; Milloy, J.A.; Murfin, W.B.; Rodeman, R.; Vandevender, S.G.

    1977-08-01

    The potential for improving nuclear power safety is analyzed by siting plants underground in mined cavities or by covering plants with fill earth after construction in an excavated cut. Potential benefits and penalties of underground plants are referenced to analogous plants located on the surface. Three representative regional sites having requisite underground geology were used to evaluate underground siting. The major factors which were evaluated for all three sites were: (1) containment of radioactive materials, (2) transport of groundwater contamination, and (3) seismic vulnerability. External protection, plant security, feasibility, operational considerations, and cost were evaluated on a generic basis. Additionally, the national availability of sites having the requisite geology for both underground siting concepts was determined

  19. Technology, safety, and costs of decommissioning a reference pressurized water reactor power station. Appendices

    International Nuclear Information System (INIS)

    Smith, R.I.; Konzek, G.J.; Kennedy, W.E. Jr.

    1978-05-01

    Detailed appendices are presented under the following headings: reference PWR facility description, reference PWR site description, estimates of residual radioactivity, alternative methods for financing decommissioning, radiation dose methodology, generic decommissioning activities, intermediate dismantlement activities, safe storage and deferred dismantlement activities, compilation of unit cost factors, and safety assessment details

  20. 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.

  1. Occupational health and safety in the Moroccan construction sites: preliminary diagnosis

    Science.gov (United States)

    Tarik, Bakeli; Adil, Hafidi Alaoui

    2018-05-01

    Managing occupational health and safety on Moroccan construction sector represents the first step for projects' success. In fact, by avoiding accidents, all the related direct and indirect costs and delays can be prevented. That leads to an important question always asked by any project manager: what are the factors responsible for accidents? How can they be avoided? Through this research, the aim is to go through these questions, to contribute in occupational health and safety principles understanding, to identify construction accidentology and risk management opportunities and to approach the case of Moroccan construction sites by an accurate diagnosis. The approach is to make researchers, managers, stakeholders and deciders aware about the criticality of construction sites health and safety situation. And, to do the first step for a scientific research project in relation with health and safety in the Moroccan construction sector. For this, the paper will study the related state of art namely about construction sites accidents causation, and will focus on Reason's `Swiss cheese' model and its utilization for Moroccan construction sites health and safety diagnosis. The research will end with an estimation of an accidents fatality rate in the Moroccan construction sector and a benchmarking with the international rates. Finally, conclusions will be presented about the necessity of Occupational Health and Safety Management System (OHSMS) implementation, which shall cover all risk levels, and insure, at the same time, that the necessary defenses against accidents are on place.

  2. Engineering study of generic site criteria for selected DOE plutonium facilities

    International Nuclear Information System (INIS)

    Kingsbury, R.J.; Greenwood, J.M.; Sandoval, M.D.

    1980-09-01

    The objectives of this study were to identify criteria that would be applied to selection of a site for plutonium facilities such as those at the Rocky Flats Plant, to establish the relative importance of these criteria, and to identify suitable areas within the United States for location of plutonium facilities with respect to these criteria. Sources of the site criteria identified include federal laws, federal agency regulations, state laws and regulations, and requirements associated with operations to be performed at the site. The criteria identified during the study were organized into 14 major categories. The relative importnace of each category and each criterion within the categories were established using group decision-making techniques. The major criteria categories, their assigned weight on a scale of 1 to 10, and their relative priority ranks are as follows: geology/seismicity; public safety; environmental impact; meteorology; hydrology; topography; transportation; utilities; personnel; safeguards/security; land area and availability; land use compatibility; and, public acceptance. A suitability analysis of the continental United States was performed using only those criteria that could be mapped at a national scale. Suitability was assessed with respect to each of these criteria, and individual suitability maps were prepared. A composite suitability map was generated using computerized overlay techniques. This map provides a starting point for identifying specific candidate sites if an actual site selection were to be conducted

  3. [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

  4. Safety criteria for siting a nuclear power plant

    International Nuclear Information System (INIS)

    2001-01-01

    The guide sets forth requirements for safety of the population and the environment in nuclear power plant siting. It also sets out the general basis for procedures employed by other competent authorities when they issue regulations or grant licences. On request STUK (Radiation and Nuclear Safety Authority of Finland) issues case-specific statements about matters relating to planning and about other matters relating to land use in the environment of nuclear power plants

  5. 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

  6. Methodology for calculating guideline concentrations for safety shot sites

    International Nuclear Information System (INIS)

    1997-06-01

    Residual plutonium (Pu), with trace quantities of depleted uranium (DU) or weapons grade uranium (WU), exists in surficial soils at the Nevada Test Site (NTS), Nellis Air Force Range (NAFR), and the Tonopah Test Range (TTR) as the result of the above-ground testing of nuclear weapons and special experiments involving the detonation of plutonium-bearing devices. The special experiments (referred to as safety shots) involving plutonium-bearing devices were conducted to study the behavior of Pu as it was being explosively compressed; ensure that the accidental detonation of the chemical explosive in a production weapon would not result in criticality; evaluate the ability of personnel to manage large-scale Pu dispersal accidents; and develop criteria for transportation and storage of nuclear weapons. These sites do not pose a health threat to either workers or the general public because they are under active institutional control. The DOE is committed to remediating the safety shot sites so that radiation exposure to the public, both now and in the future, will be maintained within the established limits and be as low as reasonably achievable. Remediation requires calculation of a guideline concentration for the Pu, U, and their decay products that are present in the surface soil. This document presents the methodology for calculating guideline concentrations of weapons grade plutonium, weapons grade uranium, and depleted uranium in surface soils at the safety shot sites. Emphasis is placed on obtaining site-specific data for use in calculating dose to potential residents from the residual soil contamination

  7. Methodology for calculating guideline concentrations for safety shot sites

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-06-01

    Residual plutonium (Pu), with trace quantities of depleted uranium (DU) or weapons grade uranium (WU), exists in surficial soils at the Nevada Test Site (NTS), Nellis Air Force Range (NAFR), and the Tonopah Test Range (TTR) as the result of the above-ground testing of nuclear weapons and special experiments involving the detonation of plutonium-bearing devices. The special experiments (referred to as safety shots) involving plutonium-bearing devices were conducted to study the behavior of Pu as it was being explosively compressed; ensure that the accidental detonation of the chemical explosive in a production weapon would not result in criticality; evaluate the ability of personnel to manage large-scale Pu dispersal accidents; and develop criteria for transportation and storage of nuclear weapons. These sites do not pose a health threat to either workers or the general public because they are under active institutional control. The DOE is committed to remediating the safety shot sites so that radiation exposure to the public, both now and in the future, will be maintained within the established limits and be as low as reasonably achievable. Remediation requires calculation of a guideline concentration for the Pu, U, and their decay products that are present in the surface soil. This document presents the methodology for calculating guideline concentrations of weapons grade plutonium, weapons grade uranium, and depleted uranium in surface soils at the safety shot sites. Emphasis is placed on obtaining site-specific data for use in calculating dose to potential residents from the residual soil contamination.

  8. Strategies for effective management of health and safety in confined site construction

    Directory of Open Access Journals (Sweden)

    John Spillane

    2013-12-01

    Full Text Available Purpose: The overall aim of this research is to identify and catalogue the numerous managerial strategies for effective management of health and safety on a confined, urban, construction site. Design/Methodology/Approach: This is achieved by utilising individual interviews, focus groups discussion on selected case studies of confined construction sites, coupled with a questionnaire survey. Findings: The top five key strategies include (1 Employ safe system of work plans to mitigate personnel health and safety issues; (2 Inform personnel, before starting on-site, of the potential issues using site inductions; (3 Effective communication among site personnel; (4 Draft and implement an effective design site layout prior to starting on-site; and (5 Use of banksman (traffic co-ordinator to segregate personnel from vehicular traffic. Practical Implication: The construction sector is one of the leading industries in accident causation and with the continued development and regeneration of our urban centres, confined site construction is quickly becoming the norm - an environment which only fuels accident creation within the construction sector. Originality/Value: This research aids on-site management that requires direction and assistance in the identification and implementation of key strategies for the management of health and safety, particularly in confined construction site environments.

  9. Savannah River Site K-Reactor Probabilistic Safety Assessment

    International Nuclear Information System (INIS)

    Brandyberry, M.D.; Bailey, R.T.; Baker, W.H.; Kearnaghan, D.P.; O'Kula, K.R.; Wittman, R.S.; Woody, N.D.; Amos, C.N.; Weingardt, J.J.

    1992-12-01

    This report gives the results of a Savannah River Site (SRS) K-Reactor Probabilistic Safety Assessment (PSA). Measures of adverse consequences to health and safety resulting from representations of severe accidents in SRS reactors are presented. In addition, the report gives a summary of the methods employed to represent these accidents and to assess the resultant consequences. The report is issued to provide useful information to the U. S. Department of Energy (DOE) on the risk of operation of SRS reactors, for insights into severe accident phenomena that contribute to this risk, and in support of improved bases for other DOE programs in Heavy Water Reactor safety

  10. 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

  11. Oak Ridge National Laboratory site data for safety-analysis report

    International Nuclear Information System (INIS)

    Fitzpatrick, F.C.

    1982-12-01

    The Oak Ridge National Laboratory site data contained herein were compiled in support of the United States Department of Energy (USDOE) Oak Ridge Operations Office Order OR 5481.1. That order sets forth assignment of responsibilities for safety analysis and review responsibilities and provides guidance relative to the content and format of safety analysis reports. The information presented in this document is intended for use by reference in individual safety analysis reports where applicable to support accident analyses or the establishment of design bases of significance to safety, and it is applicable only to Oak Ridge National Laboratory facilities in Bethel and Melton Valleys. This information includes broad descriptions of the site characteristics, radioactive waste handling and monitoring practices, and the organization and operating policies at Oak Ridge National Laboratory. The historical background of the Laboratory is discussed briefly and the overall physical situation of the facilities is described in the following paragraphs

  12. Oak Ridge National Laboratory site data for safety-analysis report

    Energy Technology Data Exchange (ETDEWEB)

    Fitzpatrick, F.C.

    1982-12-01

    The Oak Ridge National Laboratory site data contained herein were compiled in support of the United States Department of Energy (USDOE) Oak Ridge Operations Office Order OR 5481.1. That order sets forth assignment of responsibilities for safety analysis and review responsibilities and provides guidance relative to the content and format of safety analysis reports. The information presented in this document is intended for use by reference in individual safety analysis reports where applicable to support accident analyses or the establishment of design bases of significance to safety, and it is applicable only to Oak Ridge National Laboratory facilities in Bethel and Melton Valleys. This information includes broad descriptions of the site characteristics, radioactive waste handling and monitoring practices, and the organization and operating policies at Oak Ridge National Laboratory. The historical background of the Laboratory is discussed briefly and the overall physical situation of the facilities is described in the following paragraphs.

  13. 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

  14. Site Safety Plan for Lawrence Livermore National Laboratory CERCLA investigations

    Energy Technology Data Exchange (ETDEWEB)

    Bainer, R.; Duarte, J.

    1993-07-01

    The safety policy of LLNL is to take every reasonable precaution in the performance of work to protect the environment and the health and safety of employees and the public, and to prevent property damage. With respect to hazardous agents, this protection is provided by limiting human exposures, releases to the environment, and contamination of property to levels that are as low as reasonably achievable (ALARA). It is the intent of this Plan to supply the broad outline for completing environmental investigations within ALARA guidelines. It may not be possible to determine actual working conditions in advance of the work; therefore, planning must allow the opportunity to provide a range of protection based upon actual working conditions. Requirements will be the least restrictive possible for a given set of circumstances, such that work can be completed in an efficient and timely fashion. Due to the relatively large size of the LLNL Site and the different types of activities underway, site-specific Operational Safety Procedures (OSPs) will be prepared to supplement activities not covered by this Plan. These site-specific OSPs provide the detailed information for each specific activity and act as an addendum to this Plan, which provides the general plan for LLNL Main Site operation.

  15. 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

  16. Rock siting of nuclear power plants from a reactor safety standpoint

    International Nuclear Information System (INIS)

    1975-11-01

    The study has aimed at surveying the advantages and disadvantages of a rock sited nuclear power plant from a reactor safety standpoint. The studies performed are almost entirely concentrated on the BWR alternative. The design of a nuclear power plant in rock judged most appropriate has been studied in greater detail, and a relatively extensive safety analysis has been made. It is found that the presented technical design of the rock sited alternative is sufficiently advanced to form a basis for further projecting treatment. The chosen technical design of the reactor plant demands a cavern with a 45-50 metre span. Caverns without strengthening efforts with such spans are used in mines, but have no previously been used for industrial plants. Studies of the stability of such caverns show that a safety level is attainable corresponding to the safety required for the other parts of the nuclear power plant. The conditions are that the rock is of high quality, that necessary strengthening measures are taken and that careful studies of the rock are made before and during the blasting, and also during operation of the plant. When locating a rock sited nuclear power plant, the same criteria must be considered as for an above ground plant, with additional stronger demands for rock quality. The presented rock sited nuclear power plant has been assessed to cost 20 % more in total construction costs than a corresponding above ground plant. The motivations for rock siting also depend on whether a condensing plant for only electricity production, or a plant for combined power production and district heating, is considered. The latter would under certain circumstances make rock siting look more attractive. (author)

  17. Safety assessment for Area 5 radioactive-waste-management site

    International Nuclear Information System (INIS)

    Hunter, P.H.; Card, D.H.; Horton, K.

    1982-09-01

    The Area 5 Radioactive Waste Management Safety Assessment Document contains evaluations of site characteristics, facilities, and operating practices that contribute to the safe handling, storage, and disposal of low-level radioactive wastes at the Nevada Test Site. Physical geography, cultural factors, climate and meteorology, geology, hydrology (with emphasis on radionuclide migration), ecology, natural phenomena, and natural resources are discussed and determined to be suitable for effective containment of radionuclides. A separate section considers facilities and operating practices such as monitoring, storage/disposal criteria, site maintenance, equipment, and support. The section also considers the transportation and waste handling requirements supporting the new Greater Confinement Disposal Facility (GCDF), GCDF demonstration project, and other requirements for the safe handling, storage, and disposal of low-level radioactive wastes. Finally, the document provides an analysis of releases and an assessment of the near-term operational impacts and dose commitments to operating personnel and the general public from normal operations and anticipated accidental occurrences. The conclusion of this report is that the Area 5 Radioactive Waste Management Site is suitable for low-level radioactive waste handling, storage, and disposal. Also, the new GCDF demonstration project will not affect the overall safety of the Area 5 Radioactive Waste Management Site

  18. Site-specific evaluation of safety issues for high-level waste disposal in crystalline rocks. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Jobmann, M. (ed.) [DBE Technology GmbH, Peine (Germany)

    2016-03-31

    In the past, German research and development (R and D) activities regarding the disposal of radioactive waste, including spent nuclear fuel, focused mainly on domal rock salt because rock salt was the preferred host rock formation. In addition, generic R and D work regarding alternative host rocks (crystalline rocks and claystones) had been performed as well for a long time but with lower intensity. Around the year 2000, as a consequence of the moratorium on the Gorleben site, the Federal Government decided to have argillaceous rocks and crystalline rocks investigated in more detail. As Germany does not have any underground research and host rock characterization facilities, international cooperation received a high priority in the German R and D programme for high-level waste (HLW) disposal in order to increase the knowledge regarding alternative host rocks. Major cornerstones of the cooperation are joint projects and experiments conducted especially in underground research laboratories (URL) in crystalline rocks at the Grimsel Test Site (Switzerland) and the Hard Rock Laboratory (HRL) Aespoe(Sweden) and in argillaceous rocks at the URL Mont Terri (Switzerland) and Bure (France). In 2001, the topic of radioactive waste disposal was integrated into the agreement between the former Russian Ministry of Atomic Energy (Minatom, now Rosatom) and the German Ministry of Labor (BMWA), now Ministry of Economic Affairs and Energy (BMWi), on cooperation regarding R and D on the peaceful utilization of nuclear power (agreement on ''Wirtschaftlich-Technische Zusammenarbeit'' WTZ). The intention was to have a new and interesting opportunity for international R and D cooperation regarding HLW disposal in crystalline rocks and the unique possibility to perform site-specific work, to test the safety demonstration tools available, and to expand the knowledge to all aspects specific to these host rocks. Another motivation for joining this cooperation was the

  19. Empirical estimation of school siting parameter towards improving children's safety

    Science.gov (United States)

    Aziz, I. S.; Yusoff, Z. M.; Rasam, A. R. A.; Rahman, A. N. N. A.; Omar, D.

    2014-02-01

    Distance from school to home is a key determination in ensuring the safety of hildren. School siting parameters are made to make sure that a particular school is located in a safe environment. School siting parameters are made by Department of Town and Country Planning Malaysia (DTCP) and latest review was on June 2012. These school siting parameters are crucially important as they can affect the safety, school reputation, and not to mention the perception of the pupil and parents of the school. There have been many studies to review school siting parameters since these change in conjunction with this ever-changing world. In this study, the focus is the impact of school siting parameter on people with low income that live in the urban area, specifically in Johor Bahru, Malaysia. In achieving that, this study will use two methods which are on site and off site. The on site method is to give questionnaires to people and off site is to use Geographic Information System (GIS) and Statistical Product and Service Solutions (SPSS), to analyse the results obtained from the questionnaire. The output is a maps of suitable safe distance from school to house. The results of this study will be useful to people with low income as their children tend to walk to school rather than use transportation.

  20. FEP report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report documents the analysis and processing of features, events and processes, FEPs, that has been carried out within the safety assessment SR-Site, and forms an important part of the reporting of the project. The main part of the work was conducted within the earlier safety assessment SR-Can, which was a preparatory stage for the SR-Site assessment. The overall objective of the FEP analysis and processing in both SR-Can and SR-Site included development of a database of features, events and processes, an SKB FEP database, in a format that facilitates both a systematic analysis of FEPs and documentation of that FEP analysis, as well as facilitating revisions and updates to be made in connection with new safety assessments. The primary objective in SR-Site was to establish an SR-Site FEP catalogue within the framework of the SKB FEP database. This FEP catalogue was required to contain all FEPs that needed to be handled in SR-Site and is an update of the corresponding SR-Can FEP catalogue that was established for the SR-Can assessment. The starting point for the handling of FEPs in SR-Site was the SR-Can version of the SKB FEP database and associated SR-Can reports. The SR-Can version of the SKB FEP database includes the SR-Can FEP catalogue, as well as the sources for the identification of FEPs in SR-Can, namely the SR 97 processes and variables, Project FEPs in the NEA International FEP database version 1.2 and matrix interactions in the Interaction matrices developed for a deep repository of the KBS-3 type. Since the completion of the FEP work within SR-Can, an updated electronic version, version 2.1, of the NEA FEP database has become available. Compared with version 1.2 of the NEA FEP database, version 2.1 contains FEPs from two more projects. As part of SR-Site, all new Project FEPs in version 2.1 of the NEA FEP database have been mapped according to the methodology adopted in SR-Can resulting in an SR-Site version of the SKB FEP database. The SKB FEP

  1. FEP report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    2010-12-01

    This report documents the analysis and processing of features, events and processes, FEPs, that has been carried out within the safety assessment SR-Site, and forms an important part of the reporting of the project. The main part of the work was conducted within the earlier safety assessment SR-Can, which was a preparatory stage for the SR-Site assessment. The overall objective of the FEP analysis and processing in both SR-Can and SR-Site included development of a database of features, events and processes, an SKB FEP database, in a format that facilitates both a systematic analysis of FEPs and documentation of that FEP analysis, as well as facilitating revisions and updates to be made in connection with new safety assessments. The primary objective in SR-Site was to establish an SR-Site FEP catalogue within the framework of the SKB FEP database. This FEP catalogue was required to contain all FEPs that needed to be handled in SR-Site and is an update of the corresponding SR-Can FEP catalogue that was established for the SR-Can assessment. The starting point for the handling of FEPs in SR-Site was the SR-Can version of the SKB FEP database and associated SR-Can reports. The SR-Can version of the SKB FEP database includes the SR-Can FEP catalogue, as well as the sources for the identification of FEPs in SR-Can, namely the SR 97 processes and variables, Project FEPs in the NEA International FEP database version 1.2 and matrix interactions in the Interaction matrices developed for a deep repository of the KBS-3 type. Since the completion of the FEP work within SR-Can, an updated electronic version, version 2.1, of the NEA FEP database has become available. Compared with version 1.2 of the NEA FEP database, version 2.1 contains FEPs from two more projects. As part of SR-Site, all new Project FEPs in version 2.1 of the NEA FEP database have been mapped according to the methodology adopted in SR-Can resulting in an SR-Site version of the SKB FEP database. The SKB FEP

  2. Nuclear safety criteria applied in site selection - the practice in France

    International Nuclear Information System (INIS)

    Candes, P.; Aussourd, Ph.

    1975-01-01

    In France, the safety of nuclear facilities is the responsibility of the Ministry for Industry and Research (Central Department for the Safety of Nuclear Facilities). The first part of the paper deals with the conception and contents of the site studies which are included in a safety report with the object of obtaining authorization to go ahead with work on the establishment of a facility. The conception is governed by the following two considerations: (a) the site is a place where the natural elements and living organisms occur and which is characterized by the permanent presence of the human factor, while the proposed nuclear facility will - like any industrial facility - present risks and have an impact on the site, particularly through the discharge of radioactive effluent and potentially in consequence of a nuclear accident; (b) the site exercises an influence - in fact, it even imposes constraints - on the nuclear facility. The site study as submitted by the operators to the authorities responsible for the safety evaluation traditionally consists of six sections, covering: (I) description and history of the site; (II) meteorological conditions; (III) hydrology of the area; (IV) geological and seismological conditions; (V) ecological factors; (VI) natural and/or previous radioactivity at the site. These six sections contain the data which serve as a basis for applying the two considerations spelled out above. However, the two corresponding directions of study and analysis do not settle the fundamental problem of the distribution of the population around the site. Methods for dealing with this problem are suggested in the second part of the paper; they take into account the efforts made so far at the international level. The authors consider that limiting criteria should not be based solely on the radioactive effluent discharges associated with normal operation but on the radioactivity releases associated with accidents. The methods proposed by them constitute

  3. Efficacy of generic allometric equations for estimating biomass: a test in Japanese natural forests.

    Science.gov (United States)

    Ishihara, Masae I; Utsugi, Hajime; Tanouchi, Hiroyuki; Aiba, Masahiro; Kurokawa, Hiroko; Onoda, Yusuke; Nagano, Masahiro; Umehara, Toru; Ando, Makoto; Miyata, Rie; Hiura, Tsutom

    2015-07-01

    Accurate estimation of tree and forest biomass is key to evaluating forest ecosystem functions and the global carbon cycle. Allometric equations that estimate tree biomass from a set of predictors, such as stem diameter and tree height, are commonly used. Most allometric equations are site specific, usually developed from a small number of trees harvested in a small area, and are either species specific or ignore interspecific differences in allometry. Due to lack of site-specific allometries, local equations are often applied to sites for which they were not originally developed (foreign sites), sometimes leading to large errors in biomass estimates. In this study, we developed generic allometric equations for aboveground biomass and component (stem, branch, leaf, and root) biomass using large, compiled data sets of 1203 harvested trees belonging to 102 species (60 deciduous angiosperm, 32 evergreen angiosperm, and 10 evergreen gymnosperm species) from 70 boreal, temperate, and subtropical natural forests in Japan. The best generic equations provided better biomass estimates than did local equations that were applied to foreign sites. The best generic equations included explanatory variables that represent interspecific differences in allometry in addition to stem diameter, reducing error by 4-12% compared to the generic equations that did not include the interspecific difference. Different explanatory variables were selected for different components. For aboveground and stem biomass, the best generic equations had species-specific wood specific gravity as an explanatory variable. For branch, leaf, and root biomass, the best equations had functional types (deciduous angiosperm, evergreen angiosperm, and evergreen gymnosperm) instead of functional traits (wood specific gravity or leaf mass per area), suggesting importance of other traits in addition to these traits, such as canopy and root architecture. Inclusion of tree height in addition to stem diameter improved

  4. Overview of waste isoltaion safety assessment program and description of source term characterization task at PNL

    International Nuclear Information System (INIS)

    Bradley, D.

    1977-01-01

    A project is being conducted to develop and illustrate the methods and obtain the data necessary to assess the safety of long-term disposal of high-level radioactive waste in geologic formations. The methods and data will initially focus on generic geologic isolation systems but will ultimately be applied to the long-term safety assessment of specific candidate sites that are selected in the NWTS Program. The activities of waste isolation safety assessment (WISAP) are divided into six tasks: (1) Safety Assessment Concepts and Methods, (2) Disruptive Event Analysis, (3) Source Characterization, (4) Transport Modeling, (5) Transport Data and (6) Societal Acceptance

  5. 78 FR 48468 - Delphi Corporation, Electronics and Safety Division, Including On-Site Leased Workers From...

    Science.gov (United States)

    2013-08-08

    ..., Electronics and Safety Division, Including On-Site Leased Workers From Securitas, Bartech, Flint Janitorial... Adjustment Assistance on May 20, 2013, applicable to workers of Delphi Corporation, Electronics and Safety... on- site at the Flint, Michigan location of Delphi Corporation, Electronics and Safety Division. The...

  6. Sorption data bases for generic Swiss argillaceous rock systems

    International Nuclear Information System (INIS)

    Bradbury, M. H.; Baeyens, B.; Thoenen, T.

    2010-09-01

    In Switzerland the site selection procedure for both high level waste (HLW) and low and intermediate level waste (L/ILW) repositories is specified by the Swiss Federal Office of Energy in the Sectoral Plan for Deep Geological Repositories. In the forthcoming stage 2 of this plan, potential sites will be identified within regions previously selected based on the presence of suitable host rocks, namely Opalinus Clay, 'Brauner Dogger', Effingen Member and Helvetic Marl. Preliminary safety analyses are an integral part of this procedure, and require, amongst other information, the radionuclide sorption properties of the host rock. This report describes a methodology to develop a Generic Rock Sorption Data Base (GR-SDB) for argillaceous rocks. The method will be used to compile specific SDBs for the above mentioned host rocks. Arguments are presented that the main factor influencing sorption on argillaceous rocks is the phyllosilicate mineral content. These minerals are particularly effective at binding metals to their surfaces by cation exchange and surface complexation. Generally, the magnitude of sorption is directly correlated with the phyllosilicate content (2:1 type clays: illite/smectite/illitesmectite mixed layers), and this parameter best reflects the sorption potential of a given mineral assembly. Consequently, sorption measurements on illite were preferably used as source data for the GR-SDB. The second component influencing radionuclide sorption is the porewater chemistry. In the present report, generic water compositions were extracted from the analytical ranges of deep ground waters in various sedimentary formations in Switzerland. In order to cover the range of ionic strength (I) and pH values of Swiss ground waters in argillaceous rocks, five types of generic water compositions were defined, combining low, intermediate and high values of ionic strength and pH. The GR-SDB for in situ conditions was derived using conversion factors (CF). As the name

  7. New Reactor Siting in Finland, Hanhikivi Site in Pyhaejoki - STUK preliminary safety assessment

    International Nuclear Information System (INIS)

    Nevalainen, Janne

    2013-01-01

    STUK has performed a preliminary assessment of the Decision-in-Principle on the Fennovoima application. A variety of factors must be considered in the selection of a site, including effects of the site on the plant design and the effects of the plant on the site environment. These include external hazards, both natural and human-induced. Since this is a new site, an extensive siting process is followed, that can include an EIA. A site survey is performed to identify candidate sites, after investigating a large region and rejecting unsuitable sites. The remaining sites are then screened and compared on the basis of safety and other considerations to select one or more preferred sites. Natural hazards include geology, seismology, hydrology and meteorology. Offshore ice will be a particular hazard for this plant, since the site is on average only 1.5 m above sea level. The design basis earthquake corresponds to a return frequency of 100,000 years, with 50 % confidence. The existing sites in southern Finland used a design peak ground acceleration of 0.1 g with the ground response spectrum maximum at 10 Hz. The candidate sites in northern Finland will require a peak ground acceleration of 0.2 g with the ground response spectrum maximum at 25 Hz

  8. External human induced events in site evaluation for nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

    The purpose of the present Safety Guide is to provide recommendations and guidance for the examination of the region considered for site evaluation for a plant in order to identity hazardous phenomena associated with human induced events initiated by sources external to the plant. In some cases it also presents preliminary guidance for deriving values of relevant parameters for the design basis. This Safety Guide is also applicable for periodic site evaluation and site evaluation following a major human induced event, and for the design and operation of the site's environmental monitoring system. Site evaluation includes site characterization. Consideration of external events that could lead to a degradation of the safety features of the plant and cause a release of radioactive material from the plant and/or affect the dispersion of such material in the environment. And consideration of population issues and access issues significant to safety (such as the feasibility of evacuation, the population distribution and the location of resources). The process of site evaluation continues throughout the lifetime of the facility, from siting to design, construction, operation and decommissioning. The external human induced events considered in this Safety Guide are all of accidental origin. Considerations relating to the physical protection of the plant against wilful actions by third parties are outside its scope. However, the methods described herein may also have some application for the purposes of such physical protection. The present Safety Guide may also be used for events that may originate within the boundaries of the site, but from sources which are not directly involved in the operational states of the nuclear power plant units, such as fuel depots or areas for the storage of hazardous materials for the construction of other facilities at the same site. Special consideration should be given to the hazardous material handled during the construction, operation and

  9. Technology, safety and costs of decommissioning a reference boiling water reactor power station. Appendices. Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    Oak, H.D.; Holter, G.M.; Kennedy, W.E. Jr.; Konzek, G.J.

    1980-06-01

    Appendices are presented concerning the evaluations of decommissioning financing alternatives; reference site description; reference BWR facility description; radiation dose rate and concrete surface contamination data; radionuclide inventories; public radiation dose models and calculated maximum annual doses; decommissioning methods; generic decommissioning information; immediate dismantlement details; passive safe storage, continuing care, and deferred dismantlement details; entombment details; demolition and site restoration details; cost estimating bases; public radiological safety assessment details; and details of alternate study bases.

  10. Extended biosphere dataset for safety assessment of radioactive waste geological disposal

    International Nuclear Information System (INIS)

    Kato, Tomoko; Suzuki, Yuji

    2007-01-01

    JAEA has an on-going programme of research and development relating to the safety assessment of the deep geological disposal systems of high-level radioactive waste (HLW) and transuranic waste (TRU). In the safety assessment of HLW and TRU disposal systems, biosphere assessment is necessary to estimate future radiological impacts on human beings (e.g. radiation dose). In order to estimate radiation dose, consideration needs to be given to the biosphere into which future releases of radionuclides might occur and to the associated future human behaviour. The data of some biosphere parameters needed to be updated by appropriate data sources for generic and site-specific biosphere assessment to improve reliability for the biosphere assessment, because some data published in the 1980's or the early 90's were found to be inappropriate for the recent biosphere assessment. Therefore, data of the significant parameters (especially for element-dependent) were set up on the basis of recent information, to update the generic biosphere dataset. (author)

  11. 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.

  12. Groundwater well services site safety and health plan

    International Nuclear Information System (INIS)

    Tuttle, B.G.

