Guidance on the safety assessment methodology for storage of radioactive waste

International Nuclear Information System (INIS)

Kinyanjui, M.N.

2014-04-01

This project on safety assessment on storage was carried out with the main objective of ensuring safety of human life and our environment. This is the fundamental principle of radiation protection. Safety assessment has been evaluated as a tool in the safety case in the pre-construction, operational and the post closure phase of storage. In particular the iterative process of evaluating and predicting safety scenarios at each stage of the process has proved to be prudent. It is important that this concept be adopted for this type of facility to ensure safety of mankind and the environment now and in the future.

Guidelines for the review research reactor safety. Reference document for IAEA Integrated Safety Assessment of Research Reactors (INSARR)

International Nuclear Information System (INIS)

1997-01-01

In 1992, the IAEA published new safety standards for research reactors as part of the set of publications considered by its Research Reactor Safety Programme (RRSP). This set also includes publications giving guidance for all safety aspects related to the lifetime of a research reactor. In addition, the IAEA has also revised the Safety Standards for radiation protection. Consequently, it was considered advisable to revise the Integrated Safety Assessment of Research Reactors (INSARR) procedures to incorporate the new requirements and guidance as well as to extend the scope of the safety reviews to currently operating research reactors. The present report is the result of this revision. The purpose of this report is to give guidance on the preparation, execution, reporting and follow-up of safety review mission to research reactors as conducted by the IAEA under its INSARR missions safety service. However, it will also be of assistance to operators and regulators in conducting: (a) ad hoc safety assessments of research reactors to address individual issues such as ageing or safety culture; and (b) other types of safety reviews such as internal and peer reviews and regulatory inspections

Implementing DOE guidance for hazards assessments at Rocky Flats Plant

International Nuclear Information System (INIS)

Zimmerman, G.A.

1993-01-01

Hazards Assessments are performed for a variety of activities and facilities at Rocky Flats Plant. Prior to 1991, there was no guidance for performing Hazards Assessments. Each organization that performed Hazards Assessments used its own methodology with no attempt at standardization. In 1991, DOE published guidelines for the performance of Hazards Assessments for Emergency Planning (DOE-EPG-5500.1, ''Guidance for a Hazards Assessment Methodology''). Subsequently, in 1992, DOE published a standard for the performance of Hazards Assessments (DOE-STD-1027-92, ''Hazard Categorization and Accident Analysis, Techniques for Compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports''). Although these documents are a step in the direction of standardization, there remains a great deal of interpretation and subjective implementation in the performance of Hazards Assessments. Rocky Flats Plant has initiated efforts to develop a uniform and standard process to be used for Hazards Assessments

A Qualitative Assessment of Current CCF Guidance Based on a Review of Safety System Digital Implementation Changes with Evolving Technology

Energy Technology Data Exchange (ETDEWEB)

Korsah, Kofi [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Muhlheim, Michael David [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Wood, Richard [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

2016-04-01

The US Nuclear Regulatory Commission (NRC) is initiating a new rulemaking project to develop a digital system common-cause failure (CCF) rule. This rulemaking will review and modify or affirm the NRC's current digital system CCF policy as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, Instrumentation and Controls, in NRC Regulatory Guide (NUREG)-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants (ML033580677). The Oak Ridge National Laboratory (ORNL) is providing technical support to the NRC staff on the CCF rulemaking, and this report is one of several providing the technical basis to inform NRC staff members. For the task described in this report, ORNL examined instrumentation and controls (I&C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF is adequate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed.

Safety cases for radioactive waste disposal facilities: guidance on confidence building and regulatory review IAEA-ASAM co-ordinated research project

International Nuclear Information System (INIS)

Ben Belfadhel, M.; Bennett, D.G.; Metcalf, P.; Nys, V.; Goldammer, W.

2008-01-01

The IAEA has been conducting two co-ordinated research programmes (CRPs) projects to develop and apply improved safety assessment methodologies for near-surface radioactive waste disposal facilities. The more recent of these projects, ASAM (application of safety assessment methodologies), included a Regulatory Review Working Group (RRWG) which has been working to develop guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides an overview of the ASAM project, focusing on the safety case and regulatory review. (authors)

Development of an environmental safety case guidance manual

International Nuclear Information System (INIS)

Wellstead, Matthew John

2014-01-01

NDA RWMD is currently considering the scope, purpose and structure of a safety case manual that covers the development of nuclear operational, transport and environmental safety cases for a geological disposal facility in the United Kingdom. This paper considers the Environmental Safety Case (ESC) input into such a manual (herein referred to as the 'ESC Manual'), looking at the drivers and benefits that a guidance manual in this area may provide. (authors)

Eating nanomaterials: cruelty-free and safe? the EFSA guidance on risk assessment of nanomaterials in food and feed.

Science.gov (United States)

Sauer, Ursula G

2011-12-01

Nanomaterials are increasingly being added to food handling and packaging materials, or directly, to human food and animal feed. To ensure the safety of such engineered nanomaterials (ENMs), in May 2011, the European Food Safety Authority (EFSA) published a guidance document on Risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. It states that risk assessment should be performed by following a step-wise procedure. Whenever human or animal exposure to nanomaterials is expected, the general hazard characterisation scheme requests information from in vitro genotoxicity, toxicokinetic and repeated dose 90-day oral toxicity studies in rodents. Numerous prevailing uncertainties with regard to nanomaterial characterisation and their hazard and risk assessment are addressed in the guidance document. This article discusses the impact of these knowledge gaps on meeting the goal of ensuring human safety. The EFSA's guidance on the risk assessment of ENMs in food and animal feed is taken as an example for discussion, from the point of view of animal welfare, on what level of uncertainty should be considered acceptable for human safety assessment of products with non-medical applications, and whether animal testing should be considered ethically acceptable for such products.

Guidance on the environmental risk assessment of genetically modified plants

DEFF Research Database (Denmark)

Bartsch, Detlef; Chueca, Cristina; De-Schrijver, Adinda

risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant , or its compatible......This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified...... organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach...

The role of probabilistic safety assessment and probabilistic safety criteria in nuclear power plant safety

International Nuclear Information System (INIS)

1992-01-01

The purpose of this Safety Report is to provide guidelines on the role of probabilistic safety assessment (PSA) and a range of associated reference points, collectively referred to as probabilistic safety criteria (PSC), in nuclear safety. The application of this Safety Report and the supporting Safety Practice publication should help to ensure that PSA methodology is used appropriately to assess and enhance the safety of nuclear power plants. The guidelines are intended for use by nuclear power plant designers, operators and regulators. While these guidelines have been prepared with nuclear power plants in mind, the principles involved have wide application to other nuclear and non-nuclear facilities. In Section 2 of this Safety Report guidelines are established on the role PSA can play as part of an overall safety assurance programme. Section 3 summarizes guidelines for the conduct of PSAs, and in Section 4 a PSC framework is recommended and guidance is provided for the establishment of PSC values

Developing guidance in the nuclear criticality safety assessment for fuel cycle facilities

International Nuclear Information System (INIS)

Galet, C.; Evo, S.

2012-01-01

In this poster IRSN (Institute for radiation protection and nuclear safety) presents its safety guides whose purpose is to transmit the safety assessment know-how to any 'junior' staff or even to give a view of the safety approach on the overall risks to any staff member. IRSN has written a first version of such a safety guide for fuel cycle facilities and laboratories. It is organized into several chapters: some refer to types of assessments, others concern the types of risks. Currently, this guide contains 13 chapters and each chapter consists of three parts. In parallel to the development of criticality chapter of this guide, the IRSN criticality department has developed a nuclear criticality safety guide. It follows the structure of the three parts fore-mentioned, but it presents a more detailed first part and integrates, in the third part, the experience feedback collected on nuclear facilities. The nuclear criticality safety guide is online on the IRSN's web site

Safety standards for near surface disposal and the safety case and supporting safety assessment for demonstrating compliance with the standards

International Nuclear Information System (INIS)

Metcalf, P.

2003-01-01

The report presents the safety standards for near surface disposal (ICRP guidance and IAEA standards) and the safety case and supporting safety assessment for demonstrating compliance with the standards. Special attention is paid to the recommendations for disposal of long-lived solid radioactive waste. The requirements are based on the principle for the same level of protection of future individuals as for the current generation. Two types of exposure are considered: human intrusion and natural processes and protection measures are discussed. Safety requirements for near surface disposal are discussed including requirements for protection of human health and environment, requirements or safety assessments, waste acceptance and requirements etc

Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an European Food Safety Authority-tiered approach.

Science.gov (United States)

Speijers, Gerrit; Bottex, Bernard; Dusemund, Birgit; Lugasi, Andrea; Tóth, Jaroslav; Amberg-Müller, Judith; Galli, Corrado L; Silano, Vittorio; Rietjens, Ivonne M C M

2010-02-01

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.

The International Safety Framework for nuclear power source applications in outer space-Useful and substantial guidance

Science.gov (United States)

Summerer, L.; Wilcox, R. E.; Bechtel, R.; Harbison, S.

2015-06-01

In 2009, the International Safety Framework for Nuclear Power Source Applications in Outer Space was adopted, following a multi-year process that involved all major space faring nations under the auspices of a partnership between the UN Committee on the Peaceful Uses of Outer Space and the International Atomic Energy Agency. The Safety Framework reflects an international consensus on best practices to achieve safety. Following the 1992 UN Principles Relevant to the Use of Nuclear Power Sources in Outer Space, it is the second attempt by the international community to draft guidance promoting the safety of applications of nuclear power sources in space missions. NPS applications in space have unique safety considerations compared with terrestrial applications. Mission launch and outer space operational requirements impose size, mass and other space environment limitations not present for many terrestrial nuclear facilities. Potential accident conditions could expose nuclear power sources to extreme physical conditions. The Safety Framework is structured to provide guidance for both the programmatic and technical aspects of safety. In addition to sections containing specific guidance for governments and for management, it contains technical guidance pertinent to the design, development and all mission phases of space NPS applications. All sections of the Safety Framework contain elements directly relevant to engineers and space mission designers for missions involving space nuclear power sources. The challenge for organisations and engineers involved in the design and development processes of space nuclear power sources and applications is to implement the guidance provided in the Safety Framework by integrating it into the existing standard space mission infrastructure of design, development and operational requirements, practices and processes. This adds complexity to the standard space mission and launch approval processes. The Safety Framework is deliberately

Safety of magnetic fusion facilities: Volume 2, Guidance

International Nuclear Information System (INIS)

1995-01-01

This document provides guidance for the implementation of the requirements identified in Vol. 1 of this Standard. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While Vol. 1 is generally applicable in that requirements there apply to a wide range of fusion facilities, this volume is concerned mainly with large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This volume is oriented toward regulation in the Department of Energy (DOE) environment

RMP Guidance for Chemical Distributors - Appendix D: OSHA Guidance on PSM

Science.gov (United States)

Guidance on the Process Safety Management standard says information (including MSDS) about chemicals, including process intermediates, must enable accurate assessment of fire/explosion characteristics, reactivity hazards, and corrosing/erosion effects.

78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

Science.gov (United States)

2013-04-15

...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

Science.gov (United States)

2012-04-25

...] Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes... Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food... determining whether changes in manufacturing process, including the intentional reduction in particle size to...

Guidance for performing preliminary assessments under CERCLA

Energy Technology Data Exchange (ETDEWEB)

NONE

1991-09-01

EPA headquarters and a national site assessment workgroup produced this guidance for Regional, State, and contractor staff who manage or perform preliminary assessments (PAs). EPA has focused this guidance on the types of sites and site conditions most commonly encountered. The PA approach described in this guidance is generally applicable to a wide variety of sites. However, because of the variability among sites, the amount of information available, and the level of investigative effort required, it is not possible to provide guidance that is equally applicable to all sites. PA investigators should recognize this and be aware that variation from this guidance may be necessary for some sites, particularly for PAs performed at Federal facilities, PAs conducted under EPA`s Environmental Priorities Initiative (EPI), and PAs at sites that have previously been extensively investigated by EPA or others. The purpose of this guidance is to provide instructions for conducting a PA and reporting results. This guidance discusses the information required to evaluate a site and how to obtain it, how to score a site, and reporting requirements. This document also provides guidelines and instruction on PA evaluation, scoring, and the use of standard PA scoresheets. The overall goal of this guidance is to assist PA investigators in conducting high-quality assessments that result in correct site screening or further action recommendations on a nationally consistent basis.

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

2004-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

2000-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

2001-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

2002-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

Assessment of occupational exposure due to intakes of radionuclides. Safety guide

International Nuclear Information System (INIS)

1999-01-01

Occupational exposure due to radioactive materials can occur as a result of various human activities. These include work associated with the different stages of the nuclear fuel cycle, the use of radioactive sources in medicine, scientific research, agriculture and industry, and occupations which involve the handling of materials containing enhanced concentrations of naturally occurring radionuclides. In order to control this exposure, it is necessary to be able to assess the magnitude of the doses involved. Three interrelated Safety Guides, prepared jointly by the IAEA and the International Labour Office (ILO), provide guidance on the application of the requirements of the Basic Safety Standards with respect to occupational exposure. Reference [3] gives general advice on the exposure conditions for which monitoring programmes should be set up to assess radiation doses arising from external radiation and from intakes of radionuclides by workers. More specific guidance on the assessment of doses from external sources of radiation can be found in Ref. [4] and the present Safety Guide deals with intakes of radioactive materials. Recommendations related to occupational radiation protection have also been developed by the International Commission on Radiological Protection (ICRP) [5]. These and other current recommendations of the ICRP [6] have been taken into account in preparing this Safety Guide. The purpose of this Safety Guide is to provide guidance for regulatory authorities on conducting assessments of intakes of radioactive material arising from occupational exposure. This Guide will also be useful to those concerned with the planning, management and operation of occupational monitoring programmes, and to those involved in the design of equipment for use in internal dosimetry and workplace monitoring

Guidance for the definition and application of probabilistic safety criteria

International Nuclear Information System (INIS)

Holmberg, J.-E.; Knochenhauer, M.

2011-05-01

The project 'The Validity of Safety Goals' has been financed jointly by NKS (Nordic Nuclear Safety Research), SSM (Swedish Radiation Safety Authority) and the Swedish and Finnish nuclear utilities. The national financing went through NPSAG, the Nordic PSA Group (Swedish contributions) and SAFIR2010, the Finnish research programme on NPP safety (Finnish contributions). The project has been performed in four phases during 2006-2010. This guidance document aims at describing, on the basis of the work performed throughout the project, issues to consider when defining, applying and interpreting probabilistic safety criteria. Thus, the basic aim of the document is to serve as a checklist and toolbox for the definition and application of probabilistic safety criteria. The document describes the terminology and concepts involved, the levels of criteria and relations between these, how to define a probabilistic safety criterion, how to apply a probabilistic safety criterion, on what to apply the probabilistic safety criterion, and how to interpret the result of the application. The document specifically deals with what makes up a probabilistic safety criterion, i.e., the risk metric, the frequency criterion, the PSA used for assessing compliance and the application procedure for the criterion. It also discusses the concept of subsidiary criteria, i.e., different levels of safety goals. The results from the project can be used as a platform for discussions at the utilities on how to define and use quantitative safety goals. The results can also be used by safety authorities as a reference for risk-informed regulation. The outcome can have an impact on the requirements on PSA, e.g., regarding quality, scope, level of detail, and documentation. Finally, the results can be expected to support on-going activities concerning risk-informed applications. (Author)

Guidance for the definition and application of probabilistic safety criteria

Energy Technology Data Exchange (ETDEWEB)

Holmberg, J.-E. (VTT Technical Research Centre of Finland (Finland)); Knochenhauer, M. (Scandpower AB (Sweden))

2011-05-15

The project 'The Validity of Safety Goals' has been financed jointly by NKS (Nordic Nuclear Safety Research), SSM (Swedish Radiation Safety Authority) and the Swedish and Finnish nuclear utilities. The national financing went through NPSAG, the Nordic PSA Group (Swedish contributions) and SAFIR2010, the Finnish research programme on NPP safety (Finnish contributions). The project has been performed in four phases during 2006-2010. This guidance document aims at describing, on the basis of the work performed throughout the project, issues to consider when defining, applying and interpreting probabilistic safety criteria. Thus, the basic aim of the document is to serve as a checklist and toolbox for the definition and application of probabilistic safety criteria. The document describes the terminology and concepts involved, the levels of criteria and relations between these, how to define a probabilistic safety criterion, how to apply a probabilistic safety criterion, on what to apply the probabilistic safety criterion, and how to interpret the result of the application. The document specifically deals with what makes up a probabilistic safety criterion, i.e., the risk metric, the frequency criterion, the PSA used for assessing compliance and the application procedure for the criterion. It also discusses the concept of subsidiary criteria, i.e., different levels of safety goals. The results from the project can be used as a platform for discussions at the utilities on how to define and use quantitative safety goals. The results can also be used by safety authorities as a reference for risk-informed regulation. The outcome can have an impact on the requirements on PSA, e.g., regarding quality, scope, level of detail, and documentation. Finally, the results can be expected to support on-going activities concerning risk-informed applications. (Author)

LANL Safety Conscious Work Environment (SCWE) Self-Assessment

Energy Technology Data Exchange (ETDEWEB)

Hargis, Barbara C. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

2014-01-29

On December 21, 2012 Secretary of Energy Chu transmitted to the Defense Nuclear Facilities Safety Board (DNFSB) revised commitments on the implementation plan for Safety Culture at the Waste Treatment and Immobilization Plant. Action 2-5 was revised to require contractors and federal organizations to complete Safety Conscious Work Environment (SCWE) selfassessments and provide reports to the appropriate U.S. Department of Energy (DOE) - Headquarters Program Office by September 2013. Los Alamos National Laboratory (LANL) planned and conducted a Safety Conscious Work Environment (SCWE) Self-Assessment over the time period July through August, 2013 in accordance with the SCWE Self-Assessment Guidance provided by DOE. Significant field work was conducted over the 2-week period August 5-16, 2013. The purpose of the self-assessment was to evaluate whether programs and processes associated with a SCWE are in place and whether they are effective in supporting and promoting a SCWE.

Development of a quality assurance safety assessment database for near surface radioactive waste disposal

International Nuclear Information System (INIS)

Park, J. W.; Kim, C. L.; Park, J. B.; Lee, E. Y.; Lee, Y. M.; Kang, C. H.; Zhou, W.; Kozak, M. W.

2003-01-01

A quality assurance safety assessment database, called QUARK (QUality Assurance program for Radioactive waste management in Korea), has been developed to manage both analysis information and parameter database for safety assessment of Low- and Intermediate-Level radioactive Waste (LILW) disposal facility in Korea. QUARK is such a tool that serves QA purposes for managing safety assessment information properly and securely. In QUARK, the information is organized and linked to maximize the integrity of information and traceability. QUARK provides guidance to conduct safety assessment analysis, from scenario generation to result analysis, and provides a window to inspect and trace previous safety assessment analysis and parameter values. QUARK also provides default database for safety assessment staff who construct input data files using SAGE(Safety Assessment Groundwater Evaluation), a safety assessment computer code

OSART Independent Safety Culture Assessment (ISCA) Guidelines

International Nuclear Information System (INIS)

2016-01-01

Safety culture is understood as an important part of nuclear safety performance. This has been demonstrated by the analysis of significant events such as Chernobyl, Davis Besse, Vandellos II, Asco, Paks, Mihamma and Forsmark, among others. In order to enhance safety culture, one essential activity is to perform assessments. IAEA Safety Standard Series No. GS-R-3, The Management System for Facilitites and Activities, states requirements for continuous improvement of safety culture, of which self, peer and independent safety culture assessments constitute an essential part. In line with this requirement, the Independent Safety Culture Assessment (ISCA) module is offered as an add-on module to the IAEA Operational Safety Review Team (OSART) programme. The OSART programme provides advice and assistance to Member States to enhance the safety of nuclear power plants during commissioning and operation. By including the ISCA module in an OSART mission, the receiving organization benefits from the synergy between the technical and the safety culture aspects of the safety review. The joint operational safety and safety culture assessment provides the organization with the opportunity to better understand the interactions between technical, human, organizational and cultural aspects, helping the organization to take a systemic approach to safety through identifying actions that fully address the root causes of any identified issue. Safety culture assessments provide insight into the fundamental drivers that shape organizational patterns of behaviour, safety consciousness and safety performance. The complex nature of safety culture means that the analysis of the results of such assessments is not as straightforward as for other types of assessment. The benefits of the results of nuclear safety culture assessments are maximized only if appropriate tools and guidance for these assessments is used; hence, this comprehensive guideline has been developed. The methodology explained

Guidance for identifying, reporting and tracking nuclear safety noncompliances

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-12-01

This document provides Department of Energy (DOE) contractors, subcontractors and suppliers with guidance in the effective use of DOE`s Price-Anderson nuclear safety Noncompliance Tracking System (NTS). Prompt contractor identification, reporting to DOE, and correction of nuclear safety noncompliances provides DOE with a basis to exercise enforcement discretion to mitigate civil penalties, and suspend the issuance of Notices of Violation for certain violations. Use of this reporting methodology is elective by contractors; however, this methodology is intended to reflect DOE`s philosophy on effective identification and reporting of nuclear safety noncompliances. To the extent that these expectations are met for particular noncompliances, DOE intends to appropriately exercise its enforcement discretion in considering whether, and to what extent, to undertake enforcement action.

Safety assessment principles for reactor protection systems in the United Kingdom

International Nuclear Information System (INIS)

Philp, W.

1990-01-01

The duty of Nuclear Installations Inspectorate (NII) is to see that the appropriate standards are developed, achieved and maintained by the plant operators, and to monitor and regulate the safety of the plant by means of its powers under the licence. It does not issue standards or codes of practice for NPPs, but it requires each plant operator to develop its own safety criteria and requirements. The following relevant issues are described: NII assessment principles and societal risks; principles and guidance for the assessment of rector protection systems; assessment of reactor shutdown systems

Safety assessment principles for reactor protection systems in the United Kingdom

Energy Technology Data Exchange (ETDEWEB)

Philp, W

1990-07-01

The duty of Nuclear Installations Inspectorate (NII) is to see that the appropriate standards are developed, achieved and maintained by the plant operators, and to monitor and regulate the safety of the plant by means of its powers under the licence. It does not issue standards or codes of practice for NPPs, but it requires each plant operator to develop its own safety criteria and requirements. The following relevant issues are described: NII assessment principles and societal risks; principles and guidance for the assessment of rector protection systems; assessment of reactor shutdown systems.

Guidance on Dependence Assessment in SPAR-H

Energy Technology Data Exchange (ETDEWEB)

April M. Whaley

2012-06-01

As part of the effort to develop the SPAR-H user guidance, particular attention was paid to the assessment of dependence in order to address user questions about proper application of dependence. This paper presents a discussion of dependence from a psychological perspective and provides guidance on applying this information during the qualitative analysis of dependence to ensure more realistic and appropriate dependence assessments with the SPAR-H method. While this guidance was developed with SPAR-H in mind, it may be informative to other human reliability analysis methods that also use a THERP-based dependence approach, particularly if applied at the human failure event level.

The Regulatory Approach for the Assessment of Safety Culture in Germany: A Tool for Practical Use for Inspections

International Nuclear Information System (INIS)

Fassmann, W.; Beck, J.; Kopisch, C.

2016-01-01

Need for methods to assess licencees’ safety culture has been recognised since the Chernobyl accident. Several conferences organized by IAEA and OECD-NEA stated the need for regulatory oversight of safety culture and for suitable methods. In 2013, IAEA published a Technical Document (TECDOC 1707) on the process of safety culture oversight by regulatory authorities which leaves much room for regulators’ ways of performing safety culture oversight. In response to these developments, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) as the federal regulatory body commissioned GRS in 2011 to develop a practical guidance for assessing licencees’ safety culture in the process of regulatory oversight. This research and development project was completed just recently. The publicly available documentation comprises a shorter guidance document with the indispensable information for an appropriate, practical application and a report with more detailed information about the scientific basis of this guidance. To achieve best possible adaptation to regulators’ needs, GRS asked members of the regulatory authority of Baden-Wuerttemberg (one of the federal states of Germany) for comments on a draft of the guidance which was then finalised by duly considering this highly valuable and favorable feedback. Decisions regarding future use rest with German regulatory authorities.

Considerations in the safety assessment of sealed nuclear facilities

International Nuclear Information System (INIS)

1991-06-01

This report is a part of the International Atomic Energy Agency's radioactive waste management programme, whose objective is to provide assistance to Member States in developing guidance for identifying safe alternatives for isolating radioactive waste from man and his environment. This report attempts to integrate information from the previous reports on decommissioning of nuclear facilities, mitigation of accidents at such facilities, and performance assessment of disposal systems to provide useful advice and qualitative guidance to those responsible for performance and safety assessments of sealed nuclear facilities by giving an overview of possible approaches and techniques for such assessments. In this context, the establishment of requirements and rules governing the radiological safety of personnel, the general public, and the environment for sealing and post-sealing activities will enable the choice of the most appropriated approach and help to promote consistency in both decommissioning and waste management standards. The near-field effects discussed in this document include gas generation, interactions of the groundwater and the residual water with other components of the system, thermal, thermo-mechanical, radiation effects and chemical and geochemical reactions. 59 refs, figs and tabs

75 FR 3471 - International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the...

Science.gov (United States)

2010-01-21

...] International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of... the availability of a guidance entitled ``M3(R2) Nonclinical Safety Studies for the Conduct of Human... auspices of the International Conference on Harmonisation of Technical Requirements for Registration of...