    1996-08-01

    This Site Specific Health and Safety Plan covers well servicing in support of the Environmental Restoration Contractor Groundwater Project. Well servicing is an important part of environmental restoration activities supporting several pump and treat facilities and assisting in evaluation and servicing of various groundwater wells throughout the Hanford Site. Remediation of contaminated groundwater is a major part of the ERC project. Well services tasks help enhance groundwater extraction/injection as well as maintain groundwater wells for sampling and other hydrologic testing and information gathering

  13. Preliminary Safety Analysis of the Gorleben Site: Safety Concept and Application to Scenario Development Based on a Site-Specific Features, Events and Processes (FEP) Database - 13304

    Energy Technology Data Exchange (ETDEWEB)

    Moenig, Joerg; Beuth, Thomas; Wolf, Jens [Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS) mbH, Theodor-Heuss-Str. 4, D-38122 Braunschweig (Germany); Lommerzheim, Andre [DBE TECHNOLOGY GmbH, Eschenstr. 55, D-31224 Peine (Germany); Mrugalla, Sabine [Federal Institute for Geosciences and Natural Resources (BGR), Stilleweg 2, D-30655 Hannover (Germany)

    2013-07-01

    Based upon the German safety criteria, released in 2010 by the Federal Ministry of the Environment (BMU), a safety concept and a safety assessment concept for the disposal of heat-generating high-level waste have both been developed in the framework of the preliminary safety case for the Gorleben site (Project VSG). The main objective of the disposal is to contain the radioactive waste inside a defined rock zone, which is called containment-providing rock zone. The radionuclides shall remain essentially at the emplacement site, and at the most, a small defined quantity of material shall be able to leave this rock zone. This shall be accomplished by the geological barrier and a technical barrier system, which is required to seal the inevitable penetration of the geological barrier by the construction of the mine. The safe containment has to be demonstrated for probable and less probable evolutions of the site, while evolutions with very low probability (less than 1 % over the demonstration period of 1 million years) need not to be considered. Owing to the uncertainty in predicting the real evolution of the site, plausible scenarios have been derived in a systematic manner. Therefore, a comprehensive site-specific features, events and processes (FEP) data base for the Gorleben site has been developed. The safety concept was directly taken into account, e.g. by identification of FEP with direct influence on the barriers that provide the containment. No effort was spared to identify the interactions of the FEP, their probabilities of occurrence, and their characteristics (values). The information stored in the data base provided the basis for the development of scenarios. The scenario development methodology is based on FEP related to an impairment of the functionality of a subset of barriers, called initial barriers. By taking these FEP into account in their probable characteristics the reference scenario is derived. Thus, the reference scenario describes a

  14. 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.

  15. New Methodology for a Comprehensive Modular Safety Control System in a Cyclotron Site

    International Nuclear Information System (INIS)

    Kaufman, Y.; Kravitz, M.; Arad, M.; Osovizky, A.; Paran, J.; Sarussi, B.; Ellenbogen, M.; Tal, N.

    2004-01-01

    This Paper describes a new methodology for a comprehensive modular Safety Control System (SCS), for a cyclotron site. The developed SCS is a modular approach for controlling the production procedures, safety conditions and documentation aspects in the Cyclotron site. Usually, the safety conditions in cyclotron sites are maintained by a variety of sensors. The cyclotron is supplied from the manufacturer with a self-integrated control system for its operation, yet the comprehensive SCS has to be defined and setup by the customer. Therefore, customers face a lot of integration problems in trying to combine all the signals from the different safety systems such as radiation monitoring, environmental and access control, in order to maintain proper safety working conditions. The presented SCS design provides main user interface and the complete safety solution required by including preset control logic definitions and open logic for specific user applications. The knowledge for the preset control logic definitions was gathered in previous projects. Failure Mode and Effects Analysis (FMEA) method has been implemented on the SCS to analyze the potential failure modes and their impact on the product reliability

  16. Technology, Safety and Costs of Decommissioning a Reference Low-Level Waste Burial Ground. Appendices

    International Nuclear Information System (INIS)

    None

    1980-01-01

    Safety and cost information are developed for the conceptual decommissioning of commercial low-level waste (LLW) burial grounds. Two generic burial grounds, one located on an arid western site and the other located on a humid eastern site, are used as reference facilities for the study. The two burial grounds are assumed to have the same site capacity for waste, the same radioactive waste inventory, and similar trench characteristics and operating procedures. The climate, geology. and hydrology of the two sites are chosen to be typical of real western and eastern sites. Volume 2 (Appendices) contains the detailed analyses and data needed to support the results given in Volume 1.

  17. Safety leadership at construction sites: the importance of rule-oriented and participative leadership.

    Science.gov (United States)

    Grill, Martin; Pousette, Anders; Nielsen, Kent; Grytnes, Regine; Törner, Marianne

    2017-07-01

    Objectives The construction industry accounted for >20% of all fatal occupational accidents in Europe in 2014. Leadership is an essential antecedent to occupational safety. The aim of the present study was to assess the influence of transformational, active transactional, rule-oriented, participative, and laissez-faire leadership on safety climate, safety behavior, and accidents in the Swedish and Danish construction industry. Sweden and Denmark are similar countries but have a large difference in occupational accidents rates. Methods A questionnaire study was conducted among a random sample of construction workers in both countries: 811 construction workers from 85 sites responded, resulting in site and individual response rates of 73% and 64%, respectively. Results The results indicated that transformational, active transactional, rule-oriented and participative leadership predict positive safety outcomes, and laissez-faire leadership predict negative safety outcomes. For example, rule-oriented leadership predicts a superior safety climate (β=0.40, Pleadership on workers' safety behavior was moderated by the level of participative leadership (β=0.10, Pleadership behaviors on safety outcomes were largely similar in Sweden and Denmark. Rule-oriented and participative leadership were more common in the Swedish than Danish construction industry, which may partly explain the difference in occupational accident rates. Conclusions Applying less laissez-faire leadership and more transformational, active transactional, participative and rule-oriented leadership appears to be an effective way for construction site managers to improve occupational safety in the industry.

  18. Data report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    2010-12-01

    This report compiles, documents, and qualifies input data identified as essential for the long-term safety assessment of a KBS-3 repository, and forms an important part of the reporting of the safety assessment project SR-Site. The input data concern the repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock, and the biosphere in the proximity of the repository. The input data also concern external influences acting on the system, in terms of climate related data. Data are provided for a selection of relevant conditions and are qualified through traceable standardised procedures

  19. Data report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report compiles, documents, and qualifies input data identified as essential for the long-term safety assessment of a KBS-3 repository, and forms an important part of the reporting of the safety assessment project SR-Site. The input data concern the repository system, broadly defined as the deposited spent nuclear fuel, the engineered barriers surrounding it, the host rock, and the biosphere in the proximity of the repository. The input data also concern external influences acting on the system, in terms of climate related data. Data are provided for a selection of relevant conditions and are qualified through traceable standardised procedures

  20. 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

  1. Use of a Web Site to Enhance Criticality Safety Training

    International Nuclear Information System (INIS)

    Huang, S T; Morman, J

    2003-01-01

    Currently, a website dedicated to enhancing communication and dissemination of criticality safety information is sponsored by the U.S. Department of Energy (DOE) Nuclear Criticality Safety Program (NCSP). This website was developed as part of the DOE response to the Defense Nuclear Facilities Safety Board (DNFSB) Recommendation 97-2, which reflected the need to make criticality safety information available to a wide audience. The website is the focal point for DOE nuclear criticality safety (NCS) activities, resources and references, including hyperlinks to other sites actively involved in the collection and dissemination of criticality safety information. The website is maintained by the Lawrence Livermore National Laboratory (LLNL) under auspices of the NCSP management. One area of the website contains a series of Nuclear Criticality Safety Engineer Training (NCSET) modules. During the past few years, many users worldwide have accessed the NCSET section of the NCSP website and have downloaded the training modules as an aid for their training programs. This trend was remarkable in that it points out a continuing need of the criticality safety community across the globe. It has long been recognized that training of criticality safety professionals is a continuing process involving both knowledge-based training and experience-based operations floor training. As more of the experienced criticality safety professionals reach retirement age, the opportunities for mentoring programs are reduced. It is essential that some method be provided to assist the training of young criticality safety professionals to replenish this limited human expert resource to support on-going and future nuclear operations. The main objective of this paper is to present the features of the NCSP website, including its mission, contents, and most importantly its use for the dissemination of training modules to the criticality safety community. We will discuss lessons learned and several ideas

  2. Resolving the Ferrocyanide Safety Issue at the Hanford Site

    International Nuclear Information System (INIS)

    Meacham, J.E.; Cash, R.J.; Babad, H.

    1994-02-01

    Considerable data have been obtained on the chemical and physical properties of ferrocyanide waste stored in Hanford Site single-shell tanks (SSTs). Theoretical analyses and ferrocyanide waste simulant studies have led to the development of fuel, moisture, and temperature criteria that define continued safe storage. Developing the criteria provides the technical basis for closing the Ferrocyanide Unreviewed Safety Question (USQ). Using the safety criteria, the ferrocyanide tanks have been ranked into one of three safety categories: Safe, Conditionally Safe, and Unsafe. All the ferrocyanide tanks are currently ranked in either the Safe or Conditionally Safe categories. Analyses of core samples taken from three ferrocyanide tanks have shown cyanide concentrations about a factor of ten lower than predicted by the original flowsheets. Hydrolytic and radiolytic destruction (aging) of the ferrocyanide matrix has occurred during the 35 plus years the waste has been stored at the Hanford Site. Because of waste aging, it is possible that all of the ferrocyanide tanks may now contain less than the 8 wt % sodium nickel ferrocyanide specified in the fuel criterion for the Safe category. Ferrocyanide tanks that remain in the Conditionally Safe category may require monitoring and surveillance to verify that the waste remains in an unreactive state. Further characterization of the tanks by core sampling and analyses should lead to resolution of the Ferrocyanide Safety Issue by September 1997

  3. Audit Report The Procurement of Safety Class/Safety-Significant Items at the Savannah River Site

    International Nuclear Information System (INIS)

    2009-01-01

    The Department of Energy operates several nuclear facilities at its Savannah River Site, and several additional facilities are under construction. This includes the National Nuclear Security Administration's Tritium Extraction Facility (TEF) which is designated to help maintain the reliability of the U.S. nuclear stockpile. The Mixed Oxide Fuel Fabrication Facility (MOX Facility) is being constructed to manufacture commercial nuclear reactor fuel assemblies from weapon-grade plutonium oxide and depleted uranium. The Interim Salt Processing (ISP) project, managed by the Office of Environmental Management, will treat radioactive waste. The Department has committed to procuring products and services for nuclear-related activities that meet or exceed recognized quality assurance standards. Such standards help to ensure the safety and performance of these facilities. To that end, it issued Departmental Order 414.1C, Quality Assurance (QA Order). The QA Order requires the application of Quality Assurance Requirements for Nuclear Facility Applications (NQA-1) for nuclear-related activities. The NQA-1 standard provides requirements and guidelines for the establishment and execution of quality assurance programs during the siting, design, construction, operation, and decommissioning of nuclear facilities. These requirements, promulgated by the American Society of Mechanical Engineers, must be applied to 'safety-class' and 'safety-significant' structures, systems and components (SSCs). Safety-class SSCs are defined as those necessary to prevent exposure off site and to protect the public. Safety-significant SSCs are those whose failure could irreversibly impact worker safety such as a fatality, serious injury, or significant radiological or chemical exposure. Due to the importance of protecting the public, workers, and environment, we initiated an audit to determine whether the Department of Energy procured safety-class and safety-significant SSCs that met NQA-1 standards at

  4. Hanford Site Wide Transportation Safety Document [SEC 1 Thru 3

    Energy Technology Data Exchange (ETDEWEB)

    MCCALL, D L

    2002-06-01

    This safety evaluation report (SER) documents the basis for the US Department of Energy (DOE), Richland Operations Office (RL) to approve the Hanford Sitewide Transportation Safety Document (TSD) for onsite Transportation and Packaging (T&P) at Hanford. Hanford contractors, on behalf of DOE-RL, prepared and submitted the Hanford Sitewide Transportation Safety Document, DOE/RL-2001-0036, Revision 0, (DOE/RL 2001), dated October 4, 2001, which is referred to throughout this report as the TSD. In the context of the TSD, Hanford onsite shipments are the activities of moving hazardous materials, substances, and wastes between DOE facilities and over roadways where public access is controlled or restricted and includes intra-area and inter-area movements. The TSD sets forth requirements and standards for onsite shipment of radioactive and hazardous materials and wastes within the confines of the Hanford Site on roadways where public access is restricted by signs, barricades, fences, or other means including road closures and moving convoys controlled by Hanford Site security forces.

  5. Evaluating Site-Specific and Generic Spatial Models of Aboveground Forest Biomass Based on Landsat Time-Series and LiDAR Strip Samples in the Eastern USA

    Science.gov (United States)

    Ram Deo; Matthew Russell; Grant Domke; Hans-Erik Andersen; Warren Cohen; Christopher Woodall

    2017-01-01

    Large-area assessment of aboveground tree biomass (AGB) to inform regional or national forest monitoring programs can be efficiently carried out by combining remotely sensed data and field sample measurements through a generic statistical model, in contrast to site-specific models. We integrated forest inventory plot data with spatial predictors from Landsat time-...

  6. 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

  7. Safety-related site characteristics - a relative comparison of the Forsmark reference areas

    International Nuclear Information System (INIS)

    Winberg, Anders

    2010-12-01

    SKB has over the years from 2002 to 2008 conducted site investigations in Forsmark and Laxemar, with associated site modeling, design and safety analysis. In mid-2009 Forsmark was selected on the basis of analysis made as site for a future repository for spent nuclear fuel. Based on defined safety-related geoscientific location factors data from Forsmark are compared in relative terms with data from a number of locations in Sweden, previously studied by SKB. The factors compared include: the rock's composition and structures, future climate evolution, rock mechanical conditions, earthquakes, groundwater flow, groundwater composition, delay of solutes, and the ability to characterize and describe the location. Past comparisons of these properties for the selected sites show that none of these sites collectively show any significant benefit over Forsmark site for a repository. This does not preclude that there may be places on the basis of an overall assessment of geoscientific location factors could be equivalent to Forsmark

  8. 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.

  9. 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.

  10. Technology, Safety and Costs of Decommissioning a Reference Low-Level Waste Burial Ground. Main Report

    International Nuclear Information System (INIS)

    Murphy, E. S.; Holter, G. M.

    1980-01-01

    Safety and cost information are developed for the conceptual decommissioning of commercial low-level waste (LLW) burial grounds. Two generic burial grounds, one located on an arid western site and the other located on a humid eastern site, are used as reference facilities for the study. The two burial grounds are assumed to have the same site capacity for waste, the same radioactive waste inventory, and similar trench characteristics and operating procedures. The climate, geology. and hydrology of the two sites are chosen to be typical of real western and eastern sites. Volume 1 (Main Report) contains background information and study results in summary form.

  11. Technology, Safety and Costs of Decommissioning a Reference Low-Level Waste Burial Ground. Main Report

    Energy Technology Data Exchange (ETDEWEB)

    Murphy, E. S.; Holter, G. M.

    1980-06-01

    Safety and cost information are developed for the conceptual decommissioning of commercial low-level waste (LLW) burial grounds. Two generic burial grounds, one located on an arid western site and the other located on a humid eastern site, are used as reference facilities for the study. The two burial grounds are assumed to have the same site capacity for waste, the same radioactive waste inventory, and similar trench characteristics and operating procedures. The climate, geology. and hydrology of the two sites are chosen to be typical of real western and eastern sites. Volume 1 (Main Report) contains background information and study results in summary form.

  12. Chemical Safety Vulnerability Working Group report. Volume 2

    International Nuclear Information System (INIS)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 148 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 2 consists of seven appendices containing the following: Tasking memorandums; Project plan for the CSV Review; Field verification guide for the CSV Review; Field verification report, Lawrence Livermore National Lab.; Field verification report, Oak Ridge Reservation; Field verification report, Savannah River Site; and the Field verification report, Hanford Site

  13. Chemical Safety Vulnerability Working Group report. Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 148 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 2 consists of seven appendices containing the following: Tasking memorandums; Project plan for the CSV Review; Field verification guide for the CSV Review; Field verification report, Lawrence Livermore National Lab.; Field verification report, Oak Ridge Reservation; Field verification report, Savannah River Site; and the Field verification report, Hanford Site.

  14. Flamanville 3 EPR, Safety Assessment and On-site Inspections

    International Nuclear Information System (INIS)

    Piedagnel, Corinne; Tarallo, Francois; Monnot, Bernard

    2011-01-01

    As a Technical Support Organisation of the French Safety Authority (ASN), the IRSN carries out the safety assessment of EPR project design and participates in the ASN inspections performed at the construction site and in factories. The design assessment consists in defining the safety functions which should be ensured by civil structures, evaluating the EPR Technical Code for Civil works (ETC-C) in which EdF has defined design criteria and construction rules, and carrying out a detailed assessment of a selection of safety-related structures. Those detailed assessments do not consist of a technical control but of an analysis whose objectives are to ensure that design and demonstrations are robust, in accordance with safety and regulatory rules. Most assessments led IRSN to ask EdF to provide additional justification sometimes involving significant modifications. In the light of those complementary justifications and modifications, IRSN concluded that assessments carried out on design studies were globally satisfactory. The participation of IRSN to the on-site inspections led by ASN is a part of the global control of the compliance of the reactor with its safety objectives. For that purpose IRSN has defined a methodology and an inspection program intended to ASN: based on safety functions associated with civil works (confinement and resistance to aggressions), the corresponding behaviour requirements are identified and linked to a list of main civil works elements. During the inspections, deviations to the project's technical specifications or to the rules of the art were pointed out by IRSN. Those deviations cover various items, such as concrete fabrication, concrete pouring methodology, lack of reinforcement in some structures, unadapted welding procedures of the containment leak-tight steel liner and unsatisfactory treatment of concreting joints. The analysis of those problems has revealed flaws in the organisation of the contractors teams together with an

  15. Environment, Safety and Health Progress Assessment of the Hanford Site

    International Nuclear Information System (INIS)

    1992-05-01

    This report documents the result of the US Department of Energy (DOE) Environment, Safety and Health (ES ampersand H) Progress Assessment of the Hanford Site, in Richland, Washington. The assessment, which was conducted from May 11 through May 22, 1992, included a selective-review of the ES ampersand H management systems and programs of the responsible DOE Headquarters Program Offices the DOE Richland Field Office, and the site contractors. The ES ampersand H Progress Assessments are part of the Secretary of Energy's continuing effort to institutionalize line management accountability and the self-assessment process throughout DOE and its contractor organizations. The purpose of the Hanford Site ES ampersand H Progress Assessment is to provide the Secretary with an independent assessment of the adequacy and effectiveness of the DOE and contractor management structures, resources, and systems to address ES ampersand H problems and requirements. They are not intended to be comprehensive compliance assessments of ES ampersand H activities. The point of reference for assessing programs at the Hanford Site was, for the most part, the Tiger Team Assessment of the Hanford Site, which was conducted from May 21 through July 18, 1990. A summary of issues and progress in the areas of environment, safety and health, and management is included

  16. Development of a methodology for an environmental safety case in the United Kingdom

    International Nuclear Information System (INIS)

    Bailey, L.E.F.

    2008-01-01

    This presentation introduced the notion of an environmental safety case that focuses on the protection of both humans and the environment. The UK safety case will address operational, transport and post-closure safety for intermediate-level waste (ILW) and high-level waste (HLW). As there is yet no agreed site or design for a deep geological repository in the UK, the first iteration of the safety case will be generic, drawing on examples from international repository concepts. These concepts will be considered in appropriate generic geological environments typical of those found in the UK. The performance of these example concepts will be assessed using a time frames-based approach that focuses on the evolution of the multiple barriers and their associated safety functions. This approach recognizes that the relative importance of the different barriers in providing safety will evolve over time. For example, at early times the engineered barriers provide containment and the geological barriers protect the engineered barriers and provide isolation of the wastes. At later times, as the engineered barriers degrade, the geosphere provides the major barrier to radionuclide migration back to the surface and ensures the long-term stability of the system. A multi-factor safety case will be presented, using multiple lines of reasoning, including comparisons with natural and anthropogenic analogues, to provide assurance of the intrinsic safety functions of the system and their evolution over time. (author)

  17. 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

  18. Administrative goals and safety standards for hazard control on forested recreation sites

    Science.gov (United States)

    Lee A. Paine

    1973-01-01

    For efficient control of tree hazard on recreation sites, a specific administrative goal must be selected. A safety standard designed to achieve the selected goal and a uniform hazard-rating procedure will then promote a consistent level of safety at an acceptable cost. Safety standards can be established with the aid of data for past years, and dollar evaluations are...

  19. Management of construction safety at RR site

    International Nuclear Information System (INIS)

    Pathak, B.C.; Khatsuriya, J.R.

    2016-01-01

    Construction industries are one of the most hazardous industries and hence, promotion of safety remains one of the greatest challenges facing construction industry today. According to ILO estimates: Each year at least 60,000 fatal accidents occur on construction sites around the world or one fatal accident every ten minutes. One in six fatal accidents at work occurs on a construction site. In industrialized countries, as many as 25-40 per cent of work related deaths occur on construction sites, even though the sector employs only 6-10 per cent of the workforce. The number of fatalities occurring from construction work in India is also quite disturbing. Though, the fall of person from height and through openings were the major causes for fatal /serious accidents, the risk of fatal accident involving material handling equipment, either during handling or its maintenance is also significantly high due to use of large number of material handling equipments during construction work. (author)

  20. 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.

  1. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  2. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2005-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  3. 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

  4. Radioactive safety analysis and assessment of waste rock pile site in uranium tailings

    International Nuclear Information System (INIS)

    Liu Changrong; Liu Zehua; Wang Zhiyong; Zhou Xinghuo

    2007-01-01

    Based on theoretical calculation and in-situ test results, distribution and emissions of radioactive nuclides of uranium tailings impoundment and waste rock pile sites are analyzed in this paper. It is pointed out that 222 Rn is the main nuclide of uranium tailings impoundment and waste rock pile site. Also 222 Rn is the main source term of public dose. 222 Rn concentrations in the atmospheric environment around and individual dose to Rn gradually decrease with increasing distances to uranium tailings impoundment and waste rock pile site. Based on in-situ tests on five uranium tailings impoundment and waste rock pile sites, a decisive method and safety protection distance are presented, which can be used to guide the validation and design of radioactive safety protection in uranium tailings impoundment and waste rock pile sites. (authors)

  5. Safety Considerations in the Selection of Nuclear Power Plant Candidate Sites in Johor State, Malaysia

    International Nuclear Information System (INIS)

    Ramli, A.T.; Basri, N.A.; Abu Hanifah, N.Z.H.

    2014-01-01

    Nuclear power is considered as one of the best options for future energy development in Malaysia. Since Malaysia has no experience in nuclear energy generation / production, commissioning the first nuclear power plant needs tremendous effort in various aspects. The most obvious challenges are to ensure the nation’s safety and to handle security issues that may arise from a nuclear power plant site. This paper aims to propose a site for nuclear power plant in Johor State, Malaysia as well as listing the possible safety challenges in the process. The site selection uses the Malaysian Atomic Energy Licensing Board (AELB) guideline document as the main reference, supported by documents from International Atomic Energy Agency (IAEA) and from various countries. Only five site characteristics are chosen as study parameters – geological features and seismic data, air dispersion analysis using meteorological data, population distribution, safety zones and emergency supports. This paper concluded that site number 2 (CS2) at Tanjung Tenggaroh, Mersing is the most suitable area for nuclear power plant in Johor state. It has the least possible risks, safety and security issues. (author)

  6. Safety Considerations in the Selection of Nuclear Power Plant Candidate Sites in Johor State, Malaysia

    Energy Technology Data Exchange (ETDEWEB)

    Ramli, A. T.; Basri, N. A.; Abu Hanifah, N. Z.H., [Department of Physics, Faculty of Science Universiti Teknologi Malaysia Johor (Malaysia)

    2014-10-15

    Nuclear power is considered as one of the best options for future energy development in Malaysia. Since Malaysia has no experience in nuclear energy generation / production, commissioning the first nuclear power plant needs tremendous effort in various aspects. The most obvious challenges are to ensure the nation’s safety and to handle security issues that may arise from a nuclear power plant site. This paper aims to propose a site for nuclear power plant in Johor State, Malaysia as well as listing the possible safety challenges in the process. The site selection uses the Malaysian Atomic Energy Licensing Board (AELB) guideline document as the main reference, supported by documents from International Atomic Energy Agency (IAEA) and from various countries. Only five site characteristics are chosen as study parameters – geological features and seismic data, air dispersion analysis using meteorological data, population distribution, safety zones and emergency supports. This paper concluded that site number 2 (CS2) at Tanjung Tenggaroh, Mersing is the most suitable area for nuclear power plant in Johor state. It has the least possible risks, safety and security issues. (author)

  7. 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.

  8. Geoscientific long-term prognosis. Preliminary safety analysis for the site Gorleben

    International Nuclear Information System (INIS)

    Mrugalla, Sabine

    2011-07-01

    The preliminary safety analysis of the site Gorleben includes the following chapters: (1) Introduction; (2) Aim and content of the geoscientific long-term prognosis for the site Gorleben; (3) Boundary conditions at the site Gorleben: climate; geomorphology; overlying rocks and adjoining rocks; hydrogeology; salt deposit Gorleben. (4) Probable future geological developments at the site Gorleben: supraregional developments with effects on the site Gorleben; glacial period developments; developments of the geomorphology, overlying and adjoining rocks; future developments of the hydrological systems at the site Gorleben; future saliniferous specific developments of the salt deposit Gorleben. (5) Commentary on the unlikely or excludable developments of the site Gorleben.

  9. The occupational safety on the construction sites of the farm production buildings in Finland

    Directory of Open Access Journals (Sweden)

    M. Hellstedt

    2013-09-01

    Full Text Available The size of farms has increased considerably during Finland's EU membership. The growth has meant big investments in the new production buildings. The buildings have been switched to big industrialhall- like constructions from small-scale ones which have contained own timber and own work contribution. The objective of the project financed by Farmers' Social Insurance Institution was to improve occupational safety on farm building construction and renovation sites by disseminating current safety practices and by developing ways of action which are better than the prevailing ones. The project consisted of a literature review, statistical analysis, as well as a farmer and designer interviews. In the statistical analysis the MATA occupational injuries insurance claims database on farmers’ claims during construction and renovation work for the years 2005 - 2008 was compared with the register of Federation of Accident Insurance Institutions on the construction workers' injuries. In comparing the reasons of the accidents a clear difference was found; poor scaffoldings and ladders are still the main culprits on farm accidents. Farmer interviews were used to assess occupational safety measures on the construction site, occurred injuries and their types, nearmiss situations and the underlying factors which have led to the injuries. Also construction safety deficiencies as well as the direct and indirect costs caused for instance because of the delay in completion of construction project were discussed. Designer interviews aimed to find out how occupational safety and health considerations are taken into account in farm building planning and counseling, and how this experience of the designers should be utilized in order to improve safety at the construction sites on farms. Farmers knew their obligations on occupational safety poorly. The situation was further worsened by the fact that on the site the supervisor tasks were only nominally executed. The

  10. 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

  11. Safety inspections in construction sites: A systems thinking perspective.

    Science.gov (United States)

    Saurin, Tarcisio Abreu

    2016-08-01

    Although safety inspections carried out by government officers are important for the prevention of accidents, there is little in-depth knowledge on their outcomes and processes leading to these. This research deals with this gap by using systems thinking (ST) as a lens for obtaining insights into safety inspections in construction sites. Thirteen case studies of sites with prohibited works were carried out, discussing how four attributes of ST were used in the inspections. The studies were undertaken over 6 years, and sources of evidence involved participant observation, direct observations, analysis of documents and interviews. Two complementary ways for obtaining insights into inspections, based on ST, were identified: (i) the design of the study itself needs to be in line with ST; and (ii) data collection and analysis should focus on the agents involved in the inspections, the interactions between agents, the constraints and opportunities faced by agents, the outcomes of interactions, and the recommendations for influencing interactions. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. Reactor safety under design basis flood condition for inland sites

    International Nuclear Information System (INIS)

    Hajela, S.; Bajaj, S.S.; Samota, A.; Verma, U.S.P.; Warudkar, A.S.

    2002-01-01

    Full text: In June 1994, there was an incident of flooding at Kakrapar Atomic Power Station (KAPS) due to combination of heavy rains and mechanical failure in the operation of gates at the adjoining weir. An indepth review of the incident was carried out and a number of flood protection measures were recommended and were implemented at site. As part of this review, a safety analysis was also done to demonstrate reactor safety with a series of failures considered in the flood protection features. For each inland NPP site, as part of design, different flood scenarios are analysed to arrive at design basis flood (DBF) level. This level is estimated based on worst combination of heavy local precipitation, flooding in river, failure of upstream/downstream water control structures

  13. 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

  14. LCA of contaminated site remediation - integration of site-specific impact assessment of local toxic impacts

    DEFF Research Database (Denmark)

    Lemming, Gitte; Hauschild, Michael Zwicky; Chambon, Julie Claire Claudia

    2011-01-01

    impacts have typically been assessed using site-generic characterization models representing a continental scale and excluding the groundwater compartment. Soil contaminants have therefore generally been assigned as emissions to surface soil or surface water compartments. However, such site-generic...... assessments poorly reflect the fate of frequent soil contaminants such as chloroethenes as they exclude the groundwater compartment and assume that the main part escapes to the atmosphere. Another important limitation of the generic impact assessment models is that they do not include the formation......The environmental impacts from remediation can be divided into primary and secondary impacts. Primary impacts cover the local impacts associated with the on-site contamination, whereas the secondary impacts are impacts on the local, regional and global scale generated by the remediation activities...

  15. PROBLEMS OF APPLYING FIXED FORMULAE TO SAFETY CRITERIA AND SITE SELECTION

    Energy Technology Data Exchange (ETDEWEB)

    Davis, W. K.

    1963-10-15

    The problem of developing a formula or calculation procedure for that could more-or-less automatically indicate whether or not a nuclear plant would be considered safe at a particular location is discussed. The difficulties and impossibilities of any sach formula for making decisions on siting and safety involving large amounts of money and public safety are considered. (P.C.H.)

  16. 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

  17. 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...

  18. [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.

  19. Chemical Safety Vulnerability Working Group report. Volume 3

    Energy Technology Data Exchange (ETDEWEB)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 148 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 3 consists of eleven appendices containing the following: Field verification reports for Idaho National Engineering Lab., Rocky Flats Plant, Brookhaven National Lab., Los Alamos National Lab., and Sandia National Laboratories (NM); Mini-visits to small DOE sites; Working Group meeting, June 7--8, 1994; Commendable practices; Related chemical safety initiatives at DOE; Regulatory framework and industry initiatives related to chemical safety; and Chemical inventory data from field self-evaluation reports.