Assessment of the effectiveness of guidance services in senior ...

African Journals Online (AJOL)

Guidance Service Assessment Questionnaire for Teacher/Students (GSAQTS) was used to measure the extent of guidance services and their perception of it. ... to counsellor, and a misconception of the counsellors role has made guidance ...

76 FR 60503 - Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and...

Science.gov (United States)

2011-09-29

... Safety and Effectiveness Protocol Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The recommendations included in this guidance are intended...

77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

Science.gov (United States)

2012-07-27

...] Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k... serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k... unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in...

Safety assessment for the underground disposal of radioactive wastes

International Nuclear Information System (INIS)

1981-01-01

This document is addressed to authorities and specialists responsible for or involved in planning, performing and reviewing safety assessments of underground radioactive waste repositories. It introduces and discusses in a general manner approaches and areas to be considered in making such safety assessments; its emphasis is on repositories for long-lived radioactive wastes in deep geological formations. It is hoped that this document will contribute to providing a base for a common understanding among the authorities and specialists concerned with the numerous studies involving a variety of scientific disciplines. While providing guidance, the document is also intended to stimulate further international discussion on this subject. It is the intention of the IAEA to develop more specific reports providing examples for the application of safety analyses for underground waste disposal

Safety assessment for the underground disposal of radioactive wastes

Energy Technology Data Exchange (ETDEWEB)

1981-01-01

This document is addressed to authorities and specialists responsible for or involved in planning, performing and reviewing safety assessments of underground radioactive waste repositories. It introduces and discusses in a general manner approaches and areas to be considered in making such safety assessments; its emphasis is on repositories for long-lived radioactive wastes in deep geological formations. It is hoped that this document will contribute to providing a base for a common understanding among the authorities and specialists concerned with the numerous studies involving a variety of scientific disciplines. While providing guidance, the document is also intended to stimulate further international discussion on this subject. It is the intention of the IAEA to develop more specific reports providing examples for the application of safety analyses for underground waste disposal.

[Safety assessment of foods derived from genetically modified plants].

Science.gov (United States)

Pöting, A; Schauzu, M

2010-06-01

The placing of genetically modified plants and derived food on the market falls under Regulation (EC) No. 1829/2003. According to this regulation, applicants need to perform a safety assessment according to the Guidance Document of the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA), which is based on internationally agreed recommendations. This article gives an overview of the underlying legislation as well as the strategy and scientific criteria for the safety assessment, which should generally be based on the concept of substantial equivalence and carried out in relation to an unmodified conventional counterpart. Besides the intended genetic modification, potential unintended changes also have to be assessed with regard to potential adverse effects for the consumer. All genetically modified plants and derived food products, which have been evaluated by EFSA so far, were considered to be as safe as products derived from the respective conventional plants.

Human factors in safety assessment. Safety culture assessment

International Nuclear Information System (INIS)

Zhang Li; Deng Zhiliang; Wang Yiqun; Huang Weigang

1996-01-01

This paper analyses the present conditions and problems in enterprises safety assessment, and introduces the characteristics and effects of safety culture. The authors think that safety culture must be used as a 'soul' to form the pattern of modern safety management. Furthermore, they propose that the human safety and synthetic safety management assessment in a system should be changed into safety culture assessment. Finally, the assessment indicators are discussed

A New Approach to Lane Guidance Systems

OpenAIRE

Eidehall, Andreas; Pohl, Jochen; Gustafsson, Fredrik

2005-01-01

This paper presents a new automotive safety function called Emergency Lane Assist (ELA). ELA combines conventional lane guidance systems with a threat assessment module that tries to activate and deactivate the lane guidance interventions according to the actual risk level of lane departure. The goal is to only prevent dangerous lane departure manoeuvres. Such a threat assessment algorithm is dependent on detailed information about the vehicle surroundings, i.e., positions and motion of other...

Safety assessment and verification for nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2004-01-01

This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. The present publication is a revision of the IAEA Safety Guide on Management of Nuclear Power Plants for Safe Operation issued in 1984. It supplements Section 2 of the Safety Requirements publication on Safety of Nuclear Power Plants: Operation. Nuclear power technology is different from the customary technology of power generation from fossil fuel and by hydroelectric means. One major difference between the management of nuclear power plants and that of conventional generating plants is the emphasis that should be placed on nuclear safety, quality assurance, the management of radioactive waste and radiological protection, and the accompanying national regulatory requirements. This Safety Guide highlights the important elements of effective management in relation to these aspects of safety. The attention to be paid to safety requires that the management recognize that personnel involved in the nuclear power programme should understand, respond effectively to, and continuously search for ways to enhance safety in the light of any additional requirements socially and legally demanded of nuclear energy. This will help to ensure that safety policies that result in the safe operation of nuclear power plants are implemented and that margins of safety are always maintained. The structure of the organization, management standards and administrative controls should be such that there is a high degree of assurance that safety policies and decisions are implemented, safety is continuously enhanced and a strong safety culture is promoted and supported. The objective of this publication is to guide Member States in setting up an operating organization which facilitates the safe operation of nuclear power plants to a high level internationally. The second objective is to provide guidance on the most important organizational elements in order to contribute to a strong safety

Safety assessment and verification for nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2005-01-01

This Safety Guide was prepared under the IAEA programme for safety standards for nuclear power plants. The present publication is a revision of the IAEA Safety Guide on Management of Nuclear Power Plants for Safe Operation issued in 1984. It supplements Section 2 of the Safety Requirements publication on Safety of Nuclear Power Plants: Operation. Nuclear power technology is different from the customary technology of power generation from fossil fuel and by hydroelectric means. One major difference between the management of nuclear power plants and that of conventional generating plants is the emphasis that should be placed on nuclear safety, quality assurance, the management of radioactive waste and radiological protection, and the accompanying national regulatory requirements. This Safety Guide highlights the important elements of effective management in relation to these aspects of safety. The attention to be paid to safety requires that the management recognize that personnel involved in the nuclear power programme should understand, respond effectively to, and continuously search for ways to enhance safety in the light of any additional requirements socially and legally demanded of nuclear energy. This will help to ensure that safety policies that result in the safe operation of nuclear power plants are implemented and that margins of safety are always maintained. The structure of the organization, management standards and administrative controls should be such that there is a high degree of assurance that safety policies and decisions are implemented, safety is continuously enhanced and a strong safety culture is promoted and supported. The objective of this publication is to guide Member States in setting up an operating organization which facilitates the safe operation of nuclear power plants to a high level internationally. The second objective is to provide guidance on the most important organizational elements in order to contribute to a strong safety

Regulatory review of probabilistic safety assessment (PSA) Level 2

International Nuclear Information System (INIS)

2001-07-01

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

An Assessment of the Implementation of Guidance and Counselling ...

African Journals Online (AJOL)

This paper is based on a research study carried out by the author in 2003. The study assessed how Guidance and Counselling Programmes were being implemented in Gweru urban secondary schools at Ordinary level. The assessment focused on such key elements in Guidance and Counselling as time allocation, ...

Procedures for conducting probabilistic safety assessment for non-reactor nuclear facilities

International Nuclear Information System (INIS)

2002-01-01

A well performed and adequately documented safety assessment of a nuclear facility will serve as a basis to determine whether the facility complies with the safety objectives, principles and criteria as stipulated by the national regulatory body of the country where the facility is in operation. International experience shows that the practices and methodologies used to perform safety assessments and periodic safety re-assessment for non-reactor nuclear facilities differ significantly from county to country. Most developing countries do not have methods and guidance for safety assessment that are prescribed by the regulatory body. Typically the safety evaluation for the facility is based on a case by case assessment. Whilst conservative deterministic analyses are predominantly used as a licensing basis in many countries, recently probabilistic safety assessment (PSA) techniques have been applied as a useful complementary tool to support safety decision making. The main benefit of PSA is to provide insights into the safety aspects of facility design and operation. PSA points up the potential environmental impacts of postulated accidents, including the dominant risk contributors, and enables safety analysts to compare options for reducing risk. In order to advise on how to apply PSA methodology for the safety assessment of non-reactor nuclear facilities, the IAEA organized several consultants meetings, which led to the preparation of this TECDOC. This document is intended as guidance for the conduct of PSA in non-nuclear facilities. The main emphasis here is on the general procedural steps of a PSA that is specific for a non-reactor nuclear facility, rather than the details of the specific methods. The report is directed at technical staff managing or performing such probabilistic assessments and to promote a standardized framework, terminology and form of documentation for these PSAs. It is understood that the level of detail implied in the tasks presented in this

77 FR 75439 - Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New...

Science.gov (United States)

2012-12-20

...] Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide; Availability... Reporting Requirements for INDs and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE...

Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond.

Science.gov (United States)

Serabian, M A; Pilaro, A M

1999-01-01

Many scientific discussions, especially in the past 8 yr, have focused on definition of criteria for the optimal assessment of the preclinical toxicity of pharmaceuticals. With the current overlap of responsibility among centers within the Food and Drug Administration (FDA), uniformity of testing standards, when appropriate, would be desirable. These discussions have extended beyond the boundaries of the FDA and have culminated in the acceptance of formalized, internationally recognized guidances. The work of the International Committee on Harmonisation (ICH) and the initiatives developed by the FDA are important because they (a) represent a consensus scientific opinion, (b) promote consistency, (c) improve the quality of the studies performed, (d) assist the public sector in determining what may be generally acceptable to prepare product development plans, and (e) provide guidance for the sponsors in the design of preclinical toxicity studies. Disadvantages associated with such initiatives include (a) the establishment of a historical database that is difficult to relinquish, (b) the promotion of a check-the-box approach, i.e., a tendancy to perform only the minimum evaluation required by the guidelines, (c) the creation of a disincentive for industry to develop and validate new models, and (d) the creation of state-of-the-art guidances that may not allow for appropriate evaluation of novel therapies. The introduction of biotechnology-derived pharmaceuticals for clinical use has often required the application of unique approaches to assessing their safety in preclinical studies. There is much diversity among these products, which include the gene and cellular therapies, monoclonal antibodies, human-derived recombinant regulatory proteins, blood products, and vaccines. For many of the biological therapies, there will be unique product issues that may require specific modifications to protocol design and may raise additional safety concerns (e.g., immunogenicity

Regulatory review of probabilistic safety assessment (PSA) level 1

International Nuclear Information System (INIS)

2000-02-01

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

Chemical Hazards and Safety Issues in Fusion Safety Design

International Nuclear Information System (INIS)

Cadwallader, L.C.

2003-01-01

Radiological inventory releases have dominated accident consequences for fusion; these consequences are important to analyze and are generally the most severe result of a fusion facility accident event. However, the advent of, or plan for, large-scale usage of some toxic materials poses the additional hazard of chemical exposure from an accident event. Examples of toxic chemicals are beryllium for magnetic fusion and fluorine for laser fusion. Therefore, chemical exposure consequences must also be addressed in fusion safety assessment. This paper provides guidance for fusion safety analysis. US Department of Energy (DOE) chemical safety assessment practices for workers and the public are reviewed. The US Environmental Protection Agency (EPA) has published some guidance on public exposure to releases of mixtures of chemicals, this guidance has been used to create an initial guideline for treating mixed radiological and toxicological releases in fusion; for example, tritiated hazardous dust from a tokamak vacuum vessel. There is no convenient means to judge the hazard severity of exposure to mixed materials. The chemical fate of mixed material constituents must be reviewed to determine if there is a separate or combined radiological and toxicological carcinogenesis, or if other health threats exist with radiological carcinogenesis. Recommendations are made for fusion facility chemical safety evaluation and safety guidance for protecting the public from chemical releases, since such levels are not specifically identified in the DOE fusion safety standard

Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements.

Science.gov (United States)

Schilter, B; Andersson, C; Anton, R; Constable, A; Kleiner, J; O'Brien, J; Renwick, A G; Korver, O; Smit, F; Walker, R

2003-12-01

There is a growing interest by both consumers and industry for the development of food products with 'functional' properties, or health benefits. These products may take the form of dietary supplements or of foods. The health benefits are given by particular ingredients, and in many cases these are derived from botanicals. The variety of plants providing these functions is large, ranging from staple food sources such as cereals, fruits and vegetables, to herbals as used in traditional medicine. The food or ingredient conferring health properties may consist of the plants themselves, extracts thereof, or more purified components. The scientific literature is abundant with articles not only on the beneficial properties, but also on possible adverse health effects of plants and their components. The present report discusses the data required to determine the safe use of these types of ingredients, and provides advice on the development of risk assessment strategies consistent with due diligence under existing food regulations. Product specifications, composition and characterisation of standardised and authentic materials, documented history of use and comparison to existing products (taking into account the effect of industrial processing), description of the intended use and consequent exposure are highlighted as key background information on which to base a risk evaluation. The extent of experimental investigation required, such as in vitro, animal, and/or human studies, depends on the adequacy of this information. A decision tree is presented as an aid to determine the extent of data requirements based on product comparison. The ultimate safety in use depends on the establishment of an adequate safety margin between expected exposure and identified potential hazards. Health hazards may arise from inherent toxicities or contaminants of the plant materials, including the mechanism of the intended beneficial effect. A lower safety margin may therefore be expected

USNRC regulatory guidance for engineered safety feature air cleaning systems

International Nuclear Information System (INIS)

Bellamy, R.R.

1991-01-01

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

Regulatory assessment of safety culture in nuclear organisations - current trends and challenges

International Nuclear Information System (INIS)

Tronea, M.

2010-01-01

The paper gives an overview of the current practices in the area of regulatory assessment of safety culture in nuclear organisations and of the associated challenges. While the assessment and inspection procedures currently in use by regulatory authorities worldwide are directed primarily at verifying compliance with the licensing basis, there is a recognised need for a more systematic approach to the identification, collection and review of data relevant to the safety culture in licensees' organisations. The paper presents a proposal for using the existing regulatory inspection practices for gathering information relevant to safety culture and for assessing it in an integrated manner. The proposal is based on the latest requirements and guidance issued by the International Atomic Energy Agency (IAEA) on management systems for nuclear facilities and activities, particularly as regards the attributes needed for a strong nuclear safety culture. (author)

Assessment of the safety of foods derived from genetically modified (GM) crops

NARCIS (Netherlands)

König, A.; Cockburn, A.; Crevel, R.W.R.; Debruyne, E.; Grafstroem, R.; Hammerling, U.; Kimber, I.; Knudsen, I.; Kuiper, H.A.; Peijnenburg, A.A.C.M.; Penninks, A.H.; Poulsen, M.; Schauzu, M.; Wal, J.M.

2004-01-01

This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group 1 of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of

Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: Testing an EFS tired approach

NARCIS (Netherlands)

Speijers, G.; Bottex, B.; Dusemund, B.; Lugasi, A.; Toth, J.; Amberg-Muller, J.; Galli, C.; Silano, V.; Rietjens, I.

2010-01-01

This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified

78 FR 27235 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

Science.gov (United States)

2013-05-09

... Justice in Regulatory Analysis.'' The purpose of this guidance is to provide EPA analysts with technical...-566-2363. Mail: Technical Guidance for Assessing Environmental Justice in Regulatory Analysis... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9810-5] Technical Guidance for Assessing...

Guidelines for the Review of Research Reactor Safety: Revised Edition. Reference Document for IAEA Integrated Safety Assessment of Research Reactors (INSARR)

International Nuclear Information System (INIS)

2013-01-01

The Integrated Safety Assessment of Research Reactors (INSARR) is an IAEA safety review service available to Member States with the objective of supporting them in ensuring and enhancing the safety of their research reactors. This service consists of performing a comprehensive peer review and an assessment of the safety of the respective research reactor. The reviews are based on IAEA safety standards and on the provisions of the Code of Conduct on the Safety of Research Reactors. The INSARR can benefit both the operating organizations and the regulatory bodies of the requesting Member States, and can include new research reactors under design or operating research reactors, including those which are under a Project and Supply Agreement with the IAEA. The first IAEA safety evaluation of a research reactor operated by a Member State was completed in October 1959 and involved the Swiss 20 MW DIORIT research reactor. Since then, and in accordance with its programme on research reactor safety, the IAEA has conducted safety review missions in its Member States to enhance the safety of their research reactor facilities through the application of the Code of Conduct on the Safety of Research Reactors and the relevant IAEA safety standards. About 320 missions in 51 Member States were undertaken between 1972 and 2012. The INSARR missions and other limited scope safety review missions are conducted following the guidelines presented in this publication, which is a revision of Guidelines for the Review of Research Reactor Safety (IAEA Services Series No. 1), published in December 1997. This publication details those IAEA safety standards and guidance publications relevant to the safety of research reactors that have been revised or published since 1997. The purpose of this publication is to give guidance on the preparation, implementation, reporting and follow-up of safety review missions. It is also intended to be of assistance to operators and regulators in conducting

Assessment of the nuclear installation's safety significant events

International Nuclear Information System (INIS)

Vidican, D.

2005-01-01

This document tries to establish, based on the available documentation, the main steps in development of Assessment of the Events in Nuclear Installations. It takes into account: selection of the safety significant occurrences, establishing the direct cause and contributors as well as the root cause and contributors. Also, the document presents the necessary corrective actions and generic lessons to be learned from the event. The document is based especially on IAEA - ASSET guidelines and DOE root cause analysis Guidance. (author)

Synthesis of the IRSN report on its analysis of the safety guidance package (DOrS) of the ASTRID reactor project. Safety guidance document for the ASTRID prototype: Referral to the GPR. Opinion related to the safety guidance document of the ASTRID reactor project. ASTRID prototype: Safety guidance document for the ASTRID prototype

International Nuclear Information System (INIS)

Lachaume, Jean-Luc; Niel, Jean-Christophe

2013-01-01

A first document indicates the improvement guidelines for the ASTRID project based on the French experience in the field of sodium-cooled fast neutron reactors, addresses the safety objectives as they are presented for the ASTRID project, discusses how the project includes a regulation and design referential, and how it addresses various aspects of the design approach (ranking and analysis of operation situations, defence in depth, use of probabilistic studies, safety classification and qualification to accidental situations, taking internal and external aggressions into account and taking severe accidents into account at the design level). It comments the guidelines related to the first two barriers, to main safety functions (control of reactivity and of reactor cooling, containment of radioactive and toxic materials), to dismantling, to R and D for safety support. A second document is a letter sent by the ASN to the GPR (permanent group of experts in charge of nuclear reactors) about the safety guidance document for the ASTRID prototype. The third document is the answer and contains comments and recommendations by this group about the content of this document, and therefore addresses the same topics as the first document. The last document defines the framework of the approach to this document

Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations

DEFF Research Database (Denmark)

Pilegaard, Kirsten

preparation for QPS status, it has been possible to develop a structured assessment scheme that provides a practical method for assessing botanicals and botanical preparations for which an adequate body of knowledge exists and therefore without the need for further testing. Reiterative applications...... in the development of a comprehensive, systematic and transparent methodology. The Scientific Committee recommends its use as an extension of the 2009 EFSA guidance for the safety assessment of botanicals and botanical preparations intended to be used in food supplements....

Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

International Nuclear Information System (INIS)

Oh, Kyemin; Kang, Myoung-suk; Heo, Gyunyoung; Kim, Hyoung-chan

2014-01-01

Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

Energy Technology Data Exchange (ETDEWEB)

Oh, Kyemin; Kang, Myoung-suk [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Heo, Gyunyoung, E-mail: gheo@khu.ac.kr [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Kim, Hyoung-chan [National Fusion Research Institute, Daejeon-si 305-333 (Korea, Republic of)

2014-10-15

Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

International Nuclear Information System (INIS)

Yun, Y. C.; Lee, J. H.; Lee, H. C.; Lee, J. S.

2000-01-01

In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage

Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

Energy Technology Data Exchange (ETDEWEB)

Yun, Y. C. [LG-EDS Systems, Seoul (Korea, Republic of); Lee, J. H.; Lee, H. C.; Lee, J. S. [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of)

2000-05-01

In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage.

Recent Experiences of the NASA Engineering and Safety Center (NESC) Guidance Navigation and Control (GN and C) Technical Discipline Team (TDT)

Science.gov (United States)

Dennehy, Cornelius J.

2011-01-01

The NASA Engineering and Safety Center (NESC) is an independently funded NASA Program whose dedicated team of technical experts provides objective engineering and safety assessments of critical, high risk projects. NESC's strength is rooted in the diverse perspectives and broad knowledge base that add value to its products, affording customers a responsive, alternate path for assessing and preventing technical problems while protecting vital human and national resources. The Guidance Navigation and Control (GN&C) Technical Discipline Team (TDT) is one of fifteen such discipline-focused teams within the NESC organization. The TDT membership is composed of GN&C specialists from across NASA and its partner organizations in other government agencies, industry, national laboratories, and universities. This paper will briefly define the vision, mission, and purpose of the NESC organization. The role of the GN&C TDT will then be described in detail along with an overview of how this team operates and engages in its objective engineering and safety assessments of critical NASA.

Testing REACH draft technical guidance notes for conducting chemical safety assessments-the experience of a downstream user of a preparation.

Science.gov (United States)

Gade, Anne Lill; Ovrebø, Steinar; Hylland, Ketil

2008-07-01

The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.

Assessing progress in the development of safety culture

International Nuclear Information System (INIS)

Rotaru, I.; Ghita, S.; Biro, L.

2002-01-01

This paper is focussed on the organizational culture and learning processes required for the implementation of all aspects of safety culture. There is no prescriptive formula for improving safety culture. However, some common characteristics and practices are emerging that can be adopted by organizations in order to make progress. The paper refers to some approaches that have been successful in a number of countries. The experience of the international nuclear industry in the development and improvement of safety culture could be extended and found useful in other nuclear activities, irrespective of scale. The examples given of specific practice cover a wide range of activities including analysis of events, the regulatory approach on safety culture, employee participation and safety performance measures. Many of these practices may be relevant to smaller organizations and could contribute to improving safety culture, whatever the size of the organization. The most effective approach is to pursue a range of practices that can be mutually supportive in the development of a progressive safety culture, supported by professional standards, organizational and management commitment. Some guidance is also given on the assessment of safety culture and on the detection of a weakening safety culture. Few suggestions for accelerating the safety culture development and improvement process are also provided. (author)

Key performance indicators for the assessment of pediatric pharmacotherapeutic guidance.

Science.gov (United States)

Barrett, Jeffrey S; Patel, Dimple; Jayaraman, Bhuvana; Narayan, Mahesh; Zuppa, Athena

2008-07-01

Given the paucity of actual guidance provided for managing pediatric drug therapy, prescribing caregivers must be able to draw on the limited published information in pediatrics and/or guidance provided in adults with some account for expected pediatric response. Guidance for managing drug therapy in children is clearly desirable. Our objectives were to construct key performance indicators (KPIs) for pediatric pharmacotherapy guidance to identify drugs where pharmacotherapy guidance would be most beneficial. A pilot survey to assess variation in caregiver appreciation for pediatric dosing guidance has also been constructed to provide a complementary subjective assessment. Three KPI categories, drug utilization (based on hospital admission and billing data collected from 2001 through 2006), medical need, and guidance outcome value along with a KPI composite score have been proposed. Low scores are favored with respect to prioritization for pharmacotherapy guidance. The pilot survey consisted of 15 questions to assess 1) physician knowledge regarding dosing guidance, 2) attitudes toward dose modification and patient individualization, 3) the accessibility, ease of use and appropriateness of existing data stores, and 4) frequency of dosing modification, consultation of dosing compendiums and estimate of success rate in dosing guidance. Pilot results suggest that dosing guidance is generally viewed as important and that the existing resources are insufficient to guide recommendations for all drugs. While the majority of respondents check more than one resource less than 25% of the time, at least 25% of the respondents check more than one resource 25-50% of the time. The majority viewed the relevance of dosing guidance very important to the management of drug therapy. The questionnaire is being extended to the primary care centers, the Kids First Network and specialty care centers. Results will guide the development of decision support systems (DSS) that provide patient

Guidance on risk analysis and safety implications of a large liquefied natural gas (LNG) spill over water.

Energy Technology Data Exchange (ETDEWEB)

Wellman, Gerald William; Melof, Brian Matthew; Luketa-Hanlin, Anay Josephine; Hightower, Marion Michael; Covan, John Morgan; Gritzo, Louis Alan; Irwin, Michael James; Kaneshige, Michael Jiro; Morrow, Charles W.

2004-12-01

While recognized standards exist for the systematic safety analysis of potential spills or releases from LNG (Liquefied Natural Gas) storage terminals and facilities on land, no equivalent set of standards or guidance exists for the evaluation of the safety or consequences from LNG spills over water. Heightened security awareness and energy surety issues have increased industry's and the public's attention to these activities. The report reviews several existing studies of LNG spills with respect to their assumptions, inputs, models, and experimental data. Based on this review and further analysis, the report provides guidance on the appropriateness of models, assumptions, and risk management to address public safety and property relative to a potential LNG spill over water.

Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities

International Nuclear Information System (INIS)

Batandjieva, B.; Torres-Vidal, C.

2002-01-01

The International Atomic Energy Agency (IAEA) Coordinated research program ''Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities'' (ISAM) has developed improved safety assessment methodology for near surface disposal facilities. The program has been underway for three years and has included around 75 active participants from 40 countries. It has also provided examples for application to three safety cases--vault, Radon type and borehole radioactive waste disposal facilities. The program has served as an excellent forum for exchange of information and good practices on safety assessment approaches and methodologies used worldwide. It also provided an opportunity for reaching broad consensus on the safety assessment methodologies to be applied to near surface low and intermediate level waste repositories. The methodology has found widespread acceptance and the need for its application on real waste disposal facilities has been clearly identified. The ISAM was finalized by the end of 2000, working material documents are available and an IAEA report will be published in 2002 summarizing the work performed during the three years of the program. The outcome of the ISAM program provides a sound basis for moving forward to a new IAEA program, which will focus on practical application of the safety assessment methodologies to different purposes, such as licensing radioactive waste repositories, development of design concepts, upgrading existing facilities, reassessment of operating repositories, etc. The new program will also provide an opportunity for development of guidance on application of the methodology that will be of assistance to both safety assessors and regulators

Liver safety assessment in special populations (hepatitis B, C, and oncology trials).

Science.gov (United States)

Kullak-Ublick, Gerd A; Merz, Michael; Griffel, Louis; Kaplowitz, Neil; Watkins, Paul B

2014-11-01

The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver injury (DILI) is the most specific regulatory guidance currently available and has been useful in setting standards for the great majority of clinical indications involving subjects with a low risk of liver disorders. However, liver safety assessment faces challenges in populations with underlying liver disease, such as viral hepatitis or metastatic cancer. This is an important issue because there are currently many promising anti-viral and oncologic therapies in clinical development, with a trend toward oral therapies with reduced side effects. Without clearer guidelines, questions regarding liver safety may become a major factor in regulatory approval and ultimately physician uptake of the new treatments. The lack of consensus in defining stopping rules based on serum alanine aminotransferase (ALT) levels underscores the need for precompetitive data sharing to improve our understanding of DILI in these populations and to allow evidence-based rather than empirical definition of stopping rules. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

Operational safety review programmes for nuclear power plants. Guidelines for assessment

International Nuclear Information System (INIS)

2002-01-01

The IAEA has been offering the Operational Safety Review Team (OSART) programme to provide advice and assistance to Member States in enhancing the operational safety of nuclear power plants (NPPs). Simultaneously, the IAEA has encouraged self-assessment and review by Member States of their own nuclear power plants to continuously improve nuclear safety. Currently, some utilities have been implementing safety review programmes to independently review their own plants. Corporate or national operational safety review programmes may be compliance or performance based. Successful utilities have found that both techniques are necessary to provide assurance that (i) as a minimum the NPP meets specific corporate and legal requirements and (ii) management at the NPP is encouraged to pursue continuous improvement principles. These programmes can bring nuclear safety benefits to the plants and utilities. The IAEA has conducted two pilot missions to assess the effectiveness of the operational review programme. Based on these missions and on the experience gained during OSART missions, this document has been developed to provide guidance on and broaden national/corporate safety review programmes in Member States, and to assist in maximizing their benefits. These guidelines are intended primarily for the IAEA team to conduct assessment of a national/corporate safety review programme. However, this report may also be used by a country or utility to establish its own national/corporate safety review programme. The guidelines may likewise be used for self-assessment or for establishing a baseline when benchmarking other safety review programmes. This report consists of four parts. Section 2 addresses the planning and preparation of an IAEA assessment mission and Sections 3 and 4 deal with specific guidelines for conducting the assessment mission itself

Additional guidance for including nuclear safety equivalency in the Canister Storage Building and Cold Vacuum Drying Facility final safety analysis report

Energy Technology Data Exchange (ETDEWEB)

Garvin, L.J.

1997-05-20

This document provides guidance for the production of safety analysis reports that must meet both DOE Order 5480.23 and STD 3009, and be in compliance with the DOE regulatory policy that imposes certain NRC requirements.

Additional guidance for including nuclear safety equivalency in the Canister Storage Building and Cold Vacuum Drying Facility final safety analysis report

International Nuclear Information System (INIS)

Garvin, L.J.

1997-01-01

This document provides guidance for the production of safety analysis reports that must meet both DOE Order 5480.23 and STD 3009, and be in compliance with the DOE regulatory policy that imposes certain NRC requirements

General RMP Guidance - Appendix D: OSHA Guidance on PSM

Science.gov (United States)

OSHA's Process Safety Management (PSM) Guidance on providing complete and accurate written information concerning process chemicals, process technology, and process equipment; including process hazard analysis and material safety data sheets.

[Safety and efficacy of percutaneous patent ductus arteriosus closure solely under thoracic echocardiography guidance].

Science.gov (United States)

Pan, Xiangbin; Ouyang, Wenbin; Li, Shoujun; Guo, Gaili; Liu, Yao; Zhang, Dawei; Zhang, Fengwen; Pang, Kunjing; Fang, Nengxin; Hu, Shengshou

2015-01-01

To avoid the radiation injuries and use of contrast agent, we assessed the safety and efficacy of percutaneous patent ductus arteriosus closure solely under thoracic echocardiography guidance. From June 2013 to June 2014, thirty patients (mean age: (6.3 ± 2.5) years, mean body weight:(22.5 ± 7.3) kg) with pure patent ductus arteriosus were continuously included in this study. The mean diameter of patent ductus arteriosus was (3.8 ± 0.9) mm. Patients were all treated by percutaneous patent ductus arteriosus closure via right femoral artery solely under thoracic echocardiography guidance. The efficacy of the procedure was evaluated by thoracic echocardiography. Follow-up was performed at one month after procedure. All 30 cases were successfully treated with percutaneous patent ductus arteriosus closure solely under thracic echocardiography guidance. The procedural time was (32.8 ± 5.7) minutes. The mean diameter of Amplatzer ADO II was (4.9 ± 1.0) mm. Postoperative trivial residual shunt occurred in six patients immediately after the procedure. All patients survived without peripheral vascular injury or complications such as cardiac perforation. Hospitalization time was (3.4 ± 0.7) days. At one-month follow-up, no complications such as residual shunt or pericardial effusion were observed. Echocardiography guided percutaneous patent ductus arteriosus closure by femoral artery approach is safe and effective, and can avoid X-ray and the use of contrast agents.

Risk-based approach to long-term safety assessment for near surface disposal of radioactive waste in Korea

International Nuclear Information System (INIS)

Jeong, C.W.; Kim, K.I.; Lee, J.I.

2000-01-01

This paper presents the Korean regulatory approach to safety assessment consistent with probabilistic, risk-based long-term safety requirements for near surface disposal facilities. The approach is based on: (1) From the standpoint of risk limitation, normal processes and probabilistic disruptive events should be integrated in a similar manner in terms of potential exposures; and (2) The uncertainties inherent in the safety assessment should be reduced using appropriate exposure scenarios. In addition, this paper emphasizes the necessity of international guidance for quantifying potential exposures and the corresponding risks from radioactive waste disposal. (author)

Safety Assessment Context for Croatian Low and Intermediate Level Radioactive Waste Repository

International Nuclear Information System (INIS)

Levanat, I.; Lokner, V.

1998-01-01

Safety assessments in a small country are usually performed to support the national waste management strategy, demonstrating compliance with national regulation for a particular facility. However, this assessment should - quite generally - provide reasonable assurance both to the public and to decision makers than the Croatian share of LILW from NPP Krsko can be safely disposed in Croatia. More specifically, assessment should clearly present all realistic options and compare the associated long term repository performances, demonstrating that desirable safety goals can be archived by an appropriate choice of (a) location, (b) facility design, (c) institutional control period and (d) waste acceptance criteria. As relevant national legislation is presently under review, generally recognized international safety standards, criteria and recommendations (e.g. as presented in the recent IAEA publications) should provide guidance for the assessment evaluation, since it is expected that they will be incorporated in the new national regulations. Finally, since Croatian radioactive waste management strategy is yet to be developed, such an assessment may contribute to its formulation and facilitate some specific decisions. (author)

Strategic Environmental Assessment as catalyst of healthier spatial planning: The Danish guidance and practice

International Nuclear Information System (INIS)

Kornov, Lone

2009-01-01

A wide range of factors within spatial planning can affect health. There is therefore an important scope for Strategic Environmental Assessment (SEA) of spatial plans to protect and improve human health. Due to the EU Directive 2001/42/EC on SEA, health has been made explicit in Danish legislation and guidance. This paper examines the inclusion of health as a formal component in impact assessment of spatial plans. Based upon a documentary study of 100 environmental reports, the paper analyses and discusses how health impact considerations are incorporated in SEA practice. It is found that health impacts are included in SEA practice and are being interpreted in a broader sense than what the national guidance exemplifies. The frequent included health aspects are noise, drinking water, air pollution, recreation/outdoor life and traffic safety. The primary determinant for health is transport-whether it is at the overall or local planning level. The main conclusion is that SEA shows a potential to catalyse healthier spatial planning. Despite the broad inclusion of health in SEA practice the examination shows potential improvements, hereunder qualification of assessments by better explaining the nature and significance of impacts and by including the distributional aspects of human health impacts. Inclusion from the health sector is put forward as an important institutional mean to secure cross disciplinarily and higher quality assessment

Probabilistic safety assessment for food irradiation facility

International Nuclear Information System (INIS)

Solanki, R.B.; Prasad, M.; Sonawane, A.U.; Gupta, S.K.

2012-01-01

Highlights: ► Different considerations are required in PSA for Non-Reactor Nuclear Facilities. ► We carried out PSA for food irradiation facility as a part of safety evaluation. ► The results indicate that the fatal exposure risk is below the ‘acceptable risk’. ► Adequate operator training and observing good safety culture would reduce the risk. - Abstract: Probabilistic safety assessment (PSA) is widely used for safety evaluation of Nuclear Power Plants (NPPs) worldwide. The approaches and methodologies are matured and general consensus exists on using these approaches in PSA applications. However, PSA applications for safety evaluation for non-reactor facilities are limited. Due to differences in the processes in nuclear reactor facilities and non-reactor facilities, the considerations are different in application of PSA to these facilities. The food irradiation facilities utilize gamma irradiation sources, X-ray machines and electron accelerators for the purpose of radiation processing of variety of food items. This is categorized as Non-Reactor Nuclear Facility. In this paper, the application of PSA to safety evaluation of food irradiation facility is presented considering the ‘fatality due to radiation overexposure’ as a risk measure. The results indicate that the frequency of the fatal exposure is below the numerical acceptance guidance for the risk to the individual. Further, it is found that the overall risk to the over exposure can be reduced by providing the adequate operator training and observing good safety culture.

Regulatory review and confidence building in post-closure safety assessments and safety cases for near surface disposal facilities-IAEA ASAM coordinated research programme

International Nuclear Information System (INIS)

Gonzales, A.; Simeonov, G.; Bennett, D.G.; Nys, V.; Ben Belfadhel, M.

2005-01-01

Some years ago, the IAEA successfully concluded a Coordinated Research Program (CRP) called Islam, which focussed on the development of an Improved Safety Assessment Methodology for near-surface radioactive waste disposal facilities. In November 2002, and as an extension of ISAM, the IAEA launched a new CRP called ASAM, designed to test the Application of the Safety Assessment Methodology by considering a range of near-surface disposal facilities. The ASAM work programme is being implemented by three application working groups and two cross-cutting working groups. The application working groups are testing the applicability of the ISAM methodology by assessing an existing disposal facility in Hungary, a copper mine in South Africa, and a hypothetical facility containing heterogenous wastes, such as disused sealed sources. The first cross-cutting working group is addressing a number of technical issues that are common to all near-surface disposal facilities, while the second group, the Regulatory Review Working Group (RRWG) is developing guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides a brief overview of the work being conducted by the Regulatory Review Working Group. (author)

[Agricultural biotechnology safety assessment].

Science.gov (United States)

McClain, Scott; Jones, Wendelyn; He, Xiaoyun; Ladics, Gregory; Bartholomaeus, Andrew; Raybould, Alan; Lutter, Petra; Xu, Haibin; Wang, Xue

2015-01-01

Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and stability once placed into the crop genome. The safety of the proteins coded by the inserted DNA and potential effects on the crop are considered, and the purpose is to ensure that the transgenic novel proteins are safe from a toxicity, allergy, and environmental perspective. In addition, the grain that provides the processed food or animal feed is also tested to evaluate its nutritional content and identify unintended effects to the plant composition when warranted. To provide a platform for the safety assessment, the GM crop is compared to non-GM comparators in what is typically referred to as composition equivalence testing. New technologies, such as mass spectrometry and well-designed antibody-based methods, allow better analytical measurements of crop composition, including endogenous allergens. Many of the analytical methods and their intended uses are based on regulatory guidance documents, some of which are outlined in globally recognized documents such as Codex Alimentarius. In certain cases, animal models are recommended by some regulatory agencies in specific countries, but there is typically no hypothesis or justification of their use in testing the safety of GM crops. The quality and standardization of testing methods can be supported, in some cases, by employing good laboratory practices (GLP) and is recognized in China as important to ensure quality data. Although the number of recommended, in some cases, required methods for safety testing are increasing in some regulatory agencies, it should be noted that GM crops registered to date have been shown to be

HANFORD SAFETY ANALYSIS & RISK ASSESSMENT HANDBOOK (SARAH)

Energy Technology Data Exchange (ETDEWEB)

EVANS, C B

2004-12-21

The purpose of the Hanford Safety Analysis and Risk Assessment Handbook (SARAH) is to support the development of safety basis documentation for Hazard Category 2 and 3 (HC-2 and 3) U.S. Department of Energy (DOE) nuclear facilities to meet the requirements of 10 CFR 830, ''Nuclear Safety Management''. Subpart B, ''Safety Basis Requirements.'' Consistent with DOE-STD-3009-94, Change Notice 2, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'' (STD-3009), and DOE-STD-3011-2002, ''Guidance for Preparation of Basis for Interim Operation (BIO) Documents'' (STD-3011), the Hanford SARAH describes methodology for performing a safety analysis leading to development of a Documented Safety Analysis (DSA) and derivation of Technical Safety Requirements (TSR), and provides the information necessary to ensure a consistently rigorous approach that meets DOE expectations. The DSA and TSR documents, together with the DOE-issued Safety Evaluation Report (SER), are the basic components of facility safety basis documentation. For HC-2 or 3 nuclear facilities in long-term surveillance and maintenance (S&M), for decommissioning activities, where source term has been eliminated to the point that only low-level, residual fixed contamination is present, or for environmental remediation activities outside of a facility structure, DOE-STD-1120-98, ''Integration of Environment, Safety, and Health into Facility Disposition Activities'' (STD-1120), may serve as the basis for the DSA. HC-2 and 3 environmental remediation sites also are subject to the hazard analysis methodologies of this standard.

C-Band Airport Surface Communications System Engineering-Initial High-Level Safety Risk Assessment and Mitigation

Science.gov (United States)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed C-band (5091- to 5150-MHz) airport surface communication system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents an initial high-level safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the C-band communication system after the profile is finalized and system rollout timing is determined. A security risk assessment has been performed by NASA as a parallel activity. While safety analysis is concerned with a prevention of accidental errors and failures, the security threat analysis focuses on deliberate attacks. Both processes identify the events that affect operation of the system; and from a safety perspective the security threats may present safety risks.

Assessment of the safety of foods derived from genetically modified (GM) crops

DEFF Research Database (Denmark)

Konig, A.; Cockburn, A.; Crewel, R. W. R.

2004-01-01

of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use......This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group I of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics...... (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex...

Independent Safety Assessment of the TOPAZ-II space nuclear reactor power system (Revised)

International Nuclear Information System (INIS)

1993-09-01

The Independent Safety Assessment described in this study report was performed to assess the safety of the design and launch plans anticipated by the U.S. Department of Defense (DOD) in 1993 for a Russian-built, U.S.-modified, TOPAZ-II space nuclear reactor power system. Its conclusions, and the bases for them, were intended to provide guidance for the U.S. Department of Energy (DOE) management in the event that the DOD requested authorization under section 91b. of the Atomic Energy Act of 1954, as amended, for possession and use (including ground testing and launch) of a nuclear-fueled, modified TOPAZ-II. The scientists and engineers who were engaged to perform this assessment are nationally-known nuclear safety experts in various disciplines. They met with participants in the TOPAZ-II program during the spring and summer of 1993 and produced a report based on their analysis of the proposed TOPAZ-II mission. Their conclusions were confined to the potential impact on public safety and did not include budgetary, reliability, or risk-benefit analyses

Guidance on the implementation of a risk based safety performance monitoring system for nuclear power plants

International Nuclear Information System (INIS)

Sewell, R.T.; Kuritzky, A.S.; Khatib-Rahbar, M.

1997-05-01

The principal objective of the present study is to review and evaluate existing Performance Indicator (PI) monitoring programs, and to develop and demonstrate an overall PSA-based methodology and framework for the monitoring and use of risk-based PIs and SIs (Safety Indicator), that would enable: Identification of trends and patterns in safety performance at a specific plant and a population of plants; Assessment of the significance of the trends and patterns; Identification of precursors of accident sequences and safety reductions; Identification of the most critical functional areas of concern, especially as they relate to a defense-in-depth safety philosophy; Comparison of safety performance trends at a plant with those at comparable plants; Incorporation of the PIs and SIs into a risk- and performance-based decision process. To support the overall project objective, it is important that information needs and data collection procedures are clearly outlined. Of key significance in this regard is the premise that a performance monitoring system should not be burdened by an excessive number of low-level PIs that may have only a peripheral relationship to safety. Other supporting objectives of the study include: To identify and discuss other issues pertaining to the practical implementation of a safety performance monitoring system (outlining the databases and algorithms needed); and to demonstrate implementation of the preliminary guidance for monitoring and use of the selected set of PIs and SIs, within the proposed framework, via application to the operating history of a NPP having a PSA and readily available event data

HANFORD SAFETY ANALYSIS and RISK ASSESSMENT HANDBOOK (SARAH)

International Nuclear Information System (INIS)

EVANS, C.B.

2004-01-01

The purpose of the Hanford Safety Analysis and Risk Assessment Handbook (SARAH) is to support the development of safety basis documentation for Hazard Category 2 and 3 (HC-2 and 3) U.S. Department of Energy (DOE) nuclear facilities to meet the requirements of 10 CFR 830, ''Nuclear Safety Management''. Subpart B, ''Safety Basis Requirements.'' Consistent with DOE-STD-3009-94, Change Notice 2, ''Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses'' (STD-3009), and DOE-STD-3011-2002, ''Guidance for Preparation of Basis for Interim Operation (BIO) Documents'' (STD-3011), the Hanford SARAH describes methodology for performing a safety analysis leading to development of a Documented Safety Analysis (DSA) and derivation of Technical Safety Requirements (TSR), and provides the information necessary to ensure a consistently rigorous approach that meets DOE expectations. The DSA and TSR documents, together with the DOE-issued Safety Evaluation Report (SER), are the basic components of facility safety basis documentation. For HC-2 or 3 nuclear facilities in long-term surveillance and maintenance (S and M), for decommissioning activities, where source term has been eliminated to the point that only low-level, residual fixed contamination is present, or for environmental remediation activities outside of a facility structure, DOE-STD-1120-98, ''Integration of Environment, Safety, and Health into Facility Disposition Activities'' (STD-1120), may serve as the basis for the DSA. HC-2 and 3 environmental remediation sites also are subject to the hazard analysis methodologies of this standard

Review of the state of the art of human biomonitoring for chemical substances and its application to human exposure assessment for food safety

DEFF Research Database (Denmark)

Choi, Judy; Mørck, Thit Aarøe; Polcher, Alexandra

2015-01-01

Human biomonitoring (HBM) measures the levels of substances in body fluids and tissues. Many countries have conducted HBM studies, yet little is known about its application towards chemical risk assessment, particularly in relation to food safety. Therefore a literature search was performed...... in several databases and conference proceedings for 2002 – 2014. Definitions of HBM and biomarkers, HBM techniques and requirements, and the possible application to the different steps of risk assessment were described. The usefulness of HBM for exposure assessment of chemical substances from food source...... safety areas (namely exposure assessment), and for the implementation of a systematic PMM approach. But further work needs to be done to improve usability. Major deficits are the lack of HBM guidance values on a considerable number of substance groups, for which health based guidance values (HBGVs) have...

Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

International Nuclear Information System (INIS)

2002-06-01

This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

International Nuclear Information System (INIS)

2001-05-01

This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

Technical Guidance from the International Safety Framework for Nuclear Power Source Applications in Outer Space for Design and Development Phases

Science.gov (United States)

Summerer, Leopold

2014-08-01

In 2009, the International Safety Framework for Nuclear Power Source Applications in Outer Space [1] has been adopted, following a multi-year process that involved all major space faring nations in the frame of the International Atomic Energy Agency and the UN Committee on the Peaceful Uses of Outer Space. The safety framework reflects an international consensus on best practices. After the older 1992 Principles Relevant to the Use of Nuclear Power Sources in Outer Space, it is the second document at UN level dedicated entirely to space nuclear power sources.This paper analyses aspects of the safety framework relevant for the design and development phases of space nuclear power sources. While early publications have started analysing the legal aspects of the safety framework, its technical guidance has not yet been subject to scholarly articles. The present paper therefore focuses on the technical guidance provided in the safety framework, in an attempt to assist engineers and practitioners to benefit from these.

Assessment of the safety of foods derived from genetically modified (GM) crops.

Science.gov (United States)

König, A; Cockburn, A; Crevel, R W R; Debruyne, E; Grafstroem, R; Hammerling, U; Kimber, I; Knudsen, I; Kuiper, H A; Peijnenburg, A A C M; Penninks, A H; Poulsen, M; Schauzu, M; Wal, J M

2004-07-01

This paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group 1 of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine test methods for the safety assessment of foods derived from a specific GM crop. Third, the paper provides an overview on developments in this area that may prove of use in the safety assessment of GM crops, and recommendations for research priorities. It is concluded that the combination of existing test methods provides a sound test-regime to assess the safety of GM crops. Advances in our understanding of molecular biology, biochemistry, and nutrition may in future allow further improvement of test methods that will over time render the safety assessment of foods even more effective and informative. Copryright 2004 Elsevier Ltd.

Image Guidance and Assessment of Radiation Induced Gene Therapy

National Research Council Canada - National Science Library

Pelizzari, Charles

2004-01-01

Image guidance and assessment techniques are being developed for combined radiation/gene therapy, which utilizes a radiation-inducible gene promoter to cause expression of tumor necrosis factor alpha...

Guidance Manual for Conducting Screening Level Ecological Risk Assessments at the INEL

Energy Technology Data Exchange (ETDEWEB)

R. L. VanHorn; N. L. Hampton; R. C. Morris

1995-06-01

This document presents reference material for conducting screening level ecological risk assessments (SLERAs)for the waste area groups (WAGs) at the Idaho National Engineering Laboratory. Included in this document are discussions of the objectives of and processes for conducting SLERAs. The Environmental Protection Agency ecological risk assessment framework is closely followed. Guidance for site characterization, stressor characterization, ecological effects, pathways of contaminant migration, the conceptual site model, assessment endpoints, measurement endpoints, analysis guidance, and risk characterization are included.

Regulatory guidance document

International Nuclear Information System (INIS)

1994-05-01

The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

Safety assessment of emergency electric power systems for nuclear power plants

International Nuclear Information System (INIS)

1986-09-01

This paper is intended to assist the safety assessor within a regulatory body, or one working as a consultant, in assessing a given design of the Emergency Electrical Power System. Those non-electric power systems which may be used in a plant design to serve as emergency energy sources are addressed only in their general safety aspects. The paper thus relates closely to Safety Series 50-SG-D7 ''Emergency Power Systems at Nuclear Power Plants'' (1982), as far as it addresses emergency electric power systems. Several aspects are dealt with: the information the assessor may expect from the applicant to fulfill his task of safety review; the main questions the reviewer has to answer in order to determine the compliance with requirements of the NUSS documents; the national or international standards which give further guidance on a certain system or piece of equipment; comments and suggestions which may help to judge a variety of possible solutions

A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.