  20. Chemical Safety Vulnerability Working Group report. Volume 3

    International Nuclear Information System (INIS)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 148 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 3 consists of eleven appendices containing the following: Field verification reports for Idaho National Engineering Lab., Rocky Flats Plant, Brookhaven National Lab., Los Alamos National Lab., and Sandia National Laboratories (NM); Mini-visits to small DOE sites; Working Group meeting, June 7--8, 1994; Commendable practices; Related chemical safety initiatives at DOE; Regulatory framework and industry initiatives related to chemical safety; and Chemical inventory data from field self-evaluation reports

  1. Handling of future human actions in the safety assessment SR-Site

    International Nuclear Information System (INIS)

    2010-12-01

    This report documents the future human actions, FHA, considered in the long-term safety analysis of a KBS-3 repository. The report is one of the supporting documents to the safety assessment SR-Site (see further the Main report /SKB 2011/). The purpose of this report is to provide an account of general considerations concerning FHA, the methodology applied in SR-Site to assess FHA, the aspects of FHA needed to be considered in the evaluation of their impact on a deep geological repository and to select and analyse representative scenarios for illustrative consequence analysis. The main focus of this report is a time period when institutional control has ceased to be effective, thereby permitting inadvertent intrusion. However, a brief discussion of the earlier period when the repository has been closed, sealed and continuously kept under institutional control is also provided. General The potential exposure to large quantities of radiotoxic material is an inescapable consequence of the deposition of spent nuclear fuel in a final repository, and consequently intrusion into the repository needs to be considered in repository design and safety assessment. In accordance with ICRP recommendations /ICRP 2000/, intrusion in the post-closure phase of institutional control and beyond is primarily prevented through the design of the repository. In addition to that there will presumably continue to be safeguards measures, preservation of information (record keeping) and possibly some sort of markers placed at the site. During the institutional control period, activities at the site have to be restricted or directed if they have the potential to interfere with or hinder surveillance of the site, but this does not necessarily rule out all forms of access to the area. Also the fact that the repository contains fissile materials is an important aspect. Control of safeguards measures will most likely be upheld by national as well as international agencies. Furthermore, the

  2. Handling of future human actions in the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report documents the future human actions, FHA, considered in the long-term safety analysis of a KBS-3 repository. The report is one of the supporting documents to the safety assessment SR-Site (see further the Main report /SKB 2011/). The purpose of this report is to provide an account of general considerations concerning FHA, the methodology applied in SR-Site to assess FHA, the aspects of FHA needed to be considered in the evaluation of their impact on a deep geological repository and to select and analyse representative scenarios for illustrative consequence analysis. The main focus of this report is a time period when institutional control has ceased to be effective, thereby permitting inadvertent intrusion. However, a brief discussion of the earlier period when the repository has been closed, sealed and continuously kept under institutional control is also provided. General The potential exposure to large quantities of radiotoxic material is an inescapable consequence of the deposition of spent nuclear fuel in a final repository, and consequently intrusion into the repository needs to be considered in repository design and safety assessment. In accordance with ICRP recommendations /ICRP 2000/, intrusion in the post-closure phase of institutional control and beyond is primarily prevented through the design of the repository. In addition to that there will presumably continue to be safeguards measures, preservation of information (record keeping) and possibly some sort of markers placed at the site. During the institutional control period, activities at the site have to be restricted or directed if they have the potential to interfere with or hinder surveillance of the site, but this does not necessarily rule out all forms of access to the area. Also the fact that the repository contains fissile materials is an important aspect. Control of safeguards measures will most likely be upheld by national as well as international agencies. Furthermore, the

  3. VerSi - A Methodology for a Comparison of Potential Repository Sites

    International Nuclear Information System (INIS)

    Hund, Wilhelm

    2010-09-01

    In the year 2000 the moratorium on the exploration of the Gorleben salt dome as a potential repository for all kinds of radioactive waste became effective as a result of the consensus agreement between the Federal Government and the utilities about phasing out nuclear energy in Germany. All exploration activities were interrupted for at maximum ten years to clarify conceptual and safety relevant questions. A new set of safety requirements for the final disposal of heat-generating radioactive waste in deep geological formations was established in July 2009 by the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU). As the BMU intended to carry out a comparison of potential repository sites it was necessary to initiate the development of a methodology for the identification of the site with the highest level of safety. A comparison of different repository sites requires a tool ensuring most confident and objective criteria for the comparison, whereas up to present long-term safety analyses were focused on confirming the suitability of sites by meeting the protection objectives by the measures of dose and risk. Within the 2006 established project VerSi a methodology for comparing different sites in different host rocks will be developed on the basis of long-term safety analyses taking into account geoscientific databases, inventory of radioactive waste, waste containers, corresponding disposal concepts and the feasibility of appropriate backfilling and closure concepts. The development of the method is aiming at providing measures other than dose and risk for the evaluation of the level of safety. For testing the tools a HLW-repository hosted in a salt dome (Gorleben) will be compared with a generic HLW-repository in consolidated clay as a host rock. As until now in Germany no clay stone site has been investigated for hosting a HLW repository, the required data are transferred from international research projects and repository concepts

  4. 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

  5. The site of a nuclear power plant and environmental safety; Ydinvoimalaitoksen sijaintipaikka ja ympaeristoen turvallisuus

    Energy Technology Data Exchange (ETDEWEB)

    Rossi, J. [VTT Energy, Espoo (Finland)

    2001-11-01

    The purpose of this report is to give the reader a general view of the things associated with the site of a nuclear power plant. In this context the effect of a nuclear power plant and site on environmental safety is considered. Planning, construction and operating a nuclear power plant require several judgements and licenses based on different laws. The location of the planned nuclear facility project and environmental conditions contribute in great detail to the compliance arguments of permits. At first the environmental impacts of the siting project and its alternatives shall be investigated in the Environmental Impact Assessment procedure. Then the decision in principle according to the Nuclear Energy Act can be applied from the Council of State, the decision shall further be confirmed by Parliament. When the decision in principle is considered the overall good of society shall be assessed by means of considering i.a. site alternatives and safety. The safety related basic principle is that operation of a nuclear power plant may not cause danger to the environment, public or property. After the affirmative principle approval the construction license and later on the operation license can be applied from the Council of State, these licenses need to be supported i.a. by building and environmental licenses of separate authorities. Also some international contracts concern realisation of a nuclear power plant siting. The nuclear power plant site shall be suitable for the needs of the electricity production and the transmission system and it shall be technically appropriate for building and operation of a power plant. The site shall be safe enough on the other hand from the view of external events threatening the power plant - although one can be partly prepared for these things in the design of the plant - and on the other hand from the point of public safety. Requirements for the safety of the site are directed in the decision of the Council of State's general

  6. Development of a method for the comparison of final repository sites in different host rock formations; Weiterentwicklung einer Methode zum Vergleich von Endlagerstandorten in unterschiedlichen Wirtsgesteinsformationen

    Energy Technology Data Exchange (ETDEWEB)

    Fischer-Appelt, Klaus; Frieling, Gerd; Kock, Ingo; and others

    2017-10-15

    The report on the development of a method for the comparison of final repository sites in different host rock formations covers the following issues: influence of the requirement of retrievability on the methodology, study on the possible extension of the methodology for repository sites with crystalline host rocks: boundary conditions in Germany, final disposal concept for crystalline host rocks, generic extension of the VerSi method, identification, classification and relevance weighting of safety functions, relevance of the safety functions for the crystalline host rock formation, review of the methodological need for changes for crystalline rock sites under low-permeability covering; study on the applicability of the methodology for the determination of site regions for surface exploitation (phase 1).

  7. Safety aspects of geological studies around nuclear installations sites

    International Nuclear Information System (INIS)

    Faure, J.

    1988-01-01

    The experience of geological studies of about forty french nuclear sites allows to set out the objectives, the phases and the geographic extensions of workings to be realized for confirming a site. The data to be collected for the safety analysis are specified; they concern the local and regional geology, the geotechnical characteristics and the essential elements for evaluating the hazards related to the soil liquefaction, the surface fracturing and in some cases the volcanic risks. It is necessary to follow up the geology during the installation construction and life. 8 refs. (F.M.)

  8. Real-time safety risk assessment based on a real-time location system for hydropower construction sites.

    Science.gov (United States)

    Jiang, Hanchen; Lin, Peng; Fan, Qixiang; Qiang, Maoshan

    2014-01-01

    The concern for workers' safety in construction industry is reflected in many studies focusing on static safety risk identification and assessment. However, studies on real-time safety risk assessment aimed at reducing uncertainty and supporting quick response are rare. A method for real-time safety risk assessment (RTSRA) to implement a dynamic evaluation of worker safety states on construction site has been proposed in this paper. The method provides construction managers who are in charge of safety with more abundant information to reduce the uncertainty of the site. A quantitative calculation formula, integrating the influence of static and dynamic hazards and that of safety supervisors, is established to link the safety risk of workers with the locations of on-site assets. By employing the hidden Markov model (HMM), the RTSRA provides a mechanism for processing location data provided by the real-time location system (RTLS) and analyzing the probability distributions of different states in terms of false positives and negatives. Simulation analysis demonstrated the logic of the proposed method and how it works. Application case shows that the proposed RTSRA is both feasible and effective in managing construction project safety concerns.

  9. 78 FR 76391 - Proposed Enhancements to the Motor Carrier Safety Measurement System (SMS) Public Web Site

    Science.gov (United States)

    2013-12-17

    ...-0392] Proposed Enhancements to the Motor Carrier Safety Measurement System (SMS) Public Web Site AGENCY... proposed enhancements to the display of information on the Agency's Safety Measurement System (SMS) public Web site. On December 6, 2013, Advocates [[Page 76392

  10. Criticality Safety Evaluation of Hanford Site High Level Waste Storage Tanks

    Energy Technology Data Exchange (ETDEWEB)

    ROGERS, C.A.

    2000-02-17

    This criticality safety evaluation covers operations for waste in underground storage tanks at the high-level waste tank farms on the Hanford site. This evaluation provides the bases for criticality safety limits and controls to govern receipt, transfer, and long-term storage of tank waste. Justification is provided that a nuclear criticality accident cannot occur for tank farms operations, based on current fissile material and operating conditions.

  11. Criticality Safety Evaluation of Hanford Site High-Level Waste Storage Tanks

    International Nuclear Information System (INIS)

    ROGERS, C.A.

    2000-01-01

    This criticality safety evaluation covers operations for waste in underground storage tanks at the high-level waste tank farms on the Hanford site. This evaluation provides the bases for criticality safety limits and controls to govern receipt, transfer, and long-term storage of tank waste. Justification is provided that a nuclear criticality accident cannot occur for tank farms operations, based on current fissile material and operating conditions

  12. 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

  13. 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.

  14. [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.

  15. 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.

  16. 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.

  17. Empirical estimation of school siting parameter towards improving children's safety

    International Nuclear Information System (INIS)

    Aziz, I S; Yusoff, Z M; Rasam, A R A; Rahman, A N N A; Omar, D

    2014-01-01

    Distance from school to home is a key determination in ensuring the safety of hildren. School siting parameters are made to make sure that a particular school is located in a safe environment. School siting parameters are made by Department of Town and Country Planning Malaysia (DTCP) and latest review was on June 2012. These school siting parameters are crucially important as they can affect the safety, school reputation, and not to mention the perception of the pupil and parents of the school. There have been many studies to review school siting parameters since these change in conjunction with this ever-changing world. In this study, the focus is the impact of school siting parameter on people with low income that live in the urban area, specifically in Johor Bahru, Malaysia. In achieving that, this study will use two methods which are on site and off site. The on site method is to give questionnaires to people and off site is to use Geographic Information System (GIS) and Statistical Product and Service Solutions (SPSS), to analyse the results obtained from the questionnaire. The output is a maps of suitable safe distance from school to house. The results of this study will be useful to people with low income as their children tend to walk to school rather than use transportation

  18. Area 5 Radioactive Waste Management Site Safety Assessment Document

    International Nuclear Information System (INIS)

    Horton, K.K.; Kendall, E.W.; Brown, J.J.

    1980-02-01

    The Area 5 Radioactive Waste Management Safety Assessment Document evaluates site characteristics, facilities and operating practices which contribute to the safe handling and storage/disposal of radioactive wastes at the Nevada Test Site. Physical geography, cultural factors, climate and meteorology, geology, hydrology (with emphasis on radionuclide migration), ecology, natural phenomena, and natural resources are discussed and determined to be suitable for effective containment of radionuclides. Also considered, as a separate section, are facilities and operating practices such as monitoring; storage/disposal criteria; site maintenance, equipment, and support; transportation and waste handling; and others which are adequate for the safe handling and storage/disposal of radioactive wastes. In conclusion, the Area 5 Radioactive Waste Management Site is suitable for radioactive waste handling and storage/disposal for a maximum of twenty more years at the present rate of utilization

  19. End of mission report on seismic safety review mission for Belene NPP site

    International Nuclear Information System (INIS)

    Gurpinar, A.; Mohammadioun, B.; Schneider, H.; Serva, L.

    1995-01-01

    Upon the invitation of the Bulgarian government through the Committee for the Peaceful Uses of Atomic Energy and within the framework of the implementation of the Technical Cooperation project BUL/9/012 related to site and seismic of NPPs, a mission visited Sofia 3 - 7 July 1995. The mission constituted a follow-up of the interim review of subjects related to tectonic stability and seismic hazard characterization of the site which was performed in September 1993. The main objective of the mission was the final review of the subjects already reviewed in September 1993 as well as issues related to geotechnical engineering and foundation safety. The main terms of reference of the present mission was to verify the implementation of the recommendations of the Site Safety Review Mission of June 1990. This document gives findings on geology-tectonics, seismology and foundation safety. In the end conclusions and recommendations of the mission are presented

  20. Overheads, Safety Analysis and Engineering FY 1995 Site Support Program Plan WBS 6.3.5

    Energy Technology Data Exchange (ETDEWEB)

    DiVincenzo, E.P.

    1994-09-27

    The Safety Analysis & Engineering (SA&E) department provides core competency for safety analysis and risk documentation that supports achievement of the goals and mission as described in the Hanford Mission Plan, Volume I, Site Guidance (DOE-RL 1993). SA&E operations are integrated into the programs that plan and conduct safe waste management, environmental restoration, and operational activities. SA&E personnel are key members of task teams assigned to eliminate urgent risks and inherent threats that exist at the Hanford Site. Key to ensuring protection of public health and safety, and that of onsite workers, are the products and services provided by the department. SA&E will continue to provide a leadership role throughout the DOE complex with innovative, cost-effective approaches to ensuring safety during environmental cleanup operations. The SA&E mission is to provide support to direct program operations through safety analysis and risk documentation and to maintain an infrastructure responsive to the evolutionary climate at the Hanford Site. SA&E will maintain the appropriate skills mix necessary to fulfill the customers need to conduct all operations in a safe and cost-effective manner while ensuring the safety of the public and the onsite worker.

  1. Natural Elemental Concentrations and Fluxes: Their Use as Indicators of Repository Safety

    Energy Technology Data Exchange (ETDEWEB)

    Miller, Bill; Lind, Andy; Savage, Dave; Maul, Philip; Robinson, Peter [EnvirosQuantisci, Melton Mowbray (United Kingdom)

    2002-03-01

    individual processes, such as groundwater discharge, river flow and erosion at specific locations. The approach can also be of value at the generic level of repository development, before site characterisation programmes have been undertaken. They could be used, for example, as a component in comparative evaluations of alternative generic disposal concepts. The objective at the generic level would be to define typical or average natural elemental concentrations and fluxes in geological systems representative of the environments which might host a repository, and to compare these with the outputs from the associated generic PAs. To facilitate the use of the natural safety indicators methodology at the generic level, this study has undertaken to bring together and to compile much of the required information. This information has been used to quantify average elemental mass fluxes at the global scale for a range of processes, including groundwater discharge, erosion and sediment transport. The point of these calculations is that they provide a baseline against which site or geological environment specific natural fluxes, from anywhere in the world, can be compared on an equal basis to evaluate if they are higher or lower than the global average and, thus, are useful for providing a broad natural context for predicted repository releases. In separate calculations, elemental mass fluxes were quantified for a number of reference environments which are chosen to be representative of the types of sites and geological systems which may host a deep repository. The reference environments were an inland pluton, basement under sedimentary cover and a sedimentary basin. The fluxes for these environments were calculated for systems with spatial scales of a few hundred square kilometres and, as such, approximate closely to the repository systems modelled in PAs because a reference environment represents the same system, with the same rock, groundwater and surface conditions as those

  2. Environmental Management Waste Management Facility (EMWMF) Site-Specific Health and Safety Plan, Oak Ridge, Tennessee

    Energy Technology Data Exchange (ETDEWEB)

    Flynn, N.C. Bechtel Jacobs

    2008-04-21

    The Bechtel Jacobs Company LLC (BJC) policy is to provide a safe and healthy workplace for all employees and subcontractors. The implementation of this policy requires that operations of the Environmental Management Waste Management Facility (EMWMF), located one-half mile west of the U.S. Department of Energy (DOE) Y-12 National Security Complex, be guided by an overall plan and consistent proactive approach to environment, safety and health (ES&H) issues. The BJC governing document for worker safety and health, BJC/OR-1745, 'Worker Safety and Health Program', describes the key elements of the BJC Safety and Industrial Hygiene (IH) programs, which includes the requirement for development and implementation of a site-specific Health and Safety Plan (HASP) where required by regulation (refer also to BJC-EH-1012, 'Development and Approval of Safety and Health Plans'). BJC/OR-1745, 'Worker Safety and Health Program', implements the requirements for worker protection contained in Title 10 Code of Federal Regulations (CFR) Part 851. The EMWMF site-specific HASP requirements identifies safe operating procedures, work controls, personal protective equipment, roles and responsibilities, potential site hazards and control measures, site access requirements, frequency and types of monitoring, site work areas, decontamination procedures, and outlines emergency response actions. This HASP will be available on site for use by all workers, management and supervisors, oversight personnel and visitors. All EMWMF assigned personnel will be briefed on the contents of this HASP and will be required to follow the procedures and protocols as specified. The policies and procedures referenced in this HASP apply to all EMWMF operations activities. In addition the HASP establishes ES&H criteria for the day-to-day activities to prevent or minimize any adverse effect on the environment and personnel safety and health and to meet standards that define acceptable

  3. Psychometric properties of the Norwegian version of the Safety Attitudes Questionnaire (SAQ, Generic version (Short Form 2006

    Directory of Open Access Journals (Sweden)

    Hofoss Dag

    2008-09-01

    Full Text Available Abstract Background How to protect patients from harm is a question of universal interest. Measuring and improving safety culture in care giving units is an important strategy for promoting a safe environment for patients. The Safety Attitudes Questionnaire (SAQ is the only instrument that measures safety culture in a way which correlates with patient outcome. We have translated the SAQ to Norwegian and validated the translated version. The psychometric properties of the translated questionnaire are presented in this article. Methods The questionnaire was translated with the back translation technique and tested in 47 clinical units in a Norwegian university hospital. SAQ's (the Generic version (Short Form 2006 the version with the two sets of questions on perceptions of management: on unit management and on hospital management were distributed to 1911 frontline staff. 762 were distributed during unit meetings and 1149 through the postal system. Cronbach alphas, item-to-own correlations, and test-retest correlations were calculated, and response distribution analysis and confirmatory factor analysis were performed, as well as early validity tests. Results 1306 staff members completed and returned the questionnaire: a response rate of 68%. Questionnaire acceptability was good. The reliability measures were acceptable. The factor structure of the responses was tested by confirmatory factor analysis. 36 items were ascribed to seven underlying factors: Teamwork Climate, Safety Climate, Stress Recognition, Perceptions of Hospital Management, Perceptions of Unit Management, Working conditions, and Job satisfaction. Goodness-of-Fit Indices showed reasonable, but not indisputable, model fit. External validity indicators – recognizability of results, correlations with "trigger tool"-identified adverse events, with patient satisfaction with hospitalization, patient reports of possible maltreatment, and patient evaluation of organization of hospital work

  4. Why do generic drugs fail to achieve an adequate market share in Greece? Empirical findings and policy suggestions.

    Science.gov (United States)

    Balasopoulos, T; Charonis, A; Athanasakis, K; Kyriopoulos, J; Pavi, E

    2017-03-01

    Since 2010, the memoranda of understanding were implemented in Greece as a measure of fiscal adjustment. Public pharmaceutical expenditure was one of the main focuses of this implementation. Numerous policies, targeted on pharma spending, reduced the pharmaceutical budget by 60.5%. Yet, generics' penetration in Greece remained among the lowest among OECD countries. This study aims to highlight the factors that affect the perceptions of the population on generic drugs and to suggest effective policy measures. The empirical analysis is based on a national cross-sectional survey that was conducted through a sample of 2003 individuals, representative of the general population. Two ordinal logistic regression models were constructed in order to identify the determinants that affect the respondents' beliefs on the safety and the effectiveness of generic drugs. The empirical findings presented a positive and statistically significant correlation with income, bill payment difficulties, safety and effectiveness of drugs, prescription and dispensing preferences and the views toward pharmaceutical companies. Also, age and trust toward medical community have a positive and statistically significant correlation with the perception on the safety of generic drugs. Policy interventions are suggested on the bases of the empirical results on 3 major categories; (a) information campaigns, (b) incentives to doctors and pharmacists and (c) to strengthen the bioequivalence control framework and the dissemination of results. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Hanford Site Environmental Safety and Health Fiscal Year 2001 Budget-Risk management summary

    Energy Technology Data Exchange (ETDEWEB)

    REEP, I.E.

    1999-05-12

    The Hanford Site Environment, Safety and Health (ES&H) Budget-Risk Management Summary report is prepared to support the annual request to sites in the U.S. Department of Energy (DOE) Complex by DOE, Headquarters. The request requires sites to provide supplementary crosscutting information related to ES&H activities and the ES&H resources that support these activities. The report includes the following: (1) A summary status of fiscal year (FY) 1999 ES&H performance and ES&H execution commitments; (2)Status and plans of Hanford Site Office of Environmental Management (EM) cleanup activities; (3) Safety and health (S&H) risk management issues and compliance vulnerabilities of FY 2001 Target Case and Below Target Case funding of EM cleanup activities; (4) S&H resource planning and crosscutting information for FY 1999 to 2001; and (5) Description of indirect-funded S&H activities.

  6. Safety evaluation of BWR off-gas treatment systems

    International Nuclear Information System (INIS)

    Schultz, R.J.; Schmitt, R.C.

    1975-01-01

    Some of the results of a safety evaluation performed on current generic types of BWR off-gas treatment systems including cooled and ambient temperature adsorber beds and cryogenics are presented. The evaluation covered the four generic types of off-gas systems and the systems of five major vendors. This study was part of original work performed under AEC contract for the Directorate of Regulatory Standards. The analysis techniques employed for the safety evaluation of these systems include: Fault Tree Analysis; FMECA (Failure Mode Effects and Criticality Analysis); general system comparisons, contaminant, system control, and design adequacy evaluations; and resultant Off-Site Dose Calculations. The salient areas presented are some of the potential problem areas, the approach that industry has taken to mitigate or design against potential upset conditions, and areas where possible deficiencies still exist. Potential problem areas discussed include hydrogen detonation, hydrogen release to equipment areas, operator/automatic control interface, and needed engineering evaluation to insure safe system operation. Of the systems reviewed, most were in the category of advanced or improved over that commonly in use today, and a conclusion from the study was that these systems offer excellent potential for noble gas control for BWR power plants where more stringent controls may be specified -- now or in the future. (U.S.)

  7. Technology, safety, and costs of decommissioning reference light-water reactors following postulated accidents. Appendices

    Energy Technology Data Exchange (ETDEWEB)

    Murphy, E S; Holter, G M

    1982-11-01

    Appendices contain information concerning the reference site description; reference PWR facility description; details of reference accident scenarios and resultant contamination levels; generic cleanup and decommissioning information; details of activities and manpower requirements for accident cleanup at a reference PWR; activities and manpower requirements for decommissioning at a reference PWR; costs of decommissioning at a reference PWR; cost estimating bases; safety assessment details; and details of post-accident cleanup and decommissioning at a reference BWR.

  8. Strategy for safety case development: impact of a volunteering approach to siting a japanese HLW repository

    International Nuclear Information System (INIS)

    Kitayama, K.; Ishiguro, K.; Takeuchi, M.; Tsuchi, H.; Kato, T.; Sakabe, Y.; Wakasugi, K.

    2008-01-01

    NUMO strategy for safety case development is constrained by a staged siting approach, which has been initiated by a call for volunteer municipalities to host the HLW repository. For each site, the safety case is an important factor to be considered at the selection steps which narrow down towards the preferred repository location. This is particularly challenging, however, as every site requires a tailored repository concept, with associated performance assessment and an individual site evaluation programme all of which evolve with gradually increasing understanding of the host environment. In order to maintain flexibility without losing focus, NUMO has developed a formalized tailoring procedure, termed the NUMO Structured Approach (NSA). The NSA guides the interaction of the key site characterisation, repository design and performance assessment groups and is facilitated by tools to help the decision making associated with the tailoring process (e.g. a requirements management system) and with comparison of siting and design options (e.g. multi-attribute analysis). Pragmatically, the post-closure safety case will initially emphasize near-field processes and a robust engineering barrier system, considering the limited geological information at early stages. This will be complemented by a more realistic assessment of total system performance, as needed to compare options. In addition, efforts to rigorously assess operational phase safety and the practicality of assuring quality of the constructed engineered barriers are components of the total safety case which are receiving particular attention now, as they may better discriminate between sites while information is still limited. (authors)

  9. Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

    Science.gov (United States)

    Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

    2018-06-01

    Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

  10. ITER Safety and Licensing

    International Nuclear Information System (INIS)

    Girard, J-.P; Taylor, N.; Garin, P.; Uzan-Elbez, J.; GULDEN, W.; Rodriguez-Rodrigo, L.

    2006-01-01

    The site for the construction of ITER has been chosen in June 2005. The facility will be implemented in Europe, south of France close to Marseille. The generic safety scheme is now under revision to adapt the design to the host country regulation. Even though ITER will be an international organization, it will have to comply with the French requirements in the fields of public and occupational health and safety, nuclear safety, radiation protection, licensing, nuclear substances and environmental protection. The organization of the central team together with its partners organized in domestic agencies for the in-kind procurement of components is a key issue for the success of the experimentation. ITER is the first facility that will achieve sustained nuclear fusion. It is both important for the experimental one-of-a-kind device, ITER itself, and for the future of fusion power plants to well understand the key safety issues of this potential new source of energy production. The main safety concern is confinement of the tritium, activated dust in the vacuum vessel and activated corrosion products in the coolant of the plasma-facing components. This is achieved in the design through multiple confinement barriers to implement the defence in depth approach. It will be demonstrated in documents submitted to the French regulator that these barriers maintain their function in all postulated incident and accident conditions. The licensing process started by examination of the safety options. This step has been performed by Europe during the candidature phase in 2002. In parallel to the final design, and taking into account the local regulations, the Preliminary Safety Report (RPrS) will be drafted with support of the European partner and others in the framework of ITER Task Agreements. Together with the license application, the RPrS will be forwarded to the regulatory bodies, which will launch public hearings and a safety review. Both processes must succeed in order to

  11. 40 CFR 721.4587 - Lithium manganese oxide (LiMn204) (generic name).

    Science.gov (United States)

    2010-07-01

    ... methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described in § 721...) (generic name). 721.4587 Section 721.4587 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...) Hazard communication program. A significant new use of this substance is any manner or method of...

  12. 40 CFR 721.6680 - Alkanoic acid, butanediol and cyclohexanealkanol polymer (generic name).

    Science.gov (United States)

    2010-07-01

    ... information on methods for protecting against such risk, into a Material Safety Data Sheet (MSDS) as described... cyclohexanealkanol polymer (generic name). 721.6680 Section 721.6680 Protection of Environment ENVIRONMENTAL... substance is any manner or method of manufacture, import, or processing associated with any use of this...

  13. Overheads, Safety Analysis and Engineering FY 1995 Site Support Program Plan WBS 6.3.5

    International Nuclear Information System (INIS)

    DiVincenzo, E.P.

    1994-01-01

    The Safety Analysis ampersand Engineering (SA ampersand E) department provides core competency for safety analysis and risk documentation that supports achievement of the goals and mission as described in the Hanford Mission Plan, Volume I, Site Guidance (DOE-RL 1993). SA ampersand E operations are integrated into the programs that plan and conduct safe waste management, environmental restoration, and operational activities. SA ampersand E personnel are key members of task teams assigned to eliminate urgent risks and inherent threats that exist at the Hanford Site. Key to ensuring protection of public health and safety, and that of onsite workers, are the products and services provided by the department. SA ampersand E will continue to provide a leadership role throughout the DOE complex with innovative, cost-effective approaches to ensuring safety during environmental cleanup operations. The SA ampersand E mission is to provide support to direct program operations through safety analysis and risk documentation and to maintain an infrastructure responsive to the evolutionary climate at the Hanford Site. SA ampersand E will maintain the appropriate skills mix necessary to fulfill the customers need to conduct all operations in a safe and cost-effective manner while ensuring the safety of the public and the onsite worker

  14. Early Site Permit Demonstration Program: Siting Guide, Site selection and evaluation criteria for an early site permit application

    International Nuclear Information System (INIS)

    1993-01-01

    In August 1991, the Joint Contractors came to agreement with Sandia National Laboratories (SNL) and the Department of Energy (DOE) on a workscope for the cost-shared Early Site Permit Demonstration Program. One task within the scope was the development of a guide for site selection criteria and procedures. A generic Siting Guide his been prepared that is a roadmap and tool for applicants to use developing detailed siting plans for their specific region of the country. The guide presents three fundamental principles that, if used, ensure a high degree of success for an ESP applicant. First, the site selection process should take into consideration environmentally diverse site locations within a given region of interest. Second, the process should contain appropriate opportunities for input from the public. Third, the process should be applied so that it is clearly reasonable to an impartial observer, based on appropriately selected criteria, including criteria which demonstrate that the site can host an advanced light water reactor (ALWR). The Siting Guide provides for a systematic, comprehensive site selection process in which three basic types of criteria (exclusionary, avoidance, and suitability) are presented via a four-step procedure. It provides a check list of the criteria for each one of these steps. Criteria are applied qualitatively, as well as presented numerically, within the guide. The applicant should use the generic guide as an exhaustive checklist, customizing the guide to his individual situation

  15. Generic antibiotics in Japan.

    Science.gov (United States)

    Fujimura, Shigeru; Watanabe, Akira

    2012-08-01

    Generic drugs have been used extensively in many developed countries, although their use in Japan has been limited. Generic drugs reduce drug expenses and thereby national medical expenditure. Because generic drugs provide advantages for both public administration and consumers, it is expected that they will be more widely used in the future. However, the diffusion rate of generic drugs in Japan is quite low compared with that of other developed countries. An investigation on generic drugs conducted by the Ministry of Health, Labour and Welfare in Japan revealed that 17.2 % of doctors and 37.2 % of patients had not used generic drugs. The major reasons for this low use rate included distrust of off-patent products and lower drug price margin compared with the brand name drug. The generic drugs available in the market include external drugs such as wet packs, antihypertensive agents, analgesics, anticancer drugs, and antibiotics. Among them, antibiotics are frequently used in cases of acute infectious diseases. When the treatment of these infections is delayed, the infection might be aggravated rapidly. The pharmacokinetics-pharmacodynamics (PK-PD) theory has been adopted in recent chemotherapy, and in many cases, the most appropriate dosage and administration of antibiotics are determined for individual patients considering renal function; high-dosage antibiotics are used preferably for a short duration. Therefore, a highly detailed antimicrobial agent is necessary. However, some of the generic antibiotics have less antibacterial potency or solubility than the brand name products. We showed that the potency of the generic products of vancomycin and teicoplanin is lower than that of the branded drugs by 14.6 % and 17.3 %, respectively. Furthermore, we confirmed that a generic meropenem drug for injection required about 82 s to solubilize in saline, whereas the brand product required only about 21 s. It was thought that the cause may be the difference in size of bulk

  16. Management response plan for the Chemical Safety Vulnerability Working Group report. Volume 1

    International Nuclear Information System (INIS)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 146 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 1 contains a discussion of the chemical safety improvements planned or already underway at DOE sites to correct facility or site-specific vulnerabilities. The main part of the report is a discussion of each of the programmatic deficiencies; a description of the tasks to be accomplished; the specific actions to be taken; and the organizational responsibilities for implementation

  17. Final disposal of spent fuel in the Finnish bedrock. Scope and requirements for site-specific safety analysis

    International Nuclear Information System (INIS)

    1996-12-01

    The report is a summary of the research conducted in the period 1993 to 1996 into safety of spent fuel final disposal. The principal goal of the research in this period, as set in 1993, was to develop a strategy for site-specific safety analysis. At the same time efforts were to be continued to gather data and validate the technical approach for the analysis. The work aimed at having the data needed for the analysis available at the end of year 1998. A safety assessment update, TILA-96, prepared by VTT Energy, is published as a separate report. The assessment is based on the TVO-92 safety analysis, but takes into account the knowledge acquired after 1992 on safety aspects of the disposal system and the data gathered from the site investigations made by TVO and from the beginning of 1996, by Posiva. Since the site investigations are still ongoing and much of the data gathered still pending interpretation, only limited amount of new site-specific information has been available for the present assessment. (172 refs.)