Science.gov (United States)

Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K; Funk, Christoph; Hop, Cornelis E C A; Humphreys, W Griffith; Igarashi, Fumihiko; James, Alexander D; Kagan, Mark; Khojasteh, S Cyrus; Nedderman, Angus N R; Prakash, Chandra; Runge, Frank; Scheible, Holger; Spracklin, Douglas K; Swart, Piet; Tse, Susanna; Yuan, Josh; Obach, R Scott

2018-06-01

Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and nonclinical studies to generate this information. In this cross-industry review, we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites. Before the MIST guidance was issued, the method of choice for generating comprehensive metabolite profile was radio chromatography. The MIST guidance increased the focus on human drug metabolites and their potential contribution to safety and drug-drug interactions and led to changes in the practices of drug metabolism scientists. In addition, the guidance suggested that human metabolism studies should also be accelerated, which has led to more frequent determination of human metabolite profiles from multiple ascending-dose clinical studies. Generating a comprehensive and quantitative profile of human metabolites has become a more urgent task. Together with technological advances, these events have led to a general shift of focus toward earlier human metabolism studies using high-resolution mass spectrometry and to a reduction in animal radiolabel absorption/distribution/metabolism/excretion studies. The changes induced by the MIST guidance are highlighted by six case studies included herein, reflecting different stages of implementation of the MIST guidance within the pharmaceutical industry. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

78 FR 39284 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

Science.gov (United States)

2013-07-01

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9830-1] Technical Guidance for Assessing Environmental Justice in Regulatory Analysis AGENCY: Environmental Protection Agency (EPA). ACTION: Notice... Environmental Protection Agency (EPA) issued for public comment a document entitled, ``Technical Guidance for...

78 FR 70307 - Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

Science.gov (United States)

2013-11-25

...] Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products... Assessment of Investigational Cellular and Gene Therapy Products'' dated November 2013. The guidance document... products reviewed by the Office of Cellular, Tissue and Gene Therapies (OCTGT). The product areas covered...

Equipment design guidance document for flammable gas waste storage tank new equipment

International Nuclear Information System (INIS)

Smet, D.B.

1996-01-01

This document is intended to be used as guidance for design engineers who are involved in design of new equipment slated for use in Flammable Gas Waste Storage Tanks. The purpose of this document is to provide design guidance for all new equipment intended for application into those Hanford storage tanks in which flammable gas controls are required to be addressed as part of the equipment design. These design criteria are to be used as guidance. The design of each specific piece of new equipment shall be required, as a minimum to be reviewed by qualified Unreviewed Safety Question evaluators as an integral part of the final design approval. Further Safety Assessment may be also needed. This guidance is intended to be used in conjunction with the Operating Specifications Documents (OSDs) established for defining work controls in the waste storage tanks. The criteria set forth should be reviewed for applicability if the equipment will be required to operate in locations containing unacceptable concentrations of flammable gas

Consideration of the FQPA Safety Factor and Other Uncertainty Factors in Cumulative Risk Assessment of Chemicals Sharing a Common Mechanism of Toxicity

Science.gov (United States)

This guidance document provides OPP's current thinking on application of the provision in FFDCA about an additional safety factor for the protection of infants and children in the context of cumulative risk assessments.

The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

Energy Technology Data Exchange (ETDEWEB)

Hughes, P. J. [HM Nuclear Installations Inspectorate Marine Engineering Submarines Defence Nuclear Safety Regulator Serco Assurance Redgrave Court, Merton Road, Bootle L20 7HS (United Kingdom); Westwood, R.N; Mark, R. T. [FLEET HQ, Leach Building, Whale Island, Portsmouth, PO2 8BY (United Kingdom); Tapping, K. [Serco Assurance,Thomson House, Risley, Warrington, WA3 6GA (United Kingdom)

2006-07-01

The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety cases for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)

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

Human reliability analysis in probabilistic safety assessment for nuclear power plants. A Safety Practice. A publication within the NUSS programme

International Nuclear Information System (INIS)

1995-01-01

Probabilistic safety assessment (PSA) is playing an increasingly important role in the safe operation of nuclear power plants throughout the world. In order to establish a consistent framework for conducting PSA studies, for promoting technology transfer of the state of the art, and for encouraging uniformity in the way PSA is carried out, the IAEA is preparing a set of publications which gives guidance on various aspects of PSA. This document presents a practical approach for incorporating human reliability analysis (HRA) into PSA. It describes the steps needed and the documentation that should be provided both to support the PSA itself and to ensure effective communication of important information arising from the studies. It also describes a framework for analysing those human actions which could affect safety and for relating such human influences to specific parts of a PSA. This Safety Practice also addresses the limitations of PSA in taking account of human factors in relation to safety and risk. Refs, figs and tabs

Safety analysis, risk assessment, and risk acceptance criteria

International Nuclear Information System (INIS)

Jamali, K.

1997-01-01

This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities and that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, 'ensuring' plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is 'safe.' Use of RACs requires quantitative estimates of consequence frequency and magnitude

L-Band Digital Aeronautical Communications System Engineering - Initial Safety and Security Risk Assessment and Mitigation

Science.gov (United States)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

This document is being provided as part of ITT's NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract NNC05CA85C, Task 7: "New ATM Requirements--Future Communications, C-Band and L-Band Communications Standard Development." ITT has completed a safety hazard analysis providing a preliminary safety assessment for the proposed L-band (960 to 1164 MHz) terrestrial en route communications system. The assessment was performed following the guidelines outlined in the Federal Aviation Administration Safety Risk Management Guidance for System Acquisitions document. The safety analysis did not identify any hazards with an unacceptable risk, though a number of hazards with a medium risk were documented. This effort represents a preliminary safety hazard analysis and notes the triggers for risk reassessment. A detailed safety hazards analysis is recommended as a follow-on activity to assess particular components of the L-band communication system after the technology is chosen and system rollout timing is determined. The security risk analysis resulted in identifying main security threats to the proposed system as well as noting additional threats recommended for a future security analysis conducted at a later stage in the system development process. The document discusses various security controls, including those suggested in the COCR Version 2.0.

76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

Science.gov (United States)

2011-10-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

Science.gov (United States)

2011-04-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

Computer codes for level 1 probabilistic safety assessment

International Nuclear Information System (INIS)

1990-06-01

Probabilistic Safety Assessment (PSA) entails several laborious tasks suitable for computer codes assistance. This guide identifies these tasks, presents guidelines for selecting and utilizing computer codes in the conduct of the PSA tasks and for the use of PSA results in safety management and provides information on available codes suggested or applied in performing PSA in nuclear power plants. The guidance is intended for use by nuclear power plant system engineers, safety and operating personnel, and regulators. Large efforts are made today to provide PC-based software systems and PSA processed information in a way to enable their use as a safety management tool by the nuclear power plant overall management. Guidelines on the characteristics of software needed for management to prepare a software that meets their specific needs are also provided. Most of these computer codes are also applicable for PSA of other industrial facilities. The scope of this document is limited to computer codes used for the treatment of internal events. It does not address other codes available mainly for the analysis of external events (e.g. seismic analysis) flood and fire analysis. Codes discussed in the document are those used for probabilistic rather than for phenomenological modelling. It should be also appreciated that these guidelines are not intended to lead the user to selection of one specific code. They provide simply criteria for the selection. Refs and tabs

Global guidance on environmental life cycle impact assessment indicators: Progress and case study

DEFF Research Database (Denmark)

Frischknecht, Rolf; Fantke, Peter; Tschümperlin, Laura

2016-01-01

Purpose The life cycle impact assessment (LCIA) guidance flagship project of the United Nations Environment Programme (UNEP)/Society of Environmental Toxicology and Chemistry (SETAC) Life Cycle Initiative aims at providing global guidance and building scientific consensus on environmental LCIA in...

Guidance for implementing an environmental, safety, and health-assurance program. Volume 15. A model plan for line organization environmental, safety, and health-assurance programs

Energy Technology Data Exchange (ETDEWEB)

Ellingson, A.C.; Trauth, C.A. Jr.

1982-01-01

This is 1 of 15 documents designed to illustrate how an Environmental, Safety and Health (ES and H) Assurance Program may be implemented. The generic definition of ES and H Assurance Programs is given in a companion document entitled An Environmental, Safety and Health Assurance Program Standard. This particular document presents a model operational-level ES and H Assurance Program that may be used as a guide by an operational-level organization in developing its own plan. The model presented here reflects the guidance given in the total series of 15 documents.

Security of radioactive sources. Interim guidance for comment

International Nuclear Information System (INIS)

2003-06-01

In previous IAEA publications, there have been only rather general security requirements for non-nuclear radioactive material. These requirements were primarily directed to such issues as unintentional exposure to radiation, negligence and inadvertent loss. However, it is clear that more guidance is needed to not only try and prevent further events involving orphan sources, but also to prevent the deliberate attempt to acquire radioactive sources for malevolent purposes. Member States have requested guidance on the type and nature of security measures that might be put in place and on the methodology to be used in choosing such measures. These requests were also endorsed in the findings of the international conference on 'Security of Radioactive Sources' held in March 2003. Practical advice on assessing and implementing security measures complements the general commitments in the proposed Revised Code of Conduct on Safety and Security of radioactive Sources. A Safety Guide entitled 'Safety and Security of Radiation Sources' that, amongst other things, discusses these issues is being drafted. However, it is recognized that guidance material is required before this document will be finalized in order to allow Member States opportunity to put in place appropriate actions and planning to address current issues. Hence the purpose of the current document is to provide advice on security approaches and to allow comment on detailed recommendations for levels of security on radioactive sources that may be incorporated within the Safety Guide. This report is primarily addressed to Regulatory Authorities but it is also intended to provide guidance to manufacturers, suppliers and users of sources. Its objective is to assist Member States in deciding which security measures are needed to ensure consistency with the International Basic Safety Standards and the Revised Code of Conduct for the Safety and Security of Radioactive Sources. It is recognized that there must be a

Occupational radiation protection. Safety guide

International Nuclear Information System (INIS)

2002-01-01

Occupational exposure to ionizing radiation can occur in a range of industries, medical institutions, educational and research establishments and nuclear fuel cycle facilities. Adequate radiation protection of workers is essential for the safe and acceptable use of radiation, radioactive materials and nuclear energy. In 1996, the Agency published Safety Fundamentals on Radiation Protection and the Safety of Radiation Sources (IAEA Safety Series No. 120) and International Basic Safety Standards for Protection against Ionizing, Radiation and for the Safety of Radiation Sources (IAEA Safety Series No. 115), both of which were jointly sponsored by the Food and Agriculture Organization of the United Nations, the IAEA, the International Labour Organisation, the OECD Nuclear Energy Agency, the Pan American Health Organization and the World Health Organization. These publications set out, respectively, the objectives and principles for radiation safety and the requirements to be met to apply the principles and to achieve the objectives. The establishment of safety requirements and guidance on occupational radiation protection is a major component of the support for radiation safety provided by the IAEA to its Member States. The objective of the IAEA's occupational protection programme is to promote an internationally harmonized approach to the optimization of occupational radiation protection, through the development and application of guidelines for restricting radiation exposures and applying current radiation protection techniques in the workplace. Guidance on meeting the requirements of the Basic Safety Standards for occupational protection is provided in three interrelated Safety Guides, one giving general guidance on the development of occupational radiation protection programmes and two giving more detailed guidance on the monitoring and assessment of workers' exposure due to external radiation sources and from intakes of radionuclides, respectively. These Safety

Occupational radiation protection. Safety guide

International Nuclear Information System (INIS)

2006-01-01

Occupational exposure to ionizing radiation can occur in a range of industries, medical institutions, educational and research establishments and nuclear fuel cycle facilities. Adequate radiation protection of workers is essential for the safe and acceptable use of radiation, radioactive materials and nuclear energy. In 1996, the Agency published Safety Fundamentals on Radiation Protection and the Safety of Radiation Sources (IAEA Safety Series No. 120) and International Basic Safety Standards for Protection against Ionizing, Radiation and for the Safety of Radiation Sources (IAEA Safety Series No. 115), both of which were jointly sponsored by the Food and Agriculture Organization of the United Nations, the IAEA, the International Labour Organisation, the OECD Nuclear Energy Agency, the Pan American Health Organization and the World Health Organization. These publications set out, respectively, the objectives and principles for radiation safety and the requirements to be met to apply the principles and to achieve the objectives. The establishment of safety requirements and guidance on occupational radiation protection is a major component of the support for radiation safety provided by the IAEA to its Member States. The objective of the IAEA's occupational protection programme is to promote an internationally harmonized approach to the optimization of occupational radiation protection, through the development and application of guidelines for restricting radiation exposures and applying current radiation protection techniques in the workplace. Guidance on meeting the requirements of the Basic Safety Standards for occupational protection is provided in three interrelated Safety Guides, one giving general guidance on the development of occupational radiation protection programmes and two giving more detailed guidance on the monitoring and assessment of workers' exposure due to external radiation sources and from intakes of radionuclides, respectively. These Safety

Occupational radiation protection. Safety guide

International Nuclear Information System (INIS)

1999-01-01

Occupational exposure to ionizing radiation can occur in a range of industries, medical institutions, educational and research establishments and nuclear fuel cycle facilities. Adequate radiation protection of workers is essential for the safe and acceptable use of radiation, radioactive materials and nuclear energy. In 1996, the Agency published Safety Fundamentals on Radiation Protection and the Safety of Radiation Sources (IAEA Safety Series No. 120) and International Basic Safety Standards for Protection against Ionizing, Radiation and for the Safety of Radiation Sources (IAEA Safety Series No. 115), both of which were jointly sponsored by the Food and Agriculture Organization of the United Nations, the IAEA, the International Labour Organisation, the OECD Nuclear Energy Agency, the Pan American Health Organization and the World Health Organization. These publications set out, respectively, the objectives and principles for radiation safety and the requirements to be met to apply the principles and to achieve the objectives. The establishment of safety requirements and guidance on occupational radiation protection is a major component of the support for radiation safety provided by the IAEA to its Member States. The objective of the IAEA's occupational protection programme is to promote an internationally harmonized approach to the optimization of occupational radiation protection, through the development and application of guidelines for restricting radiation exposures and applying current radiation protection techniques in the workplace. Guidance on meeting the requirements of the Basic Safety Standards for occupational protection is provided in three interrelated Safety Guides, one giving general guidance on the development of occupational radiation protection programmes and two giving more detailed guidance on the monitoring and assessment of workers' exposure due to external radiation sources and from intakes of radionuclides, respectively. These Safety

Occupational radiation protection. Safety guide

International Nuclear Information System (INIS)

2004-01-01

Occupational exposure to ionizing radiation can occur in a range of industries, medical institutions, educational and research establishments and nuclear fuel cycle facilities. Adequate radiation protection of workers is essential for the safe and acceptable use of radiation, radioactive materials and nuclear energy. In 1996, the Agency published Safety Fundamentals on Radiation Protection and the Safety of Radiation Sources (IAEA Safety Series No. 120) and International Basic Safety Standards for Protection against Ionizing, Radiation and for the Safety of Radiation Sources (IAEA Safety Series No. 115), both of which were jointly sponsored by the Food and Agriculture Organization of the United Nations, the IAEA, the International Labour Organisation, the OECD Nuclear Energy Agency, the Pan American Health Organization and the World Health Organization. These publications set out, respectively, the objectives and principles for radiation safety and the requirements to be met to apply the principles and to achieve the objectives. The establishment of safety requirements and guidance on occupational radiation protection is a major component of the support for radiation safety provided by the IAEA to its Member States. The objective of the IAEA's occupational protection programme is to promote an internationally harmonized approach to the optimization of occupational radiation protection, through the development and application of guidelines for restricting radiation exposures and applying current radiation protection techniques in the workplace. Guidance on meeting the requirements of the Basic Safety Standards for occupational protection is provided in three interrelated Safety Guides, one giving general guidance on the development of occupational radiation protection programmes and two giving more detailed guidance on the monitoring and assessment of workers' exposure due to external radiation sources and from intakes of radionuclides, respectively. These Safety

Guide on a national system for collecting, assessing and disseminating information on safety-related events in nuclear power plants

International Nuclear Information System (INIS)

1983-02-01

There is a wide spectrum of safety significance in the events that can occur during nuclear power plant operations. It is important that lessons be learned from safety-related events (hereinafter referred to as unusual events) so as to improve the safety of nuclear power plants. Hence formal procedures should be established for this purpose. The purpose of this document is to provide guidance to Member States for establishing a system (hereinafter referred to as a national system) for collecting, storing, retrieving, assessing and disseminating information on unusual events in nuclear power plants. The guidance given is based on experience gained in the use of existing national and international systems. This guide covers a national system that is part of a programme to improve nuclear power plant safety using experience gained from operating plants both within and outside the country. Implementing the recommendations in this guide would render any national system compatible with other national systems and facilitate the participation in the IAEA System for Reporting Unusual Events with Safety Significance (hereinafter referred to as the IAEA Incident Reporting System, IAEA-IRS) for more widespread dissemination of lessons learned from nuclear power plant operation

Guidance for the application of an assessment methodology for innovative nuclear energy systems. INPRO manual - Safety of nuclear fuel cycle facilities. Vol. 9 of the final report of phase 1 of the International Project on Innovative Nuclear Reactors and Fuel Cycles (INPRO)

International Nuclear Information System (INIS)

2008-11-01

The International Project on Innovative Nuclear Reactors and Fuel Cycles (INPRO) was initiated in the year 2000, based on a resolution of the IAEA General Conference (GC(44)/RES/21). The main objectives of INPRO are (1) to help to ensure that nuclear energy is available to contribute in fulfilling energy needs in the 21st century in a sustainable manner, (2) to bring together both technology holders and technology users to consider jointly the international and national actions required to achieve desired innovations in nuclear reactors and fuel cycles; and (3) to create a forum to involve all relevant stakeholders that will have an impact on, draw from, and complement the activities of existing institutions, as well as ongoing initiatives at the national and international level. The INPRO manual is comprised of an overview volume (No. 1), and eight additional volumes covering the areas of economics (Volume 2), infrastructure (Volume 3), waste management (Volume 4), proliferation resistance (Volume 5), physical protection (Volume 6), environment (Volume 7), safety of nuclear reactors (Volume 8), and safety of nuclear fuel cycle facilities (laid out in this report) (Volume 9).This report elaborates on the guidance given in the INPRO report 'Methodology for the assessment of innovative nuclear reactors and fuel cycles', IAEA-TECDOC-1434, and the previous INPRO report 'Guidance for the evaluation for innovative nuclear reactors and fuel cycles', IAEA-TECDOC-1362 (2003), in the area of safety of nuclear reactors. The present version of this manual deals with safety issues related to design and operation of mining, milling, refining, conversion, enrichment, fuel fabrication, fuel storage and fuel reprocessing facilities. The INPRO Manual starts with an introduction in Chapter 1. Chapter 2 sets out the necessary input for an INPRO assessment of the safety of an innovative nuclear fuel cycle facility. This includes information on the design for the plant and the safety

76 FR 65734 - Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption...

Science.gov (United States)

2011-10-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0733] Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

Social Impact Assessment : Guidance for assessing and managing the social impacts of projects

NARCIS (Netherlands)

Vanclay, Francis; Esteves, Ana Maria; Aucamp, Ilse; Franks, Daniel

2015-01-01

The purpose of this Guidance Note is to provide advice to various stakeholders about what is expected in good practice social impact assessment (SIA) and social impact management processes, especially in relation to project development. Project development refers to dams, mines, oil and gas

Procedures for conducting probabilistic safety assessments of nuclear power plants (Level 1)

International Nuclear Information System (INIS)

1992-01-01

This report provides guidance for conducting a Level 1 of probabilistic safety assessment (PSA), that is a PSA concerned with events leading to core damage. The scope of this report is confined to internal initiating events (excluding internal fires and floods). A particular aim is to promote a standardized framework, terminology and form of documentation for PSAs so as to facilitate external review of the results of such studies. The report is divided into the following major sections: management and organization; identification of sources of radioactive releases and accident initiators; accident sequence modelling; data assessment and parameter estimation; accident sequence quantification; documentation of the analysis: display and interpretation of result. 45 refs, 7 figs, 23 tabs

IAEA Safety Standards on Management Systems and Safety Culture

International Nuclear Information System (INIS)

Persson, Kerstin Dahlgren

2007-01-01

The IAEA has developed a new set of Safety Standard for applying an integrated Management System for facilities and activities. The objective of the new Safety Standards is to define requirements and provide guidance for establishing, implementing, assessing and continually improving a Management System that integrates safety, health, environmental, security, quality and economic related elements to ensure that safety is properly taken into account in all the activities of an organization. With an integrated approach to management system it is also necessary to include the aspect of culture, where the organizational culture and safety culture is seen as crucial elements of the successful implementation of this management system and the attainment of all the goals and particularly the safety goals of the organization. The IAEA has developed a set of service aimed at assisting it's Member States in establishing. Implementing, assessing and continually improving an integrated management system. (author)

A study on the establishment of safety assessment guidelines of commercial grade item dedication in digitalized safety systems

International Nuclear Information System (INIS)

Hwang, H. S.; Kim, B. R.; Oh, S. H.

1999-01-01

Because of obsolescing the components used in safety related systems of nuclear power plants, decreasing the number of suppliers qualified for the nuclear QA program and increasing maintenance costs of them, utilities have been considering to use commercial grade digital computers as an alternative for resolving such issues. However, commercial digital computers use the embedded pre-existing software, including operating system software, which are not developed by using nuclear grade QA program. Thus, it is necessary for utilities to establish processes for dedicating digital commercial grade items. A regulatory body also needs guidance to evaluate the digital commercial products properly. This paper surveyed the regulations and their regulatory guides, which establish the requirements for commercial grade items dedication, industry standards and guidances applicable to safety related systems. This paper provides some guidelines to be applied in evaluating the safety of digital upgrades and new digital plant protection systems in Korea

Survey of probabilistic methods in safety and risk assessment for nuclear power plant licensing

International Nuclear Information System (INIS)

1984-04-01

After an overview about the goals and general methods of probabilistic approaches in nuclear safety the main features of probabilistic safety or risk assessment (PRA) methods are discussed. Mostly in practical applications not a full-fledged PRA is applied but rather various levels of analysis leading from unavailability assessment of systems over the more complex analysis of the probable core damage stages up to the assessment of the overall health effects on the total population from a certain practice. The various types of application are discussed in relation to their limitation and benefits for different stages of design or operation of nuclear power plants. This gives guidance for licensing staff to judge the usefulness of the various methods for their licensing decisions. Examples of the application of probabilistic methods in several countries are given. Two appendices on reliability analysis and on containment and consequence analysis provide some more details on these subjects. (author)

Selection of the situations taken into account for the safety demonstration of a repository in deep geological formations - French regulatory guidance and IPSN modelling experience

International Nuclear Information System (INIS)

Escalier des Orres, P.; Greneche, D.

1993-01-01

A regulatory guidance has been recently set up in France for the safety assessment of radwaste deep geological disposal: the present paper deals with the methodology related to the safety demonstration of such a disposal, particularly the situations to be taken into account to address the potential evolution of the repository under natural or human induced events. This approach, based on a selection of events considered as reasonably envisageable, relies on a reference scenario characterized by a great stability of the geological formation and on hypothetical situations corresponding to the occurrence of random events of natural origin or of conventional nature. The implementation of this methodology within the framework of the IPSN (Protection and Nuclear Safety Institute, CEA) participation in the CEC EVEREST project is addressed. This programme consists in the evaluation of the sensitivity of the radiological consequences associated to deep radwaste disposal systems to the different elements of the performance assessment (scenario characteristics, phenomena, physico-chemical parameters) in three types of geological formations (granite, salt and clay).(author). 11 refs., 3 tabs

NASA System Safety Handbook. Volume 2: System Safety Concepts, Guidelines, and Implementation Examples

Science.gov (United States)

Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Feather, Martin; Rutledge, Peter; Sen, Dev; Youngblood, Robert

2015-01-01

This is the second of two volumes that collectively comprise the NASA System Safety Handbook. Volume 1 (NASASP-210-580) was prepared for the purpose of presenting the overall framework for System Safety and for providing the general concepts needed to implement the framework. Volume 2 provides guidance for implementing these concepts as an integral part of systems engineering and risk management. This guidance addresses the following functional areas: 1.The development of objectives that collectively define adequate safety for a system, and the safety requirements derived from these objectives that are levied on the system. 2.The conduct of system safety activities, performed to meet the safety requirements, with specific emphasis on the conduct of integrated safety analysis (ISA) as a fundamental means by which systems engineering and risk management decisions are risk-informed. 3.The development of a risk-informed safety case (RISC) at major milestone reviews to argue that the systems safety objectives are satisfied (and therefore that the system is adequately safe). 4.The evaluation of the RISC (including supporting evidence) using a defined set of evaluation criteria, to assess the veracity of the claims made therein in order to support risk acceptance decisions.