  18. Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature

    Directory of Open Access Journals (Sweden)

    Alrasheedy AA

    2014-04-01

    Full Text Available Alian A Alrasheedy,1 Mohamed Azmi Hassali,1 Kay Stewart,2 David CM Kong,2 Hisham Aljadhey,3 Mohamed Izham Mohamed Ibrahim,4 Saleh Karamah Al-Tamimi1 1Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia; 2Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, VIC, Australia; 3Medication Safety Research Chair, Clinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia; 4College of Pharmacy, Qatar University, Doha, Qatar Background: Generic medicines have the same quality, safety, and efficacy as their counterpart original brand medicines. Generic medicines provide the same therapeutic outcomes but at a much cheaper cost, so are promoted in many countries to contain pharmaceutical expenditure and sustain the health care system. Thus, the perspective of patients and medicine consumers as end users of these medicines is an important factor to enhance the use and utilization of generic medicines. The objective of this paper is to review patients’ and consumers’ knowledge, perceptions, acceptance, and views of generic medicines in the current literature. Methods: An extensive literature search was performed in several databases, namely Scopus, PubMed, ISI Web of Knowledge, Proquest, and the Wiley online library, to identify relevant studies published in the English literature for the period 1990–2013. Results: A total of 53 studies were included in the review, comprising 24 studies from Europe, ten from North America, six from Asia, five from Australia and New Zealand, five from the Middle East, one from Africa, one from Latin America, and one from the Caribbean region. A large body of literature has reported misconceptions and negative perceptions about generic medicines on the part of patients and medicine consumers. Moreover, although it is reported in almost all countries, the percentage of consumers who had

  19. Health and Safety Procedures Manual for hazardous waste sites

    Energy Technology Data Exchange (ETDEWEB)

    Thate, J.E.

    1992-09-01

    The Oak Ridge National Laboratory Chemical Assessments Team (ORNL/CAT) has developed this Health and Safety Procedures Manual for the guidance, instruction, and protection of ORNL/CAT personnel expected to be involved in hazardous waste site assessments and remedial actions. This manual addresses general and site-specific concerns for protecting personnel, the general public, and the environment from any possible hazardous exposures. The components of this manual include: medical surveillance, guidance for determination and monitoring of hazards, personnel and training requirements, protective clothing and equipment requirements, procedures for controlling work functions, procedures for handling emergency response situations, decontamination procedures for personnel and equipment, associated legal requirements, and safe drilling practices.

  20. Medication persistence and the use of generic and brand-name blood pressure-lowering agents.

    Science.gov (United States)

    Corrao, Giovanni; Soranna, Davide; La Vecchia, Carlo; Catapano, Alberico; Agabiti-Rosei, Enrico; Gensini, Gianfranco; Merlino, Luca; Mancia, Giuseppe

    2014-05-01

    Because of their lower cost, healthcare systems recommend physicians to prefer generic products, rather than brand-name medicaments. There is then considerable interest and debate concerning safety and effectiveness of generic products. Few studies have compared patients treated with brand-name and generic drugs for adherence to treatment, with somewhat inconsistent results. The primary objective of this study was to compare the risk of discontinuing antihypertensive drug therapy in patients treated with generic or brand-name agents. The 101,618 beneficiaries of the Healthcare system of Lombardy, Italy, aged 18 years or older who were newly treated on monotherapy with antihypertensive generic or brand-name drugs during 2008, were followed until the earliest date among those of the occurrence of treatment discontinuation to whatever antihypertensive drug therapy (outcome), or censoring (death, emigration, 12 months after treatment initiation). Hazard ratios of discontinuation associated with starting on generic or brand-name products (intention-to-treat analysis), and incidence rate ratio of discontinuation during periods on generic and brand-name products (as-treated analysis) were respectively estimated from a cohort and self-controlled case series analyses. Patients who started on generics did not experience a different risk of discontinuation compared with those starting on brand-name agents (hazard ratio: 1.00; 95% confidence interval 0.98-1.02). Discontinuation did not occur with different rates during periods covered by generics or brand-name agents (incidence rate ratio: 1.01; 95% confidence interval 0.96-1.11) within the same individuals. A number of sensitivity and subgroup analyses confirmed the robustness of these findings. Generic products are not responsible for the high rate of discontinuation from antihypertensive drug therapy. Assuming therapeutic equivalence, clinical implication is of prescribing generic drug therapies.

  1. 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

  2. Development of Onsite Transportation Safety Documents for Nevada Test Site

    International Nuclear Information System (INIS)

    Frank Hand; Willard Thomas; Frank Sciacca; Manny Negrete; Susan Kelley

    2008-01-01

    Department of Energy (DOE) Orders require each DOE site to develop onsite transportation safety documents (OTSDs). The Nevada Test Site approach divided all onsite transfers into two groups with each group covered by a standalone OTSD identified as Non-Nuclear and Nuclear. The Non-Nuclear transfers involve all radioactive hazardous material in less than Hazard Category (HC)-3 quantities and all chemically hazardous materials. The Nuclear transfers involve all radioactive material equal to or greater than HC-3 quantities and radioactive material mated with high explosives regardless of quantity. Both OTSDs comply with DOE O 460.1B requirements. The Nuclear OTSD also complies with DOE O 461.1A requirements and includes a DOE-STD-3009 approach to hazard analysis (HA) and accident analysis as needed. All Nuclear OTSD proposed transfers were determined to be non-equivalent and a methodology was developed to determine if 'equivalent safety' to a fully compliant Department of Transportation (DOT) transfer was achieved. For each HA scenario, three hypothetical transfers were evaluated: a DOT-compliant, uncontrolled, and controlled transfer. Equivalent safety is demonstrated when the risk level for each controlled transfer is equal to or less than the corresponding DOT-compliant transfer risk level. In this comparison the typical DOE-STD-3009 risk matrix was modified to reflect transportation requirements. Design basis conditions (DBCs) were developed for each non-equivalent transfer. Initial DBCs were based solely upon the amount of material present. Route-, transfer-, and site-specific conditions were evaluated and the initial DBCs revised as needed. Final DBCs were evaluated for each transfer's packaging and its contents

  3. Health, Safety and Environmental Risk Assessment in Laboratory Sites

    Directory of Open Access Journals (Sweden)

    2012-05-01

    Full Text Available Introduction: ”Exposing to danger” or in other words, “risk” is a process which is led to an uncertain result in every field. Project risks are uncertain contingent events or situations that if they occur will have positive or negative effects on project’s objectives. Todays, research and educational process and more complicated and the professional risk management become much more difficult, as a result. .Material and Method: In this research, the health and safety issues have been studied and analyzed using ISO 14121 and the environmental issues by EMEA to determine the risk level separately for research laboratories and to prioritize corrective measure in each field (school. .Result: The finding in this study showed that from all the main risks within the rage of 38-86 percent have been decreased. Moreover average of the risk level for the health, safety and environment cases showed a significant decrease (Pvalue<0.0001 by implement controlling and protective countermeasures compariy to the priority state without any measures. . Conclusion: The risk assessment with hazards control strategy based on ISO 14121 is a compatible method in laboratory site as universities and other reasearch sites.

  4. Safety in nuclear power plant siting. A code of practice

    International Nuclear Information System (INIS)

    1978-01-01

    This publication is brought out within the framework of establishing Codes of Practice and Safety Guides for nuclear power plants: NUSS programme. The scope of the document encompasses site and site-plant interaction factors related to operational states and accident conditions. The purpose of the Code is to give criteria and procedures to be applied as appropriate to operational states and accident conditions, including those which could lead to emergency situations. This Code is mainly concerned with severe events of low probability which relate to the siting of nuclear power plants and have to be considered in designing a particular nuclear power plant. Annex: Examples of natural and man-made events relevant for design basis evaluation

  5. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

    Atanassow, F.; Clarke, D.; Jeuring, J.T.

    2003-01-01

    A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

  6. Scripting XML with Generic Haskell

    NARCIS (Netherlands)

    Atanassow, F.; Clarke, D.; Jeuring, J.T.

    2007-01-01

    A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

  7. Factors influencing consumer purchasing patterns of generic versus brand name over-the-counter drugs.

    Science.gov (United States)

    Kohli, Erol; Buller, Allison

    2013-02-01

    US consumers spend more than $20 billion/year on over-the-counter (OTC) drugs. Although generic and brand name OTC drugs share the same active ingredients and undergo the same rigorous Food and Drug Administration approval process, brand name formulations continue to lead the OTC drug market with a higher market share. There is a limited amount of publicly available information regarding consumer perceptions and awareness about generic and brand name OTC drugs. The main objective of this research was to understand what factors influence US consumers to purchase generic versus brand name OTC drugs. The researchers used a 20-question, self-administered, multiple-choice survey to collect data on the factors influencing consumers' preferences for generic versus brand name OTC drugs. Results revealed that the single most influential factor for participants when purchasing OTC drugs was lower cost. Although economic factors play an important role in influencing consumers to choose generic formulations, a variety of other factors including advertisements, duration of the OTC effectiveness, severity of sickness, preferable form of OTC medication, safety of the OTC, relief of multiple symptoms, and preferred company will persuade others to pay more for brand name drugs. Ultimately, increased awareness and use of generic OTC drugs may result in substantial cost savings for consumers.

  8. Workers’ Age and the Impact of Psychological Factors on the Perception of Safety at Construction Sites

    Directory of Open Access Journals (Sweden)

    Muhammad Dawood Idrees

    2017-05-01

    Full Text Available The safety of construction workers is always a major concern at construction sites as the construction industry is inherently dangerous with many factors influencing worker safety. Several studies concluded that psychological factors such as workload, organizational relationships, mental stress, job security, and job satisfaction have significant effects on workers’ safety. However, research on psychological factors that are characteristic of different age groups have been limited. The aim of this study was to examine the impact of psychological factors on the perception of worker safety for two different age groups. After an extensive literature review, different psychological factors were identified, and a hypothetical research model was developed based on psychological factors that could affect workers’ perception of safety. A survey instrument was developed, and data were collected from seven different construction sites in Pakistan. Structural equation modeling (SEM was employed to test the hypothetical model for both age groups. The results revealed that workload and job satisfaction are significantly dominant factors on workers’ perception of safety in older workers, whereas organizational relationships, mental stress, and job security are dominant factors for younger workers at construction sites.

  9. Generic Reliability-Based Inspection Planning for Fatigue Sensitive Details

    DEFF Research Database (Denmark)

    Sørensen, John Dalsgaard; Straub, Daniel; Faber, Michael Havbro

    2005-01-01

    of fatigue sensitive details in fixed offshore steel jacket platforms and FPSO ship structures. Inspection and maintenance activities are planned such that code based requirements to the safety of personnel and environment for the considered structure are fulfilled and at the same time such that the overall......The generic approach for planning of in-service NDT inspections is extended to cover the case where the fatigue load is modified during the design lifetime of the structure. Generic reliability-based inspection planning has been developed as a practical approach to perform inspection planning...... expected costs for design, inspections, repairs and failures are minimized. The method is based on the assumption of “no-finds” of cracks during inspections. Each fatigue sensitive detail is categorized according to their type of details (SN curves), FDF values, RSR values, inspection, repair and failure...

  10. Development of the methodology on priority of element-specific biosphere parameters for geological disposal applicable to any proposed repository site

    International Nuclear Information System (INIS)

    Kato, Tomoko; Ohi, Takao; Suzuki, Yuji

    2009-01-01

    It is difficult to acquire all of biosphere parameters for geological disposal at the repository site because several hundreds of the parameters have to be dealt with in one calculation case of the biosphere assessment. Before site-specific activities, it is important to develop the data acquisition methodology of biosphere parameters applicable to any proposed repository site. The methodology for identification of the priority of the parameters was developed for the effective data acquisition of biosphere parameters at the site. First of all, flow diagram was constructed to evaluate the availability of the existing generic biosphere dataset. It was found to be effective for the data acquisition at the site to focus on the element-specific parameters with the existing dataset. Secondly, the priority of the data acquisition was identified for element-specific parameters at the site, with considering the variation of dose rate by combining the significant element-specific parameters. The availability of the existing generic biosphere dataset and the priority on data acquisition were identified for the element-specific parameters of key radionuclides in the safety assessment of geological disposal that should be acquired at the site. This priority list would be useful for effective data acquisition at the site. (author)

  11. Association of Safety Culture with Surgical Site Infection Outcomes.

    Science.gov (United States)

    Fan, Caleb J; Pawlik, Timothy M; Daniels, Tania; Vernon, Nora; Banks, Katie; Westby, Peggy; Wick, Elizabeth C; Sexton, J Bryan; Makary, Martin A

    2016-02-01

    Hospital workplace culture may have an impact on surgical outcomes; however, this association has not been established. We designed a study to evaluate the association between safety culture and surgical site infection (SSI). Using the Hospital Survey on Patient Safety Culture and National Healthcare Safety Network definitions, we measured 12 dimensions of safety culture and colon SSI rates, respectively, in the surgical units of Minnesota community hospitals. A Pearson's r correlation was calculated for each of 12 dimensions of surgical unit safety culture and SSI rate and then adjusted for surgical volume and American Society of Anesthesiologists (ASA) classification. Seven hospitals participated in the study, with a mean survey response rate of 43%. The SSI rates ranged from 0% to 30%, and surgical unit safety culture scores ranged from 16 to 92 on a scale of 0 to 100. Ten dimensions of surgical unit safety culture were associated with colon SSI rates: teamwork across units (r = -0.96; 95% CI [-0.76, -0.99]), organizational learning (r = -0.95; 95% CI [-0.71, -0.99]), feedback and communication about error (r = -0.92; 95% CI [-0.56, -0.99]), overall perceptions of safety (r = -0.90; 95% CI [-0.45, -0.99]), management support for patient safety (r = -0.90; 95% CI [-0.44, -0.98]), teamwork within units (r = -0.88; 95% CI [-0.38, -0.98]), communication openness (r = -0.85; 95% CI [-0.26, -0.98]), supervisor/manager expectations and actions promoting safety (r = -0.85; 95% CI [-0.25, -0.98]), non-punitive response to error (r = -0.78; 95% CI [-0.07, -0.97]), and frequency of events reported (r = -0.76; 95% CI [-0.01, -0.96]). After adjusting for surgical volume and ASA classification, 9 of 12 dimensions of surgical unit safety culture were significantly associated with lower colon SSI rates. These data suggest an important role for positive safety and teamwork culture and engaged hospital management in producing high-quality surgical

  12. Assessment of the living and workplace health and safety conditions of site-resident construction workers in Tehran, Iran.

    Science.gov (United States)

    Mohseni, Peyman Hossein; Farshad, Ali Asghar; Mirkazemi, Roksana; Orak, Rouhangiz Jamshidi

    2015-01-01

    The purpose of this study was to assess living and workplace safety conditions of construction workers in Tehran, Iran. This cross-sectional study was conducted among 410 construction sites in a municipal area of Tehran whose municipal building permits were issued in 2011. Data on ventilation, workplace safety and hygiene were collected by direct observation and interviews with site foremen. Noise levels were estimated from 10 sound-level-meter stations in the municipality area. Lack of ventilation in the workers' rooms was abundant. Bathrooms were unhygienic and minimum requirements such as lighting and ventilation did not exist in 80% of the cases. In nearly 50% of large construction sites, sewage and garbage disposal were inappropriate. Elevator safety was poor at all sites and no measures for fall prevention were present in over 88% of active construction sites. This study showed that the mean 24-h equivalent continuous sound level Leq was over 70 dB in 80% of the sites during weekdays. The results of this study revealed poor health and safety living and working conditions of construction workers in Tehran.

  13. Environmental Assessment: Waste Tank Safety Program, Hanford Site, Richland, Washington

    International Nuclear Information System (INIS)

    1994-02-01

    The US Department of Energy (DOE) needs to take action in the near-term, to accelerate resolution of waste tank safety issues at the Hanford Site near the City of Richland, Washington, and reduce the risks associated with operations and management of the waste tanks. The DOE has conducted nuclear waste management operations at the Hanford Site for nearly 50 years. Operations have included storage of high-level nuclear waste in 177 underground storage tanks (UST), both in single-shell tank (SST) and double-shell tank configurations. Many of the tanks, and the equipment needed to operate them, are deteriorated. Sixty-seven SSTs are presumed to have leaked a total approximately 3,800,000 liters (1 million gallons) of radioactive waste to the soil. Safety issues associated with the waste have been identified, and include (1) flammable gas generation and episodic release; (2) ferrocyanide-containing wastes; (3) a floating organic solvent layer in Tank 241-C-103; (4) nuclear criticality; (5) toxic vapors; (6) infrastructure upgrades; and (7) interim stabilization of SSTs. Initial actions have been taken in all of these areas; however, much work remains before a full understanding of the tank waste behavior is achieved. The DOE needs to accelerate the resolution of tank safety concerns to reduce the risk of an unanticipated radioactive or chemical release to the environment, while continuing to manage the wastes safely

  14. Improving the safety of remote site emergency airway management.

    Science.gov (United States)

    Wijesuriya, Julian; Brand, Jonathan

    2014-01-01

    Airway management, particularly in non-theatre settings, is an area of anaesthesia and critical care associated with significant risk of morbidity & mortality, as highlighted during the 4th National Audit Project of the Royal College of Anaesthetists (NAP4). A survey of junior anaesthetists at our hospital highlighted a lack of confidence and perceived lack of safety in emergency airway management, especially in non-theatre settings. We developed and implemented a multifaceted airway package designed to improve the safety of remote site airway management. A Rapid Sequence Induction (RSI) checklist was developed; this was combined with new advanced airway equipment and drugs bags. Additionally, new carbon dioxide detector filters were procured in order to comply with NAP4 monitoring recommendations. The RSI checklists were placed in key locations throughout the hospital and the drugs and advanced airway equipment bags were centralised in the Intensive Care Unit (ICU). It was agreed with the senior nursing staff that an appropriately trained ICU nurse would attend all emergency situations with new airway resources upon request. Departmental guidelines were updated to include details of the new resources and the on-call anaesthetist's responsibilities regarding checks and maintenance. Following our intervention trainees reported higher confidence levels regarding remote site emergency airway management. Nine trusts within the Northern Region were surveyed and we found large variations in the provision of remote site airway management resources. Complications in remote site airway management due lack of available appropriate drugs, equipment or trained staff are potentially life threatening and completely avoidable. Utilising the intervention package an anaesthetist would be able to safely plan and prepare for airway management in any setting. They would subsequently have the drugs, equipment, and trained assistance required to manage any difficulties or complications

  15. Early Site Permit Demonstration Program: Siting Guide, Site selection and evaluation criteria for an early site permit application. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-24

    In August 1991, the Joint Contractors came to agreement with Sandia National Laboratories (SNL) and the Department of Energy (DOE) on a workscope for the cost-shared Early Site Permit Demonstration Program. One task within the scope was the development of a guide for site selection criteria and procedures. A generic Siting Guide his been prepared that is a roadmap and tool for applicants to use developing detailed siting plans for their specific region of the country. The guide presents three fundamental principles that, if used, ensure a high degree of success for an ESP applicant. First, the site selection process should take into consideration environmentally diverse site locations within a given region of interest. Second, the process should contain appropriate opportunities for input from the public. Third, the process should be applied so that it is clearly reasonable to an impartial observer, based on appropriately selected criteria, including criteria which demonstrate that the site can host an advanced light water reactor (ALWR). The Siting Guide provides for a systematic, comprehensive site selection process in which three basic types of criteria (exclusionary, avoidance, and suitability) are presented via a four-step procedure. It provides a check list of the criteria for each one of these steps. Criteria are applied qualitatively, as well as presented numerically, within the guide. The applicant should use the generic guide as an exhaustive checklist, customizing the guide to his individual situation.

  16. MAAP4 CANDU analysis of a generic CANDU-6 plant: preliminary results

    Energy Technology Data Exchange (ETDEWEB)

    Petoukhov, S.M.; Mathew, P.M

    2001-10-01

    To support the generic probabilistic safety analysis (PSA) program at AECL, in particular to conduct Level 2 PSA analysis of a CANDU 6 plant undergoing a postulated severe accident, the capability to conduct severe accident consequence analysis for a CANDU plant is required. For this purpose, AECL selected MAAP4 CANDU from a number of other severe accident codes. The necessary models for a generic CANDU 6 station have been implemented in the code, and the code version 0.2 beta was tested using station data, which were assembled for a generic CANDU 6 station. This paper describes the preliminary results of the consequence analysis using MAAP4 CANDU for a generic CANDU 6 station, when it undergoes a station blackout and a large loss-of-coolant accident scenario. The analysis results show that the plant response is consistent with the physical phenomena modeled and the failure criteria used. The results also confirm that the CANDU design is robust with respect to severe accidents, which is reflected in the calculated long times that are available for administering accident management measures to arrest the accident progression before the calandria vessel or containment become at risk. (author)

  17. 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.

  18. The United States program for the safety assessment of geologic disposal of commercial radioactive wastes

    International Nuclear Information System (INIS)

    Claiborne, H.C.

    1977-01-01

    The safe disposal of commercial radioactive wastes in deep geologic formations is the goal of the National Waste Terminal Storage (NWTS) Program. Safety assessment begins with selection of a disposal site; that is, all geologic and hydrologic factors must indicate long-term stability of the formation and prospective isolation of wastes from circulating ground waters for hundreds of thousands of years. The long-term stability of each site under thermal loading must then be demonstrated by sophisticated rock mechanic analyses. Therefore, it can be expected that the sites that are chosen will effectively isolate the waste for a very long period of time. However, to help provide answers on the mechanisms and consequences of an unlikely breach in the integrity of the repository, a Waste Isolation Safety Assessment Program (WISAP) is studied. The overall objective of this program is an assessment of the safety associated with the long-term disposal of high-level radioactive waste in a geologic formation. This objective will be achieved by developing methods and generating data necessary to characterize the safety of generic geological waste disposal concepts, which are to be applied in the assessment of specific sites. It is expected that no one particular model will suffice. Both deterministic and probabilistic approaches will be used, and the entire spectrum of phenomena that could influence geologic isolation will be considered

  19. International workshop on site investigation and evaluation based on the siting process in Sweden

    International Nuclear Information System (INIS)

    Andersson, Johan; Stroem, A.

    2001-06-01

    SKB's goal is to commence surface based site investigations in 2002. Extensive preparations are now being made for this transition to the next phase in the siting process for the deep repository for spent nuclear fuel. The purpose of the international workshop on site characterisation held at Aespoe April 2001 was to: present the SKB site investigation and evaluation programme to a group of international experts; discuss whether the available toolbox of investigation methods for surface based site investigations is appropriate and state-of-the-art in an international perspective; and by working group sessions discuss the level of ambition in the programme for site investigation for each discipline. This report summarises the conclusions of the workshop in general terms. Many of the detailed comments and ideas obtained at the workshop have already inspired and will also directly inspire the on-going planning work for site characterisation. The core activity at the workshop was the work performed by working groups. They addressed what should be considered for a site characterisation programme, based on the generic planning made so far by SKB. The working groups also outlined site specific characterisation programmes for the sites suggested by SKB. The tasks were strictly confined to technical and scientific modelling issues. The working group chairmen presented the working group results at the workshop and have also submitted short memos to SKB. The present document is a compilation of these memos. The SKB generic programme as presented in the existing top level documents, 'Requirements and Criteria and Overall Programme', received general endorsement and was appreciated for being comprehensive and systematic. For example, it contains comprehensive lists of parameters to be measured. However, there is need for prioritisation and sequencing. This is actually included in the current planning process at SKB where the generic programme later this year will be adapted to

  20. The Hanford Site generic component failure-rate database compared with other generic failure-rate databases

    International Nuclear Information System (INIS)

    Reardon, M.F.; Zentner, M.D.

    1992-11-01

    The Risk Assessment Technology Group, Westinghouse Hanford Company (WHC), has compiled a component failure rate database to be used during risk and reliability analysis of nonreactor facilities. Because site-specific data for the Hanford Site are generally not kept or not compiled in a usable form, the database was assembled using information from a variety of other established sources. Generally, the most conservative failure rates were chosen from the databases reviewed. The Hanford Site database has since been used extensively in fault tree modeling of many Hanford Site facilities and systems. The purpose of this study was to evaluate the reasonableness of the data chosen for the Hanford Site database by comparing the values chosen with the values from the other databases

  1. Use of a web site to enhance criticality safety training

    International Nuclear Information System (INIS)

    Huang, Song T.; Morman, James A.

    2003-01-01

    Establishment of the NCSP (Nuclear Criticality Safety Program) website represents one attempt by the NCS (Nuclear Criticality Safety) community to meet the need to enhance communication and disseminate NCS information to a wider audience. With the aging work force in this important technical field, there is a common recognition of the need to capture the corporate knowledge of these people and provide an easily accessible, web-based training opportunity to those people just entering the field of criticality safety. A multimedia-based site can provide a wide range of possibilities for criticality safety training. Training modules could range from simple text-based material, similar to the NCSET (Nuclear Criticality Safety Engineer Training) modules, to interactive web-based training classes, to video lecture series. For example, the Los Alamos National Laboratory video series of interviews with pioneers of criticality safety could easily be incorporated into training modules. Obviously, the development of such a program depends largely upon the need and participation of experts who share the same vision and enthusiasm of training the next generation of criticality safety engineers. The NCSP website is just one example of the potential benefits that web-based training can offer. You are encouraged to browse the NCSP website at http://ncsp.llnl.gov. We solicit your ideas in the training of future NCS engineers and welcome your participation with us in developing future multimedia training modules. (author)

  2. Development and optimisation of generic decommissioning strategies for civil Magnox reactors

    International Nuclear Information System (INIS)

    Carpenter, G.; Hebditch, D.; Meek, N.; Patel, A.; Reeve, P.

    2004-01-01

    BNFL Environmental Services has formulated updated proposals for the use of decision analysis in the development of decommissioning strategy. The proposals are based on the Department of Transport, Local Government and the Regions manual for practitioners on multi-criteria analysis, specifically multi-criteria decision analysis, as suited to complex problems with a mixture of monetary and non-monetary objectives. They take account of up-to-date academic methodology, the newly issued BNFL decision analysis framework for environmental decisions and a wide variety of other engineering, optioneering and optimisation processes. The paper also summarises legislative and company policy areas of importance to decommissioning strategy development. Higher-level generic reactor and site remediation strategies already exist. At the lower level, various generic decommissioning reference processes and project options need development. For the past year, Environmental Services has held responsibility to respond to the Nuclear Installations Inspectorates' quinquennial review, develop and maintain up-to-date strategies, institute the review of a selected number of key strategies, and respond to changing circumstances including stakeholder views. Environmental Services is performing a range of generic studies for selection of strategies and end-points as used for a variety of waste management and site care and maintenance preparations. (author)

  3. 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.

  4. 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

  5. Dispersion of radioactive material in air and water and consideration of population distribution in site evaluation for nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

    The IAEA issues Safety Requirements and Safety Guides pertaining to nuclear power plants and activities in the field of nuclear energy, on the basis of its Safety Fundamentals publication on The Safety of Nuclear Installations. The present Safety Guide, which supplements the Code on the Safety of Nuclear Power Plants: Siting, concerns the effects of a nuclear power plant on the surrounding region and the consideration of population distribution in the siting of a plant. This Safety Guide makes recommendations on how to meet the requirements of the Code on the Safety of Nuclear Power Plants: Siting, on the basis of knowledge of the mechanisms for the dispersion of effluents discharged into the atmosphere and into surface water and groundwater. Relevant site characteristics and safety considerations are discussed. Population distribution, the projected population growth rate, particular geographical features, the capabilities of local transport networks and communications networks, industry and agriculture in the region, and recreational and institutional activities in the region should be considered in assessing the feasibility of developing an emergency response plan. In the selection of a site for a facility using radioactive material, such as a nuclear power plant, account should be taken of any local features that might be affected by the facility and of the feasibility of off-site intervention, including emergency response and protective actions. This is in addition to the evaluation of any features of the site itself that might affect the safety of the facility. This Safety Guide recommends methods for the assessment of regional and local characteristics. This Safety Guide supersedes four earlier IAEA Safety Guides, namely: Atmospheric Dispersion in Nuclear Power Plant Siting (Safety Series No. 50-SG-S3 (1980)). Site Selection and Evaluation for Nuclear Power Plants with Respect to Population Distribution (Safety Series No. 50-SG-S4 (1980)). Hydrological

  6. Dispersion of radioactive material in air and water and consideration of population distribution in site evaluation for nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2002-01-01

    The IAEA issues Safety Requirements and Safety Guides pertaining to nuclear power plants and activities in the field of nuclear energy, on the basis of its Safety Fundamentals publication on The Safety of Nuclear Installations. The present Safety Guide, which supplements the Code on the Safety of Nuclear Power Plants: Siting, concerns the effects of a nuclear power plant on the surrounding region and the consideration of population distribution in the siting of a plant. This Safety Guide makes recommendations on how to meet the requirements of the Code on the Safety of Nuclear Power Plants: Siting, on the basis of knowledge of the mechanisms for the dispersion of effluents discharged into the atmosphere and into surface water and groundwater. Relevant site characteristics and safety considerations are discussed. Population distribution, the projected population growth rate, particular geographical features, the capabilities of local transport networks and communications networks, industry and agriculture in the region, and recreational and institutional activities in the region should be considered in assessing the feasibility of developing an emergency response plan. In the selection of a site for a facility using radioactive material, such as a nuclear power plant, account should be taken of any local features that might be affected by the facility and of the feasibility of off-site intervention, including emergency response and protective actions. This is in addition to the evaluation of any features of the site itself that might affect the safety of the facility. This Safety Guide recommends methods for the assessment of regional and local characteristics. This Safety Guide supersedes four earlier IAEA Safety Guides, namely: Atmospheric Dispersion in Nuclear Power Plant Siting (Safety Series No. 50-SG-S3 (1980)); Site Selection and Evaluation for Nuclear Power Plants with Respect to Population Distribution (Safety Series No. 50-SG-S4 (1980)); Hydrological

  7. General safety guidelines for looking for a low mass activity-long life waste storage site

    International Nuclear Information System (INIS)

    2008-01-01

    The objective of this document is to define general guidelines which must be followed during the stages of search for a site and stages of design of a storage facility for low activity-long life radioactive wastes, in order to ensure its safety after closure. After having specified the considered wastes, geological shapes, and situations, this document defines the fundamental objective and the associated criteria (protection against chemical risk, radioprotection). It presents the design aspects related to safety (safety principles and functions, waste packages, public works engineering, geological environment, storage concepts). The last part deals with the safety demonstration after site closure which includes the control of some components, the assessment of disturbances in the storage facility or due to its presence, the taking of uncertainty and sensitivity studies into account, the influence of natural events

  8. Generic, Extensible, Configurable Push-Pull Framework for Large-Scale Science Missions

    Science.gov (United States)

    Foster, Brian M.; Chang, Albert Y.; Freeborn, Dana J.; Crichton, Daniel J.; Woollard, David M.; Mattmann, Chris A.

    2011-01-01

    The push-pull framework was developed in hopes that an infrastructure would be created that could literally connect to any given remote site, and (given a set of restrictions) download files from that remote site based on those restrictions. The Cataloging and Archiving Service (CAS) has recently been re-architected and re-factored in its canonical services, including file management, workflow management, and resource management. Additionally, a generic CAS Crawling Framework was built based on motivation from Apache s open-source search engine project called Nutch. Nutch is an Apache effort to provide search engine services (akin to Google), including crawling, parsing, content analysis, and indexing. It has produced several stable software releases, and is currently used in production services at companies such as Yahoo, and at NASA's Planetary Data System. The CAS Crawling Framework supports many of the Nutch Crawler's generic services, including metadata extraction, crawling, and ingestion. However, one service that was not ported over from Nutch is a generic protocol layer service that allows the Nutch crawler to obtain content using protocol plug-ins that download content using implementations of remote protocols, such as HTTP, FTP, WinNT file system, HTTPS, etc. Such a generic protocol layer would greatly aid in the CAS Crawling Framework, as the layer would allow the framework to generically obtain content (i.e., data products) from remote sites using protocols such as FTP and others. Augmented with this capability, the Orbiting Carbon Observatory (OCO) and NPP (NPOESS Preparatory Project) Sounder PEATE (Product Evaluation and Analysis Tools Elements) would be provided with an infrastructure to support generic FTP-based pull access to remote data products, obviating the need for any specialized software outside of the context of their existing process control systems. This extensible configurable framework was created in Java, and allows the use of

  9. 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.

  10. 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

  11. Effectiveness and Safety of Generic Fixed-Dose Combination of Tenofovir/Emtricitabine/Efavirenz in HIV-1-Infected Patients in Western India.