Review of probabilistic safety assessments by regulatory bodies

International Nuclear Information System (INIS)

2002-01-01

This report provides guidance to assist regulatory bodies in carrying out reviews of the PSAs produced by utilities. In following this guidance, it is important that the regulatory body is able to satisfy itself that the PSA has been carried out to an acceptable standard and that it can be used for its intended applications. The review process becomes an important phase in determining the acceptability of the PSA since this provides a degree of assurance of the PSA scope, validity and limitations, as well as a better understanding of plants themselves. This report is also intended to assist technical experts managing or performing PSA reviews. A particular aim is to promote a standardized framework, terminology and form of documentation for the results of PSA reviews. The information presented in this report supports IAEA Safety Guide No. GS-G-1.2. Recommendations on the scope and methods to be used by the utility in the preparation of a PSA study is provided in IAEA Safety Guide No. NSG- 1.2. Information on these Safety Guides and other IAEA safety standards for nuclear power plants can be found on the following Internet site: http://www.iaea.org/ns/coordinet. The scope of this report covers the review of Level 1, 2 and 3 PSAs for event sequences occurring in all modes of plant operation (including full power, low power and shutdown). Where the scope of the analysis is narrower than this, a subset of the guidance can be identified and used. Information is provided on carrying out the review of a PSA throughout the PSA production process, i.e. from the initial decision to carry out the PSA through to the completion of the study and the production of the final PSA report. However, the same procedure can be applied to a completed PSA or to one already in progress. As a result of the performance of a PSA, changes to the design or operation of the plant are often identified that would increase the level of safety. This might include the addition of further safety

Women's journey to safety - the Transtheoretical model in clinical practice when working with women experiencing Intimate Partner Violence: a scientific review and clinical guidance.

Science.gov (United States)

Reisenhofer, Sonia; Taft, Angela

2013-12-01

Review the applicability of the Transtheoretical model and provide updated guidance for clinicians working with women experiencing intimate partner violence. Critical review of related primary research conducted from 1990 to March 2013. Women's experiences of creating change within abusive relationships can be located within a stages of change continuum by identifying dominant behavioral clusters. The processes of change and constructs of decisional-balance and turning-points are evident in women's decision-making when they engage in change. Clinicians can use the stages of change to provide a means of assessing women's movement toward their nominated outcomes, and the processes of change, decisional-balance and turning-points, to enhance understanding of, and promote women's movement across stages in their journey to safety. Clinicians should assess women individually for immediate and ongoing safety and well-being, and identify their overarching stage of change. Clinicians can support women in identifying and implementing their personal objectives to enhance self-efficacy and create positive change movement across stages. The three primary objectives identified for clinician support are: 1. Minimizing harm and promoting well-being within an abusive relationship, 2. Achieving safety and well-being within the relationship; halting the abuse, or 3. Achieving safety by ending/leaving intimate relationships. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

The role of risk assessment and safety analysis in integrated safety assessments

International Nuclear Information System (INIS)

Niall, R.; Hunt, M.; Wierman, T.E.

1990-01-01

To ensure that the design and operation of both nuclear and non- nuclear hazardous facilities is acceptable, and meets all societal safety expectations, a rigorous deterministic and probabilistic assessment is necessary. An approach is introduced, founded on the concept of an ''Integrated Safety Assessment.'' It merges the commonly performed safety and risk analyses and uses them in concert to provide decision makers with the necessary depth of understanding to achieve ''adequacy.'' 3 refs., 1 fig

Remote assessment and guidance of liver harvesting for transplantation.

OpenAIRE

Eadie, L. H.

2005-01-01

The harvesting of livers for transplantation involves assessment of the liver's suitability, including an examination of the colour and general appearance of the liver. If the organ is to be split for transplantation into two recipients, the vasculature of the liver must be studied and recorded. Remote assessment of livers and telesurgical guidance could save time and money. This thesis highlights the importance of colour in liver diagnosis, using animal and human models to examine the colour...

Self-Assessment of Nuclear Security Culture in Facilities and Activities. Technical Guidance

International Nuclear Information System (INIS)

2017-01-01

The IAEA has developed a comprehensive methodology for evaluating nuclear security culture. When implemented by a State, this methodology will help to make nuclear security culture sustainable. It will also promote cooperation and the sharing of good practices related to nuclear security culture. This publication is the first guidance for assessing nuclear security culture and analysing its strengths and weaknesses within a facility or activity, or an organization. It reflects, within the context of assessment, the nuclear security culture model, principles and criteria set out in the Implementing Guide, IAEA Nuclear Security Series No. 7. This guidance will be useful for organizations and operating facilities in conducting the self-assessment of nuclear security culture by providing practical methods and tools. It will also help regulatory bodies and other competent authorities to understand the self-assessment methodology used by operators, encourage operators to start the self-assessment process or, if appropriate, conduct independent assessments of nuclear security culture.

75 FR 71133 - Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and...

Science.gov (United States)

2010-11-22

... Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0571] Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of...

Guidance to Risk-Informed Evaluation of Technical Specifications using PSA

International Nuclear Information System (INIS)

Baeckstroem, Ola; Haeggstroem, Anna; Maennistoe, Ilkka

2010-04-01

This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance

Guidance to risk-informed evaluation of technical specifications using PSA

International Nuclear Information System (INIS)

Baeckstroem, O.; Haeggstroem, A.; Maennistoe, I.

2010-10-01

This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance

Guidance to risk-informed evaluation of technical specifications using PSA

Energy Technology Data Exchange (ETDEWEB)

Baeckstroem, O.; Haeggstroem, A. (Scandpower AB, Stockholm (Sweden)); Maennistoe, I. (VTT, Helsingfors (Finland))

2010-04-15

This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance

Guidance to Risk-Informed Evaluation of Technical Specifications using PSA

Energy Technology Data Exchange (ETDEWEB)

Baeckstroem, Ola; Haeggstroem, Anna (Scandpower AB, Stockholm (Sweden)); Maennistoe, Ilkka (VTT, Helsingfors (Finland))

2010-04-15

This report presents guidance for evaluation of Technical Specification conditions with PSA. It covers quality in PSA, how to verify that the PSA model is sufficiently robust and sufficiently complete and general requirements on methods. Acceptance criteria for evaluation of changes in the TS conditions are presented. As the probabilistic safety assessment (PSA) has developed over the years, it has demonstrated to constitute a useful tool for evaluating many aspects of the TS from a risk point of view. and in that way making the PSAs as well as the decision tools better. This also means that it will be possible to take credit for safety system overcapacity as well as inherent safety features and strength of non-safety classed systems. However, PSA is only one of the tools that shall be used in an evaluation process of TS changes (strengthening/relaxation). PSA is an excellent tool to be used to verify the importance, and thereby possibly relaxation, of TS requirements. But, since PSA is only one tool in the evaluation, it is not sufficient in itself for defining which equipment that shall or shall not have TS requirements. The purpose of this guidance document is to provide general requirements, requirements on methods and acceptance criteria on risk-informed evaluation of TS changes based on PSA. The purpose is not to provide a single solution. As part of the review of the TS conditions this guidance specify requirements on: - Quality verification of the PSA model; - Verification that the PSA model is sufficiently robust with regard to SSCs for which requirements both are and are not defined by the TS; - Verification that the SSCs, for which TS demands are to be evaluated, are modelled in a sufficient manner; - Methods for performing the evaluation; - Which evaluation criteria that shall be used (and how that is verified to be correct); - Acceptance criteria: This guidance also briefly discusses the documentation of the analysis of the TS changes. This guidance

DOE Handbook: Supplementary guidance and design experience for the fusion safety standards DOE-STD-6002-96 and DOE-STD-6003-96

Energy Technology Data Exchange (ETDEWEB)

None

1999-01-01

Two standards have been developed that pertain to the safety of fusion facilities. These are DOE- STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements, and DOE-STD-6003-96, Safety of Magnetic Fusion Facilities: Guidance. The first of these standards identifies requirements that subscribers to that standard must meet to achieve safety in fusion facilities. The second standard contains guidance to assist in meeting the requirements identified in the first This handbook provides additional documentation on good operations and design practices as well as lessons learned from the experiences of designers and operators of previous fusion facilities and related systems. It is intended to capture the experience gained in the various fields and pass it on to designers of future fusion facilities as a means of enhancing success and safety. The sections of this document are presented according to the physical location of the major systems of a fusion facility, beginning with the vacuum vessel and proceeding to those systems and components outside the vacuum vessel (the "Ex-vessel Systems"). The last section describes administrative procedures that cannot be localized to specific components. It has been tacitly assumed that the general structure of the fusion facilities addressed is that of a tokamak though the same principles would apply to other magnetic confinement options.

Review of SKB's interim report of SR-Can: SKI's and SSI's evaluation of SKB's up-dated methodology for safety assessment

International Nuclear Information System (INIS)

Dverstorp, Bjoern; Moberg, Leif; Wiebert, Anders; Xu Shulan; Stroemberg, Bo; Kautsky, Fritz; Lilja, Christina; Simic, Eva; Sundstroem, Benny; Toverud, Oeivind

2005-07-01

This report presents the findings of a review of the Swedish Nuclear Fuel and Waste Management Co.'s (SKB) interim report of the safety assessment SR-Can (SKB TR 04-11), conducted by the Swedish Radiation Protection Authority (SSI) and the Swedish Nuclear Power Inspectorate (SKI). SKB's interim report describes and exemplifies the safety assessment methodology that SKB plans to use in the oncoming licence applications for an encapsulation plant and a final repository for spent nuclear fuel. The authorities' review takes into account the findings of an international peer review of SKB's interim report. The authorities conclude that SKB has improved its safety assessment methodology in several aspects compared to earlier safety reports. Among other things the authorities commend SKB for giving a comprehensive account of relevant regulations and guidance, and for the systematic approach to identification and documentation of features, events and processes that need to be considered in the safety assessment. However, the authorities also conclude that important parts of SKB's method need to be further developed before they are mature enough to be used as a basis for a license application. The authorities' overall assessment is summarised in chapter 8 of this report

Disposal of disused sealed sources and approach for safety assessment of near surface disposal facilities (national practice of Ukraine)

International Nuclear Information System (INIS)

Alekseeva, Z.; Letuchy, A.; Tkachenko, N.V.

2003-01-01

' (NRBU-97/D-2000). A guidance on safety assessment methodology application basing on ISAM methodology is under development. The final result of the work is expected to be the technical document that will include both the guidance on application of near surface disposal safety assessment methodology and the demonstration of developed guidance application for the case of module repository being constructed within exclusive zone

Assessment of Safety Culture

International Nuclear Information System (INIS)

Bilic Zabric, T.; Kavsek, D.

2006-01-01

A strong safety culture leads to more effective conduct of work and a sense of accountability among managers and employees, who should be given the opportunity to expand skills by training. The resources expended would thus result in tangible improvements in working practices and skills, which encourage further improvement of safety culture. In promoting an improved safety culture, NEK has emphasized both national and organizational culture with an appropriate balance of behavioural sciences and quality management systems approaches. In recent years there has been particular emphasis put on an increasing awareness of the contribution that human behavioural sciences can make to develop good safety practices. The purpose of an assessment of safety culture is to increase the awareness of the present culture, to serve as a basis for improvement and to keep track of the effects of change or improvement over a longer period of time. There is, however, no single approach that is suitable for all purposes and which can measure, simultaneously, all the intangible aspects of safety culture, i.e. the norms, values, beliefs, attitudes or the behaviours reflecting the culture. Various methods have their strengths and weaknesses. To prevent significant performance problems, self-assessment is used. Self-assessment is the process of identifying opportunities for improvement actively or, in some cases, weaknesses that could cause more serious errors or events. Self-assessments are an important input to the corrective action programme. NEK has developed questionnaires for safety culture self-assessment to obtain information that is representative of the whole organization. Questionnaires ensure a greater degree of anonymity, and create a less stressful situation for the respondent. Answers to questions represent the more apparent and conscious values and attitudes of the respondent. NEK proactively co-operates with WANO, INPO, IAEA in the areas of Safety Culture and Human

Objective and character of safety culture

International Nuclear Information System (INIS)

Aastrand, K.

2005-01-01

The main topics of the lecture include: (1) concepts of safety culture introduced in INSAG-4, (2) stages of development of safety culture, (3) general practises to develop organizational effectiveness as a means of implementing and improving safety culture, (4) specific practises to develop safety culture applying to all stages of a nuclear installation's life cycle, (5) suggestions on assessing the progress of development of safety culture in an organization and on evaluating the influence of major environmental and internal organizational factors on that culture, and (6) guidance on the detection of incipient weaknesses in safety culture that may be of particular interest to regulators and those responsible for self-assessment in organization

Probabilistic safety assessments of nuclear power plants for low power and shutdown modes

International Nuclear Information System (INIS)

2000-03-01

Within the past several years the results of nuclear power plant operating experience and performance of probabilistic safety assessments (PSAs) for low power and shutdown operating modes have revealed that the risk from operating modes other than full power may contribute significantly to the overall risk from plant operations. These early results have led to an increased focus on safety during low power and shutdown operating modes and to an increased interest of many plant operators in performing shutdown and low power PSAs. This publication was developed to provide guidance and insights on the performance of PSA for shutdown and low power operating modes. The preparation of this publication was initiated in 1994. Two technical consultants meetings were conducted in 1994 and one in February 1999 in support of the development of this report

Guidance for implementing an environmental, safety, and health assurance program. Volume 10. Model guidlines for line organization environmental, safety and health audits and appraisals

International Nuclear Information System (INIS)

Ellingson, A.C.

1981-10-01

This is 1 of 15 documents designed to illustrate how an Environmental, Safety and Health (ES and H) Assurance Program may be implemented. The generic definition of ES and H Assurance Programs is given in a companion document entitled An Environmental, Safety and Health Assurance Program Standard. The Standard specifies that the operational level of an institution must have an internal assurance function, and this document provides guidance for the audit/appraisal portion of the operational level's ES and H program. The appendixes include an ES and H audit checklist, a sample element rating guide, and a sample audit plan for working level line organization internal audits

Fewer can be More: Nuclear Safety and Security Culture Self-Assessment in the Hungarian Public Ltd. for Radioactive Waste Management

International Nuclear Information System (INIS)

Horváth, K.; Solymosi, M.; Vass, G.

2016-01-01

The Hungarian regulator and operators show strong commitment towards robust nuclear safety and security culture. The paper discusses the evolution and the basis of the regulation of Hungarian safety and security culture. Because of security considerations nuclear safety incidents have always received and for sure will receive more publicity than malicious acts. That is probably the main reason behind that mostly nuclear safety incidents influence the common beliefs. This kind of primacy is noticeable as well in regulations and also in practice. Although there is a strong connection nuclear safety and security culture, their relationship has not been researched for a long time. The paper also presents an already achieved, combined nuclear safety and security culture survey type assessment. Survey is a well known type of organizational culture self assessment. The applied methods, relationship between these two cultures and of course some difficulties of the process are summarized. The presented method is appropriate to combine different guidance and characteristics to measure different attitude in a single survey. The method in practice is shown through the nuclear safety and security culture assessment conducted at Hungarian Public Ltd. Of Radioactive Waste Management. (author)

Safety assessment, safety performance indicators at the Paks Nuclear Power Plant

International Nuclear Information System (INIS)

Baji, C.; Vamos, G.; Toth, J.

2001-01-01

The Paks Nuclear Power Plant has been using different methods of safety assessment (event analysis, self-assessment, probabilistic safety analysis), including performance indicators characterizing both operational and safety performance since the early years of operation of the plant. Regarding the safety performance, the indicators include safety system performance, number of scrams, release of radioactive materials, number of safety significant events, industrial safety indicator, etc. The Paks NPP also reports a set of ten indicators to WANO Performance Indicator Programme which, among others, include safety related indicators as well. However, a more systematic approach to structuring and trending safety indicators is needed so that they can contribute to the enhancement of the operational safety. A more comprehensive set of indicators and a systematic evaluation process was introduced in 1996. The performance indicators framework proposed by the IAEA was adapted to Paks in this year to further improve the process. Safety culture assessment and characterizing safety culture is part of the assessment process. (author)

Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.

Science.gov (United States)

Samuel, Gbeminiyi O; Hoffmann, Sebastian; Wright, Robert A; Lalu, Manoj Mathew; Patlewicz, Grace; Becker, Richard A; DeGeorge, George L; Fergusson, Dean; Hartung, Thomas; Lewis, R Jeffrey; Stephens, Martin L

2016-01-01

Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

IAEA safety requirements for safety assessment of fuel cycle facilities and activities

International Nuclear Information System (INIS)

Jones, G.

2013-01-01

The IAEA's Statute authorises the Agency to establish standards of safety for protection of health and minimisation of danger to life and property. In that respect, the IAEA has established a Safety Fundamentals publication which contains ten safety principles for ensuring the protection of workers, the public and the environment from the harmful effects of ionising radiation. A number of these principles require safety assessments to be carried out as a means of evaluating compliance with safety requirements for all nuclear facilities and activities and to determine the measures that need to be taken to ensure safety. The safety assessments are required to be carried out and documented by the organisation responsible for operating the facility or conducting the activity, are to be independently verified and are to be submitted to the regulatory body as part of the licensing or authorisation process. In addition to the principles of the Safety Fundamentals, the IAEA establishes requirements that must be met to ensure the protection of people and the environment and which are governed by the principles in the Safety Fundamentals. The IAEA's Safety Requirements publication 'Safety Assessment for Facilities and Activities', establishes the safety requirements that need to be fulfilled in conducting and maintaining safety assessments for the lifetime of facilities and activities, with specific attention to defence in depth and the requirement for a graded approach to the application of these safety requirements across the wide range of fuel cycle facilities and activities. Requirements for independent verification of the safety assessment that needs to be carried out by the operating organisation, including the requirement for the safety assessment to be periodically reviewed and updated are also covered. For many fuel cycle facilities and activities, environmental impact assessments and non-radiological risk assessments will be required. The

The European ASAMPSA_E project : towards guidance to model the impact of high amplitude natural hazards in the probabilistic safety assessment of nuclear power plants. Information on the project progress and needs from the geosciences.

Science.gov (United States)

Raimond, Emmanuel; Decker, Kurt; Guigueno, Yves; Klug, Joakim; Loeffler, Horst

2015-04-01

The Fukushima nuclear accident in Japan resulted from the combination of two correlated extreme external events (earthquake and tsunami). The consequences, in particular flooding, went beyond what was considered in the initial engineering design design of nuclear power plants (NPPs). Such situations can in theory be identified using probabilistic safety assessment (PSA) methodology. PSA results may then lead industry (system suppliers and utilities) or Safety Authorities to take appropriate decisions to reinforce the defence-in-depth of the NPP for low probability event but high amplitude consequences. In reality, the development of such PSA remains a challenging task. Definitions of the design basis of NPPs, for example, require data on events with occurrence probabilities not higher than 10-4 per year. Today, even lower probabilities, down to 10-8, are expected and typically used for probabilistic safety analyses (PSA) of NPPs and the examination of so-called design extension conditions. Modelling the combinations of natural or man-made hazards that can affect a NPP and affecting some meaningful probability of occurrence seems to be difficult. The European project ASAMPSAE (www.asampsa.eu) gathers more than 30 organizations (industry, research, safety control) from Europe, US and Japan and aims at identifying some meaningful practices to extend the scope and the quality of the existing probabilistic safety analysis developed for nuclear power plants. It offers a framework to discuss, at a technical level, how "extended PSA" can be developed efficiently and be used to verify if the robustness of Nuclear Power Plants (NPPs) in their environment is sufficient. The paper will present the objectives of this project, some first lessons and introduce which type of guidance is being developed. It will explain the need of expertise from geosciences to support the nuclear safety assessment in the different area (seismotectonic, hydrological, meteorological and biological

Experiences in assessing safety culture

International Nuclear Information System (INIS)

Spitalnik, J.

2002-01-01

Based on several Safety Culture self-assessment applications in nuclear organisations, the paper stresses relevant aspects to be considered when programming an assessment of this type. Reasons for assessing Safety Culture, basic principles to take into account, necessary resources, the importance of proper statistical analyses, the feed-back of results, and the setting up of action plans to enhance Safety Culture are discussed. (author)

Analysis of cold leg LOCA with failed HPSI by means of integrated safety assessment methodology

International Nuclear Information System (INIS)

Gonzalez-Cadelo, J.; Queral, C.; Montero-Mayorga, J.

2014-01-01

Highlights: • Results of ISA for considered sequences endorse EOPs guidance in an original way. • ISA allows to obtain accurate available times for accident management actions. • RCP-trip adequacy and available time for beginning depressurization are evaluated. • ISA minimizes the necessity of expert judgment to perform safety assessment. - Abstract: The integrated safety assessment (ISA) methodology, developed by the Spanish Nuclear Safety Council (CSN), has been applied to a thermal–hydraulic analysis of cold leg LOCA sequences with unavailable High Pressure Injection System in a Westinghouse 3-loop PWR. This analysis has been performed with TRACE 5.0 patch 1 code. ISA methodology allows obtaining the Damage Domain (the region of space of parameters where a safety limit is exceeded) as a function of uncertain parameters (break area) and operator actuation times, and provides to the analyst useful information about the impact of these uncertain parameters in safety concerns. In this work two main issues have been analyzed: the effect of reactor coolant pump trip and the available time for beginning of secondary-side depressurization. The main conclusions are that present Emergency Operating Procedures (EOPs) are adequate for managing this kind of sequences and the ISA methodology is able to take into account time delays and parameter uncertainties

Probabilistic safety analysis and interpretation thereof

International Nuclear Information System (INIS)

Steininger, U.; Sacher, H.

1999-01-01

Increasing use of the instrumentation of PSA is being made in Germany for quantitative technical safety assessment, for example with regard to incidents which must be reported and forwarding of information, especially in the case of modification of nuclear plants. The Commission for Nuclear Reactor Safety recommends regular execution of PSA on a cycle period of ten years. According to the PSA guidance instructions, probabilistic analyses serve for assessing the degree of safety of the entire plant, expressed as the expectation value for the frequency of endangering conditions. The authors describe the method, action sequence and evaluation of the probabilistic safety analyses. The limits of probabilistic safety analyses arise in the practical implementation. Normally the guidance instructions for PSA are confined to the safety systems, so that in practice they are at best suitable for operational optimisation only to a limited extent. The present restriction of the analyses has a similar effect on power output operation of the plant. This seriously degrades the utilitarian value of these analyses for the plant operators. In order to further develop PSA as a supervisory and operational optimisation instrument, both authors consider it to be appropriate to bring together the specific know-how of analysts, manufacturers, plant operators and experts. (orig.) [de

Significant Guidance Issued by the Federal Motor Carrier Safety Administration

Data.gov (United States)

Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

Assessment and management of aging of nuclear power plant safety-related structures

International Nuclear Information System (INIS)

Naus, D.J.; Graves, H.L. III; Ellingwood, B.R.

2003-01-01

Background information and data have been developed for improving existing and developing new methods to assist in quantifying the effects of age-related degradation on the performance of nuclear power plant (NPP) safety-related structures. Factors that can lead to age-related degradation of safety-related structures are identified and their manifestations described. Current regulatory testing and inspection requirements are reviewed and a summary of degradation experience presented. Techniques commonly used to inspect NPP concrete structures to assess and quantify age-related degradation are summarized. An approach for conduct of condition assessments of structures in NPPs is presented. Criteria, based primarily on visual indications, are provided for use in classification and assessment of concrete degradation. Materials and techniques for repair of degraded structures are noted and guidance provided on repair options available for various forms of degradation. A probabilistic methodology for condition assessment and reliability-based life prediction has been developed and applied to structures subject to combinations of structural load processes and to structural systems. The methodology has also been used to investigate optimization of in-service inspection and maintenance strategies to maintain failure probability below a specified target value as well as to minimize costs. Fragility assessments involving analytical solutions and finite-element methods have been utilized to predict the effect of aging degradation on structural component performance. (author)

Metrics design for safety assessment

NARCIS (Netherlands)

Luo, Yaping; van den Brand, M.G.J.

2016-01-01

Context:In the safety domain, safety assessment is used to show that safety-critical systems meet the required safety objectives. This process is also referred to as safety assurance and certification. During this procedure, safety standards are used as development guidelines to keep the risk at an

EMP Attachment 3 DOE-SC PNNL Site Dose Assessment Guidance

Energy Technology Data Exchange (ETDEWEB)

Snyder, Sandra F.

2011-12-21

This Dose Assessment Guidance (DAG) describes methods to use to determine the Maximally-Exposed Individual (MEI) location and to estimate dose impact to that individual under the U.S. Department of Energy Office of Science (DOE-SC) Pacific Northwest National Laboratory (PNNL) Site Environmental Monitoring Plan (EMP). This guidance applies to public dose from radioactive material releases to the air from PNNL Site operations. This document is an attachment to the Pacific Northwest National Laboratory (PNNL) Environmental Monitoring Plan (EMP) and describes dose assessment guidance for radiological air emissions. The impact of radiological air emissions from the U.S. Department of Energy Office of Science (DOE-SC) PNNL Site is indicated by dose estimates to a maximally exposed member of the public, referred to as the maximally exposed individual (MEI). Reporting requirements associated with dose to members of the public from radiological air emissions are in 40 CFR Part 61.94, WAC 246-247-080, and DOE Order 458.1. The DOE Order and state standards for dose from radioactive air emissions are consistent with U.S. Environmental Protection Agency (EPA) dose standards in 40 CFR 61.92 (i.e., 10 mrem/yr to a MEI). Despite the fact that the current Contract Requirements Document (CRD) for the DOE-SC PNNL Site operations does not include the requirement to meet DOE CRD 458.1, paragraph 2.b, public dose limits, the DOE dose limits would be met when EPA limits are met.