    Science.gov (United States)

    Pujari, Sanjay; Dravid, Ameet; Gupte, Nikhil; Joshix, Kedar; Bele, Vivek

    2008-08-20

    To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India. Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity. One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3-4 central nervous system disturbances, 4 for grade 3-4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3-4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction. A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions.

  12. Optimizing Generic Functions

    NARCIS (Netherlands)

    Alimarine, A.; Smetsers, J.E.W.

    2004-01-01

    Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular type. An instance on a specific type is generated by interpretation of the type's structure. A direct

  13. Management response plan for the Chemical Safety Vulnerability Working Group report. Volume 2

    International Nuclear Information System (INIS)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 146 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. To address the facility-specific and site-specific vulnerabilities, responsible DOE and site-contractor line organizations have developed initial site response plans. These plans, presented as Volume 2 of this Management Response Plan, describe the actions needed to mitigate or eliminate the facility- and site-specific vulnerabilities identified by the CSV Working Group field verification teams. Initial site response plans are described for: Brookhaven National Lab., Hanford Site, Idaho National Engineering Lab., Lawrence Livermore National Lab., Los Alamos National Lab., Oak Ridge Reservation, Rocky Flats Plant, Sandia National Laboratories, and Savannah River Site

  14. Cadmium control/safety rod disposal at the Savannah River Site

    International Nuclear Information System (INIS)

    McInnis, S.H.

    1995-01-01

    Four heavy-water-moderated reactors at the Savannah River Site will undergo the removal of 862 activated cadmium control/safety rods. Although these reactors are 40 years old, they offer 4 basic advantages for decommissioning: the equipment is still in some sort of operable state; the reactor is blow the floor in a large process room, allowing access; Control/safety rods can be handled remotely by existing equipment; a radiologically shielded removal path exists. Drawbacks include the following: age of reactors; improvements in technology have caused incompatibility problems; more strigent standards; compliance with environmental regulations. This article details how the removal was carried out and the current status of the project, keeping in mind the above considerations

  15. 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

  16. United States program for the safety assessment of geologic disposal of commercial radioactive wastes

    International Nuclear Information System (INIS)

    Claiborne, H.C.

    1977-01-01

    The safe disposal of commercial radioactive wastes in deep geologic formations is the goal of the National Waste Terminal Storage (NWTS) Program. A comprehensive safety assessment program has been established which will proceed on a schedule consistent with the start-up of two waste repositories in late 1985. Safety assessment begins with selection of a disposal site; that is, all geologic and hydrologic factors must indicate long-term stability of the formation and prospective isolation of wastes from circulating around waters for hundreds of thousands of years. The long-term stability of each site must be demonstrated by sophisticated rock mechanics analyses. To help provide answers on the mechanism and consequences of an unlikely breach in the integrity of the repository, a Waste Isolation Safety Assessment Program (WISAP) is being sponsored at the Battelle Pacific Northwest Laboratories. Methods and data necessary to characterize the safety of generic geological waste disposal concepts, which are to be applied in the assessment of specific sties, will be developed. Other long-term safety-related studies that complement WISAP are in progress, for example, borehole plugging, salt dissolutioning, and salt transport in vertical boreholes. Requirements for licensing are in the process of being formulated by the NRC

  17. Generic analyses for evaluation of low Charpy upper-shelf energy effects on safety margins against fracture of reactor pressure vessel materials

    International Nuclear Information System (INIS)

    Dickson, T.L.

    1993-07-01

    Appendix G to 10 CFR Part 50 requires that reactor pressure vessel beltline material maintain Charpy upper-shelf energies of no less than 50 ft-lb during the plant operating life, unless it is demonstrated in a manner approved by the Nuclear Regulatory Commission (NRC), that lower values of Charpy upper-shelf energy provide margins of safety against fracture equivalent to those in Appendix G to Section XI of the ASME Code. Analyses based on acceptance criteria and analysis methods adopted in the ASME Code Case N-512 are described herein. Additional information on material properties was provided by the NRC, Office of Nuclear Regulatory Research, Materials Engineering Branch. These cases, specified by the NRC, represent generic applications to boiling water reactor and pressurized water reactor vessels. This report is designated as HSST Report No. 140

  18. Generic Example Proving Criteria for All

    Science.gov (United States)

    Yopp, David; Ely, Rob; Johnson­-Leung, Jennifer

    2015-01-01

    We review literature that discusses generic example proving and highlight ambiguities that pervade our research community's discourse about generic example arguments. We distinguish between pedagogical advice for choosing good examples that can serve as generic examples when teaching and advice for developing generic example arguments. We provide…

  19. Generic and biosimilar medicines: quid?

    Directory of Open Access Journals (Sweden)

    Steven Simoens

    2012-12-01

    Full Text Available Once intellectual property protection, data and marketing exclusivity of reference medicines have expired, generic medicines and biosimilar medicines can enter the off-patent market. This market entry is conditional on the approval of marketing authorization, pricing and reimbursement. Given that there tends to be confusion surrounding generic and biosimilar medicines, this Editorial introduces basic concepts related to generic and biosimilar medicines and presents the different studies and articles included in this supplement dedicated to generic and biosimilar medicines.

  20. New safety concept for geological disposal in Japan - -16339

    International Nuclear Information System (INIS)

    Kitayama, Kazumi

    2009-01-01

    This paper describes a new safety concept for the Japanese geological disposal program, which is a development of the conventional multi-barrier system concept. The Japanese government established the 'Nuclear Waste Management Organization of Japan' (NUMO) as an implementation body in 2000 based on the 'Final disposal act' following the publication of the 'H-12 Report', which confirmed the scientific and engineering feasibility of HLW geological disposal in Japan. Since then, NUMO has undertaken further technical developments aimed at achieving safe and efficient implementation of final disposal. The safety concept developed in the 'H-12 Report' provides sufficient safety on the basis of site-generic considerations. However, it is considered to be over-conservative and therefore does not represent the most probable performance of the engineered or natural barriers. Recently, concrete measures have been proposed requiring the safety case to be presented in terms of a realistic assessment of the most probable performance. This approach takes into account the safety functions of both engineered and natural barriers as well as the long-term static geochemical equilibrium. In particular, the evolution of the safety performance of engineered and natural barriers can be efficiently augmented by the realistic long-term geochemical equilibrium. (author)

  1. Buffer, backfill and closure process report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    Sellin, Patrik

    2010-11-01

    This report gives an account of how processes in buffer, deposition tunnel backfill and the closure important for the long-term evolution of a KBS-3 repository for spent nuclear fuel, will be documented in the safety assessment SR-Site

  2. Buffer, backfill and closure process report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Sellin, Patrik (ed.)

    2010-11-15

    This report gives an account of how processes in buffer, deposition tunnel backfill and the closure important for the long-term evolution of a KBS-3 repository for spent nuclear fuel, will be documented in the safety assessment SR-Site

  3. Geotechnical aspects of site evaluation and foundations for nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2003-01-01

    This publication is a revision of the former safety standards of IAEA Safety Series No. 50-SG-S8. The scope has been extended to cover not only foundations but also design questions related to geotechnical science and engineering, such as the bearing capacity of foundations, design of earth structures and design of buried structures. Seismic aspects also play an important role in this field, and consequently the Safety Guide on Evaluation of Seismic Hazards for Nuclear Power Plants, Safety Standards Series No. NS-G-3.3, which discusses the determination of seismic input motion, is referenced on several occasions. The present Safety Guide provides an interpretation of the Safety Requirements on Site Evaluation for Nuclear Installations and guidance on how to implement them. It is intended for the use of safety assessors or regulators involved in the licensing process as well as the designers of nuclear power plants, and it provides them with guidance on the methods and procedures for analyses to support the assessment of the geotechnical aspects of the safety of nuclear power plants

  4. Geotechnical aspects of site evaluation and foundations for nuclear power plants. Safety guide

    International Nuclear Information System (INIS)

    2006-01-01

    This publication is a revision of the former safety standards of IAEA Safety Series No. 50-SG-S8. The scope has been extended to cover not only foundations but also design questions related to geotechnical science and engineering, such as the bearing capacity of foundations, design of earth structures and design of buried structures Seismic aspects also play an important role in this field, and consequently the Safety Guide on Evaluation of Seismic Hazards for Nuclear Power Plants, Safety Standards Series No. NS-G-3.3, which discusses the determination of seismic input motion, is referenced on several occasions. The present Safety Guide provides an interpretation of the Safety Requirements on Site Evaluation for Nuclear Installations and guidance on how to implement them. It is intended for the use of safety assessors or regulators involved in the licensing process as well as the designers of nuclear power plants, and it provides them with guidance on the methods and procedures for analyses to support the assessment of the geotechnical aspects of the safety of nuclear power plants

  5. A plan for safety evaluation of tsunamis at the Uljin nuclear power plant site

    International Nuclear Information System (INIS)

    Lee, H. K.; Lee, D. S.

    1999-01-01

    The sites of many nuclear and thermal power plants are located along the coast line to obtain necessary cooling water. Therefore, they are vulnerable to coastal disasters like tsunamis. The safety evaluation on tsunamis of the site of Uljin nuclear power plants was performed with the maximum potential earthquake magnitude and related fault parameters in 1986. But according to the results of recent research, the possibility was suggested that the earthquake which has bigger magnitude than was expected is likely to happen in the seismic gaps near Akita, Japan. Therefore, a plan for safety evaluation of tsunamis at the Uljin nuclear power plants was laid out

  6. Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates.

    Science.gov (United States)

    Olszynski, Wojciech P; Adachi, Jonathan D; Davison, K Shawn

    2014-01-01

    The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly (P disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies.

  7. Advertising and generic market entry.

    Science.gov (United States)

    Königbauer, Ingrid

    2007-03-01

    The effect of purely persuasive advertising on generic market entry and social welfare is analysed. An incumbent has the possibility to invest in advertising which affects the prescribing physician's perceived relative qualities of the brand-name and the generic version of the drug. Advertising creates product differentiation and can induce generic market entry which is deterred without differentiation due to strong Bertrand competition. However, over-investment in advertising can deter generic market entry under certain conditions and reduces welfare as compared to accommodated market entry.

  8. Safety Evaluation Report Restart of K-Reactor Savannah River Site

    International Nuclear Information System (INIS)

    1991-10-01

    In April 1991, the Department of Energy (DOE) issued DOE/DP-0084T, ''Safety Evaluation Report Restart of K-Reactor Savannah River Site.'' The Safety Evaluation Report (SER) documents the results of DOE reviews and evaluations of the programmatic aspects of a large number of issues necessary to be satisfactorily addressed before restart. The issues were evaluated for compliance with the restart criteria included in the SER. The results of those evaluations determined that the restart criteria had been satisfied for some of the issues. However, for most of the issues at least part of the applicable restart criteria had not been found to be satisfied at the time the evaluations were prepared. For those issues, open or confirmatory items were identified that required resolution. In August 1991, DOE issued DOE/DP-0090T, ''Safety Evaluation Report Restart of K-Reactor Savannah River Site Supplement 1.'' That document was the first Supplement to the April 1991 SER, and documented the resolution of 62 of the open items identified in the SER. This document is the second Supplement to the April 1991 SER. This second SER Supplement documents the resolution of additional open times identified in the SER, and includes a complete list of all remaining SER open items. The resolution of those remaining open items will be documented in future SER Supplements. Resolution of all open items for an issue indicates that its associated restart criteria have been satisfied, and that DOE concludes that the programmatic aspects of the issue have been satisfactorily addressed

  9. HSE Nuclear Safety Research Program

    Energy Technology Data Exchange (ETDEWEB)

    Bagley, M.J. [Health and Safety Executive, Sheffield (United Kingdom)

    1995-12-31

    HSE funds two programmes of nuclear safety research: a programme of {approx} 2.2M of extramural research to support the Nuclear Safety Division`s regulatory activities and a programme of {approx} 11M of generic safety research managed by the Nuclear Safety Research Management Unit (NSRMU) in Sheffield, UK. This paper is concerned only with the latter programme; it describes how it is planned and procured and outlines some of the work on structural integrity problems. It also describes the changes that are taking place in the way nuclear safety research is procured in the UK. (author).

  10. HSE Nuclear Safety Research Program

    International Nuclear Information System (INIS)

    Bagley, M.J.

    1995-01-01

    HSE funds two programmes of nuclear safety research: a programme of ∼ 2.2M of extramural research to support the Nuclear Safety Division's regulatory activities and a programme of ∼ 11M of generic safety research managed by the Nuclear Safety Research Management Unit (NSRMU) in Sheffield, UK. This paper is concerned only with the latter programme; it describes how it is planned and procured and outlines some of the work on structural integrity problems. It also describes the changes that are taking place in the way nuclear safety research is procured in the UK. (author)

  11. Information report on nuclear safety and radiation protection of the Tricastin AREVA site, 2010 edition

    International Nuclear Information System (INIS)

    2010-01-01

    This report presents the Tricastin site, the different arrangements concerning nuclear safety and radiation protection on this site, and recent nuclear events. It describes how site releases are managed and how the environment is controlled and monitored, how wastes are managed, and how other impacts are controlled. It finally presents the different actions regarding transparency and information

  12. 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

  13. Replacement cross-site transfer system project W-058 safety class upgrade summary report

    International Nuclear Information System (INIS)

    Schlosser, R.L.

    1998-01-01

    This report evaluates the design of the replacement cross-site transfer system structures, systems, and components for safety related applications as defined in the Tank Waste Remediation Systems Basis for Interim Operations

  14. Generic procedures for assessment and response during a radiological emergency

    International Nuclear Information System (INIS)

    2000-08-01

    One of the most important aspects of managing a radiological emergency is the ability to promptly and adequately determine and take actions to protect members of the public and emergency workers. Radiological accident assessment must take account of all critical information available at any time and must be an iterative and dynamic process aimed at reviewing the response as more detailed and complete information becomes available. This manual provides the tools, generic procedures and data needed for an initial response to a non-reactor radiological accident. This manual is one out of a set of IAEA publications on emergency preparedness and response, including Method for the Development of Emergency Response Preparedness for Nuclear or Radiological Accidents (IAEA-TECDOC-953), Generic Assessment Procedures for Determining Protective Actions During a Reactor Accident (IAEA-TECDOC-955) and Intervention Criteria in a Nuclear or Radiation Emergency (Safety Series No. 109)

  15. Development of SAGE, A computer code for safety assessment analyses for Korean Low-Level Radioactive Waste Disposal

    International Nuclear Information System (INIS)

    Zhou, W.; Kozak, Matthew W.; Park, Joowan; Kim, Changlak; Kang, Chulhyung

    2002-01-01

    This paper describes a computer code, called SAGE (Safety Assessment Groundwater Evaluation) to be used for evaluation of the concept for low-level waste disposal in the Republic of Korea (ROK). The conceptual model in the code is focused on releases from a gradually degrading engineered barrier system to an underlying unsaturated zone, thence to a saturated groundwater zone. Doses can be calculated for several biosphere systems including drinking contaminated groundwater, and subsequent contamination of foods, rivers, lakes, or the ocean by that groundwater. The flexibility of the code will permit both generic analyses in support of design and site development activities, and straightforward modification to permit site-specific and design-specific safety assessments of a real facility as progress is made toward implementation of a disposal site. In addition, the code has been written to easily interface with more detailed codes for specific parts of the safety assessment. In this way, the code's capabilities can be significantly expanded as needed. The code has the capability to treat input parameters either deterministic ally or probabilistic ally. Parameter input is achieved through a user-friendly Graphical User Interface.

  16. Waste isolation safety assessment program. Summary of FY-77 progress

    International Nuclear Information System (INIS)

    Burkholder, H.C.; Greenborg, J.; Stottlemyre, J.A.; Bradley, D.J.; Raymond, J.R.; Serne, R.J.

    1977-11-01

    Objective is to provide long-term safety information for the National Waste Terminal Storage Program. Work in FY 77 supported the development of the generic assessment method (release scenario analysis, release consequence analysis) and of the generic data base (waste form release rate data, radionuclide geochemical interaction data)

  17. Encouraging generic use can yield significant savings.

    Science.gov (United States)

    Zimmerman, Christina

    2012-11-01

    Key findings. (1) Zero copayment for generic drugs is the greatest influencer of generic statin utilization. (2) Both higher copayments for generic drugs and lower copayments for competing brands are associated with a decreased probability of using generic statins. (3) Prior authorization and step therapy requirements for brand-name statins are associated with an increased use of generic drugs. (4) Greater use of generic statins should reduce costs for patients, plans, and Medicare.

  18. Criticality safety engineering at the Savannah River Site - the 1990s

    International Nuclear Information System (INIS)

    Chandler, J.R.; Apperson, C.E. Jr.

    1996-01-01

    The privatization and downsizing effort that is ongoing within the U.S. Department of Energy (DOE) is requiring a change in the management of criticality safety engineering resources at the Savannah River Site (SRS). Downsizing affects the number of criticality engineers employed by the prime contractor, Westinghouse Savannah River Company (WSRC), and privatization affects the manner in which business is conducted. In the past, criticality engineers at the SRS have been part of the engineering organizations that support each facility handling fissile material. This practice led to different criticality safety engineering organizations dedicated to fuel fabrication activities, reactor loading and unloading activities, separation and waste management operations, and research and development

  19. Cooperation of the site and public fire and safety services in case of an incident

    International Nuclear Information System (INIS)

    Bauch, M.

    1997-01-01

    This report describes the cooperation between the site and the public fire and safety services in case of an incident. As an example, the measures and facilities of the Hoechst site of the Hoechst AG and the organisational and technical background are presented. (orig.) [de

  20. Chemical Safety Vulnerability Working Group report. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 148 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 1 contains the Executive summary; Introduction; Summary of vulnerabilities; Management systems weaknesses; Commendable practices; Summary of management response plan; Conclusions; and a Glossary of chemical terms.

  1. Chemical Safety Vulnerability Working Group report. Volume 1

    International Nuclear Information System (INIS)

    1994-09-01

    The Chemical Safety Vulnerability (CSV) Working Group was established to identify adverse conditions involving hazardous chemicals at DOE facilities that might result in fires or explosions, release of hazardous chemicals to the environment, or exposure of workers or the public to chemicals. A CSV Review was conducted in 148 facilities at 29 sites. Eight generic vulnerabilities were documented related to: abandoned chemicals and chemical residuals; past chemical spills and ground releases; characterization of legacy chemicals and wastes; disposition of legacy chemicals; storage facilities and conditions; condition of facilities and support systems; unanalyzed and unaddressed hazards; and inventory control and tracking. Weaknesses in five programmatic areas were also identified related to: management commitment and planning; chemical safety management programs; aging facilities that continue to operate; nonoperating facilities awaiting deactivation; and resource allocations. Volume 1 contains the Executive summary; Introduction; Summary of vulnerabilities; Management systems weaknesses; Commendable practices; Summary of management response plan; Conclusions; and a Glossary of chemical terms

  2. 76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-16

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors AGENCY: Nuclear Regulatory Commission... FR 54507), that requested public comment on Draft NRC Generic Letter 2011- XX: Seismic Risk...

  3. Resolution of the ferrocyanide safety issue for the Hanford site high-level waste tanks

    International Nuclear Information System (INIS)

    Cash, R.J.

    1996-01-01

    This paper describes the approach used to resolve the ferrocyanide safety issue, a process that began in 1990 after heightened concern was expressed by various government agencies about the safety of Hanford site high-level waste tanks. At the time, little was known about ferrocyanide-nitrate/nitrite reactions and the potential for offsite releases of radioactivity from the Hanford Site. Recent studies have shown that the combined effects of temperature, radiation, and pH during more than 38 years of storage have destroyed most of the ferrocyanide originally added to tanks. This has been proven in the laboratory using flowsheet-derived waste simulants and confirmed by waste samples obtained from the ferrocyanide tanks. The resulting tank waste sludges are too dilute to support a sustained exothermic reaction, even if dried out and heated to temperatures of at least 250 C. The US Department of Energy (DOE) has been requested to close the ferrocyanide safety issue

  4. Environmental restoration contractor facility safety plan -- MO-561 100-D site remediation project

    International Nuclear Information System (INIS)

    Donahoe, R.L.

    1996-11-01

    This safety plan is applicable to Environmental Restoration Contractor personnel who are permanently assigned to MO-561 or regularly work in the facility. The MO-561 Facility is located in the 100-D Area at the Hanford Site in Richland, Washington. This plan will: (a) identify hazards potentially to be encountered by occupants of MO-561; (b) provide requirements and safeguards to ensure personnel safety and regulatory compliance; (c) provide information and actions necessary for proper emergency response

  5. Legislation and regulatory infrastructure for the safety of radioactive waste management

    International Nuclear Information System (INIS)

    Hoegberg, L.

    2000-01-01

    The essential generic characteristics of a national legislative and regulatory system for the safety of radioactive waste management are defined and discussed. The Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management as well as other relevant international legal instruments and guidelines are discussed. Special emphasis is given to the following characteristics of a national legislative and regulatory system: (i) definition of responsibilities, (ii) financing of future costs, (iii) nuclear and radiation safety requirements, (iv) siting and licensing procedures, (v) regulatory functions, and (vi) international co-operation. It is concluded that there exists an internationally endorsed basis for establishing effective national legislation and regulatory infrastructures for the safety of radioactive waste management. It is underlined that the continuing internationalization of the nuclear industry stresses the need for national legislation and regulatory infrastructure to be based on such internationally endorsed principles and standards. It is pointed out that regulators are accountable to the public and have to gain public trust by being active in the public arena, demonstrating their competence and integrity. Finally, prescriptive and goal-oriented international safety regimes are briefly discussed in the light of experience so far gained with the Convention on Nuclear Safety. (author)

  6. International assessment of application of the Code of Conduct on the Safety of Research Reactors

    Energy Technology Data Exchange (ETDEWEB)

    Shokr, A.M. [Atomic Energy Authority, Abouzabal (Egypt). Egypt Second Research Reactor

    2015-11-15

    The self-assessments performed by thirty-eight countries on application of the Code of Conduct on the Safety of Research Reactors were analyzed and discussed. The results of this analysis were used to identify areas of satisfactory application of the Code and area needing improvements, and therefore require more attention worldwide. The results showed improvement in application of the Code provisions; notably in aging management, regulatory supervision, and consideration of human factors. However, there is a continuing need for further improvement in these areas, as well as in operational radiation protection, emergency preparedness and decommissioning planning. Additionally, increased attention needs to be given to periodic safety reviews, evaluation of site-specific hazards, and assessment of extreme external events. The results showed consistency with the feedback from other sources of information on generic safety issues for research reactors.

  7. International assessment of application of the Code of Conduct on the Safety of Research Reactors

    International Nuclear Information System (INIS)

    Shokr, A.M.

    2015-01-01

    The self-assessments performed by thirty-eight countries on application of the Code of Conduct on the Safety of Research Reactors were analyzed and discussed. The results of this analysis were used to identify areas of satisfactory application of the Code and area needing improvements, and therefore require more attention worldwide. The results showed improvement in application of the Code provisions; notably in aging management, regulatory supervision, and consideration of human factors. However, there is a continuing need for further improvement in these areas, as well as in operational radiation protection, emergency preparedness and decommissioning planning. Additionally, increased attention needs to be given to periodic safety reviews, evaluation of site-specific hazards, and assessment of extreme external events. The results showed consistency with the feedback from other sources of information on generic safety issues for research reactors.

  8. Generics Pricing: The Greek Paradox.

    Science.gov (United States)

    Karafyllis, Ioannis; Variti, Lamprini

    2017-01-01

    This paper explains and develops a methodological framework to help evaluate the performance of generic pharmaceutical policies and the correct evaluation of generics sales. Until today erroneous recording of generics does not help proper pricing and their penetration in the Greek market. This classifies Greece on the outliners in every study or comparison that is referred on papers or studies.

  9. Control of safety and risk management software at the Savannah River Site

    International Nuclear Information System (INIS)

    Ades, M.J.; Toffer, H.; Crowe, R.D.

    1992-01-01

    As a part of its Reactor Operations Improvement Program at the Savannah River Site (SRS), Westinghouse Savannah River Company (WSRC), in cooperation with the Westinghouse Hanford Company, has developed and implemented software quality assurance (SQA) for computer codes essential to the safety and reliability of reactor operations. This effort includes the use of quality standards and attendant procedures developed for and applied to computer codes used in safety and risk management analyses. The certification process that was recently implemented is in compliance with site wide and departmental SQA requirements. Certification consists of preparing a specific verification and validation (V and V) plan, a configuration control plan, and user qualifications. Applicable documentation is reviewed to determine compliance with V and V and configuration control action items. The results of this review are documented and serve as a baseline for additional certification activities. Resource commitment and schedules are drawn up for each individual code to complete certification in accordance with SQA requirements

  10. Pharmaceutical quality of seven generic Levodopa/Benserazide products compared with original Madopar® / Prolopa®.

    Science.gov (United States)

    Gasser, Urs E; Fischer, Anton; Timmermans, Jan P; Arnet, Isabelle

    2013-04-23

    a safety concern. Our results should prompt caution when prescribing a generic of Madopar®/Prolopa®, and also invite to further investigations in view of a more comprehensive approach, both pharmaceutical and clinical.

  11. Site safety progress review of spent fuel central interim storage facility. Final report

    International Nuclear Information System (INIS)

    Gurpinar, A.; Serva, L.; Giuliani

    1995-01-01

    Following the request of the Czech Power Board (CEZ) and within the scope of the Technical Cooperation Project CZR/9/003, a progress review of the site safety of the Spent Fuel Central Interim Storage Facility (SFCISF) was performed. The review involved the first two stages of the works comprising the regional survey and identification of candidate sites for the underground and surface storage options. Five sites have been identified as a result of the previous works. The following two stages will involved the identification of the preferred candidate sites for the two options and the final site qualification. The present review had the purpose of assessing the work already performed and making recommendations for the next two stages of works

  12. NET 40 Generics Beginner's Guide

    CERN Document Server

    Mukherjee, Sudipta

    2012-01-01

    This is a concise, practical guide that will help you learn Generics in .NET, with lots of real world and fun-to-build examples and clear explanations. It is packed with screenshots to aid your understanding of the process. This book is aimed at beginners in Generics. It assumes some working knowledge of C# , but it isn't mandatory. The following would get the most use out of the book: Newbie C# developers struggling with Generics. Experienced C++ and Java Programmers who are migrating to C# and looking for an alternative to other generic frameworks like STL and JCF would find this book handy.

  13. 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

  14. Determining Safety Inspection Thresholds for Employee Incentives Programs on Construction Sites.

    Science.gov (United States)

    Sparer, Emily; Dennerlein, Jack

    2013-01-01

    The goal of this project was to evaluate approaches of determining the numerical value of a safety inspection score that would activate a reward in an employee safety incentive program. Safety inspections are a reflection of the physical working conditions at a construction site and provide a safety score that can be used in incentive programs to reward workers. Yet it is unclear what level of safety should be used when implementing this kind of program. This study explored five ways of grouping safety inspection data collected during 19 months at Harvard University-owned construction projects. Each approach grouped the data by one of the following: owner, general contractor, project, trade, or subcontractor. The median value for each grouping provided the threshold score. These five approaches were then applied to data from a completed project in order to calculate the frequency and distribution of rewards in a monthly safety incentive program. The application of each approach was evaluated qualitatively for consistency, competitiveness, attainability, and fairness. The owner-specific approach resulted in a threshold score of 96.3% and met all of the qualitative evaluation goals. It had the most competitive reward distribution (only 1/3 of the project duration) yet it was also attainable. By treating all workers equally and maintaining the same value throughout the project duration, this approach was fair and consistent. The owner-based approach for threshold determination can be used by owners or general contractors when creating leading indicator incentives programs and by researchers in future studies on incentive program effectiveness.

  15. NAGRA - Sites for geological repositories - Technical safety factors: Suggestions for stage 3

    International Nuclear Information System (INIS)

    2015-01-01

    This comprehensive brochure published by the Swiss National Cooperative for the Disposal of Radioactive Waste (NAGRA) examines the six sites for repositories for nuclear wastes in Switzerland which have been proposed in Stage 1 of the program concerning nuclear waste repositories. Three of these sites are proposed for both highly radioactive wastes as well as for low and medium-active wastes, the other three for low and medium-active wastes only. The evaluation of the sites is discussed. The sites are to be further evaluated in Stage 2 of the program. The work to be done in the further stages involved in the selection of the final site (or sites) is described. Along with definition of the regions where deep repositories could possibly be built, suggestions for the placing of the facilities required on the surface are discussed. Geological requirements on the repositories and safety-relevant characteristics of the various site options are discussed. The results of the assessments made are presented in tabular form. Maps and geological cross-sections of all the suggested areas are included

  16. 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

  17. Efficient Generic Functional Programming

    NARCIS (Netherlands)

    Alimarine, A.; Smetsers, J.E.W.

    2005-01-01

    Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular data type. An instance on a specific type is generated by interpretation of the type's structure. A

  18. Generic robot architecture

    Science.gov (United States)

    Bruemmer, David J [Idaho Falls, ID; Few, Douglas A [Idaho Falls, ID

    2010-09-21

    The present invention provides methods, computer readable media, and apparatuses for a generic robot architecture providing a framework that is easily portable to a variety of robot platforms and is configured to provide hardware abstractions, abstractions for generic robot attributes, environment abstractions, and robot behaviors. The generic robot architecture includes a hardware abstraction level and a robot abstraction level. The hardware abstraction level is configured for developing hardware abstractions that define, monitor, and control hardware modules available on a robot platform. The robot abstraction level is configured for defining robot attributes and provides a software framework for building robot behaviors from the robot attributes. Each of the robot attributes includes hardware information from at least one hardware abstraction. In addition, each robot attribute is configured to substantially isolate the robot behaviors from the at least one hardware abstraction.

  19. Natural Elemental Concentrations and Fluxes: Their Use as Indicators of Repository Safety

    International Nuclear Information System (INIS)

    Miller, Bill; Lind, Andy; Savage, Dave; Maul, Philip; Robinson, Peter

    2002-03-01

    individual processes, such as groundwater discharge, river flow and erosion at specific locations. The approach can also be of value at the generic level of repository development, before site characterisation programmes have been undertaken. They could be used, for example, as a component in comparative evaluations of alternative generic disposal concepts. The objective at the generic level would be to define typical or average natural elemental concentrations and fluxes in geological systems representative of the environments which might host a repository, and to compare these with the outputs from the associated generic PAs. To facilitate the use of the natural safety indicators methodology at the generic level, this study has undertaken to bring together and to compile much of the required information. This information has been used to quantify average elemental mass fluxes at the global scale for a range of processes, including groundwater discharge, erosion and sediment transport. The point of these calculations is that they provide a baseline against which site or geological environment specific natural fluxes, from anywhere in the world, can be compared on an equal basis to evaluate if they are higher or lower than the global average and, thus, are useful for providing a broad natural context for predicted repository releases. In separate calculations, elemental mass fluxes were quantified for a number of reference environments which are chosen to be representative of the types of sites and geological systems which may host a deep repository. The reference environments were an inland pluton, basement under sedimentary cover and a sedimentary basin. The fluxes for these environments were calculated for systems with spatial scales of a few hundred square kilometres and, as such, approximate closely to the repository systems modelled in PAs because a reference environment represents the same system, with the same rock, groundwater and surface conditions as those

  20. Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization

    Directory of Open Access Journals (Sweden)

    Dajun Sun

    2018-01-01

    Full Text Available The objective of this study was to evaluate physicochemical equivalence between brand (i.e., Ferrlecit and generic sodium ferric gluconate (SFG in sucrose injection by conducting a series of comparative in vitro characterizations using advanced analytical techniques. The elemental iron and carbon content, thermal properties, viscosity, particle size, zeta potential, sedimentation coefficient, and molecular weight were determined. There was no noticeable difference between brand and generic SFG in sucrose injection for the above physical parameters evaluated, except for the sedimentation coefficient determined by sedimentation velocity analytical ultracentrifugation (SV-AUC and molecular weight by asymmetric field flow fractionation-multi-angle light scattering (AFFF-MALS. In addition, brand and generic SFG complex products showed comparable molecular weight distributions when determined by gel permeation chromatography (GPC. The observed minor differences between brand and generic SFG, such as sedimentation coefficient, do not impact their biological activities in separate studies of in vitro cellular uptake and rat biodistribution. Coupled with the ongoing clinical study comparing the labile iron level in healthy volunteers, the FDA-funded post-market studies intended to illustrate comprehensive surveillance efforts ensuring safety and efficacy profiles of generic SFG complex in sucrose injection, and also to shed new light on the approval standards on generic parenteral iron colloidal products.

  1. 42 CFR 447.506 - Authorized generic drugs.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

  2. Generic phytosanitary irradiation treatments

    International Nuclear Information System (INIS)

    Hallman, Guy J.

    2012-01-01

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies. - Highlights: ► The history of phytosanitary irradiation (PI) treatments is given. ► Generic PI treatments in use today are discussed. ► Suggestions for future research are presented. ► A dose of 250 Gy for most insects may suffice.

  3. The Role of Geographical Indication in Supporting Food Safety: A not Taken for Granted Nexus

    Science.gov (United States)

    2014-01-01

    The paper focuses on the role of geographical indication in supporting strategies of food safety. Starting from the distinction between generic and specific quality, the article analyses the main factors influencing food safety in cases of geographical indication products, by stressing the importance of traceability systems and biodiversity in securing generic and specific quality. In the second part, the paper investigates the coordination problems behind a designation of origin and conditions to foster an effective collective action, a prerequisite to grant food safety through geographical indications. PMID:27800417

  4. 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

  5. Determinants of generic drug substitution in Switzerland

    Directory of Open Access Journals (Sweden)

    Lufkin Thomas M

    2011-01-01

    Full Text Available Abstract Background Since generic drugs have the same therapeutic effect as the original formulation but at generally lower costs, their use should be more heavily promoted. However, a considerable number of barriers to their wider use have been observed in many countries. The present study examines the influence of patients, physicians and certain characteristics of the generics' market on generic substitution in Switzerland. Methods We used reimbursement claims' data submitted to a large health insurer by insured individuals living in one of Switzerland's three linguistic regions during 2003. All dispensed drugs studied here were substitutable. The outcome (use of a generic or not was modelled by logistic regression, adjusted for patients' characteristics (gender, age, treatment complexity, substitution groups and with several variables describing reimbursement incentives (deductible, co-payments and the generics' market (prices, packaging, co-branded original, number of available generics, etc.. Results The overall generics' substitution rate for 173,212 dispensed prescriptions was 31%, though this varied considerably across cantons. Poor health status (older patients, complex treatments was associated with lower generic use. Higher rates were associated with higher out-of-pocket costs, greater price differences between the original and the generic, and with the number of generics on the market, while reformulation and repackaging were associated with lower rates. The substitution rate was 13% lower among hospital physicians. The adoption of the prescribing practices of the canton with the highest substitution rate would increase substitution in other cantons to as much as 26%. Conclusions Patient health status explained a part of the reluctance to substitute an original formulation by a generic. Economic incentives were efficient, but with a moderate global effect. The huge interregional differences indicated that prescribing behaviours and

  6. Review of the SQUG type seismic program at Savannah River Site

    International Nuclear Information System (INIS)

    Bitner, J.L.; Lin, C.W.; Anderson, N.R.; Bezler, P.

    1991-01-01

    The production reactors at Savannah River were shut down in 1988 because of questions about their safety. One question is whether they can withstand earthquakes. To answer the earthquake question, the site operator (Westinghouse Savannah River Company) developed a program to evaluate the capability of the safety systems in the K, L, and P reactors to function during and after an earthquake, and to upgrade them if necessary. The seismic program for Savannah River relies heavily on the Generic Implementation Procedure (GIP) developed by the Seismic qualification Utility Group. The GIP was originally developed for application to over 65 commercial power reactors throughout the U.S. It has been thoroughly reviewed by the U.S. Nuclear Regulatory Commission. The objectives of the ISWRT (Independent Seismic Walkdown Review Team) review were to: evaluate the program and evaluate its execution. The first objective was accomplished using an in-office review of the program. The second objective was accomplished using an in-office review and in-plant walkdown of selected safety systems. The ISWRT review and walkdown are summarized in this paper

  7. The SCALE Web site: Resources for the worldwide nuclear criticality safety community

    International Nuclear Information System (INIS)

    Bowman, S.M.

    2000-01-01

    The Standardized Computer Analyses for Licensing Evaluations (SCALE) computer software system developed at Oak Ridge National Laboratory (ORNL) is widely used and accepted around the world for criticality safety analyses. SCALE includes the well-known KENO V.a and KENO VI three-dimensional Monte Carlo criticality computer codes. For several years, the SCALE staff at ORNL has maintained a Web site to provide information and support to sponsors and users in the worldwide criticality safety community. The SCALE WEB site is located at www.cped.ornl.gov/scale and provides information in the following areas: 1. important notices to users; 2. SCALE Users Electronic Notebook; 3. current and past issues of the SCALE Newsletter; 4. verification and validation (V and V) and benchmark reports; 5. download updates, utilities, and V and V input files; 6. SCALE training course information; 7. SCALE Manual on-line; 8. overview of SCALE system; 9. how to install and run SCALE; 10. SCALE quality assurance documents; and 11. nuclear resources on the Internet

  8. UMTRA Project: Environment, Safety, and Health Plan

    International Nuclear Information System (INIS)

    1995-02-01

    The US Department of Energy has prepared this UMTRA Project Environment, Safety, and Health (ES and H) Plan to establish the policy, implementing requirements, and guidance for the UMTRA Project. The requirements and guidance identified in this plan are designed to provide technical direction to UMTRA Project contractors to assist in the development and implementation of their ES and H plans and programs for UMTRA Project work activities. Specific requirements set forth in this UMTRA Project ES and H Plan are intended to provide uniformity to the UMTRA Project's ES and H programs for processing sites, disposal sites, and vicinity properties. In all cases, this UMTRA Project ES and H Plan is intended to be consistent with applicable standards and regulations and to provide guidance that is generic in nature and will allow for contractors' evaluation of site or contract-specific ES and H conditions. This plan specifies the basic ES and H requirements applicable to UMTRA Project ES and H programs and delineates responsibilities for carrying out this plan. DOE and contractor ES and H personnel are expected to exercise professional judgment and apply a graded approach when interpreting these guidelines, based on the risk of operations

  9. Generic phytosanitary irradiation treatments

    Energy Technology Data Exchange (ETDEWEB)

    Hallman, Guy J [United States Department of Agriculture, Agricultural Research Service, Weslaco, TX (United States)

    2013-01-15

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies. (author)

  10. Generic phytosanitary irradiation treatments

    Science.gov (United States)

    Hallman, Guy J.

    2012-07-01

    The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies.

  11. Design and implementation of an identification system in construction site safety for proactive accident prevention.

    Science.gov (United States)

    Yang, Huanjia; Chew, David A S; Wu, Weiwei; Zhou, Zhipeng; Li, Qiming

    2012-09-01

    Identifying accident precursors using real-time identity information has great potential to improve safety performance in construction industry, which is still suffering from day to day records of accident fatality and injury. Based on the requirements analysis for identifying precursor and the discussion of enabling technology solutions for acquiring and sharing real-time automatic identification information on construction site, this paper proposes an identification system design for proactive accident prevention to improve construction site safety. Firstly, a case study is conducted to analyze the automatic identification requirements for identifying accident precursors in construction site. Results show that it mainly consists of three aspects, namely access control, training and inspection information and operation authority. The system is then designed to fulfill these requirements based on ZigBee enabled wireless sensor network (WSN), radio frequency identification (RFID) technology and an integrated ZigBee RFID sensor network structure. At the same time, an information database is also designed and implemented, which includes 15 tables, 54 queries and several reports and forms. In the end, a demonstration system based on the proposed system design is developed as a proof of concept prototype. The contributions of this study include the requirement analysis and technical design of a real-time identity information tracking solution for proactive accident prevention on construction sites. The technical solution proposed in this paper has a significant importance in improving safety performance on construction sites. Moreover, this study can serve as a reference design for future system integrations where more functions, such as environment monitoring and location tracking, can be added. Copyright © 2011 Elsevier Ltd. All rights reserved.

  12. Generic Advantages

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Generic Advantages. Scalability an incremental coverage. Standardization. Business Plan Flexibility. Lifecycle Flexibility. Reliability. Service Interoperability. Changed Industry dynamics.

  13. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Science.gov (United States)

    2012-08-27

    ... generic drugs program. GDUFA will also significantly improve global supply chain transparency by requiring... promote global supply chain transparency. The information provided through self-identification will enable... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD...

  14. 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

  15. Generic penetration in the retail antidepressant market.

    Science.gov (United States)

    Ventimiglia, Jeffrey; Kalali, Amir H

    2010-06-01

    In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

  16. Safety of Research Reactors. Safety Requirements

    International Nuclear Information System (INIS)

    2010-01-01

    The main objective of this Safety Requirements publication is to provide a basis for safety and a basis for safety assessment for all stages in the lifetime of a research reactor. Another objective is to establish requirements on aspects relating to regulatory control, the management of safety, site evaluation, design, operation and decommissioning. Technical and administrative requirements for the safety of research reactors are established in accordance with these objectives. This Safety Requirements publication is intended for use by organizations engaged in the site evaluation, design, manufacturing, construction, operation and decommissioning of research reactors as well as by regulatory bodies

  17. Information report on nuclear safety and radiation protection of the Tricastin AREVA site - Issue 2014. Figures and information about nuclear safety and radiation protection of the Tricastin AREVA site - Issue 2014

    International Nuclear Information System (INIS)

    2015-06-01

    Published in compliance with the French code of the environment, this report first presents different aspects of the Areva's Tricastin site which comprises five basic nuclear installations or INBs, and seven ICPE (installation classified for environment protection). The activities are dedicated to uranium conversion, uranium enrichment, uranium chemistry, industrial services, and fuel manufacturing. The report presents this important industrial site, describes the various measures regarding nuclear safety and radiation protection, reports nuclear events which occurred on this site and had to be declared, reports the management of releases by this site and the control of the environment. The next part addresses the management of the various wastes produced by the different installations present on this site. The management of other impacts is also reported. The last chapter reviews the actions undertaken in the field of transparency and information

  18. Information report on nuclear safety and radiation protection of the Tricastin AREVA site - Issue 2013. Figures and information about nuclear safety and radiation protection of the Tricastin AREVA site - Issue 2013

    International Nuclear Information System (INIS)

    2014-06-01

    Published in compliance with the French code of the environment, this report first presents different aspects of the Areva's Tricastin site which comprises five basic nuclear installations or INBs, and seven ICPE (installation classified for the protection of the environment). The activities are dedicated to uranium conversion, uranium enrichment, uranium chemistry, industrial services, and fuel manufacturing. The report presents this important industrial site, describes the various measures regarding nuclear safety and radiation protection, reports nuclear events which occurred on this site and had to be declared, reports the management of releases by this site and the control of the environment. The next part addresses the management of the various wastes produced by the different installations present on this site. The management of other impacts is also reported. The last chapter reviews the actions undertaken in the field of transparency and information

  19. The Management System for Nuclear Installations Safety Guide

    International Nuclear Information System (INIS)

    2009-01-01

    This Safety Guide is applicable throughout the lifetime of a nuclear installation, including any subsequent period of institutional control, until there is no significant residual radiation hazard. For a nuclear installation, the lifetime includes site evaluation, design, construction, commissioning, operation and decommissioning. These stages in the lifetime of a nuclear installation may overlap. This Safety Guide may be applied to nuclear installations in the following ways: (a)To support the development, implementation, assessment and improvement of the management system of those organizations responsible for research, site evaluation, design, construction, commissioning, operation and decommissioning of a nuclear installation; (b)As an aid in the assessment by the regulatory body of the adequacy of the management system of a nuclear installation; (c)To assist an organization in specifying to a supplier, via contractual documentation, any specific element that should be included within the supplier's management system for the supply of products. This Safety Guide follows the structure of the Safety Requirements publication on The Management System for Facilities and Activities, whereby: (a)Section 2 provides recommendations on implementing the management system, including recommendations relating to safety culture, grading and documentation. (b)Section 3 provides recommendations on the responsibilities of senior management for the development and implementation of an effective management system. (c)Section 4 provides recommendations on resource management, including guidance on human resources, infrastructure and the working environment. (d)Section 5 provides recommendations on how the processes of the installation can be specified and developed, including recommendations on some generic processes of the management system. (e)Section 6 provides recommendations on the measurement, assessment and improvement of the management system of a nuclear installation. (f

  20. Exploration and safety evaluations of salt formations and site selection procedures; Erkundung und Sicherheitsbewertung von Salzformationen und Standortauswahlverfahren

    Energy Technology Data Exchange (ETDEWEB)

    Krapf, Eva Barbara

    2016-12-12

    In 2011 the final decision for the withdrawal from the nuclear energy program was decided in the Federal Republic of Germany. The majority of the produced radioactive waste originate in the operation as well as in the decommissioning and dismantling of nuclear facilities. The long-term containment of especially heat-developing and high-level waste in an underground disposal facility is pursued. The Site Selection Act (StandAG), passed in 2013, defined further procedural steps as well as responsibilities and the way of public participation during the site selection. In this context the newly founded Commission Storage of Highly Radioactive Waste was assigned with the task of giving relevant recommendations based on their investigation of specific aspects and fundamental questions. The objective of this procedure is the selection of the site that can provide the best possible safety for humans and the environment during the defined period of one million years. The Commissions' final report was published in July 2016. In this thesis a possible approach for exploring sites in connection with safety investigations is recommended. The site selection procedure described in the StandAG represents the basis for the considerations. Geoscientific exclusion criteria, minimum requirements as well as weighing criteria can be developed regarding the relevant geoscientific and climatic changes during the defined period of one million years. In contrast to the recommendations made by the Commission Storage of Highly Radioactive Waste no previously existing report has been revised and adapted. Rather, all issues relevant for the long-term containment of radioactive waste in a disposal facility had been newly developed. The considerations are related to salt domes as host rock. Furthermore, according to the StandAG preliminary safety investigations are required in every step of the site selection. The recommendations made in this thesis concerning content and feasibility of

  1. 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

  2. Therapeutic equivalence and pharmacokinetics of generic tacrolimus formulation in de novo kidney transplant patients.

    Science.gov (United States)

    Min, Sang-Il; Ha, Jongwon; Kim, Yon Su; Ahn, Sang Hyun; Park, Taejin; Park, Dae Do; Kim, Suh Min; Min, Seung-Kee; Hong, Hyejin; Ahn, Curie; Kim, Sang Joon

    2013-12-01

    There is a growing concern about the therapeutic equivalence of the generic tacrolimus formulation (GEN Tacrolimus) to the reference tacrolimus (REF Tacrolimus) in solid organ transplantation. A prospective, randomized study of 126 de novo renal transplant patients was conducted to compare the efficacy, safety and pharmacokinetic (PK) profiles between GEN tacrolimus (n = 63) and REF tacrolimus (n = 63). The PK of tacrolimus was evaluated on Day 10 and 6 months under steady-state condition. Crossover study was carried out in 66 patients at 6 months. On Day 10, 117 patients completed PK profiles (54 GEN tacrolimus and 63 REF tacrolimus) and GEN tacrolimus showed comparable C(0) (9.8 ± 2.5 versus 9.7 ± 3.0 ng/mL, P = 0.80) but significantly higher dose-normalized C(max) (309.1 ± 191.9 versus 192.5 ± 95.2 ng/mL/mg/kg, P PK profiles evaluated at 9 months showed that generic substitution also resulted in an 'early and high C(max)'. Efficacy and safety data were comparable over the 9-month study period. Therapeutic equivalence and the PK of GEN tacrolimus should be evaluated in patients undergoing de novo renal transplantation.

  3. DOE contractor radiation safety CBT [computer based training] course

    International Nuclear Information System (INIS)

    Gardner, P.R.

    1986-01-01

    Westinghouse Hanford Company developed a generic Radiation Worker safety CBT course for Department of Energy contractors. Task analysis concentrated on actual and potential tasks and included visits to fourteen different contractor sites. Team Design and Prototype verification formed the major portion of the development phase. Lesson entry was accomplished using the WISE author system from WICAT Systems, Inc. The course features graded task simulations for both Pretest and Final; fourteen Topics in five Lessons, each Topic keyed to ''Critical Acts'' and Questions in the Pretest and Final; Automatic, Intensive, and Manual modes of instruction available for each Lesson; Practical Problems and Sample Questions associated with each Topic; and provisions for local configuration in several areas. The course is deliverable on IBM PC compatible equipment. 2 refs

  4. Perencanaan Site Layout Facilities Berdasarkan Traveling Distance Dan Safety Index Pada Proyek Pembangunan Hotel The Alimar Surabaya

    Directory of Open Access Journals (Sweden)

    Angga Sukma Wijaya

    2017-01-01

    Full Text Available Proyek pembangunan hotel The Alimar Surabaya dengan 7 lantai , mempunyai luas tanah sebesar 900 m2 dengan KDB  650 m2 KLB 4550 m2. Permasalahan yang terjadi adalah bangunan tersebut mempunyai lahan yang tidak terlalu luas dan  berhimpitan langsung dengan rumah warga. Ruang gerak yang sempit akan sulit untuk menentukan penempatan site facilities. Dengan perencanaan site layout facilities yang dapat menghemat pemakaian ruang bangun. Semakin besar area yang digunakan dalam penempatan site facilities maka perjalanan antar fasilitas juga semakin banyak memakan waktu. Pembuatan alternatif site layout perlu dilakukan agar memperoleh site facilities yang optimal. Pada penelitian ini dilakukan perencanaan site layout facilities dengan traveling distance dan safety index  atau bisa disebut multi objectives function sebagai acuannya. Perencanaan site layout tersebut pada dasarnya dibagi dua tahap yaitu pada saat pekerjaan sub structure dan pekerjaan upper structure. Dari kedua tahap pekerjaan tersebut dapat menggunakan metode equal maupun unequal site layout. Pada perencanaan fasilitas juga diperhitungkan kebutuhan luas dan fasilitas material pada stock yard. Setelah melakukan iterasi dan membuat skenario-skenario bentuk site layout yang berbeda-beda kemudian terpilih salah satu yang mempunyai nilai multi objectives function paling minimum. Kemudian dengan menggunakan grafik pareto optima maka grafik tersebut mampu menunjukkan titik-titik objectives function yang paling minimum. Hasil yang di dapatkan adalah pada saat pekerjaan Sub Structure, site layout yang paling optimal adalah pada alternatif 665 yang mempunyai travelling distance dan safety index terendah dengan nilai TD sebesar 13246,18 m atau mengalami penurunan sebesar 3,30% dan nilai SI sebesar 1048 atau mengalami penurunan sebesar 5,76% dari kondisi perencanaan awal. Sedangkan Pada saat pekerjaan Upper Structure, site layout yang paling optimal adalah pada alternatif 122 yang mempunyai

  5. US Department of Energy Environment, Safety and Health Progress Assessment of the Nevada Test Site

    Energy Technology Data Exchange (ETDEWEB)

    1992-08-01

    This report documents the result of the US Department of Energy (DOE) Environment, Safety, and Health (ES&H) Progress Assessment of the Nevada Test Site (NTS), Nye County, Nevada. The assessment, which was conducted from July 20 through August 4, 1992, included a selective review of the ES&H management systems and progress of the responsible DOE Headquarters Program Offices; the DOE Nevada Field Office (NV); and the site contractors. The ES&H Progress Assessments are part of the Secretary of Energy`s continuing effort to institutionalize line management accountability and the self-assessment process throughout DOE and its contractor organizations. This report presents a summary of issues and progress in the areas of environment, safety and health, and management.

  6. US Department of Energy Environment, Safety and Health Progress Assessment of the Nevada Test Site

    International Nuclear Information System (INIS)

    1992-08-01

    This report documents the result of the US Department of Energy (DOE) Environment, Safety, and Health (ES ampersand H) Progress Assessment of the Nevada Test Site (NTS), Nye County, Nevada. The assessment, which was conducted from July 20 through August 4, 1992, included a selective review of the ES ampersand H management systems and progress of the responsible DOE Headquarters Program Offices; the DOE Nevada Field Office (NV); and the site contractors. The ES ampersand H Progress Assessments are part of the Secretary of Energy's continuing effort to institutionalize line management accountability and the self-assessment process throughout DOE and its contractor organizations. This report presents a summary of issues and progress in the areas of environment, safety and health, and management

  7. Public safety risk management at socio-economic and / or historic-cultural significant dam sites

    Energy Technology Data Exchange (ETDEWEB)

    Earle, Gordon D.; Ryan, Katherine; Pyykonen, Nicole K.; Pitts, Lucas [Otonabee Region Conservation Authority, Peterborough, (Canada)

    2010-07-01

    The Lang Dam and adjoining gristmill, located near Peterborough are integral parts of the Lang Pioneer Village museum. Activities occurring within close proximity to the dam have led to safety issues. The owner (ORCA) has developed and implemented public safety management plans (PSMPs) for each of its water control structures, including the Lang Dam. ORCA gave special attention to the social, economic, aesthetic, historic and cultural dimensions associated the implementation of public safety management plans. These factors play a significant role in how well public safety measures (PSMs) are received by stakeholder groups and the general public. This paper reported the challenges of developing and implementing a PSMP for the Lang Dam, with the focus on property site-specific PSMS while preserving socio-economic and historic-cultural character and values. It was demonstrated that the dam owners, regulatory authorities, control agencies and preservationists need to come together to develop a holistic public safety management process.

  8. Long-term safety for the final repository for spent nuclear fuel at Forsmark. Main report of the SR-Site project

    Energy Technology Data Exchange (ETDEWEB)

    2011-03-15

    The central conclusion of the safety assessment SR-Site is that a KBS-3 repository that fulfils long-term safety requirements can be built at the Forsmark site. This conclusion is reached because the favourable properties of the Forsmark site ensure the required long-term durability of the barriers of the KBS-3 repository. In particular, the copper canisters with their cast iron inserts have been demonstrated to provide a sufficient resistance to the mechanical and chemical loads to which they may be subjected in the repository environment. The conclusion is underpinned by: - The reliance of the KBS-3 repository on i) a geological environment that exhibits long-term stability with respect to properties of importance for long-term safety, i.e. mechanical stability, low groundwater flow rates at repository depth and the absence of high concentrations of detrimental components in the groundwater, and ii) the choice of naturally occurring materials (copper and bentonite clay) for the engineered barriers that are sufficiently durable in the repository environment to provide the barrier longevity required for safety. - The understanding, through decades of research at SKB and in international collaboration, of the phenomena that affect long-term safety, resulting in a mature knowledge base for the safety assessment. - The understanding of the characteristics of the site through several years of surface-based investigations of the conditions at depth and of scientific interpretation of the data emerging from the investigations, resulting in a mature model of the site, adequate for use in the safety assessment. - The detailed specifications of the engineered parts of the repository and the demonstration of how components fulfilling the specifications are to be produced in a quality assured manner, thereby providing a quality assured initial state for the safety assessment. The detailed analyses demonstrate that canister failures in a one million year perspective are rare

  9. Long-term safety for the final repository for spent nuclear fuel at Forsmark. Main report of the SR-Site project

    International Nuclear Information System (INIS)

    2011-03-01

    The central conclusion of the safety assessment SR-Site is that a KBS-3 repository that fulfils long-term safety requirements can be built at the Forsmark site. This conclusion is reached because the favourable properties of the Forsmark site ensure the required long-term durability of the barriers of the KBS-3 repository. In particular, the copper canisters with their cast iron inserts have been demonstrated to provide a sufficient resistance to the mechanical and chemical loads to which they may be subjected in the repository environment. The conclusion is underpinned by: - The reliance of the KBS-3 repository on i) a geological environment that exhibits long-term stability with respect to properties of importance for long-term safety, i.e. mechanical stability, low groundwater flow rates at repository depth and the absence of high concentrations of detrimental components in the groundwater, and ii) the choice of naturally occurring materials (copper and bentonite clay) for the engineered barriers that are sufficiently durable in the repository environment to provide the barrier longevity required for safety. - The understanding, through decades of research at SKB and in international collaboration, of the phenomena that affect long-term safety, resulting in a mature knowledge base for the safety assessment. - The understanding of the characteristics of the site through several years of surface-based investigations of the conditions at depth and of scientific interpretation of the data emerging from the investigations, resulting in a mature model of the site, adequate for use in the safety assessment. - The detailed specifications of the engineered parts of the repository and the demonstration of how components fulfilling the specifications are to be produced in a quality assured manner, thereby providing a quality assured initial state for the safety assessment. The detailed analyses demonstrate that canister failures in a one million year perspective are rare

  10. Evaluation of geological documents available for provisional safety analyses of potential sites for nuclear waste repositories - Are additional geological investigations needed?

    International Nuclear Information System (INIS)

    2010-10-01

    The procedure for selecting repository sites for all categories of radioactive waste in Switzerland is defined in the conceptual part of the Sectoral Plan for Deep Geological Repositories, which foresees a selection of sites in three stages. In Stage I, Nagra proposed geological siting regions based on criteria relating to safety and engineering feasibility. The Swiss Government (the Federal Council) is expected to decide on the siting proposals in 2011. The objective of Stage 2 is to prepare proposals for the location of the surface facilities within the planning perimeters defined by the Federal Council in its decision on Stage 1 and to identify potential sites. Nagra also has to carry out a provisional safety analysis for each site and a safety-based comparison of the sites. Based on this, and taking into account the results of the socio-economic-ecological impact studies, Nagra then has to propose at least two sites for each repository type to be carried through to Stage 3. The proposed sites will then be investigated in more detail in Stage 3 to ensure that the selection of the sites for the General Licence Applications is well founded. In order to realise the objectives of the upcoming Stage 2, the state of knowledge of the geological conditions at the sites has to be sufficient to perform the provisional safety analyses. Therefore, in preparation for Stage 2, the conceptual part of the Sectoral Plan requires Nagra to clarify the need for additional investigations aimed at providing input for the provisional safety analyses. The purpose of the present report is to document Nagra's technical-scientific assessment of this need. The focus is on evaluating the geological information based on processes and parameters that are relevant for safety and engineering feasibility. In evaluating the state of knowledge the key question is whether additional information could lead to a different decision regarding the selection of the sites to be carried through to Stage 3

  11. Management of construction safety at KKNPP site

    International Nuclear Information System (INIS)

    Khare, P.K.

    2016-01-01

    Construction is considered as one of the most hazardous activities owing to the number of accidents and injuries. At KKNPP, management of industrial safety has been envisaged since the preliminary stage of construction planning, including design aspects. The governing principles of safety management are evolved from the Factories Act, 1948, the Atomic Energy(Factories) Rules, 1996, AERB safety guidelines on Control of works (2011) and Corporate HSE policy of NPCIL (2014). Numerous risk assessment and hazard control measures are adopted consistently to ensure a safe work environment during the construction, which includes Job Hazard Analysis, work permit through Computerized Maintenance Management System, safety procedures, exclusive safety training facility for the contractor's workmen, safety motivational measures, safety surveillance and reporting through Safety Related Deficiencies Management System. Assessment of efficacy of safety management system is continuously done through safety audits and observations are being circulated and discussed in committee meetings. Fire safety is also being taken care of since inception of project work. Well-equipped fire station with trained fire fighters was made available since the beginning as per AERB safety standard on fire protection system for Nuclear facilities. Fire prevention measures specific to the work are implemented during all activities. (author)

  12. Rethinking generic skills

    Directory of Open Access Journals (Sweden)

    Roy Canning

    2013-10-01

    Full Text Available The paper provides a critical analysis of the notion of generic or transversal skillscontained with European Union policy discourses. The author presents a conceptualframework that challenges the idea that generic skills are universal, transferable andautonomous. An alternative analysis is put forward that argues the case forcontextualising skills and knowledge within particular understandings and cultures thatare more collective than individualistic in nature. The arguments are framed withinwider cross-disciplinary debates in linguistics, geosemiotics and social-cultural theoryand build upon an earlier paper exploring core skills in the UK (Canning, 2007.

  13. Health and Safety Plan for Operations Performed for the Environmental Restoration Program: Task, Characterization of Potential Waste Sources at Auxiliary Reactor Area-1 Operable Unit 5--07 site ARA-02

    International Nuclear Information System (INIS)

    Pickett, S.L.; Morton, S.L.

    1992-06-01

    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 ERP. 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

  14. Health and Safety Plan for Operations Performed for the Environmental Restoration Program: Task, Characterization of Potential Waste Sources at Auxiliary Reactor Area-1 Operable Unit 5--07 site ARA-02

    Energy Technology Data Exchange (ETDEWEB)

    Pickett, S.L.; Morton, S.L.

    1992-06-01

    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 ERP. 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.

  15. Health and Safety Plan for Operations Performed for the Environmental Restoration Program: Task, Characterization of Potential Waste Sources at Auxiliary Reactor Area-1 Operable Unit 5--07 site ARA-02

    Energy Technology Data Exchange (ETDEWEB)

    Pickett, S.L.; Morton, S.L.

    1992-06-01

    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 ERP. 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.

  16. Equivalent linear and nonlinear site response analysis for design and risk assessment of safety-related nuclear structures

    International Nuclear Information System (INIS)

    Bolisetti, Chandrakanth; Whittaker, Andrew S.; Mason, H. Benjamin; Almufti, Ibrahim; Willford, Michael

    2014-01-01

    Highlights: • Performed equivalent linear and nonlinear site response analyses using industry-standard numerical programs. • Considered a wide range of sites and input ground motions. • Noted the practical issues encountered while using these programs. • Examined differences between the responses calculated from different programs. • Results of biaxial and uniaxial analyses are compared. - Abstract: Site response analysis is a precursor to soil-structure interaction analysis, which is an essential component in the seismic analysis of safety-related nuclear structures. Output from site response analysis provides input to soil-structure interaction analysis. Current practice in calculating site response for safety-related nuclear applications mainly involves the equivalent linear method in the frequency-domain. Nonlinear time-domain methods are used by some for the assessment of buildings, bridges and petrochemical facilities. Several commercial programs have been developed for site response analysis but none of them have been formally validated for large strains and high frequencies, which are crucial for the performance assessment of safety-related nuclear structures. This study sheds light on the applicability of some industry-standard equivalent linear (SHAKE) and nonlinear (DEEPSOIL and LS-DYNA) programs across a broad range of frequencies, earthquake shaking intensities, and sites ranging from stiff sand to hard rock, all with a focus on application to safety-related nuclear structures. Results show that the equivalent linear method is unable to reproduce the high frequency acceleration response, resulting in almost constant spectral accelerations in the short period range. Analysis using LS-DYNA occasionally results in some unrealistic high frequency acceleration ‘noise’, which can be removed by smoothing the piece-wise linear backbone curve. Analysis using DEEPSOIL results in abrupt variations in the peak strains of consecutive soil layers

  17. Analysis of generic exemption levels for radioactive material

    International Nuclear Information System (INIS)

    Bossio, Maria C.; Muniz, Carolina C.

    2007-01-01

    In essence, exemption may be considered a generic authorization granted by the regulatory body, which, once issued, releases the practice or source from the requirements that would otherwise apply, in particular, the requirements relating to notification and authorization. The exemption figures included in the Basic Safety Standards BSS 115 were derived from the scenarios postulated in the document 'Radiation Protection 65' of the Commission of the European Communities considering quantitative exemption criteria. After presenting the basic exemption criteria for limited quantities of radioactive materials this paper describes and analyses the exposure scenarios utilized, namely: 1- Normal use (workplace) scenario; 2- Accidental ( workplace) scenario; 3- Disposal (public) scenario. Each one has different exposure pathways, summing up a total of 24, covering external exposure, ingestion and inhalation. These scenarios were used to calculate both, exempted activity concentrations (Bq/g) and total activity (Bq), though in the first case exemption applies to limited masses of low concentration activity materials. For each radionuclide, the generic exemption 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 (Bq) or activity concentration (Bq/g). The individual dose per unit (Bq or Bq/g, as applicable) was calculated by a formula that was adjusted, for each scenario and pathway, through different parameters, such as exposure time, dosimetric factors and geometric factors. In general, the critical pathways for α emitters were inhalation of dust and aerosols in workplace for activity concentration scenario and inhalation of dust and volatiles from an accidental fire in the workplace for total activity scenario. For β emitters the critical pathways were ingestion of an object from a landfill site by a member of the public for activity concentration

  18. Quality of generic medicines in South Africa

    DEFF Research Database (Denmark)

    Patel, Aarti; Gauld, Robin; Norris, Pauline

    2012-01-01

    Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines ...