DOE Handbook: Supplementary guidance and design experience for the fusion safety standards DOE-STD-6002-96 and DOE-STD-6003-96

International Nuclear Information System (INIS)

1999-01-01

Two standards have been developed that pertain to the safety of fusion facilities. These are DOE- STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements, and DOE-STD-6003-96, Safety of Magnetic Fusion Facilities: Guidance. The first of these standards identifies requirements that subscribers to that standard must meet to achieve safety in fusion facilities. The second standard contains guidance to assist in meeting the requirements identified inthefirst This handbook provides additional documentation on good operations and design practices as well as lessons learned from the experiences of designers and operators of previous fusion facilities and related systems. It is intended to capture the experience gained in the various fields and pass it on to designers of future fusion facilities as a means of enhancing success and safeiy. The sections of this document are presented according to the physical location of the major systems of a t%sion facility, beginning with the vacuum vessel and proceeding to those systems and components outside the vacuum vessel (the ''Ex-vessel Systems''). The last section describes administrative procedures that cannot be localized to specific components. It has been tacitly assumed that the general structure of the fusion facilities addressed is that of a tokamak though the same principles would apply to other magnetic confinement options

The role of PRA in the safety assessment of VVER Nuclear Power Plants in Ukraine

International Nuclear Information System (INIS)

Kot, C.

1999-01-01

Ukraine operates thirteen (13) Soviet-designed pressurized water reactors, VVERS. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs), in accordance with new SAR content requirements issued in September 1995, by the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine. The requirements are in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. The last two requirements, on PRA and BDBA, are new, and the DBA requirements are an expanded version of the older SAR requirements. The US Department of Energy (USDOE), as part of its Soviet-Designed Reactor Safety activities, is providing assistance and technology transfer to Ukraine to support their nuclear power plants (NPPs) in developing a Western-type technical basis for the new SARs. USDOE sponsored In-Depth Safety Assessments (ISAs) are in progress at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1, and a follow-on study has been initiated at Khmenytskyy Unit 1. The ISA projects encompass most areas of plant safety evaluation, but the initial emphasis is on performing a detailed, plant-specific Level 1 Internal Events PRA. This allows the early definition of the plant risk profile, the identification of risk significant accident sequences and plant vulnerabilities and provides guidance for the remainder of the safety assessments

Towards harmonised self assessment of research reactor safety status in operating organisations

International Nuclear Information System (INIS)

Kirchsteiger, C.; Boeck, H.

2006-01-01

The objective of this paper is to describe the development of a methodology and corresponding web-based tool for mapping and cross-comparing the safety approaches in European and other Research Reactor (RR) facilities in order to detect the principal similarities and differences. As an example, the performance of a Probabilistic Safety Assessment (PSA) for RRs is mapped, as follows: is PSA performed at all? (Yes/No); if so, is PSA mandatory or just recommended? (Yes/No); what is the scope of PSA?, its objective? and practical use? (set of more detailed questions), etc. In this way, information on different types of safety verification practices and requirements for RRs from Europe, Argentina, Australia, Canada, South Africa and the USA has been collected in a systematic way and included in the web-based benchmarking tool DARES (DAtabase for REsearch Reactor Safety). DARES has been developed and filled with sample data by the European Commission's Joint Research Centre (JRC) together with members of the European Research Reactors Operator Group (RROG). A systematic mapping by using DARES in parallel to an international Working Group, consisting of both operators and authorities could be the starting point towards harmonisation of RR safety verification on an international level. In addition, the availability of a user-friendly Information System on the Internet such as DARES containing this information is considered a useful mechanism to exchange international experiences and practices in the area among qualified users. This approach is currently considered to be proposed to the International Atomic Energy Agency (IAES) as one possible application of the recently adopted IAEA Code of Conduct on the Safety of Research Reactors. The resulting process would be a self-assessment of the RR safety status in regulatory bodies and operating organisations relative to the guidance in the Code, practically realised and monitored by an Information System similar to DARES. (orig.)

Correlation between safety climate and contractor safety assessment programs in construction.

Science.gov (United States)

Sparer, Emily H; Murphy, Lauren A; Taylor, Kathryn M; Dennerlein, Jack T

2013-12-01

Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Four hundred and one construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers' safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. Am. J. Ind. Med. 56:1463-1472, 2013. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

Tiered guidance for risk-informed environmental health and safety testing of nanotechnologies

International Nuclear Information System (INIS)

Collier, Zachary A.; Kennedy, Alan J.; Poda, Aimee R.; Cuddy, Michael F.; Moser, Robert D.; MacCuspie, Robert I.; Harmon, Ashley; Plourde, Kenton; Haines, Christopher D.; Steevens, Jeffery A.

2015-01-01

Provided the rapid emergence of novel technologies containing engineered nanomaterials, there is a need to better understand the potential environmental, health, and safety effects of nanotechnologies before wide-scale deployment. However, the unique properties of nanomaterials and uncertainty regarding applicable test methods have led to a lack of consensus regarding the collection and evaluation of data related to hazard and exposure potentials. Often, overly conservative approaches to characterization and data collection result in prolonged, unfocused, or irrelevant testing, which increases costs and delays deployment. In this paper, we provide a novel testing guidance framework for determining whether a nanotechnology has the potential to release material with nano-specific parameters that pose a risk to humans or the environment. The framework considers methods to categorize nanotechnologies by their structure and within their relevant-use scenarios to inform testing in a time- and resource-limited reality. Based on the precedent of dredged sediment testing, a five-tiered approach is proposed in which opportunities are presented to conclude testing once sufficient risk-related information has been collected, or that the technology in question does not require nano-specific scrutiny. A series of screening stages are suggested, covering relevant aspects including size, surface area, distribution, unique behaviors, and release potential. The tiered, adaptive guidance approach allows users to concentrate on collecting the most relevant data, thus accelerating technology deployment while minimizing risk

Safety assessment principles for nuclear plants

International Nuclear Information System (INIS)

1992-01-01

The present Safety Assessment Principles result from the revision of those which were drawn up following a recommendation arising from the Sizewell-B enquiry. The principles presented here relate only to nuclear safety; there is a section on risks from normal operation and accident conditions and the standards against which those risks are assessed. A major part of the document deals with the principles that cover the design of nuclear plants. The revised Safety assessment principles are aimed primarily at the safety assessment of new nuclear plants but they will also be used in assessing existing plants. (UK)

Storage of Spent Nuclear Fuel. Specific Safety Guide

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide provides recommendations and guidance on the storage of spent nuclear fuel. It covers all types of storage facilities and all types of spent fuel from nuclear power plants and research reactors. It takes into consideration the longer storage periods that have become necessary owing to delays in the development of disposal facilities and the decrease in reprocessing activities. It also considers developments associated with nuclear fuel, such as higher enrichment, mixed oxide fuels and higher burnup. The Safety Guide is not intended to cover the storage of spent fuel if this is part of the operation of a nuclear power plant or spent fuel reprocessing facility. Guidance is provided on all stages for spent fuel storage facilities, from planning through siting and design to operation and decommissioning, and in particular retrieval of spent fuel. Contents: 1. Introduction; 2. Protection of human health and the environment; 3. Roles and responsibilities; 4. Management system; 5. Safety case and safety assessment; 6. General safety considerations for storage of spent fuel. Appendix I: Specific safety considerations for wet or dry storage of spent fuel; Appendix II: Conditions for specific types of fuel and additional considerations; Annex: I: Short term and long term storage; Annex II: Operational and safety considerations for wet and dry spent fuel storage facilities; Annex III: Examples of sections of operating procedures for a spent fuel storage facility; Annex IV: Site conditions, processes and events for consideration in a safety assessment (external human induced phenomena); Annex V: Site conditions, processes and events for consideration in a safety assessment (external natural phenomena); Annex VI: Site conditions, processes and events for consideration in a safety assessment (external human induced phenomena); Annex VII: Postulated initiating events for consideration in a safety assessment (internal phenomena).

The IAEA's sub programme on the safety of radiation sources and the security of radioactive materials

International Nuclear Information System (INIS)

Ortiz, P.; Oresegun, M.; Bilbao, A.; Webb, G.A.M.; Cunninghan, R.

1998-01-01

In compliance with its mandate to establish standards of safety and to provide for their application with respect to radiation sources, the International Atomic Energy Agency has developed a subprogramme aimed at providing Member States guidance and assistance on achieving regulatory control and the safe use of the sources. The guidance addresses the establishment of a Regulatory Programme, with focus on a system for notification and authorization (registration and licensing) and inspection of radiation sources, including check lists for review of safety. It also includes methods for assessing its effectiveness of the Regulatory Programme and is complemented with tools for the management of data by the Regulatory Authority and Services to assist Member States in assessment and implementation of the programme. In addition, technical guidance for the safety of radiation sources includes both prospective and retrospective safety assessment. Retrospective methods have been used resulting in the publication and dissemination of information and lessons from accidents, both individual accident reports and lessons from collection of accident for the practices with major sources (industrial radiography, irradiators and radiotherapy). Prospective methods will include guidance on the application of the principles of radiation protection to potential exposure, as well as methods to apply the principles, such as identification and evaluation of scenarios. Practice specific reports will address the major radiation sources. A research programme will be dedicated to apply Probabilistic Safety Assessment (PSA) to radiation sources. (author)

76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

Science.gov (United States)

2011-01-04

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

Development of safety related technology and infrastructure for safety assessment

International Nuclear Information System (INIS)

Venkat Raj, V.

1997-01-01

Development and optimum utilisation of any technology calls for the building up of the necessary infrastructure and backup facilities. This is particularly true for a developing country like India and more so for an advanced technology like nuclear technology. Right from the inception of its nuclear power programme, the Indian approach has been to develop adequate infrastructure in various areas such as design, construction, manufacture, installation, commissioning and safety assessment of nuclear plants. This paper deals with the development of safety related technology and the relevant infrastructure for safety assessment. A number of computer codes for safety assessment have been developed or adapted in the areas of thermal hydraulics, structural dynamics etc. These codes have undergone extensive validation through data generated in the experimental facilities set up in India as well as participation in international standard problem exercises. Side by side with the development of the tools for safety assessment, the development of safety related technology was also given equal importance. Many of the technologies required for the inspection, ageing assessment and estimation of the residual life of various components and equipment, particularly those having a bearing on safety, were developed. This paper highlights, briefly, the work carried out in some of the areas mentioned above. (author)

Use and development of probabilistic safety assessment - CSNI WGRISK

International Nuclear Information System (INIS)

Siu, Nathan; Monninger, John; Gomez-Cobo, Ana; Kao, Tsu-Mu; Schoen, Gerhard; Gunsell, Lars; Nyman, Ralph; Jelinek, Tomas; Hultquist, Goeran; Rapp, Anders; Eriksson, Stefan; Lantaron, Alfredo; Vojnovic, Djordje; Husarcek, Jan; Kovacs, Zoltan; Versteeg, M.F.; Lopez Morones, Ramon; Lee, Chang-Ju; Fukuda, Mamoru; Burgazzi, Luciano; Caporali, Rino; RoeWEKAMP, Marina; MACSUGA, Geza; Bareith, Attila; Lanore, J.M.; Sorel, Vincent; Virolainen, Reino; Patrik, Milan; Mlady, Ondrej; Raducu, Gheorghe; De Gelder, Pieter; Hendrickx, Isabelle; Lanore, Jeanne-Marie; Murphy, Joseph A.; Shepherd, Charles; Pyy, Pekka T.; Mauny, Elisabeth

2007-01-01

The CSNI WGRISK produced a report in July 2002 on 'The Use and Development of Probabilistic Safety Assessment in NEA Member Countries'. This provides a description of the PSA programmes in the member countries at the time that the report was produced. However, there have been significant developments in PSA since 2002. Consequently, a decision was made at the WGRISK meeting in October 2005 to produce an updated version of the report. The aim was to produce an updated, stand alone version of the report that presents an analysis of the position on the use and development of PSA in the WGRISK member countries as of spring 2006. A detailed questionnaire was circulated to WGRISK members and to the IAEA to ascertain the state of the art in PSA use and development at the end of 2006. Detailed responses were prepared by 20 countries totalling several hundred pages of information. After first compilation of information, an updating round was organized by showing to the countries all the answers and the summary made of them by a small group of experts. The process led to some clarifications and more consistency in the report. The collected information was finally analyzed and summarized to reach the conclusions presented in this report. The set of section headings in the report is as follows: Executive summary. 1. Introduction. 2. PSA Framework and Environment. 3. Numerical Safety Criteria. 4. PSA Standards and Guidance. 5. Status and Scope of PSA Programmes. 6. PSA Methodology and Data. 7. PSA Applications. 8. Results and Insights from the PSAs. 9. Future Developments. Appendix A: Overview of the Status of PSA Programmes. Appendix B: Contact information. Appendix C: Questionnaire and Guidance to authors

Thinking of the safety assessment of HLW disposal

International Nuclear Information System (INIS)

Li Honghui; Zhao Shuaiwei; Liu Jianqin; Liu Wei; Wan Lei; Yang Zhongtian; An Hongxiang; Sun Qinghong

2014-01-01

The function and the research methods of safety assessment are discussed. Two methods about safety assessment and the requirement of safety assessment are introduced. The key parameters and influence factors in nuclide transport of safety assessment are specialized. The works will be done on safety assessment is discussed which will give some suggests for the development of safety assessment. (authors)

ALARP considerations in criticality safety assessments

International Nuclear Information System (INIS)

Bowden, Russell L.; Barnes, Andrew; Thorne, Peter R.; Venner, Jack

2003-01-01

Demonstrating that the risk to the public and workers is As Low As Reasonably Practicable (ALARP) is a fundamental requirement of safety cases for nuclear facilities in the United Kingdom. This is embodied in the Safety Assessment Principles (SAPs) published by the Regulator, the essence of which is incorporated within the safety assessment processes of the various nuclear site licensees. The concept of ALARP within criticality safety assessments has taken some time to establish in the United Kingdom. In principle, the licensee is obliged to search for a deterministic criticality safety solution, such as safe geometry vessels and passive control features, rather than placing reliance on active measurement devices and plant administrative controls. This paper presents a consideration of some ALARP issues in relation to the development of criticality safety cases. The paper utilises some idealised examples covering a range of issues facing the criticality safety assessor, including new plant design, operational plant and decommissioning activities. These examples are used to outline the elements of the criticality safety cases and present a discussion of ALARP in the context of criticality safety assessments. (author)

Safety culture assessment developed by JANTI

International Nuclear Information System (INIS)

Hamada, Jun

2009-01-01

Japan's JCO accident in September 1999 provided a real-life example of what can happen when insufficient attention is paid to safety culture. This accident brought to light the importance of safety culture and reinforced the movement to foster a safety culture. Despite this, accidents and inappropriate conduct have continued to occur. Therefore, there is a strong demand to instill a safety culture throughout the nuclear power industry. In this context, Japan's nuclear power regulator, the Nuclear and Industrial Safety Agency (NISA), decided to include in its safety inspections assessments of the safety culture found in power utilities' routine safety operations to get signs of deterioration in the organizational climate. In 2007, NISA constructed guidelines for their inspectors to carry out these assessments. At the same time, utilities have embarked on their own independent safety culture initiatives, such as revising their technical specifications and building effective PDCA cycle to promote safety culture. In concert with these developments, JANTI has also instituted safety culture assessments. (author)

78 FR 9054 - Issuance of Final Guidance Publication

Science.gov (United States)

2013-02-07

... NIOSH-144] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The National Institute...), announces the availability of the following publication: ``NIOSH Criteria for a Recommended Standard...

78 FR 25454 - Issuance of Final Guidance Publication

Science.gov (United States)

2013-05-01

... NIOSH-161-A] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety... Human Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The National...), announces the availability of the following publication: ``NIOSH Current Intelligence Bulletin 65...

77 FR 74194 - Issuance of Final Guidance Publication

Science.gov (United States)

2012-12-13

... NIOSH-238] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The National Institute...), announces the availability of the following publication: NIOSH Alert entitled ``Preventing Occupational...

78 FR 66936 - Issuance of Final Guidance Publication

Science.gov (United States)

2013-11-07

... NIOSH-156] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The National Institute...), announces the availability of the following publication: ``Current Intelligence Bulletin 66--Derivation of...

Rad waste disposal safety analysis / Integrated safety assessment of a waste repository

International Nuclear Information System (INIS)

Jeong, Jongtae; Choi, Jongwon; Kang, Chulhyung

2012-04-01

We developed CYPRUS+and adopted PID and RES method for the development of scenario. Safety performance assessment program was developed using GoldSim for the safety assessment of disposal system for the disposal of spnet fuels and wastes resulting from the pyrpoprocessing. Biosphere model was developed and verified in cooperation with JAEA. The capability to evaluate post-closure performance and safety was added to the previously developed program. And, nuclide migration and release to the biosphere considering site characteristics was evaluated by using deterministic and probabilistic approach. Operational safety assessment for drop, fire, and earthquake was also statistically evaluated considering well-established input parameter distribution. Conservative assessment showed that dose rate is below the limit value of low- and intermediate-level repository. Gas generation mechanism within engineered barrier was defined and its influence on safety was evaluated. We made probabilistic safety assessment by obtaining the probability distribution functions of important input variables and also made a sensitivity analysis. The maximum annual dose rate was shown to be below the safety limit value of 10 mSv/yr. The structure and element of safety case was developed to increase reliability of safety assessment methodology for a deep geological repository. Finally, milestone for safety case development and implementation strategy for each safety case element was also proposed

Supplementary guidance for the investigation and risk-assessment of potentially contaminated sediments

Energy Technology Data Exchange (ETDEWEB)

Baker, K.; Spadaro, P.; Starr, J.; Thomas, J. [Arcadis, Arnhem (Netherlands); Hildenbrand, B. [Energy Institute, London (United Kingdom); Smith, J.W.N.; Dunk, M.; Grosjean, T.; De Ibarra, M.; Medve, A.; Den Haan, K.

2013-11-15

This report provides guidance on the investigation and assessment of potentially contaminated sediments, focusing on the inland, estuarine and coastal environments. It is designed as a complementary, technical companion document to Energy Institute and CONCAWE (2013) report 'Guidance on characterising, assessing and managing risks associated with potentially contaminated sediments' (Report E1001). It highlights a number of significant challenges associated with assessing the aquatic and water bottom environment, which means that a sediment assessment should not be undertaken lightly. Where a decision is taken to undertake a site assessment, this report promotes the use of an iterative process of Conceptual Site Model (CSM) development, data collection, data evaluation and a continuous CSM refinement, taking into account the results obtained. Risk-based assessment is described throughout the report, entailing four tiers of assessment, which progress from a qualitative assessment (Tier 0) through to a detailed cause-attribution assessment (Tier 3), in which the decrease in uncertainty in the assessment process is balanced against the increased costs and timescales with progress to a higher tier assessment. The application of this evidence-driven risk-based approach to sediment site management, including remedial control measures, should help to overcome at least some of the challenges associated with contaminants in sediment sites in Europe, and promote a sustainable approach to sediment management on a case-by-case basis.

Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

Science.gov (United States)

Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

2012-07-01

Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

Application of the management system for facilities and activities. Safety guide

International Nuclear Information System (INIS)

2006-01-01

This Safety Guide supports the Safety Requirements publication on The Management System for Facilities and Activities. It provides generic guidance to aid in establishing, implementing, assessing and continually improving a management system that complies with the requirements established. In addition to this Safety Guide, there are a number of Safety Guides for specific technical areas. Together these provide all the guidance necessary for implementing these requirements. This publication supersedes Safety Series No. 50-SG-Q1-Q7 (1996). The guidance provided here may be used by organizations in the following ways: - To assist in the development of the management systems of organizations directly responsible for operating facilities and activities and providing services for: Nuclear facilities; Activities using sources of ionizing radiation; Radioactive waste management; The transport of radioactive material; Radiation protection activities; Any other practices or circumstances in which people may be exposed to radiation from naturally occurring or artificial sources; The regulation of such facilities and activities; - To assist in the development of the management systems of the relevant regulatory bodies; - By the operator, to specify to a supplier, via contractual documentation, any guidance of this Safety Guide that should be included in the supplier's management system for the supply and delivery of products

76 FR 22106 - Issuance of Final Guidance Publication

Science.gov (United States)

2011-04-20

... NIOSH-033] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... Health and Human Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The... (CDC) announces the availability of the following publication: NIOSH Current Intelligence Bulletin 63...

SCART guidelines. Reference report for IAEA Safety Culture Assessment Review Team (SCART)

International Nuclear Information System (INIS)

2008-01-01

The IAEA Director General stressed the role of safety culture in his concluding remarks at the Meeting of the Contracting Parties to the Convention on Nuclear Safety in 2002: 'As we have learned in other areas, it is not enough simply to have a structure; it is not enough to say that we have the necessary laws and the appropriate regulatory bodies. All these are important, but equally important is that we have in place a safety culture that gives effect to the structure that we have developed. To me, effectiveness and transparency are keys. So, it is an issue which I am pleased to see, you are giving the attention it deserves and we will continue to work with you in clarifying, developing and applying safety culture through our programmes and through our technical cooperation activities.' The concept of safety culture was initially developed by the International Nuclear Safety Advisory Group (INSAG) after the Chernobyl accident in 1986. Since then the IAEA's perspective of safety culture has expanded with time as its recognition of the complexities of the concept developed. Safety culture is considered to be specific organizational culture in all types of organizations with activities that give rise to radiation risks. The aim is to make safety culture strong and sustainable, so that safety becomes a primary focus for all activities in such organizations, even for those, which might not look safety-related at first. SCART (Safety Culture Assessment Review Team) is a safety review service, which reflects the expressed interest of Members States for methods and tools for safety culture assessment. It is a replacement for the earlier service ASCOT (Assessment of Safety Culture in Organizations Team). The IAEA Safety Fundamentals, Requirements and Guides (Safety Standards) are the basis for the SCART Safety Review Service. The reports of INSAG, identifying important current nuclear safety issues, serve also as references during a SCART mission. SCART missions are based

Assessment and management of ageing of major nuclear power plant components important to safety: BWR pressure vessel internals

International Nuclear Information System (INIS)

2005-10-01

At present, there are over four hundred operational nuclear power plants (NPPs) in IAEA Member States. Operating experience has shown that ineffective control of the ageing degradation of the major NPP components (caused for instance by unanticipated phenomena and by operating maintenance or manufacturing errors) can jeopardize plant safety and also plant life. Ageing in these NPPs must be therefore effectively managed to ensure the availability of design functions throughout the plant service life. From the safety perspective, this means controlling, within acceptable limits, the ageing degradation and ware out of components important to safety so that adequate safety margins remain, i.e. integrity and functional capability in excess of normal operating requirements. This TECDOC is one in a series of guidance reports on the assessment and management of ageing of the major NPP components important to safety. The reports are based on experience and practices of NPP operators, regulators, designers, manufacturers, and technical support organizations and a widely accepted Methodology for the Management of Ageing of NPP Components Important to Safety, which was issued by the IAEA in 1992. Since the reports are written from a safety perspective, they do not address life or life cycle management of plant components, which involves economic considerations. The current practices for the assessment of safety margins (fitness for service) and the inspection, monitoring and mitigation of ageing degradation of selected components of heavy water moderated reactors (HWRs), boiling water reactors (BWRs), pressurized water reactors (PWRs), and water moderated, water cooled energy reactors (WWERs) are documented in the reports. These practices are intended to help all involved directly and indirectly in ensuring the safe operation of NPPs, and also to provide a common technical basis for dialogue between plant operators and regulators when dealing with age related licensing issues

Quality assurance guidance for laboratory assessment plates in support of EM environmental sampling and analysis activities

International Nuclear Information System (INIS)

1994-05-01

This document is one of several guidance documents developed to support the EM (DOE Environmental Restoration and Waste Management) Analytical Services program. Its purpose is to introduce assessment plates that can be used to conduct performance assessments of an organization's or project's ability to meet quality goals for analytical laboratory activities. These assessment plates are provided as non-prescriptive guidance to EM-support organizations responsible for collection of environmental data for remediation and waste management programs at DOE facilities. The assessments evaluate objectively all components of the analytical laboratory process to determine their proper selection and use

International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

Science.gov (United States)

2010-01-21

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

Safety assessment for facilities and activities. General safety requirements. Pt. 4

International Nuclear Information System (INIS)

2009-01-01

The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation. The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF 6 ; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are installed; (i

Safety Assessment for Facilities and Activities. General Safety Requirements. Pt. 4

International Nuclear Information System (INIS)

2009-01-01

The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation. The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF6; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are installed; (i

Safety Assessment for Facilities and Activities. General Safety Requirements. Pt. 4

International Nuclear Information System (INIS)

2010-01-01

The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation. The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF6; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are installed; (i

Safety Assessment for Facilities and Activities. General Safety Requirements. Pt. 4

International Nuclear Information System (INIS)

2009-01-01

The Safety Fundamentals publication, Fundamental Safety Principles, establishes principles for ensuring the protection of workers, the public and the environment, now and in the future, from harmful effects of ionizing radiation.? read more The objective of this Safety Requirements publication is to establish the generally applicable requirements to be fulfilled in safety assessment for facilities and activities, with special attention paid to defence in depth, quantitative analyses and the application of a graded approach to the ranges of facilities and of activities that are addressed. The publication also addresses the independent verification of the safety assessment that needs to be carried out by the originators and users of the safety assessment. This publication is intended to provide a consistent and coherent basis for safety assessment across all facilities and activities, which will facilitate the transfer of good practices between organizations conducting safety assessments and will assist in enhancing the confidence of all interested parties that an adequate level of safety has been achieved for facilities and activities. The requirements, which are derived from the Fundamental Safety Principles, relate to any human activity that may cause people to be exposed to radiation risks arising from facilities and activities, as follows: Facilities includes: (a) Nuclear power plants; (b) Other reactors (such as research reactors and critical assemblies); (c) Enrichment facilities and fuel fabrication facilities; (d) Conversion facilities used to generate UF6; (e) Storage and reprocessing plants for irradiated fuel; (f) Facilities for radioactive waste management where radioactive waste is treated, conditioned, stored or disposed of; (g) Any other places where radioactive materials are produced, processed, used, handled or stored; (h) Irradiation facilities for medical, industrial, research and other purposes, and any places where radiation generators are

Elaboration of methods for assessment of radio-ecological safety state of objects, situated on the territories contaminated with Chernobyl radionuclides

International Nuclear Information System (INIS)

Saltanov, Eugene; Saltanova, Irina

2008-01-01

The main purpose of assessment of radio-ecological state of object is to elaborate recommendations to reduce both radiation dose and negative action of other contaminators on human organism. The basis of objects' ecological safety assessment is considering complex influence of multiple negative factors, such as radioactive contamination, firstly, and air, water, soil and noise pollution, secondly. The objects of assessments are social, industrial, rural enterprises and their production: school buildings and territories, all kinds of recreational institutions, civil buildings, etc. The described method is embodied in a computer program, which enables calculation of integral indicator of contamination and gives information about object's safety state. The results of the work may be proposed to the corresponding supervisor institutions as a prototype of practical guidance to control ecological state of the objects and territories. Particularly, the proposed methods are necessary to determine the order of measures, normally undertaken to deactivate objects, and to provide unified approach to radio-ecological safety assessment of objects, situated in the territories contaminated with Chernobyl radionuclides. (author)

Safety Culture Monitoring: How to Assess Safety Culture in Real Time?