  19. Nuclear power plants. Electrical equipment of the safety system. Qualification

    International Nuclear Information System (INIS)

    2001-01-01

    This International Standard applies to electrical parts of safety systems employed at nuclear power plants, including components and equipment of any interface whose failure could affect unfavourably properties of the safety system. The standard also applies to non-electrical safety-related interfaces. Furthermore, the standard describes the generic process of qualification certification procedures and methods of qualification testing and related documentation. (P.A.)

  20. Generic environmental impact statement for license renewal of nuclear plants. Final report

    International Nuclear Information System (INIS)

    1996-05-01

    This GEIS examines the possible environmental impacts that could occur as a result of renewing the licenses of individual nuclear power plants under 10 CFR 54. To the extent possible, it establishes the bounds and significance of these potential impacts. The analysis encompasses all operating light-water reactors. For each type of environmental impact, the GEIS attempts to establish generic findings covering as many plants as possible. While plant and site-specific information is used in developing the generic findings, the NRC does not intend for the GEIS to be a compilation of individual plant environmental impacts statements. This document has three principal objectives: (1) to provide an understanding of the types and severity of environmental impacts that may occur as a result of license renewal, (2) to identify and assess those impacts that are expected to be generic to license renewal, and (3) to support rulemaking (10 CFR 51) to define the number and scope of issues that need to be addressed by the applicants in plant-by-plant license renewal proceedings

  1. Generic medicines: solutions for a sustainable drug market?

    Science.gov (United States)

    Dylst, Pieter; Vulto, Arnold; Godman, Brian; Simoens, Steven

    2013-10-01

    Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.

  2. Site specific information in site selection

    International Nuclear Information System (INIS)

    Aeikaes, T.; Hautojaervi, A.

    1998-01-01

    The programme for the siting of a deep repository for final disposal of spent nuclear fuel was started already in 1983 and is carried out today by Posiva Oy which continues the work started by Teollisuuden Voima Oy. The programme aims at site selection by the end of the year 2000. The programme has progressed in successive interim stages with defined goals. After an early phase for site identification, five sites were selected in 1987 for preliminary site characterisation. Three of these were selected and judged to be best suited for the more detailed characterisation in 1992. An additional new site was included into the programme based on a separate feasibility study in the beginning of 1997. Since the year 1983 several safety assessments together with technical plans of the facility have been completed. When approaching the site selection the needs for more detailed consideration of the site specific properties in the safety assessment have been increased. The Finnish regulator STUK has published a proposal for general safety requirements for the final disposal of spent nuclear fuel in Finland. This set of requirements has been projected to be used in conjunction of the decision making by the end 2000. Based on the site evaluation all sites can provide a stable environment and there is evidence that the requirements for the longevity of the canister can be fulfilled at each site. In this manner the four candidate sites do not differ too much from each other. The main difference between the sites is in the salinity of the deep groundwater. The significance of differences in the salinity for the long-term safety cannot be defined yet. The differences may contribute to the discussion of the longevity of the bentonite buffer and also to the modelling of the groundwater flow and transport. The use of the geosphere as a transport barrier is basically culminated on the questions about sparse but fast flow routes and 'how bad channeling can be'. To answer these questions

  3. Electronuclear reactors - EDF - Orientations of generic studies to be performed for the safety re-examination of 1300 MWe reactors associated to their third decennial inspection

    International Nuclear Information System (INIS)

    2011-01-01

    This report expresses the ASN's opinion on the framework and objectives of the EDF program concerning the generic studies of the safety re-examination of the 1300 MWe reactors associated with their third decennial inspection. This comprises lessons from the Fukushima accident, the improvement of the 'internal explosion' referential by using a probabilistic study, the application of the seismic margin assessment approach as soon as possible, checking the absence of any 'cliff effect' for cooling functions, a deepened re-examination of hurricane frequencies in France. Other request by the ASN concern the verification of the pertinence of release authorizations, taking the TSN law into account, taking the AP1300 project into account, the expansion of the complementary domain, the project of reactor lifetime extension. Some technical requests are discussed in appendix

  4. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2006-01-01

    The last decade has seen a number of approaches to generic programming: PolyP, Functorial ML, `Scrap Your Boilerplate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some suggest

  5. Generic Hurricane Extreme Seas State

    DEFF Research Database (Denmark)

    Wehmeyer, Christof; Skourup, Jesper; Frigaard, Peter

    2012-01-01

    Extreme sea states, which the IEC 61400-3 (2008) standard requires for the ultimate limit state (ULS) analysis of offshore wind turbines are derived to establish the design basis for the conceptual layout of deep water floating offshore wind turbine foundations in hurricane affected areas....... Especially in the initial phase of floating foundation concept development, site specific metocean data are usually not available. As the areas of interest are furthermore not covered by any design standard, in terms of design sea states, generic and in engineering terms applicable environmental background...... data is required for a type specific conceptual design. ULS conditions for different return periods are developed, which can subsequently be applied in siteindependent analysis and conceptual design. Recordings provided by National Oceanic and Atmospheric Administration (NOAA), of hurricanes along...

  6. Generic Switching and Non-Persistence among Medicine Users

    DEFF Research Database (Denmark)

    Østergaard Rathe, Jette; Andersen, Morten; Jarbøl, Dorte Ejg

    2015-01-01

    BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. It is strictly regulated with respect to its bioequivalence, and all products must have undergone appropriate studies. Although generic substitution is widely...... implemented, it still remains to be answered how generic switch influences persistence to long-term treatment, and if it is modified by patients' concerns about medicine and views on generic medicine. This study focuses on users of antidepressants and antiepileptics, and their experience of generic switching....... METHODS: The study was an observational cohort study. By use of a prescription database, we identified patients who had redeemed prescriptions on generically substitutable drugs, and a questionnaire was mailed to them. We analyzed predictors of discontinuation in relation to generic switch and patients...

  7. Article choice in plural generics

    NARCIS (Netherlands)

    Farkas, D.F.; Swart, Henriëtte de

    2007-01-01

    We discuss two groups of languages where article use contrasts in generic plural sentences but is otherwise essentially similar. The languages in the first group (English and Dutch) use bare plurals in the expression of kind reference (‘Dinosaurs are extinct’) and in generic

  8. Remedial actions of nuclear safety shot sites: Double Tracks and Clean Slates

    International Nuclear Information System (INIS)

    Sanchez, M.; Shotton, M.; Lyons, C.

    1998-03-01

    Remedial actions of plutonium (Pu)-contaminated soils are in the preliminary stages of development at the Nevada Test Site (NTS). Interim clean-up actions were completed at the Double Tracks and Clean Slate 1 safety shot sites in 1996 and 1997, respectively. Soil at both sites, with a total transuranic activity greater than 20 picoCuries per gram (pCi/g), was excavated and shipped to the NTS for disposal. Characterization and assessment efforts were initiated at the Double Tracks site in 1995, and the clean-up of this site as an interim action was completed in 1996. Clean-up of this site consisted of taking site-specific data and applying rationale for dose and risk calculations in selecting parameter values for the interim corrective action level. The remediation process included excavating and stockpiling the contaminated soil and loading the soil into supersacks with approximately 1,513 cubic meters (53,500 cubic feet) being shipped to the NTS for disposal. In 1997, remediation began on the Clean Slate 1 site on which characterization had already been completed using a very similar approach; however, the site incorporated lessons learned, cost efficiencies, and significant improvements to the process. This paper focuses on those factors and the progress that has been made in cleaning up the sites. The application of a technically reasonable remediation method, as well as the cost factors that supported transport and disposal of the low-level waste in bulk are discussed

  9. German data for risk based fire safety assessment

    International Nuclear Information System (INIS)

    Roewekamp, M.; Berg, H.P.

    1998-01-01

    Different types of data are necessary to perform risk based fire safety assessments and, in particular, to quantify the fire event tree considering the plant specific conditions. Data on fire barriers, fire detection and extinguishing, including also data on secondary effects of a fire, have to be used for quantifying the potential hazard and damage states. The existing German database on fires in nuclear power plants (NPPs) is very small. Therefore, in general generic data, mainly from US databases, are used for risk based safety assessments. Due to several differences in the plant design and conditions generic data can only be used as conservative assumptions. World-wide existing generic data on personnel failures in case of fire fighting have only to be adapted to the plant specific conditions inside the NPP to be investigated. In contrary, unavailabilities of fire barrier elements may differ strongly depending on different standards, testing requirements, etc. In addition, the operational behaviour of active fire protection equipment may vary depending on type and manufacturer. The necessity for more detailed and for additional plant specific data was the main reason for generating updated German data on the operational behaviour of active fire protection equipment/features in NPPs to support risk based fire safety analyses being recommended to be carried out as an additional tool to deterministic fire hazard analyses in the frame of safety reviews. The results of these investigations revealed a broader and more realistic database for technical reliability of active fire protection means, but improvements as well as collection of further data are still necessary. (author)

  10. Categorization of safety related motor operated valve safety significance for Ulchin Unit 3

    International Nuclear Information System (INIS)

    Kang, D. I.; Kim, K. Y.

    2002-03-01

    We performed a categorization of safety related Motor Operated Valve (MOV) safety significance for Ulchin Unit 3. The safety evaluation of MOV of domestic nuclear power plants affects the generic data used for the quantification of MOV common cause failure ( CCF) events in Ulchin Units 3 PSA. Therefore, in this study, we re-estimated the MGL(Multiple Greek Letter) parameter used for the evaluation of MOV CCF probabilities in Ulchin Units 3 Probabilistic Safety Assessment (PSA) and performed a classification of the MOV safety significance. The re-estimation results of the MGL parameter show that its value is decreased by 30% compared with the current value in Ulchin Unit 3 PSA. The categorization results of MOV safety significance using the changed value of MGL parameter shows that the number of HSSCs(High Safety Significant Components) is decreased by 54.5% compared with those using the current value of it in Ulchin Units 3 PSA

  11. 40 CFR 721.9973 - Zirconium dichlorides (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Zirconium dichlorides (generic). 721... Substances § 721.9973 Zirconium dichlorides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as zirconium dichlorides (PMNs P...

  12. Comparing approaches to generic programming in Haskell

    NARCIS (Netherlands)

    Hinze, R.; Jeuring, J.T.; Löh, A.

    2006-01-01

    The last decade has seen a number of approaches to data- type-generic programming: PolyP, Functorial ML, `Scrap Your Boiler- plate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some

  13. Identification of competencies for Malaysian occupational safety and health professionals.

    Science.gov (United States)

    Daud, Rabaayah; Ismail, Maimunah; Omar, Zoharah

    2010-01-01

    Competencies of occupational safety and health (OSH) professionals have become a concern due to the significance of safety management in the field of safety engineering. The purpose of this article is to identify competencies needed by OSH professionals. These competencies are required by professionals in administrating and enforcing legislations related to OSH in Malaysia. This study used Delphi technique in three rounds of data collection. The benefits of this research approach are the use of experts in gaining opinions without time and geographical restraints. The results show 25 generic competencies with combinations of cognitive, interpersonal and intrapersonal competencies and 33 functional or specific competencies including knowledge and skills needed by OSH professionals. Both generic and functional competencies are also divided into threshold and differentiating competencies that would be used to differentiate average and excellent performance of OSH professionals.

  14. New safety standards of nuclear power station with no requirements of site evaluation. No public dose limit published with possible inappropriateness of reactor site

    International Nuclear Information System (INIS)

    Takitani, Koichi

    2013-01-01

    Nuclear Regulation Authority was preparing new safety standards in order to aim at starting safety reviews of existing nuclear power station in July 2013. This article commented on issues of major accident, which was defined as severely damaged core event. Accumulated dose at the site boundary of the Fukushima Daiichi Nuclear Power Station totaled to about 234 mSv on March just after the accident with rare gas of 500 PBq, iodine 131 of 500 PBq, cesium 134 of 10 PBq and cesium 137 of 10 PBq released to the atmosphere, which was beyond 100 mSv. As measures for preventing containment vessel failure after core severely damaged, filtered venting system was required to be installed for low radiological risk to the public. However filter was not effective to rare gas. Accumulated doses at the site boundary of several nuclear power stations after filtered venting with 100% release of rare gas could be estimated to be 2-37 Sv mostly depending on the site condition, which might be surely greater than 100 mSv. Omitting site evaluation for major accident, which was beyond design basis accident, was great concern. (T. Tanaka)

  15. 40 CFR 721.9959 - Polyurethane polymer (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Polyurethane polymer (generic). 721... Substances § 721.9959 Polyurethane polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a polyurethane polymer (PMN P-01...

  16. Proceedings Workshop on Generic Programming (WGP2000)

    NARCIS (Netherlands)

    Jeuring, J.T.

    2000-01-01

    This report contains the papers selected for presentation at the 2nd Workshop on Generic Programming (WGP2000), which was held on July 6, 2000 in Ponte de Lima, Portugal. Generic programming is about making programs more adaptable by making them more general. Generic programs often embody

  17. Skin rash during treatment with generic itraconazole.

    Science.gov (United States)

    De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

    2014-04-01

    Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.

  18. Model summary report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    Vahlund, Fredrik; Zetterstroem Evins, Lena; Lindgren, Maria

    2010-12-01

    This document is the model summary report for the safety assessment SR-Site. In the report, the quality assurance (QA) measures conducted for assessment codes are presented together with the chosen QA methodology. In the safety assessment project SR-Site, a large number of numerical models are used to analyse the system and to show compliance. In order to better understand how the different models interact and how information are transferred between the different models Assessment Model Flowcharts, AMFs, are used. From these, different modelling tasks can be identify and the computer codes used. As a large number of computer codes are used in the assessment the complexity of these differs to a large extent, some of the codes are commercial while others are developed especially for the assessment at hand. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined for all codes: - It must be demonstrated that the code is suitable for its purpose. - It must be demonstrated that the code has been properly used. - It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. - It must be described how data are transferred between the different computational tasks. Although the requirements are identical for all codes in the assessment, the measures used to show that the requirements are fulfilled will be different for different types of codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented together with a discussion on how the requirements are met

  19. Model summary report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    Vahlund, Fredrik; Zetterstroem Evins, Lena (Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden)); Lindgren, Maria (Kemakta Konsult AB, Stockholm (Sweden))

    2010-12-15

    This document is the model summary report for the safety assessment SR-Site. In the report, the quality assurance (QA) measures conducted for assessment codes are presented together with the chosen QA methodology. In the safety assessment project SR-Site, a large number of numerical models are used to analyse the system and to show compliance. In order to better understand how the different models interact and how information are transferred between the different models Assessment Model Flowcharts, AMFs, are used. From these, different modelling tasks can be identify and the computer codes used. As a large number of computer codes are used in the assessment the complexity of these differs to a large extent, some of the codes are commercial while others are developed especially for the assessment at hand. QA requirements must on the one hand take this diversity into account and on the other hand be well defined. In the methodology section of the report the following requirements are defined for all codes: - It must be demonstrated that the code is suitable for its purpose. - It must be demonstrated that the code has been properly used. - It must be demonstrated that the code development process has followed appropriate procedures and that the code produces accurate results. - It must be described how data are transferred between the different computational tasks. Although the requirements are identical for all codes in the assessment, the measures used to show that the requirements are fulfilled will be different for different types of codes (for instance due to the fact that for some software the source-code is not available for review). Subsequent to the methodology section, each assessment code is presented together with a discussion on how the requirements are met

  20. Is bioavailability altered in generic versus brand anticonvulsants?

    Science.gov (United States)

    Jankovic, Slobodan M; Ignjatovic Ristic, Dragana

    2015-03-01

    Therapeutic window of anticonvulsants is not a wide one, with phenytoin being one extreme, which can be classified as a narrow therapeutic index drug, since its ratio between the least toxic and the least effective concentration is less than twofold. In order to obtain marketing authorization, a generic anticonvulsant should demonstrate relative bioequivalence with its brand-name counterpart. However, although bioequivalent, generic anticonvulsants still do not have the same bioavailability as brand-name drugs, which may lead to larger fluctuations of steady-state plasma concentrations, and sometimes to loss of seizure control if a patient is switched from brand-name to generic or from generic to generic anticonvulsant. Generic anticonvulsants are effective, safe and affordable drugs for treatment of epilepsy, and patients could be successfully treated with them from the very beginning. It is switching from brand-name to generic anticonvulsant or from one generic anticonvulsant to another that should be avoided in clinical practice, since subtle differences in bioavailability may disturb optimal degree of seizure control to which the patient was previously successfully titrated.

  1. 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

  2. Site specific health and safety plan for drilling in support of in situ redox manipulation

    International Nuclear Information System (INIS)

    Tuttle, B.G.

    1997-02-01

    This document contains the Site Specific Health and Safety Plan for Drilling in support of the In Situ REDOX Manipulation in the 100-HR-3 Operable Unit. Approximately eight wells will be drilled in the 100-D/DR Area using rotary, sonic, or cable tool drilling methods. Split-spoon sampling will be done in conjunction with the drilling. The drilling may be spread out over several months. Included in this document are checklists for health and safety procedures

  3. A multicenter experience with generic tacrolimus conversion.

    Science.gov (United States)

    McDevitt-Potter, Lisa M; Sadaka, Basma; Tichy, Eric M; Rogers, Christin C; Gabardi, Steven

    2011-09-27

    The first generic tacrolimus product gained Food and Drug Administration approval in August 2009. This prospective, observational trial sought to determine the need for dose titrations and measure drug cost savings on conversion to generic tacrolimus. Transplant recipients on stable tacrolimus doses were converted from brand to generic tacrolimus on a mg:mg basis. Data were collected at the time of generic conversion (study arm) and at a time point exactly 6 months before conversion (control arm) for all subjects. Seventy conversions from four centers are reported. Subjects were a mean of 70 months after kidney (n=37), liver (n=28), or multiorgan (n=5) transplant. In the study arm, mean tacrolimus doses were 4.4 and 4.5 mg/d and mean tacrolimus trough concentrations were 5.8 and 5.9 ng/mL before and after conversion, respectively. In the control arm, mean tacrolimus doses were 4.6 and 4.6 mg/d and mean tacrolimus trough concentrations were 6.1 and 5.9 ng/mL before and after the control time point, respectively. Dose titrations occurred in five patients (7%) in the control arm and 15 patients (21%) in the study arm (P=0.028). Mean monthly drug costs were $645 for brand, $593 for generic, and $595 for generic after dose titrations. Mean monthly patient copays were $38 for brand and $15 for generic. These cumulative data show that dose requirements and trough levels are similar between brand and generic tacrolimus and that generic substitution allows for savings. However, postconversion monitoring is prudent as patients may require dose titration.

  4. Brand loyalty, patients and limited generic medicines uptake.

    Science.gov (United States)

    Costa-Font, Joan; Rudisill, Caroline; Tan, Stefanie

    2014-06-01

    The sluggish development of European generic drug markets depends heavily on demand side factors, and more specifically, patients' and doctors' loyalty to branded products. Loyalty to originator drugs, to the point where originator prices rise upon generic entry has been described as the 'generics paradox'. Originator loyalty can emerge for a plethora of reasons; including costs, perceptions about quality and physician advice. We know very little about the behavioural underpinnings of brand loyalty from the consumer or patient standpoint. This paper attempts to test the extent to which patients are brand loyal by drawing upon Spain's 2002 Health Barometer survey as it includes questions about consumer acceptance of generics in a country with exceptionally low generic uptake and substitution at the time of the study. Our findings suggest that at least 13% of the population would not accept generics as substitutes to the originator. These results confirm evidence of brand loyalty for a minority. Alongside high levels of awareness of generics, we find that low cost-sharing levels explain consumer brand loyalty but their impact on acceptance of generic substitution is very small. Higher cost-sharing and exempting fewer patients from cost-sharing have the potential to encourage generic acceptance. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. 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

  6. Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

    Directory of Open Access Journals (Sweden)

    Michael A. Partridge

    2016-01-01

    Full Text Available Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and nonneutralizing anti-drug antibodies, especially in clinical phases of drug development. Different assay methodologies have been used to detect all anti-drug antibodies, including ELISA, radioimmunoassay, surface plasmon resonance, and electrochemiluminescence-based technologies. The most commonly used method is a bridging assay, performed in an ELISA or on the Meso Scale Discovery platform. In this report, we aim to review the emerging new assay technologies that can complement or address challenges associated with the bridging assay format in screening and confirmation of ADAs. We also summarize generic anti-drug antibody assays that do not require drug-specific reagents for nonclinical studies. These generic assays significantly reduce assay development efforts and, therefore, shorten the assay readiness timeline.

  7. Influencers of generic drug utilization: A systematic review.

    Science.gov (United States)

    Howard, Jennifer N; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Qian, Jingjing; Hansen, Richard

    2017-08-04

    With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions. Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies. Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors. Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Information report on nuclear safety and radiation protection of the Romans site - Issue 2014

    International Nuclear Information System (INIS)

    2015-06-01

    In compliance with the French Code of the Environment, this annual document describes the arrangements regarding nuclear safety and radiation protection, reports incidents and accidents of nuclear safety and radiation protection which must be declared according to this Code and which occurred within the installation, as well as the actions undertaken to limit their development and the consequences for people health for the environment, describes the nature and results of measurements of radioactive and not radioactive releases by the installation in the environment, describes the nature and quantities of radioactive wastes which are warehoused on the installation site as well as measures to limit their volume and their impact on health and on the environment, notably in soils and waters. After a presentation of the AREVA plant located in Romans-sur-Isere which comprises two basic nuclear installations (INB) and where fuel assemblies are manufactured, the different parts of this report address the measures regarding nuclear safety and radiation protection, nuclear events according to the INES scale, the management of releases by the different installations of this site and the control of the environment, the management of radioactive wastes, and the actions undertaken regarding information and transparency. Recommendations of the CHSCT are also reported

  9. Information report on nuclear safety and radiation protection of the Romans site - Issue 2012

    International Nuclear Information System (INIS)

    2013-06-01

    In compliance with the French Code of the Environment, this annual document describes the arrangements regarding nuclear safety and radiation protection, reports incidents and accidents of nuclear safety and radiation protection which must be declared according to this Code and which occurred within the installation, as well as the actions undertaken to limit their development and the consequences for people health for the environment, describes the nature and results of measurements of radioactive and not radioactive releases by the installation in the environment, describes the nature and quantities of radioactive wastes which are warehoused on the installation site as well as measures to limit their volume and their impact on health and on the environment, notably in soils and waters. After a presentation of the AREVA plant located in Romans-sur-Isere which comprises two basic nuclear installations (INB) and where fuel assemblies are manufactured, the different parts of this report address the measures regarding nuclear safety and radiation protection, nuclear events according to the INES scale, the management of releases by the different installations of this site and the control of the environment, the management of radioactive wastes, and the actions undertaken regarding information and transparency. Recommendations of the CHSCT are also reported

  10. Information report on nuclear safety and radiation protection of the Romans site - Issue 2013

    International Nuclear Information System (INIS)

    2014-06-01

    In compliance with the French Code of the Environment, this annual document describes the arrangements regarding nuclear safety and radiation protection, reports incidents and accidents of nuclear safety and radiation protection which must be declared according to this Code and which occurred within the installation, as well as the actions undertaken to limit their development and the consequences for people health for the environment, describes the nature and results of measurements of radioactive and not radioactive releases by the installation in the environment, describes the nature and quantities of radioactive wastes which are warehoused on the installation site as well as measures to limit their volume and their impact on health and on the environment, notably in soils and waters. After a presentation of the AREVA plant located in Romans-sur-Isere which comprises two basic nuclear installations (INB) and where fuel assemblies are manufactured, the different parts of this report address the measures regarding nuclear safety and radiation protection, nuclear events according to the INES scale, the management of releases by the different installations of this site and the control of the environment, the management of radioactive wastes, and the actions undertaken regarding information and transparency. Recommendations of the CHSCT are also reported

  11. Generic domain models in software engineering

    Science.gov (United States)

    Maiden, Neil

    1992-01-01

    This paper outlines three research directions related to domain-specific software development: (1) reuse of generic models for domain-specific software development; (2) empirical evidence to determine these generic models, namely elicitation of mental knowledge schema possessed by expert software developers; and (3) exploitation of generic domain models to assist modelling of specific applications. It focuses on knowledge acquisition for domain-specific software development, with emphasis on tool support for the most important phases of software development.

  12. TRANSIT: model for providing generic transportation input for preliminary siting analysis

    International Nuclear Information System (INIS)

    McNair, G.W.; Cashwell, J.W.

    1985-02-01

    To assist the US Department of Energy's efforts in potential facility site screening in the nuclear waste management program, a computerized model, TRANSIT, is being developed. Utilizing existing data on the location and inventory characteristics of spent nuclear fuel at reactor sites, TRANSIT derives isopleths of transportation mileage, costs, risks and fleet requirements for shipments to storage sites and/or repository sites. This technique provides a graphic, first-order method for use by the Department in future site screening efforts. 2 refs

  13. Seismic sensitivity study of a generic CANDU nuclear power plant: Soil-structure interaction

    International Nuclear Information System (INIS)

    Lee, L.S.S.; Duff, C.G.

    1983-01-01

    The seismic sensitivity and capability study for a generic CANDU Plant is part of an overall development program of design standardization. The purpose of this paper is to investigate the sensitivities of structural responses and floor response spectra (FRS) to variations of structural and soil parameters. In the seismic design standardization, a wide range of soil conditions is considered and the envelopes of the resulting site spectra (soil-structure interaction effect) are then used for the design of the generic plant. The nuclear island structures considered herein have different relative stiffness and one of them has two layout/structure schemes: one is relatively flexible and the other is moderately stiff. In the preliminary phase of the seismic sensitivity study presented hereby, the soil-structure interaction seismic analysis is based on the half-space modelling (soil-spring lumped-mass) method and the response spectrum method for the seismic responses. Distinct patterns and sensitivity of the site spectrum analysis for structure schemes of different relative stiffness and for different structural elevations are observed and discussed. (orig.)

  14. 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.

  15. 76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

    Science.gov (United States)

    2011-09-01

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic... functions. SSCs in operating nuclear power plants are designed either in accordance with, or have been... nuclear reactors. The background information relevant to this GL includes the individual plant...

  16. Practicing the Generic (City)

    DEFF Research Database (Denmark)

    Hansen, Lone Koefoed

    2010-01-01

    Flanagan proposes that most locative media artworks neglect the particularities of spaces, their historical and political layers. Koolhaas, on the other hand, states that all urban areas are alike, that we are facing a global Generic City. The paper analyses digital media artist Esther Polak......’s NomadicMILK project in light of the generic and particular properties of space as laid out by Flanagan and Koolhaas in order to discuss the possible reconfiguring practices of locative media....

  17. 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

  18. A refined safety analysis approach for closure of the Hanford Site flammable gas unreviewed safety question

    International Nuclear Information System (INIS)

    Bratzel, D.R.

    1997-01-01

    Following a 1990 investigation into flammable gas generation, retention, and release mechanisms within the Hanford Site high-level waste tanks, personnel concluded that the existing Authorization Basis documentation did not adequately evaluate flammable gas hazards. This declaration was based primarily on the fact that personnel did not adequately consider hydrogen and nitrous oxide evolution within the material in certain waste tanks and subsequent hypothetical ignition in the development of safety documentation for the waste tanks. The US Department of Energy-Headquarters subsequently declared an Unreviewed Safety Question (USQ). Although work scope has been focused on closure of the USQ since 1990, the DOE has yet to close the USQ because of considerable uncertainty regarding essential technical parameters and associated risk. The DOE recently approved a Basis for Interim Operation to revise the Authorization Basis for managing the tank farms, however, the USQ remains open. The two fundamental requirements for closure of the flammable gas USQ are as follows: development of a defensible technical basis for existing controls; development of a process to assess the adequacy of controls as the waste tank mission progresses

  19. Savannah River Site management response plan for chemical safety vulnerability field assessment. Revision 1

    International Nuclear Information System (INIS)

    Kahal, E.J.; Murphy, S.L.; Salaymeh, S.R.

    1994-09-01

    As part of the U.S. Department of Energy's (DOE) initiative to identify potential chemical safety vulnerabilities in the DOE complex, the Chemical Safety Vulnerability Core Working Group issued a field verification assessment report. While the report concluded that Savannah River Site (SRS) is moving in a positive direction, the report also identified five chemical safety vulnerabilities with broad programmatic impact that are not easily nor quickly remedied. The May 1994 SRS Management Response Plan addressed the five SRS vulnerabilities identified in the field assessment report. The SRS response plan listed observations supporting the vulnerabilities and any actions taken or planned toward resolution. Many of the observations were resolved by simple explanations, such as the existence of implementation plans for Safety Analysis Report updates. Recognizing that correcting individual observations does not suffice in remedying the vulnerabilities, a task team was assembled to address the broader programmatic issues and to recommend corrective actions

  20. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

    Science.gov (United States)

    Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

    2018-01-01

    Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine

  1. Nuclear safety culture evaluation model based on SSE-CMM

    International Nuclear Information System (INIS)

    Yang Xiaohua; Liu Zhenghai; Liu Zhiming; Wan Yaping; Peng Guojian

    2012-01-01

    Safety culture, which is of great significance to establish safety objectives, characterizes level of enterprise safety production and development. Traditional safety culture evaluation models emphasis on thinking and behavior of individual and organization, and pay attention to evaluation results while ignore process. Moreover, determining evaluation indicators lacks objective evidence. A novel multidimensional safety culture evaluation model, which has scientific and completeness, is addressed by building an preliminary mapping between safety culture and SSE-CMM's (Systems Security Engineering Capability Maturity Model) process area and generic practice. The model focuses on enterprise system security engineering process evaluation and provides new ideas and scientific evidences for the study of safety culture. (authors)

  2. The motivational safety helmet : Redesign suggestions improving the intrinsic motivation of construction site workers

    NARCIS (Netherlands)

    Beldman, T. (Teunis); Boer, de J. (Johannes); Lemmens, P. (Pim); Stilma, M. (Margot)

    2014-01-01

    In reaction to the lack of intrinsic motivation of construction site workers, to wear their safety helmets at all times, a series of research projects studied causes and possible solutions. Goal is to gain an inspirational discussion to get the design onto the next level. This paper describes a

  3. [Can we transfer the mechanisms of the generics market to biosimilars?

    Science.gov (United States)

    Jacke, Ch O; Wild, F

    2016-12-15

    Personalized medicines such as biologics and their generic equivalents, biosimilars, are pouring onto the pharmaceutical markets. Data of 16 private health insurance companies were used to describe the market shares of selected biosimilars available in 2014 and 2015. The purpose of this study focuses on the question of whether market access of biosimilars will lead to a price competition of the expense of innovation competition. The results show that prescriptions of biosimilars made up 37% of total prescriptions in 2015 compared to 35% in 2014, and that their share of prescription costs went up from 21% to 23% in the same period. Price competition similar to that found in the generic markets has been established for erythropoietin and filgrastim. The same has not been observed for follitropin alfa and somatropin due to the limited number of competitors and products available at this stage. No definitive conclusions can be drown from the results at this stage. Time will tell whether it will be possible for physicians and individuals with private health insurance to fully leverage the savings potential of biosimilars while safeguarding patient safety.

  4. Contact Geometry of Hyperbolic Equations of Generic Type

    Directory of Open Access Journals (Sweden)

    Dennis The

    2008-08-01

    Full Text Available We study the contact geometry of scalar second order hyperbolic equations in the plane of generic type. Following a derivation of parametrized contact-invariants to distinguish Monge-Ampère (class 6-6, Goursat (class 6-7 and generic (class 7-7 hyperbolic equations, we use Cartan's equivalence method to study the generic case. An intriguing feature of this class of equations is that every generic hyperbolic equation admits at most a nine-dimensional contact symmetry algebra. The nine-dimensional bound is sharp: normal forms for the contact-equivalence classes of these maximally symmetric generic hyperbolic equations are derived and explicit symmetry algebras are presented. Moreover, these maximally symmetric equations are Darboux integrable. An enumeration of several submaximally symmetric (eight and seven-dimensional generic hyperbolic structures is also given.

  5. Retailing policies for generic medicines.

    Science.gov (United States)

    Narciso, Susana

    2005-06-01

    As there is general disagreement about the way generic medicines should be commercialized, two retailing policies are analyzed, taking into account their effects on the welfare of patients, government, pharmacies and physicians. In the first policy scenario, pharmacies are allowed to substitute generic medicines for branded ones, while in the second, substitution is forbidden. In both cases a pharmacies association is allowed to have a share in the production of generic medicines. The model predicts that under some conditions patients may prefer substitution by pharmacies but when doctors' decisions are binding, they are never "excessively bad". However, the policy choice belongs to the government, which prefers to allow for substitution more often than patients would like.

  6. Generic Accounting and Reporting Software for Research Reactors

    International Nuclear Information System (INIS)

    Jaernry, C.

    2010-01-01

    This poster will give a general description of a generic accounting and reporting software for research reactors. The program has been designed to be a powerful working tool for the operator. The software is designed to be extremely easy to handle and at the same time give the operator the maximal power of searches, calculations and reports that a modern advanced system can produce. The systems are designed to take make the relevant accountancy for the site and perform the reporting to IAEA in Code 10. Generic software for accounting and reporting for research and other smaller facilities is something that has been asked for by many parties. Software like this could be distributed to facilities in need of a powerful accountancy and reporting system for a much lower cost than the systems that is now custom made for these facilities. This will greatly increase the quality of accountancy at these facilities and the quality of the reporting to IAEA and other state offices etc. The software is based on our advanced custom made software series 'STAR' that has been in use in many places for more than a decade with successful use. (author)

  7. Reactor Safety Assessment System

    International Nuclear Information System (INIS)

    Sebo, D.E.; Bray, M.A.; King, M.A.

    1987-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSAS is designed for use at the USNRC Operations Center in the event of a serious incident at a licensed nuclear power plant. RSAS is a situation assessment expert system which uses plant parametric data to generate conclusions for use by the NRC Reactor Safety Team. RSAS uses multiple rule bases and plant specific setpoint files to be applicable to all licensed nuclear power plants in the United States. RSAS currently covers several generic reactor categories and multiple plants within each category

  8. Reactor safety assessment system

    International Nuclear Information System (INIS)

    Sebo, D.E.; Bray, M.A.; King, M.A.

    1987-01-01

    The Reactor Safety Assessment System (RSAS) is an expert system under development for the United States Nuclear Regulatory Commission (USNRC). RSA is designed for use at the USNRC Operations Center in the event of a serious incident at a licensed nuclear power plant. RSAS is a situation assessment expert system which uses plant parametric data to generate conclusions for use by the NRC Reactor Safety Team. RSAS uses multiple rule bases and plant specific setpoint files to be applicable to all licensed nuclear power plants in the United States. RSAS currently covers several generic reactor categories and multiple plants within each category

  9. Generic penetration in the retail atypical antipsychotic market.

    Science.gov (United States)

    Lenderts, Susan; Kalali, Amir H; Buckley, Peter

    2010-03-01

    In this article, we explore the penetration of generic atypical antipsychotics in the United States market before and after the availability of generic risperidone in July 2008. Analysis suggests that, overall, generic penetration into the atypical antipsychotic market has grown from approximately three percent in January 2008 to more than 25 percent in December 2009. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

  10. 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)

  11. 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).

  12. Investigation of Bioequivalence Between Brand-name and Generic Irinotecan Products.

    Science.gov (United States)

    Saito, Ken-Ichi; Inoue, Yutaka; Ikegami, Yoji; Nanbo, Izumi; Onozuka, Mari; Sano, Kazumi; Yoshida, Hisahiro; Sakamoto, Toshihiro; Tatebayashi, Emi; Fujita, Ken-Ichi; Sasaki, Yasutsuna; Kitazawa, Takaki

    2016-11-01

    To investigate bioequivalence among generic and brand-name irinotecan products. Products of Yakult and Daiichi-Sankyo (brand-name products), Sandoz, Nippon Kayaku, Taiho, and Sawai were compared with respect to their composition and antitumor activity. High-performance liquid chromatography demonstrated that related substances were within the acceptable range. The 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay revealed significant differences in cytotoxicity for four cancer cell lines among the products. The concentration of the active compound SN-38 was highest in Yakult's product (23.82 ng/ml) and lowest in Daiichi-Sankyo's product (8.96 ng/ml). MTT assay data were correlated with the SN-38 concentration, suggesting that it influenced differences in cytocidal activity among products. However, the SN-38 concentration was far lower than that of irinotecan (20 mg/ml), suggesting a negligible clinical effect. Metabolism of irinotecan to SN-38 or open-ring forms did not differ significantly among the products. The generic products showed equivalent efficacy and safety to the brand-name products. Copyright© 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  13. Nuclear Criticality Safety Data Book

    Energy Technology Data Exchange (ETDEWEB)

    Hollenbach, D. F. [Y-12 National Security Complex, Oak Ridge, TN (United States)

    2016-11-14

    The objective of this document is to support the revision of criticality safety process studies (CSPSs) for the Uranium Processing Facility (UPF) at the Y-12 National Security Complex (Y-12). This design analysis and calculation (DAC) document contains development and justification for generic inputs typically used in Nuclear Criticality Safety (NCS) DACs to model both normal and abnormal conditions of processes at UPF to support CSPSs. This will provide consistency between NCS DACs and efficiency in preparation and review of DACs, as frequently used data are provided in one reference source.

  14. Nuclear Criticality Safety Data Book

    International Nuclear Information System (INIS)

    Hollenbach, D. F.

    2016-01-01

    The objective of this document is to support the revision of criticality safety process studies (CSPSs) for the Uranium Processing Facility (UPF) at the Y-12 National Security Complex (Y-12). This design analysis and calculation (DAC) document contains development and justification for generic inputs typically used in Nuclear Criticality Safety (NCS) DACs to model both normal and abnormal conditions of processes at UPF to support CSPSs. This will provide consistency between NCS DACs and efficiency in preparation and review of DACs, as frequently used data are provided in one reference source.

  15. The Management System for Nuclear Installations. Safety Guide (Spanish Edition)

    International Nuclear Information System (INIS)

    2017-01-01

    This Safety Guide is applicable throughout the lifetime of a nuclear installation, including any subsequent period of institutional control, until there is no significant residual radiation hazard. For a nuclear installation, the lifetime includes site evaluation, design, construction, commissioning, operation and decommissioning. These stages in the lifetime of a nuclear installation may overlap. This Safety Guide may be applied to nuclear installations in the following ways: (a) To support the development, implementation, assessment and improvement of the management system of those organizations responsible for research, site evaluation, design, construction, commissioning, operation and decommissioning of a nuclear installation; (b) As an aid in the assessment by the regulatory body of the adequacy of the management system of a nuclear installation; (c) To assist an organization in specifying to a supplier, via contractual documentation, any specific element that should be included within the supplier's management system for the supply of products. This Safety Guide follows the structure of the Safety Requirements publication on The Management System for Facilities and Activities, whereby: (a) Section 2 provides recommendations on implementing the management system, including recommendations relating to safety culture, grading and documentation. (b) Section 3 provides recommendations on the responsibilities of senior management for the development and implementation of an effective management system. (c) Section 4 provides recommendations on resource management, including guidance on human resources, infrastructure and the working environment. (d) Section 5 provides recommendations on how the processes of the installation can be specified and developed, including recommendations on some generic processes of the management system. (e) Section 6 provides recommendations on the measurement, assessment and improvement of the management system of a nuclear

  16. Impact of Site Elevation on Mg Smelter Design

    Science.gov (United States)

    Baker, Phillip W.

    Site elevation has many surprising and significant impacts on the engineering design of metallurgical plant of all types. Electrolytic magnesium smelters maybe built at high elevation for a variety of reasons including availability of raw material, energy or electric power. Because of the unit processes they typically involve, Mg smelters can be extensively impacted by site elevation. In this paper, generic examples of the design changes required to adapt a smelter originally designed for sea level to operate at 2700 m are presented. While the examples are drawn from a magnesium plant design case, these changes are generically applicable to all industrial plants utilizing similar unit processes irrespective of product.

  17. Operational and safety aspects of vitrified waste casks

    International Nuclear Information System (INIS)

    Kirchner, B.

    1993-01-01

    For the time being two technical solutions have been developed for the interim storage: 1) one is based on forced air cooled pits set out in a concrete structure, as presently provided close to the Vitrification Facilities on reprocessing sites; 2) the other one is based on transportable storage casks standing vertically onto a storage pad, following principles similar to those already experienced with spent fuel storage casks. Considering these two solutions for interim storage, TRANSNUCLEAIRE has developed two main types of transportable casks for vitrified HAW; one is a routine transport cask; the other one is a transportable storage cask. Both are covered by the generic name TN28V and have already been described in previous papers. This paper deals with the safety and operation aspects of the casks under both transport and storage conditions. (J.P.N.)

  18. US Department of Energy DOE Nevada Operations Office, Nevada Test Site: Underground safety and health standards

    Energy Technology Data Exchange (ETDEWEB)

    1993-05-01

    The Nevada Test Site Underground Safety and Health Standards Working Group was formed at the direction of John D. Stewart, Director, Nevada Test Site Office in April, 1990. The objective of the Working Group was to compile a safety and health standard from the California Tunnel Safety Orders and OSHA for the underground operations at the NTS, (excluding Yucca Mountain). These standards are called the NTS U/G Safety and Health Standards. The Working Group submits these standards as a RECOMMENDATION to the Director, NTSO. Although the Working Group considers these standards to be the most integrated and comprehensive standards that could be developed for NTS Underground Operations, the intent is not to supersede or replace any relevant DOE orders. Rather the intent is to collate the multiple safety and health references contained in DOE Order 5480.4 that have applicability to NTS Underground Operations into a single safety and heath standard to be used in the underground operations at the NTS. Each portion of the standard was included only after careful consideration by the Working Group and is judged to be both effective and appropriate. The specific methods and rationale used by the Working Group are outlined as follows: The letter from DOE/HQ, dated September 28, 1990 cited OSHA and the CTSO as the safety and health codes applicable to underground operations at the NTS. These mandated codes were each originally developed to be comprehensive, i.e., all underground operations of a particular type (e.g., tunnels in the case of the CTSO) were intended to be adequately regulated by the appropriate code. However, this is not true; the Working Group found extensive and confusing overlap in the codes in numerous areas. Other subjects and activities were addressed by the various codes in cursory fashion or not at all.

  19. US Department of Energy DOE Nevada Operations Office, Nevada Test Site: Underground safety and health standards

    International Nuclear Information System (INIS)

    1993-05-01

    The Nevada Test Site Underground Safety and Health Standards Working Group was formed at the direction of John D. Stewart, Director, Nevada Test Site Office in April, 1990. The objective of the Working Group was to compile a safety and health standard from the California Tunnel Safety Orders and OSHA for the underground operations at the NTS, (excluding Yucca Mountain). These standards are called the NTS U/G Safety and Health Standards. The Working Group submits these standards as a RECOMMENDATION to the Director, NTSO. Although the Working Group considers these standards to be the most integrated and comprehensive standards that could be developed for NTS Underground Operations, the intent is not to supersede or replace any relevant DOE orders. Rather the intent is to collate the multiple safety and health references contained in DOE Order 5480.4 that have applicability to NTS Underground Operations into a single safety and heath standard to be used in the underground operations at the NTS. Each portion of the standard was included only after careful consideration by the Working Group and is judged to be both effective and appropriate. The specific methods and rationale used by the Working Group are outlined as follows: The letter from DOE/HQ, dated September 28, 1990 cited OSHA and the CTSO as the safety and health codes applicable to underground operations at the NTS. These mandated codes were each originally developed to be comprehensive, i.e., all underground operations of a particular type (e.g., tunnels in the case of the CTSO) were intended to be adequately regulated by the appropriate code. However, this is not true; the Working Group found extensive and confusing overlap in the codes in numerous areas. Other subjects and activities were addressed by the various codes in cursory fashion or not at all

  20. 40 CFR 721.2083 - Polysubstituted carbomonocyclic hydroxylamine (generic).

    Science.gov (United States)

    2010-07-01

    ... hydroxylamine (generic). 721.2083 Section 721.2083 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.2083 Polysubstituted carbomonocyclic hydroxylamine (generic). (a... generically as a polysubstituted carbomonocyclic hydroxylamine (PMN P-97-878) is subject to reporting under...

  1. COMPARISON OF PHARMACOKINETICS AND PHARMACODYNAMICS OF THE ORIGINAL AND GENERIC ENALAPRIL IN THE ELDERLY PATIENTS WITH ARTERIAL HYPERTENSION

    Directory of Open Access Journals (Sweden)

    O. P. Bobrova

    2015-12-01

    Full Text Available Aim. To study the pharmacokinetic, pharmacodynamic and pharmacoeconomic parameters of the original and generic enalaprils in the treatment of the elderly patients with hypertension (HT. Material and Methods. Patients (n=40 75–90 years with HT were included in the open randomized comparative study. Patients were randomized into two groups. Patients of the group 1 received generic enalapril, patients of the group 2 — the original enalapril consisting of combined therapy. Pharmacokinetic single-dose study of original and generic enalapril were carried out with high-performance liquid chromatography. Pharmacodynamic study was carried out in single-dose administration as well as after 2 and 4 weeks of treatment with original and generic enalapril. Pharmacoeconomic evaluation of antihypertensive drugs was carried out on the basis of cost minimization analysis. Results. Original enalapril dose necessary to achieve the target blood pressure (BP was 10 mg/day as a part of two-component therapy. This for generic enalapril was 20 mg/day consisting of three- or four-component therapy. Both drugs have shown an acceptable safety profile. Pharmacokinetic differences were revealed between original and generic enalapril: area under pharmacokinetic curve 204.14 (202.25–206.05 vs 136.23 (134.17–137.65 ng*h/ml, respectively; time of the drug retention in the blood plasma 5.42 (5.26–5.76 vs 4.88 (4.86–4.94 hours, respectively; p<0.001. Original enalapril demonstrated more stable 24-hour antihypertensive effect in once daily administration in comparison with this in generic enalapril: trough/peak ratio 78.67% (47.61–91.35% vs 44.96% (32.44–55.49%, respectively , p<0.01. The average daily cost of combined therapy containing generic enalapril was 15.91 rubles per patient, while this in combined therapy containing original enalapril — 13.78 rubles per patient. Conclusion. Medicines on the basis of original and generic enalapril have pharmacokinetic

  2. Software quality assurance for safety analysis and risk management at the Savannah River Site

    International Nuclear Information System (INIS)

    Ades, M.J.; Toffer, H.; Crowe, R.D.

    1991-01-01

    As part of its Reactor Operations Improvement Program at the Savannah River Site (SRS), Westinghouse Savannah River Company (WSRC), in cooperation with the Westinghouse Hanford Company, has developed and implemented quality assurance for safety-related software for technical programs essential to the safety and reliability of reactor operations. More specifically, the quality assurance process involved the development and implementation of quality standards and attendant procedures based on industry software quality standards. These procedures were then applied to computer codes in reactor safety and probabilistic risk assessment analyses. This paper provides a review of the major aspects of the WSRC safety-related software quality assurance. In particular, quality assurance procedures are described for the different life cycle phases of the software that include the Requirements, Software Design and Implementation, Testing and Installation, Operation and Maintenance, and Retirement Phases. For each phase, specific provisions are made to categorize the range of activities, the level of responsibilities, and the documentation needed to assure the control of the software. The software quality assurance procedures developed and implemented are evolutionary in nature, and thus, prone to further refinements. These procedures, nevertheless, represent an effective controlling tool for the development, production, and operation of safety-related software applicable to reactor safety and probabilistic risk assessment analyses

  3. Preliminary site description Laxemar stage 2.1. Feedback for completion of the site investigation including input from safety assessment and repository engineering

    International Nuclear Information System (INIS)

    2006-09-01

    The Laxemar subarea is the focus for the complete site investigations in the Simpevarp area. The south and southwestern parts of the subarea (the so-called 'focused area') have been designated for focused studies during the remainder of the site investigations. This area, some 5.3 square kilometres in size, is characterised on the surface by an arc shaped body of quartz monzodiorite gently dipping to the north, flanked in the north and south by Aevroe granite. The current report documents work conducted during stage 2.1 of the site-descriptive modelling of the Laxemar subarea. The primary objective of the work performed is to provide feedback to the site investigations at Laxemar to ensure that adequate and timely data and information are obtained during the remaining investigation stage. The work has been conducted in cooperation with the site investigation team at Laxemar and representatives from safety assessment and repository engineering. The principal aim of this joint effort has been to safeguard that adequate data are collected that resolve the remaining issues/uncertainties which are of importance for repository layout and long-term safety. The proposed additional works presented in this report should be regarded as recommended additions and/or modifications in relation to the CSI programme published early 2006. The overall conclusion of the discipline-wise review of critical issues is that the CSI programme overall satisfies the demands to resolve the remaining uncertainties. This is interpreted to be partly a result of the close interaction between the site modelling team, site investigation team and the repository engineering teams, which has been in operation since early 2005. In summary, the performed interpretations and modelling have overall confirmed the version 1.2 results. The exception being Hydrogeology where the new Laxemar 2.1 borehole data suggest more favourable conditions in the south and west parts of the focused area compared with the

  4. 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...

  5. Patient safety climate and worker safety behaviours in acute hospitals in Scotland.

    Science.gov (United States)

    Agnew, Cakil; Flin, Rhona; Mearns, Kathryn

    2013-06-01

    To obtain a measure of hospital safety climate from a sample of National Health Service (NHS) acute hospitals in Scotland and to test whether these scores were associated with worker safety behaviors, and patient and worker injuries. Data were from 1,866 NHS clinical staff in six Scottish acute hospitals. A Scottish Hospital Safety Questionnaire measured hospital safety climate (Hospital Survey on Patient Safety Culture), worker safety behaviors, and worker and patient injuries. The associations between the hospital safety climate scores and the outcome measures (safety behaviors, worker and patient injury rates) were examined. Hospital safety climate scores were significantly correlated with clinical workers' safety behavior and patient and worker injury measures, although the effect sizes were smaller for the latter. Regression analyses revealed that perceptions of staffing levels and managerial commitment were significant predictors for all the safety outcome measures. Both patient-specific and more generic safety climate items were found to have significant impacts on safety outcome measures. This study demonstrated the influences of different aspects of hospital safety climate on both patient and worker safety outcomes. Moreover, it has been shown that in a hospital setting, a safety climate supporting safer patient care would also help to ensure worker safety. The Scottish Hospital Safety Questionnaire has proved to be a usable method of measuring both hospital safety climate as well as patient and worker safety outcomes. Copyright © 2013 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

  6. Generics, Supergenerics and Patent Strategies--SMi's 13th Annual Meeting.

    Science.gov (United States)

    Edwards, Catherine

    2010-07-01

    SMi's 13th Annual Meeting on Generics, Supergenerics and Patent Strategies, held in London, included topics covering new trends in the generics field, the difficulties faced by companies in entering the generics market and recent developments in IP. This conference report highlights selected presentations on generics in India, protecting pharmaceutical products in China, changes in generics law and litigation in the US and Europe, challenges for market selection and entry for generics companies, the influence of changes in the healthcare market on the generics industry, supergenerics, and biosimilars.

  7. PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

    Directory of Open Access Journals (Sweden)

    S. N. Tolpygina

    2009-01-01

    Full Text Available The main differences between original and generic drugs as well as registration criteria for generics are described. Possible reasons of discrepancy in bioequivalence and therapeutic equivalence of original and generic drugs are reviewed. The examples of such a discrepancy as a result of comparative clinical trails (enalapril maleate are discussed. Approaches to planning of comparative trails on drug therapeutic equivalence are presented. 

  8. A generic coordinate system and a set of generic variables for MFE database

    International Nuclear Information System (INIS)

    Miner, W.H. Jr.; Ross, D.W.; Solano, E.R.; Valanju, P.M.; Wiley, J.C.

    1993-01-01

    Over the last several years, profile data from nine different tokamaks have been stored in the magnetic fusion energy database (MFEDB). These data sets have come from a variety of sources and most are given in different coordinate systems. In order to attempt any intermachine analysis, it is convenient to transform these data sets into one generic coordinate system and to choose a uniform set of variable names. The authors describe the data sets from each tokamak indicating the source of the data and the coordinate system in which it is given. Next, they discuss the generic coordinate that has been adopted and show how it is implemented for each tokamak. Finally, the generic naming convention that has been adopted is discussed. It follows closely that which was used by Christiansen et al. for the ITER Global Energy Confinement H-Mode Database. For further clarification, they discuss the characteristics of the magnetic geometry given a Fourier representation of the magnetic equilibria

  9. Corrosion calculations report for the safety assessment SR-Site

    International Nuclear Information System (INIS)

    2010-12-01

    This report is a compilation of the quantitative assessments of corrosion of the copper canisters in a KBS-3 repository. The calculations are part of the safety assessment SR-Site that is the long-term safety assessment to support the license application for building a final repository for spent nuclear fuel at Forsmark, Sweden. The safety assessment methodology gives the frame for the structured and documented approach to assess all conceivable corrosion processes. The quantitative assessments are done in different ways depending on the nature of the process and on the implications for the long-term safety. The starting point for the handling of the corrosion processes is the description of all known corrosion processes for copper with the current knowledge base and applied to the specific system and geology. Already at this stage some processes are excluded for further analysis, for example if the repository environment is not a sufficient prerequisite for the process to occur. The next step is to identify processes where the extent of corrosion could be bounded, e.g. by a mass balance approach. For processes where a mass balance is not limiting, the mass transport of corrodants (or corrosion products) is taken into account. A simple approach would be just to calculate the diffusive transport of corrodants through the bentonite, but generally the transport resistance for the interface between groundwater in a rock fracture intersecting the deposition hole and the bentonite buffer is more important. In SR-Site, the concept of equivalent flowrate, Q eq , is used. This assessment is done integrated with the evaluation of the geochemical and hydrogeological evolution of the repository. For most of the corrosion processes analysed, the corrosion depth is much smaller than the copper shell thickness, even for the assessment time of 10 6 years. Several processes give corrosion depths less than 100 μm, but no process give corrosion depths larger than a few millimetres

  10. Corrosion calculations report for the safety assessment SR-Site

    Energy Technology Data Exchange (ETDEWEB)

    2010-12-15

    This report is a compilation of the quantitative assessments of corrosion of the copper canisters in a KBS-3 repository. The calculations are part of the safety assessment SR-Site that is the long-term safety assessment to support the license application for building a final repository for spent nuclear fuel at Forsmark, Sweden. The safety assessment methodology gives the frame for the structured and documented approach to assess all conceivable corrosion processes. The quantitative assessments are done in different ways depending on the nature of the process and on the implications for the long-term safety. The starting point for the handling of the corrosion processes is the description of all known corrosion processes for copper with the current knowledge base and applied to the specific system and geology. Already at this stage some processes are excluded for further analysis, for example if the repository environment is not a sufficient prerequisite for the process to occur. The next step is to identify processes where the extent of corrosion could be bounded, e.g. by a mass balance approach. For processes where a mass balance is not limiting, the mass transport of corrodants (or corrosion products) is taken into account. A simple approach would be just to calculate the diffusive transport of corrodants through the bentonite, but generally the transport resistance for the interface between groundwater in a rock fracture intersecting the deposition hole and the bentonite buffer is more important. In SR-Site, the concept of equivalent flowrate, Q{sub eq}, is used. This assessment is done integrated with the evaluation of the geochemical and hydrogeological evolution of the repository. For most of the corrosion processes analysed, the corrosion depth is much smaller than the copper shell thickness, even for the assessment time of 106 years. Several processes give corrosion depths less than 100 mum, but no process give corrosion depths larger than a few

  11. Generic Software Architecture for Launchers

    Science.gov (United States)

    Carre, Emilien; Gast, Philippe; Hiron, Emmanuel; Leblanc, Alain; Lesens, David; Mescam, Emmanuelle; Moro, Pierre

    2015-09-01

    The definition and reuse of generic software architecture for launchers is not so usual for several reasons: the number of European launcher families is very small (Ariane 5 and Vega for these last decades); the real time constraints (reactivity and determinism needs) are very hard; low levels of versatility are required (implying often an ad hoc development of the launcher mission). In comparison, satellites are often built on a generic platform made up of reusable hardware building blocks (processors, star-trackers, gyroscopes, etc.) and reusable software building blocks (middleware, TM/TC, On Board Control Procedure, etc.). If some of these reasons are still valid (e.g. the limited number of development), the increase of the available CPU power makes today an approach based on a generic time triggered middleware (ensuring the full determinism of the system) and a centralised mission and vehicle management (offering more flexibility in the design and facilitating the long term maintenance) achievable. This paper presents an example of generic software architecture which could be envisaged for future launchers, based on the previously described principles and supported by model driven engineering and automatic code generation.

  12. Identification of scenarios in the safety assessment of a deep geological site for radioactive waste disposal

    International Nuclear Information System (INIS)

    Escalier des Orres, P.; Devillers, C.; Cernes, A.

    1990-01-01

    The selection and qualification procedure of a site for radioactive wastes disposal in a deep geologic formation, has begun in France in the early eighties. The public authorities, on ANDRA's proposal, has preselected in 1987 four sites, each of them corresponding to a type of geologic formations (granite, clay, salt and shale). Within two years, one of these sites will be chosen for the location of an underground laboratory. The safety analysis for the site's qualification uses evolution scenarios of the repository and its environment, chosen according to a deterministic method. With an appropriate detail level, are defined a reference scenario and scenario with random events. 4 refs., 1 tab [fr

  13. 40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkoxylated acrylate polymer (generic... Substances § 721.324 Alkoxylated acrylate polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkoxylated acrylate polymer...

  14. Generic maintenance immunosuppression in solid organ transplant recipients.

    Science.gov (United States)

    Ensor, Christopher R; Trofe-Clark, Jennifer; Gabardi, Steven; McDevitt-Potter, Lisa M; Shullo, Michael A

    2011-11-01

    Survival after solid organ transplantation has increased in the era of tacrolimus and mycophenolate. This increased survival could be due in part to the broad clinical use of these potent and specific agents for maintenance immunosuppression. These drugs have enhanced specificity and potency for T and B lymphocytes compared with their predecessors, cyclosporine and azathioprine. Between 2008 and 2010, the United States Food and Drug Administration approved several generic formulations of both tacrolimus and mycophenolate mofetil. Deciding whether generic products can be safely substituted for the innovator product is a clinical dilemma similar to that which occurred when generic formulations of cyclosporine became available. We describe the concerns regarding generic immunosuppression use, summarize expert opinion and consensus statements in transplantation, analyze the potential impact of generic substitution, and provide estimates of populations affected based on generic drug market penetration. Formulary considerations such as cost, availability, and potential drug ordering and drug selection errors are described, and transplant coordinator and patient perspectives are reviewed. Finally, general recommendations about the use of generic maintenance immunosuppression in solid organ transplant recipients are provided. Although more research is needed to confirm clinical and therapeutic equivalence and pharmacoeconomic benefit, generic immunosuppressants can be safely substituted for innovator products as long as patients consistently receive the same product, patients and clinicians are aware of when substitutions occur, and enhanced therapeutic drug monitoring is provided during the transition.

  15. Skin rash during treatment with generic itraconazole

    OpenAIRE

    De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

    2014-01-01

    Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re...

  16. YUCCA MOUNTAIN SITE CHARACTERIZATIONS PROJECT TUNNEL BORING MACHINE (TBM) SYSTEM SAFETY ANALYSIS

    International Nuclear Information System (INIS)

    1997-01-01

    The purpose of this analysis is to systematically identify and evaluate hazards related to the tunnel boring machine (TBM) used in the Exploratory Studies Facility (ESF) at the Yucca Mountain Site Characterization Project. This process is an integral part of the systems engineering process; whereby safety is considered during planning, design, testing, and construction. Since the TBM is an ''as built'' system, the MandO is conducting the System Safety Analysis during the construction or assembly phase of the TBM. A largely qualitative approach was used since a radiological System Safety Analysis is not required. The risk assessment in this analysis characterizes the accident scenarios associated with the TBM in terms of relative risk and includes recommendations for mitigating all identified risks. The priority for recommending and implementing mitigation control features is: (1) Incorporate measures to reduce risks and hazards into the system/subsystem/component design, (2) add safety features and capabilities to existing designs, and (3) develop procedures and conduct training to increase worker awareness of potential hazards, on methods to reduce exposure to hazards, and on the actions required to avoid accidents or correct hazardous conditions. The scope of this analysis is limited to the TBM during normal operations, excluding hazards occurring during assembly and test of the TBM or maintenance of the TBM equipment

  17. YUCCA MOUNTAIN SITE CHARACTERIZATIONS PROJECT TUNNEL BORING MACHINE (TBM) SYSTEM SAFETY ANALYSIS

    Energy Technology Data Exchange (ETDEWEB)

    N/A

    1997-02-19

    The purpose of this analysis is to systematically identify and evaluate hazards related to the tunnel boring machine (TBM) used in the Exploratory Studies Facility (ESF) at the Yucca Mountain Site Characterization Project. This process is an integral part of the systems engineering process; whereby safety is considered during planning, design, testing, and construction. Since the TBM is an ''as built'' system, the M&O is conducting the System Safety Analysis during the construction or assembly phase of the TBM. A largely qualitative approach was used since a radiological System Safety Analysis is not required. The risk assessment in this analysis characterizes the accident scenarios associated with the TBM in terms of relative risk and includes recommendations for mitigating all identified risks. The priority for recommending and implementing mitigation control features is: (1) Incorporate measures to reduce risks and hazards into the system/subsystem/component design, (2) add safety features and capabilities to existing designs, and (3) develop procedures and conduct training to increase worker awareness of potential hazards, on methods to reduce exposure to hazards, and on the actions required to avoid accidents or correct hazardous conditions. The scope of this analysis is limited to the TBM during normal operations, excluding hazards occurring during assembly and test of the TBM or maintenance of the TBM equipment.

  18. 40 CFR 721.5350 - Substituted nitrile (generic name).

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Substituted nitrile (generic name... Substances § 721.5350 Substituted nitrile (generic name). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted nitrile (PMN P-83...

  19. Information report on nuclear safety and radiation protection of the Tricastin AREVA site - Issue 2012

    International Nuclear Information System (INIS)

    2013-06-01

    Published in compliance with the French code of the environment, this report first presents different aspects of the Areva's Tricastin site which comprises five basic nuclear installations or INBs, and seven ICPE (installation classified for the protection of the environment). The activities are dedicated to uranium conversion, uranium enrichment, uranium chemistry, industrial services, and fuel manufacturing. The report presents this important industrial site, describes the various measures regarding nuclear safety and radiation protection, reports nuclear events which occurred on this site and had to be declared, reports the management of releases by this site and the control of the environment. The next part addresses the management of the various wastes produced by the different installations present on this site. The management of other impacts is also reported. The last chapter reviews the actions undertaken in the field of transparency and information

  20. Generic Penetration of the SSRI Market.

    Science.gov (United States)

    Cascade, Elisa F; Kalali, Amir H

    2008-04-01

    In this article, we investigate the penetration of generic selective serotonin reuptake inhibitors (SSRIs) in the US market and the implications for patient out-of-pocket expense. The data suggest that generic penetration into the SSRI market has grown from approximately nine percent in 2000, the year that the patent for Prozac((R)) expired, to 72 percent in 2007. For December, 2007, the difference in patient out-of-pocket expense for branded vs. generic agents was, on average, $55.42 for patients paying by cash (i.e., they had no prescription drug insurance) and $22.39 for patients with insurance coverage.