International Nuclear Information System (INIS)

Zronek, B.; Maryska, J.; Treslova, L.

2016-01-01

Do you know what is current level of safety culture in your company? Are you able to follow trend changes? Do you know what your recent issues are? Since safety culture is understood as vital part of nuclear industry daily life, it is crucial to know what the current level is. It is common to perform safety culture survey or ad hoc assessment. This contribution shares Temelin NPP, CEZ approach how to assess safety culture level permanently. Using behavioral related outputs of gap solving system, observation program, dedicated surveys, regulatory assessment, etc., allows creating real time safety culture monitoring without the need to perform any other activities. (author)

Regulatory review of safety cases and safety assessments - associated challenges

International Nuclear Information System (INIS)

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

2006-01-01

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

Intermediate probabilistic safety assessment approach for safety critical digital systems

International Nuclear Information System (INIS)

Taeyong, Sung; Hyun Gook, Kang

2001-01-01

Even though the conventional probabilistic safety assessment methods are immature for applying to microprocessor-based digital systems, practical needs force to apply it. In the Korea, UCN 5 and 6 units are being constructed and Korean Next Generation Reactor is being designed using the digital instrumentation and control equipment for the safety related functions. Korean regulatory body requires probabilistic safety assessment. This paper analyzes the difficulties on the assessment of digital systems and suggests an intermediate framework for evaluating their safety using fault tree models. The framework deals with several important characteristics of digital systems including software modules and fault-tolerant features. We expect that the analysis result will provide valuable design feedback. (authors)

Safety assessments for potential exposures

International Nuclear Information System (INIS)

Dunn, D.I.

2012-04-01

Safety Assessment of potential exposures have been carried out in major practices, namely: industrial radiography, gamma irradiators and electron accelerators used in industry and research, and radiotherapy. This paper focuses on reviewing safety assessment methodologies and using developed software to analyse radiological accidents, also review, and discuss these past accidents.The primary objective of the assessment is to assess the adequacy of planned or existing measures for protection and safety and to identify any additional measures that should be put in place. As such, both routine use of the source and the probability and magnitude of potential exposures arising from accidents or incidents should be considered. Where the assessment indicates that there is a realistic possibility of an accident affecting workers or members of the public or having consequences for the environment, the registrant or licensee should prepare a suitable emergency plan. A safety assessment for normal operation addresses all the conditions under which the radiation source operates as expected, including all phases of the lifetime of the source. Due account needs to be taken of the different factors and conditions that will apply during non-operational phases, such as installation, commissioning and maintenance. (author)

Development of a Safety Assessment Information System for the Management of Periodic Safety Assessment Activities

International Nuclear Information System (INIS)

Song, Tae Young

2007-01-01

At present, the 10-year Periodic Safety Review(PSR) has been performing to confirm all the aspects of safety issues for all the operating plants in compliance with domestic nuclear law of article 23, subarticle 3. For each plant, in addition, Probabilistic Safety Assessment(PSA) and Severe Accident Management Guideline(SAMG) are being implemented and revised periodically to reflect the latest safety level according to principle fulfillment of severe accident policy statement. The assessment reports, as one of outcomes from these activities, are submitted into and reviewed by domestic regulatory body. During reviewing (in-office duty) and licensing (regulatory duty) process, a large number of outcomes of which most are the formal technical reports and licensing materials, are inevitably produced. Moreover, repeated review process over the plants can make them accumulated and produce a variety of documents additionally. This circumstance motivates to develop effective tool or system for the management of these reports and related technical documents for the future use in licensing process and for subsequent plant assessments. This paper presents the development status of Safety Assessment Information System(SAIS) which manages safety-related documents of PSR, PSA and SAMG for practical use for experienced engineers in charge of these areas

Development of a Safety Assessment Information System for the Management of Periodic Safety Assessment Activities

Energy Technology Data Exchange (ETDEWEB)

Song, Tae Young [Nuclear Engineering and Technology Institute, Daejeon (Korea, Republic of)

2007-07-01

At present, the 10-year Periodic Safety Review(PSR) has been performing to confirm all the aspects of safety issues for all the operating plants in compliance with domestic nuclear law of article 23, subarticle 3. For each plant, in addition, Probabilistic Safety Assessment(PSA) and Severe Accident Management Guideline(SAMG) are being implemented and revised periodically to reflect the latest safety level according to principle fulfillment of severe accident policy statement. The assessment reports, as one of outcomes from these activities, are submitted into and reviewed by domestic regulatory body. During reviewing (in-office duty) and licensing (regulatory duty) process, a large number of outcomes of which most are the formal technical reports and licensing materials, are inevitably produced. Moreover, repeated review process over the plants can make them accumulated and produce a variety of documents additionally. This circumstance motivates to develop effective tool or system for the management of these reports and related technical documents for the future use in licensing process and for subsequent plant assessments. This paper presents the development status of Safety Assessment Information System(SAIS) which manages safety-related documents of PSR, PSA and SAMG for practical use for experienced engineers in charge of these areas.

Overview of IAEA guidelines for fire safety inspection and operation in nuclear power plants

International Nuclear Information System (INIS)

Mowrer, D.S.

1998-01-01

In 1992, the International Atomic Energy Agency began an ambitious project on fire safety in nuclear power plants. The purpose of this ongoing project is to provide specific guidance on compliance with the requirements set forth through the IAEA Nuclear Safety Standards program established in 1974. The scope of the Fire Safety project encompasses several tasks, including the development of new standards and guidelines to assist Member States in assessing the level of fire safety in existing plants. Five new Safety Practices, one new Safety Guide and a Technical Document have been developed for use by the fire safety community. The primary intent of these new documents is to provide detailed guidance and a consistent format for the assessment of the overall level of fire safety being provided in existing nuclear power plants around the world and especially in developing countries. Sufficient detail is provided in the Safety Guide and Safety Practices to allow technically knowledgeable plant personnel, outside consultants or other technical experts to assess the adequacy of fire safety within the plant facilities. This paper describes topics addressed by each of the IAEA Fire Safety documents and discussed the relationship of each document to others in the series. (author)

78 FR 78822 - Draft Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals-Acoustic...

Science.gov (United States)

2013-12-27

... Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals--Acoustic Threshold Levels for... available in electronic form via the Internet at http://www.nmfs.noaa.gov/pr/acoustics/ . You may submit...: Acoustic Guidance. Instructions: All comments received are a part of the public record and will generally...

Assessment and management of ageing of major nuclear power plant components important to safety: In-containment instrumentation and control cables. Volume I

International Nuclear Information System (INIS)

2000-12-01

At present, there are over four hundred operational nuclear power plants (NPPs) in IAEA Member States. Operating experience has shown that ineffective control of the ageing degradation of major NPP components (e.g. caused by unanticipated phenomena and by operating, maintenance, design or manufacturing error) can jeopardize plant safety and also plant life. Ageing in these NPPs must be therefore effectively managed to ensure the availability of design functions throughout the plant service life. From the safety perspective, this means controlling within acceptable limits the ageing degradation and wear-out of plant components important to safety so that adequate safety margins remain, i.e. integrity and functional capability in excess of normal operating requirements. This publication is one in a series of guidance reports on the assessment and management of ageing of the major NPP components important to safety. The reports are based on experience and practices of NPP operators, regulators, designers, manufacturers, and technical support organizations and a widely accepted Methodology for the Management of Ageing of NPP Components Important to Safety, which was issued by the IAEA in 1992. The current practices for the assessment of safety margins (fitness-for-service) and the inspection, monitoring and mitigation of ageing degradation of selected components of Canadian deuterium-uranium (CANDU) reactors, boiling water reactors (BWRs), pressurized water reactors (PWRs), including the Soviet designed 'water moderated and water cooled energy reactors' (WWERs), are documented in the reports. These practices are intended to help all involved directly and indirectly in ensuring the safe operation of NPPs, and to provide a common technical basis for dialogue between plant operators and regulators when dealing with age related licensing issues. The guidance reports are directed at technical experts and managers from NPPs and from regulatory, plant design, manufacturing

Assessment and management of ageing of major nuclear power plant components important to safety: In-containment instrumentation and control cables. Volume II

International Nuclear Information System (INIS)

2000-12-01

At present, there are over four hundred operational nuclear power plants (NPPs) in IAEA Member States. Operating experience has shown that ineffective control of the ageing degradation of major NPP components (e.g. caused by unanticipated phenomena and by operating, maintenance, design or manufacturing error) can jeopardize plant safety and also plant life. Ageing in these NPPs must be therefore effectively managed to ensure the availability of design functions throughout the plant service life. From the safety perspective, this means controlling within acceptable limits the ageing degradation and wear-out of plant components important to safety so that adequate safety margins remain, i.e. integrity and functional capability in excess of normal operating requirements. This publication is one in a series of guidance reports on the assessment and management of ageing of the major NPP components important to safety. The reports are based on experience and practices of NPP operators, regulators, designers, manufacturers, and technical support organizations and a widely accepted Methodology for the Management of Ageing of NPP Components Important to Safety, which was issued by the IAEA in 1992. The current practices for the assessment of safety margins (fitness-for-service) and the inspection, monitoring and mitigation of ageing degradation of selected components of Canadian deuterium-uranium (CANDU) reactors, boiling water reactors (BWRs), pressurized water reactors (PWRs), including the Soviet designed 'water moderated and water cooled energy reactors' (WWERs), are documented in the reports. These practices are intended to help all involved directly and indirectly in ensuring the safe operation of NPPs, and to provide a common technical basis for dialogue between plant operators and regulators when dealing with age related licensing issues. The guidance reports are directed at technical experts and managers from NPPs and from regulatory, plant design, manufacturing

Code of Conduct on the Safety and Security of Radioactive Sources and the Supplementary Guidance on the Import and Export of Radioactive Sources

International Nuclear Information System (INIS)

2005-01-01

In operative paragraph 4 of its resolution GC(47)/RES/7.B, the General Conference, having welcomed the approval by the Board of Governors of the revised IAEA Code of Conduct on the Safety and Security of Radioactive Sources (GC(47)/9), and while recognizing that the Code is not a legally binding instrument, urged each State to write to the Director General that it fully supports and endorses the IAEA's efforts to enhance the safety and security of radioactive sources and is working toward following the guidance contained in the IAEA Code of Conduct. In operative paragraph 5, the Director General was requested to compile, maintain and publish a list of States that have made such a political commitment. The General Conference, in operative paragraph 6, recognized that this procedure 'is an exceptional one, having no legal force and only intended for information, and therefore does not constitute a precedent applicable to other Codes of Conduct of the Agency or of other bodies belonging to the United Nations system'. In operative paragraph 7 of resolution GC(48)/RES/10.D, the General Conference welcomed the fact that more than 60 States had made political commitments with respect to the Code in line with resolution GC(47)/RES/7.B and encouraged other States to do so. In operative paragraph 8 of resolution GC(48)/RES/10.D, the General Conference further welcomed the approval by the Board of Governors of the Supplementary Guidance on the Import and Export of Radioactive Sources (GC(48)/13), endorsed this Guidance while recognizing that it is not legally binding, noted that more than 30 countries had made clear their intention to work towards effective import and export controls by 31 December 2005, and encouraged States to act in accordance with the Guidance on a harmonized basis and to notify the Director General of their intention to do so as supplementary information to the Code of Conduct, recalling operative paragraph 6 of resolution GC(47)/RES/7.B. 4. The

Consideration of aging in probabilistic safety assessment

International Nuclear Information System (INIS)

Titina, B.; Cepin, M.

2007-01-01

Probabilistic safety assessment is a standardised tool for assessment of safety of nuclear power plants. It is a complement to the safety analyses. Standard probabilistic models of safety equipment assume component failure rate as a constant. Ageing of systems, structures and components can theoretically be included in new age-dependent probabilistic safety assessment, which generally causes the failure rate to be a function of age. New age-dependent probabilistic safety assessment models, which offer explicit calculation of the ageing effects, are developed. Several groups of components are considered which require their unique models: e.g. operating components e.g. stand-by components. The developed models on the component level are inserted into the models of the probabilistic safety assessment in order that the ageing effects are evaluated for complete systems. The preliminary results show that the lack of necessary data for consideration of ageing causes highly uncertain models and consequently the results. (author)

A Methodology for Safety Culture Impact Assessment

Energy Technology Data Exchange (ETDEWEB)

Han, Kiyoon; Jae, Moosung [Hanyang Univ., Seoul (Korea, Republic of)

2014-05-15

The purpose of this study is to develop methodology for assessing safety culture impact on nuclear power plants. A new methodology for assessing safety culture impact index has been developed and applied for the reference nuclear power plants. The developed SCII model might contribute to comparing the level of safety culture among nuclear power plants as well as to improving the safety of nuclear power plants. Safety culture is defined to be fundamental attitudes and behaviors of the plant staff which demonstrate that nuclear safety is the most important consideration in all activities conducted in nuclear power operation. Through several accidents of nuclear power plant including the Fukusima Daiichi in 2011 and Chernovyl accidents in 1986, the safety of nuclear power plant is emerging into a matter of interest. From the accident review report, it can be easily found out that safety culture is important and one of dominant contributors to accidents. However, the impact methodology for assessing safety culture has not been established analytically yet. It is difficult to develop the methodology for assessing safety culture impact quantitatively.

A Methodology for Safety Culture Impact Assessment

International Nuclear Information System (INIS)

Han, Kiyoon; Jae, Moosung

2014-01-01

The purpose of this study is to develop methodology for assessing safety culture impact on nuclear power plants. A new methodology for assessing safety culture impact index has been developed and applied for the reference nuclear power plants. The developed SCII model might contribute to comparing the level of safety culture among nuclear power plants as well as to improving the safety of nuclear power plants. Safety culture is defined to be fundamental attitudes and behaviors of the plant staff which demonstrate that nuclear safety is the most important consideration in all activities conducted in nuclear power operation. Through several accidents of nuclear power plant including the Fukusima Daiichi in 2011 and Chernovyl accidents in 1986, the safety of nuclear power plant is emerging into a matter of interest. From the accident review report, it can be easily found out that safety culture is important and one of dominant contributors to accidents. However, the impact methodology for assessing safety culture has not been established analytically yet. It is difficult to develop the methodology for assessing safety culture impact quantitatively

Three-dimensional Image Fusion Guidance for Transjugular Intrahepatic Portosystemic Shunt Placement.

Science.gov (United States)

Tacher, Vania; Petit, Arthur; Derbel, Haytham; Novelli, Luigi; Vitellius, Manuel; Ridouani, Fourat; Luciani, Alain; Rahmouni, Alain; Duvoux, Christophe; Salloum, Chady; Chiaradia, Mélanie; Kobeiter, Hicham

2017-11-01

To assess the safety, feasibility and effectiveness of image fusion guidance with pre-procedural portal phase computed tomography with intraprocedural fluoroscopy for transjugular intrahepatic portosystemic shunt (TIPS) placement. All consecutive cirrhotic patients presenting at our interventional unit for TIPS creation from January 2015 to January 2016 were prospectively enrolled. Procedures were performed under general anesthesia in an interventional suite equipped with flat panel detector, cone-beam computed tomography (CBCT) and image fusion technique. All TIPSs were placed under image fusion guidance. After hepatic vein catheterization, an unenhanced CBCT acquisition was performed and co-registered with the pre-procedural portal phase CT images. A virtual path between hepatic vein and portal branch was made using the virtual needle path trajectory software. Subsequently, the 3D virtual path was overlaid on 2D fluoroscopy for guidance during portal branch cannulation. Safety, feasibility, effectiveness and per-procedural data were evaluated. Sixteen patients (12 males; median age 56 years) were included. Procedures were technically feasible in 15 of the 16 patients (94%). One procedure was aborted due to hepatic vein catheterization failure related to severe liver distortion. No periprocedural complications occurred within 48 h of the procedure. The median dose-area product was 91 Gy cm 2 , fluoroscopy time 15 min, procedure time 40 min and contrast media consumption 65 mL. Clinical benefit of the TIPS placement was observed in nine patients (56%). This study suggests that 3D image fusion guidance for TIPS is feasible, safe and effective. By identifying virtual needle path, CBCT enables real-time multiplanar guidance and may facilitate TIPS placement.

Software for computer based systems important to safety in nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2004-01-01

systems important to safety in nuclear power plants, for all phases of the system life cycle. The guidance is applicable to systems important to safety. Since at present the reliability of a computer based system cannot be predicted on the sole basis of, or built in by, the design process, it is difficult to define and to agree systematically on any possible relaxation in the guidance to apply to software for safety related systems. Whenever possible, recommendations which apply only to safety systems and not to safety related systems are explicitly identified. The guidance relates primarily to the software used in computer based systems important to safety. Guidance on the other aspects of computer based systems, such as those concerned with the design of the computer based system itself and its hardware, is limited to the issues raised by the development, verification and validation of software.The main focus of this Safety Guide is on the preparation of documentation that is used for an adequate demonstration of the safety and reliability of computer based systems important to safety.This Safety Guide applies to all types of software: pre-existing software or firmware (such as an operating system), software to be specifically developed for the project, or software to be developed from an existing pre developed equipment family of hardware or software modules. This Safety Guide is intended for use by those involved in the production, assessment and licensing of computer based systems, including plant system designers, software designers and programmers, verifiers, validators, certifiers and regulators, as well as plant operators. The various interfaces between those involved are considered. (author)

Software for computer based systems important to safety in nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2005-01-01

systems important to safety in nuclear power plants, for all phases of the system life cycle. The guidance is applicable to systems important to safety. Since at present the reliability of a computer based system cannot be predicted on the sole basis of, or built in by, the design process, it is difficult to define and to agree systematically on any possible relaxation in the guidance to apply to software for safety related systems. Whenever possible, recommendations which apply only to safety systems and not to safety related systems are explicitly identified. The guidance relates primarily to the software used in computer based systems important to safety. Guidance on the other aspects of computer based systems, such as those concerned with the design of the computer based system itself and its hardware, is limited to the issues raised by the development, verification and validation of software.The main focus of this Safety Guide is on the preparation of documentation that is used for an adequate demonstration of the safety and reliability of computer based systems important to safety. This Safety Guide applies to all types of software: pre-existing software or firmware (such as an operating system), software to be specifically developed for the project, or software to be developed from an existing pre developed equipment family of hardware or software modules. This Safety Guide is intended for use by those involved in the production, assessment and licensing of computer based systems, including plant system designers, software designers and programmers, verifiers, validators, certifiers and regulators, as well as plant operators. The various interfaces between those involved are considered

Software for computer based systems important to safety in nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2000-01-01

systems important to safety in nuclear power plants, for all phases of the system life cycle. The guidance is applicable to systems important to safety. Since at present the reliability of a computer based system cannot be predicted on the sole basis of, or built in by, the design process, it is difficult to define and to agree systematically on any possible relaxation in the guidance to apply to software for safety related systems. Whenever possible, recommendations which apply only to safety systems and not to safety related systems are explicitly identified. The guidance relates primarily to the software used in computer based systems important to safety. Guidance on the other aspects of computer based systems, such as those concerned with the design of the computer based system itself and its hardware, is limited to the issues raised by the development, verification and validation of software.The main focus of this Safety Guide is on the preparation of documentation that is used for an adequate demonstration of the safety and reliability of computer based systems important to safety.This Safety Guide applies to all types of software: pre-existing software or firmware (such as an operating system), software to be specifically developed for the project, or software to be developed from an existing pre developed equipment family of hardware or software modules. This Safety Guide is intended for use by those involved in the production, assessment and licensing of computer based systems, including plant system designers, software designers and programmers, verifiers, validators, certifiers and regulators, as well as plant operators. The various interfaces between those involved are considered

Regulatory review of safety cases and safety assessments for near surface

International Nuclear Information System (INIS)

Nys, V.

2003-01-01

The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

Safety Auditing and Assessments

Science.gov (United States)

Goodin, James Ronald (Ronnie)

2005-01-01

Safety professionals typically do not engage in audits and independent assessments with the vigor as do our quality brethren. Taking advantage of industry and government experience conducting value added Independent Assessments or Audits benefits a safety program. Most other organizations simply call this process "internal audits." Sources of audit training are presented and compared. A relation of logic between audit techniques and mishap investigation is discussed. An example of an audit process is offered. Shortcomings and pitfalls of auditing are covered.

Image registration assessment in radiotherapy image guidance based on control chart monitoring.

Science.gov (United States)

Xia, Wenyao; Breen, Stephen L

2018-04-01

Image guidance with cone beam computed tomography in radiotherapy can guarantee the precision and accuracy of patient positioning prior to treatment delivery. During the image guidance process, operators need to take great effort to evaluate the image guidance quality before correcting a patient's position. This work proposes an image registration assessment method based on control chart monitoring to reduce the effort taken by the operator. According to the control chart plotted by daily registration scores of each patient, the proposed method can quickly detect both alignment errors and image quality inconsistency. Therefore, the proposed method can provide a clear guideline for the operators to identify unacceptable image quality and unacceptable image registration with minimal effort. Experimental results demonstrate that by using control charts from a clinical database of 10 patients undergoing prostate radiotherapy, the proposed method can quickly identify out-of-control signals and find special cause of out-of-control registration events.

Confidence building in safety assessments

International Nuclear Information System (INIS)

Grundfelt, Bertil

1999-01-01

Future generations should be adequately protected from damage caused by the present disposal of radioactive waste. This presentation discusses the core of safety and performance assessment: The demonstration and building of confidence that the disposal system meets the safety requirements stipulated by society. The major difficulty is to deal with risks in the very long time perspective of the thousands of years during which the waste is hazardous. Concern about these problems has stimulated the development of the safety assessment discipline. The presentation concentrates on two of the elements of safety assessment: (1) Uncertainty and sensitivity analysis, and (2) validation and review. Uncertainty is associated both with respect to what is the proper conceptual model and with respect to parameter values for a given model. A special kind of uncertainty derives from the variation of a property in space. Geostatistics is one approach to handling spatial variability. The simplest way of doing a sensitivity analysis is to offset the model parameters one by one and observe how the model output changes. The validity of the models and data used to make predictions is central to the credibility of safety assessments for radioactive waste repositories. There are several definitions of model validation. The presentation discusses it as a process and highlights some aspects of validation methodologies

Reference biospheres for the long term safety assessment of radioactive waste disposal facilities

International Nuclear Information System (INIS)

Crossland, I.G.; Torres, C.

2002-01-01

Regulatory guidance on the safety assessment of radioactive waste disposals usually requires the consequences of any radionuclide releases to be considered in terms of their potential impact on human health. This requires consideration of the prevailing biosphere and the habits of the potentially exposed humans within it. However, it could take many thousands of years for migrating radionuclides to reach the surface environment. In these circumstances, an assessment model that was based on the present-day biosphere could be inappropriate while future biospheres would be unpredictable. These and other considerations suggest that a standardised, or reference biosphere, approach may be useful. Theme 1 of the IAEA BIOMASS project was established to develop the concept of reference biospheres into a practical system that can be applied to the assessment of the long term safety of geological disposal facilities for radioactive waste. The technical phase of the project lasted for four years until November 2000 and brought together disparate interests from many countries including waste disposal agencies, regulators and technical experts. Building on the experience from earlier BIOMOVS projects, a methodology was constructed for the logical and defensible construction of mathematical biosphere models that can be used in the total system performance assessment of radioactive waste disposal. The methodology was then further developed through the creation of a series of BIOMASS Example Reference Biospheres ('Examples'). These are stylised biosphere models that, in addition to illustrating the methodology, are intended to be useful assessment tools in their own right. (author)

Vehicle Battery Safety Roadmap Guidance

Energy Technology Data Exchange (ETDEWEB)

Doughty, D. H.

2012-10-01

The safety of electrified vehicles with high capacity energy storage devices creates challenges that must be met to assure commercial acceptance of EVs and HEVs. High performance vehicular traction energy storage systems must be intrinsically tolerant of abusive conditions: overcharge, short circuit, crush, fire exposure, overdischarge, and mechanical shock and vibration. Fail-safe responses to these conditions must be designed into the system, at the materials and the system level, through selection of materials and safety devices that will further reduce the probability of single cell failure and preclude propagation of failure to adjacent cells. One of the most important objectives of DOE's Office of Vehicle Technologies is to support the development of lithium ion batteries that are safe and abuse tolerant in electric drive vehicles. This Roadmap analyzes battery safety and failure modes of state-of-the-art cells and batteries and makes recommendations on future investments that would further DOE's mission.

Highway Safety Program Manual: Volume 3: Motorcycle Safety.

Science.gov (United States)

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 3 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on aspects of motorcycle safety. The purpose and specific objectives of a State motorcycle safety program are outlined. Federal authority in the highway safety area and general policies…

Safety issues of botanicals and botanical preparations in functional foods

International Nuclear Information System (INIS)

Kroes, R.; Walker, R.

2004-01-01

Although botanicals have played a role in the marketing of health products for ages, there is an increased interest today due to their perceived health benefits. Not only do consumers increasingly take charge of their health, but the scientific information and understanding of the beneficial health effects of bioactive substances in food, functional foods and food supplements have improved. Increasing use of these products has also led to concerns about their actual safety. Recorded cases of intoxications have triggered such concerns. The safety assessment of these substances is complicated by, amongst others, the variability of composition. Furthermore, consumption of such functional products is expected to produce physiological effects, which may lead to low margins of safety as the margin between exposure of such products and the safe level of intake are likely to be small. The safety assessment of botanicals and botanical preparations in food and food supplement should at least involve: - the characterisation and quality of the material, its quality control; - the intended use and consequent exposure; - history of use and exposure; - product comparison(s); - toxicological information gathering; - Risk characterisation/safety assessment; As a guidance tool, a decision tree approach is proposed to assist in determining the extent of data requirements based on the nature of the such product. This guidance tool in safety assessment was developed by an expert group of the International Life Sciences Institute (ILSI), European Branch, and is currently in press. In this paper a summarised version of this tool is presented

A comprehensive conceptual framework for road safety strategies.

Science.gov (United States)

Hughes, B P; Anund, A; Falkmer, T

2016-05-01

Road safety strategies (generally called Strategic Highway Safety Plans in the USA) provide essential guidance for actions to improve road safety, but often lack a conceptual framework that is comprehensive, systems theory based, and underpinned by evidence from research and practice. This paper aims to incorporate all components, policy tools by which they are changed, and the general interactions between them. A framework of nine mutually interacting components that contribute to crashes and ten generic policy tools which can be applied to reduce the outcomes of these crashes was developed and used to assess 58 road safety strategies from 22 countries across 15 years. The work identifies the policy tools that are most and least widely applied to components, highlighting the potential for improvements to any individual road safety strategy, and the potential strengths and weaknesses of road safety strategies in general. The framework also provides guidance for the development of new road safety strategies, identifying potential consequences of policy tool based measures with regard to exposure and risk, useful for both mobility and safety objectives. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety Management and Safety Culture Self Assessment of Kartini Research Reactor

Energy Technology Data Exchange (ETDEWEB)

Syarip, S., E-mail: syarip@batan.go.id [Centre for Accelerator and Material Process Technology, National Nuclear Energy Agency (BATAN), Yogyakarta (Indonesia)

2014-10-15

The self-assessment of safety culture and safety management status of Kartini research reactor is a step to foster safety culture and management by identifying good practices and areas for improvement, and also to improve reactor safety in a whole. The method used in this assessment is based on questionnaires provided by the Forum for Nuclear Cooperation in Asia (FNCA), then reviewed by experts. Based on the assessment and evaluation results, it can be concluded that there were several good practices in maintaining the safety status of Kartini reactor such as: reactor operators and radiation protection workers were aware and knowledgeable of the safety standards and policies that apply to their operation, readily accept constructive criticism from their management and from the inspectors of regulatory body that address safety performance. As a proof, for the last four years the number of inspection/audit findings from Regulatory Body (BAPETEN) tended to decrease while the reactor utilization and its operating hour increased. On the other hands there were also some comments and recommendations for improvement of reactor safety culture, such as that there should be more frequent open dialogues between employees and managers, to grow and attain a mutual support to achieve safety goals. (author)

Application of probabilistic safety assessment to research reactors

International Nuclear Information System (INIS)

1989-07-01

This document has been prepared to assist in the performance of a research reactor probabilistic safety assessment (PSA). It offers examples of experience gained by a number of Member States in carrying out PSA for research reactors. These examples are illustrative of the types of approach adopted, the problems that arise and the judgements entered into when conducting a PSA. The illustrative examples of experiences gained are discussed in a series of thirteen chapters which address some of the issues that arise in a PSA. The examples are not exhaustive and offer evidence of how other analyses have approached the task of preparing a PSA, for their particular plant. The principles should be capable of being utilised and the various issues which are discussed should be translated into the needs of the analyst. Each PSA will make its own demands on the analyst depending on the reactor and so the illustrations must only be used as guidance and not adopted as published, without critical appreciation. Refs, figs and tabs

Systematic assessment of laser safety in otolaryngology

Science.gov (United States)

Oswal, V. H.

2001-01-01

Risk management of lasers can be broadly define das a process of identification of the risk, assessment of the risk and steps taken to avert the risk. The risk management may be divided into: Risk inherent to the technology and risk in clinical use. Within the National Health Service in the UK, a useful document, which provides hospital laser users with advice on safety, is the 'Guidance on the Safe Use of Lasers in Medical and Dental Practice' issued by the Medical Devices Agency for the Department of Health in the UK. It recommends the appointment of a Laser Protection Adviser (LPA) who is knowledgeable in the evaluation of laser hazards. One of the duties LPA is to ensure that Local Rules are drawn up for each specific application of a laser. A Laser Protection Supervisor (LPS) should also be appointed with responsibility to ensure that the Local Rules are observed. It is a sensible precaution that laser users should be those approved by the Laser Protection Supervisor in consultation with the Laser Protection Advisor. All laser users should sign a statement that they have read and understood the Local Rules.

Determination of Safety Performance Grade of NPP Using Integrated Safety Performance Assessment (ISPA) Program

International Nuclear Information System (INIS)

Chung, Dae Wook

2011-01-01

Since the beginning of 2000, the safety regulation of nuclear power plant (NPP) has been challenged to be conducted more reasonable, effective and efficient way using risk and performance information. In the United States, USNRC established Reactor Oversight Process (ROP) in 2000 for improving the effectiveness of safety regulation of operating NPPs. The main idea of ROP is to classify the NPPs into 5 categories based on the results of safety performance assessment and to conduct graded regulatory programs according to categorization, which might be interpreted as 'Graded Regulation'. However, the classification of safety performance categories is highly comprehensive and sensitive process so that safety performance assessment program should be prepared in integrated, objective and quantitative manner. Furthermore, the results of assessment should characterize and categorize the actual level of safety performance of specific NPP, integrating all the substantial elements for assessing the safety performance. In consideration of particular regulatory environment in Korea, the integrated safety performance assessment (ISPA) program is being under development for the use in the determination of safety performance grade (SPG) of a NPP. The ISPA program consists of 6 individual assessment programs (4 quantitative and 2 qualitative) which cover the overall safety performance of NPP. Some of the assessment programs which are already implemented are used directly or modified for incorporating risk aspects. The others which are not existing regulatory programs are newly developed. Eventually, all the assessment results from individual assessment programs are produced and integrated to determine the safety performance grade of a specific NPP

Track 2 sites: Guidance for assessing low probability hazard sites at the INEL

International Nuclear Information System (INIS)

1994-01-01

This document presents guidance for assessment of Track 2 low probability hazard sites (LPHS) at the Idaho National Engineering Laboratory (INEL). The Track 2 classification was developed specifically for the INEL to streamline the implementation of Comprehensive Environmental Response, Compensation, and Liability Act. Track 2 LPHSs are described as sites where insufficient data are available to make a decision concerning the risk level or to select or design a remedy. As such, these types of sites are not described in the National Contingency Plan or existing regulatory guidance. The goal of the Track 2 process is to evaluate LPHSs using existing qualitative and quantitative data to minimize the collection of new environmental data. To this end, this document presents a structured format consisting of a series of questions and tables. A qualitative risk assessment is used. The process is iterative, and addresses an LPHS from multiple perspectives (i.e., historical, empirical, process) in an effort to generate a reproducible and defensible method. This rigorous approach follows the data quality objective process and establishes a well organized, logical approach to consolidate and assess existing data, and set decision criteria. If necessary, the process allows for the design of a sampling and analysis strategy to obtain new environmental data of appropriate quality to support decisions for each LPHS. Finally, the guidance expedites consensus between regulatory parties by emphasizing a team approach to Track 2 investigations

Efficacy and safety in performing of large bore percutaneous nephrostomy under ultrasound guidance

International Nuclear Information System (INIS)

Smilov, N.; Mlachkova, D.; Rizov, A.; Lozev, I.

2009-01-01

The aim of the study was to compare the success rate, complications and the outcomes from large-bore percutaneous nephrostomy under ultrasound guidance performed to 178 cases with another 54 when nephrostomy under x-ray control was performed. We have performed 178 large-bore percutaneous nephrostomy under ultrasound guidance and another 54 percutaneous nephrostomy under x-ray guidance to patients diagnosed with obstructive uropathy resulting from benign or malignant supravesical obstruction. We have performed successful nephrostomy in 93,8% of the cases under ultrasound guidance and 100% successful nephrostomy in the cases under x-ray control. In 2,8% of patients under ultrasound guidance the nephrostomy was performed using 4 additional punctures of the pyelocaliceal system and artificially caused hydronephrosis via infiltration of normal saline; and in the remaining 1,7% it was successful at the second attempt after 24 hours. It was not necessary to perform open surgery nephrostomy in any of the cases. The performance of percutaneous nephrostomy under ultrasound guidance has a success rate similar to the one done under x-ray guidance and with commensurable frequency and severity of complications, however without the patient and the operator being exposed to x-ray radiation. In general, the percutaneous nephrostomy under ultrasound guidance is performed without difficulties in the cases of third or fourth degree hydronephrosis. The lateral decubital patient position, the appropriate place for the puncture, the usage of Color Doppler imaging when the puncture is performed and the continuos ultrasound guidance during dilatation and placement of the nephrostomy tube should ensure the successful performance of the procedure in the case of first or second degree hydronephrosis. When hydronephrosis is absent, the nephrostomy should be performed under x-ray guidance. In emergency cases the application of ultrasound guidance allows the nephrostomy to be performed along the

Building competence in radiation protection and the safe use of radiation sources. Safety guide (Spanish ed.)

International Nuclear Information System (INIS)

2010-01-01

This Safety Guide makes recommendations concerning the building of competence in protection and safety within a national radiation protection infrastructure and provides guidance for setting up the structure for a national strategy. It relates to the training and assessment of qualification of new personnel and the retraining of existing personnel in order to develop and maintain appropriate levels of competence. It provides the necessary guidance to meet the requirements laid down in Safety Series No. 115, International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. Contents: 1. Introduction; 2. Responsibilities for building competence in protection and safety; 3. Education, training and work experience; 4. A national strategy for building competence in protection and safety.

Building competence in radiation protection and the safe use of radiation sources. Safety guide (Arabic ed.)

International Nuclear Information System (INIS)

2006-01-01

This Safety Guide makes recommendations concerning the building of competence in protection and safety within a national radiation protection infrastructure and provides guidance for setting up the structure for a national strategy. It relates to the training and assessment of qualification of new personnel and the retraining of existing personnel in order to develop and maintain appropriate levels of competence. It provides the necessary guidance to meet the requirements laid down in Safety Series No. 115, International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. Contents: 1. Introduction; 2. Responsibilities for building competence in protection and safety; 3. Education, training and work experience; 4. A national strategy for building competence in protection and safety.

Safety assessment in plant layout design using indexing approach: Implementing inherent safety perspective

International Nuclear Information System (INIS)

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-01-01

Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design

77 FR 71194 - Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

Science.gov (United States)

2012-11-29

...] Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy... Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products,'' dated November... Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this...

Ecological risk assessment guidance for preparation of remedial investigation/feasibility study work plans

International Nuclear Information System (INIS)

Pentecost, E.D.; Vinikour, W.S.

1993-08-01

This guidance document (1) provides instructions on preparing the components of an ecological work plan to complement the overall site remedial assessment investigation/feasibility study (RI/FS) work plan and (2) directs the user on how to implement ecological tasks identified in the plan. Under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfired Amendments and Reauthorization Act of 1986 (SARA), an RI/FS work plan win have to be developed as part of the site-remediation scoping the process. Specific guidance on the RI/FS process and the preparation of work plans has been developed by the US Environmental Protection Agency (EPA 1988a). This document provides guidance to US Department of Energy (DOE) staff and contractor personnel for incorporation of ecological information into environmental remediation planning and decision making at CERCLA sites. An overview analysis of early ecological risk assessment methods (i.e., in the 1980s) at Superfund sites was conducted by the EPA (1989a). That review provided a perspective of attention given to ecological issues in some of the first RI/FS studies. By itself, that reference is of somewhat limited value; it does, however, establish a basis for comparison of past practices in ecological risk with current, more refined methods

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

Safety analysis for research reactors

International Nuclear Information System (INIS)

2008-01-01

The aim of safety analysis for research reactors is to establish and confirm the design basis for items important to safety using appropriate analytical tools. The design, manufacture, construction and commissioning should be integrated with the safety analysis to ensure that the design intent has been incorporated into the as-built reactor. Safety analysis assesses the performance of the reactor against a broad range of operating conditions, postulated initiating events and other circumstances, in order to obtain a complete understanding of how the reactor is expected to perform in these situations. Safety analysis demonstrates that the reactor can be kept within the safety operating regimes established by the designer and approved by the regulatory body. This analysis can also be used as appropriate in the development of operating procedures, periodic testing and inspection programmes, proposals for modifications and experiments and emergency planning. The IAEA Safety Requirements publication on the Safety of Research Reactors states that the scope of safety analysis is required to include analysis of event sequences and evaluation of the consequences of the postulated initiating events and comparison of the results of the analysis with radiological acceptance criteria and design limits. This Safety Report elaborates on the requirements established in IAEA Safety Standards Series No. NS-R-4 on the Safety of Research Reactors, and the guidance given in IAEA Safety Series No. 35-G1, Safety Assessment of Research Reactors and Preparation of the Safety Analysis Report, providing detailed discussion and examples of related topics. Guidance is given in this report for carrying out safety analyses of research reactors, based on current international good practices. The report covers all the various steps required for a safety analysis; that is, selection of initiating events and acceptance criteria, rules and conventions, types of safety analysis, selection of

Procedures for conducting common cause failure analysis in probabilistic safety assessment

International Nuclear Information System (INIS)

1992-05-01

The principal objective of this report is to supplement the procedure developed in Mosleh et al. (1988, 1989) by providing more explicit guidance for a practical approach to common cause failures (CCF) analysis. The detailed CCF analysis following that procedure would be very labour intensive and time consuming. This document identifies a number of options for performing the more labour intensive parts of the analysis in an attempt to achieve a balance between the need for detail, the purpose of the analysis and the resources available. The document is intended to be compatible with the Agency's Procedures for Conducting Probabilistic Safety Assessments for Nuclear Power Plants (IAEA, 1992), but can be regarded as a stand-alone report to be used in conjunction with NUREG/CR-4780 (Mosleh et al., 1988, 1989) to provide additional detail, and discussion of key technical issues

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

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

77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

Science.gov (United States)

2012-08-15

...] Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in... ``Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of... suicidal ideation and behavior in clinical trials of drug and biological products, including drugs for...

Independent assessment for new nuclear reactor safety

Directory of Open Access Journals (Sweden)

D'Auria Francesco

2017-01-01

Full Text Available A rigorous framework for safety assessment is established in all countries where nuclear technology is used for the production of electricity. On the one side, industry, i.e. reactor designers, vendors and utilities perform safety analysis and demonstrate consistency between results of safety analyses and requirements. On the other side, regulatory authorities perform independent assessment of safety and confirm the acceptability of safety of individual reactor units. The process of comparing results from analyses by reactor utilities and regulators is very complex. The process is also highly dependent upon mandatory approaches pursued for the analysis and from very many details which required the knowledge of sensitive proprietary data (e.g. spacer designs. Furthermore, all data available for the design, construction and operation of reactors produced by the nuclear industry are available to regulators. Two areas for improving the process of safety assessment for individual Nuclear Power Plant Units are identified: New details introduced by industry are not always and systematically requested by regulators for the independent assessment; New analytical techniques and capabilities are not necessarily used in the analyses by regulators (and by the industry. The established concept of independent assessment constitutes the way for improving the process of safety assessment. This is possible, or is largely facilitated, by the recent availability of the so-called Best Estimate Plus Uncertainty approach.

Independent assessment for new nuclear reactor safety

International Nuclear Information System (INIS)

D'Auria, F.; Glaeser, H.; Debrecin, N.

2017-01-01

A rigorous framework for safety assessment is established in all countries where nuclear technology is used for the production of electricity. On one side, industry, i.e. reactor designers, vendors and utilities perform safety analysis and demonstrate consistency between results of safety analyses and requirements. On the other side, regulatory authorities perform independent assessment of safety and confirm the acceptability of safety of individual reactor units. The process of comparing results from analyses by reactor utilities and regulators is very complex. The process is also highly dependent upon mandatory approaches pursued for the analysis and from very many details which required the knowledge of sensitive proprietary data (e.g. spacer designs). Furthermore, all data available for the design, construction and operation of reactors produced by the nuclear industry are available to regulators. Two areas for improving the process of safety assessment for individual Nuclear Power Plant Units are identified: New details introduced by industry are not always and systematically requested by regulators for the independent assessment; New analytical techniques and capabilities are not necessarily used in the analyses by regulators (and by the industry). The established concept of independent assessment constitutes the way for improving the process of safety assessment. This is possible, or is largely facilitated, by the recent availability of the so-called Best Estimate Plus Uncertainty (BEPU) approach. (authors)

The IAEA Safety Regime for Decommissioning

International Nuclear Information System (INIS)

Bell, M.J.

2002-01-01

Full text of publication follows: The International Atomic Energy Agency is developing an international framework for decommissioning of nuclear facilities that consists of the Joint Convention on the Safety of Spent Fuel Management and the Safety of Radioactive Waste Management, and a hierarchy of Safety Standards applicable to decommissioning. The Joint Convention entered into force on 18 June 2001 and as of December 2001 had been ratified by 27 IAEA Member States. The Joint Convention contains a number of articles dealing with planning for, financing, staffing and record keeping for decommissioning. The Joint Convention requires Contracting Parties to apply the same operational radiation protection criteria, discharge limits and criteria for controlling unplanned releases during decommissioning that are applied during operations. The IAEA has issued Safety Requirements document and three Safety Guides applicable to decommissioning of facilities. The Safety Requirements document, WS-R-2, Pre-disposal Management of Radioactive Waste, including Decommissioning, contains requirements applicable to regulatory control, planning and funding, management of radioactive waste, quality assurance, and environmental and safety assessment of the decommissioning process. The three Safety Guides are WS-G-2.1, Decommissioning of Nuclear Power Plants and Research Reactors, WS-G-2.2, Decommissioning of Medical, Industrial and Research Facilities, an WS-G-2.4, Decommissioning of Nuclear Fuel Cycle Facilities. They contain guidance on how to meet the requirements of WS-R-2 applicable to decommissioning of specific types of facilities. These Standards contain only general requirements and guidance relative to safety assessment and do not contain details regarding the content of the safety case. More detailed guidance will be published in future Safety Reports currently in preparation within the Waste Safety Section of the IAEA. Because much material arising during the decommissioning

AGR core safety assessment methodologies

International Nuclear Information System (INIS)

McLachlan, N.; Reed, J.; Metcalfe, M.P.

1996-01-01

To demonstrate the safety of its gas-cooled graphite-moderated AGR reactors, nuclear safety assessments of the cores are based upon a methodology which demonstrates no component failures, geometrical stability of the structure and material properties bounded by a database. All AGRs continue to meet these three criteria. However, predictions of future core behaviour indicate that the safety case methodology will eventually need to be modified to deal with new phenomena. A new approach to the safety assessment of the cores is currently under development, which can take account of these factors while at the same time providing the same level of protection for the cores. This approach will be based on the functionality of the core: unhindered movement of control rods, continued adequate cooling of the fuel and the core, continued ability to charge and discharge fuel. (author). 5 figs

How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

Science.gov (United States)

Tyner, Katherine M; Zheng, Nan; Choi, Stephanie; Xu, Xiaoming; Zou, Peng; Jiang, Wenlei; Guo, Changning; Cruz, Celia N

2017-07-01

The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

A new assessment method for demonstrating the sufficiency of the safety assessment and the safety margins of the geological disposal system

International Nuclear Information System (INIS)

Ohi, Takao; Kawasaki, Daisuke; Chiba, Tamotsu; Takase, Toshio; Hane, Koji

2013-01-01

A new method for demonstrating the sufficiency of the safety assessment and safety margins of the geological disposal system has been developed. The method is based on an existing comprehensive sensitivity analysis method and can systematically identify the successful conditions, under which the dose rate does not exceed specified safety criteria, using analytical solutions for nuclide migration and the results of a statistical analysis. The successful conditions were identified using three major variables. Furthermore, the successful conditions at the level of factors or parameters were obtained using relational equations between the variables and the factors or parameters making up these variables. In this study, the method was applied to the safety assessment of the geological disposal of transuranic waste in Japan. Based on the system response characteristics obtained from analytical solutions and on the successful conditions, the classification of the analytical conditions, the sufficiency of the safety assessment and the safety margins of the disposal system were then demonstrated. A new assessment procedure incorporating this method into the existing safety assessment approach is proposed in this study. Using this procedure, it is possible to conduct a series of safety assessment activities in a logical manner. (author)

IAEA Expert Team Completes Mission to Review Japan's Nuclear Power Plant Safety Assessment Process, 31 January 2012, Tokyo, Japan

International Nuclear Information System (INIS)

2012-01-01

utilities, emergency safety measures were promptly addressed in Japanese NPPs following the accident on 11 March 2011; NISA's practice of conducting an independent walkdown of emergency measures implemented at nuclear power plants enhances confidence that plants and operators can respond effectively during an emergency; and By observing European stress tests, NISA is demonstrating its commitment to improving Japanese nuclear safety by gaining experience from other countries. Improvements that would enhance the overall effectiveness of the Comprehensive Safety Assessment process include: Although NISA has demonstrated a notable level of transparency and interested party consultation related to the Comprehensive Safety Assessment and its review process, NISA should conduct additional meetings with interested parties near nuclear facilities that are subject to Comprehensive Safety Assessment; NISA should use the experience it gains from the first few reviews to clarify its guidance for how nuclear power plants should conduct their Comprehensive Safety Assessments and for how NISA should review those assessments; In the Secondary Assessment, there are areas that NISA could address more thoroughly, such as seismic safety margins and severe accident management; and NISA should ensure that the Secondary Assessments are completed, evaluated and confirmed by regulatory review within an appropriate timeframe. 'We enjoyed excellent cooperation from our Japanese counterparts during this mission', Lyons said. 'I encourage all nations to implement the IAEA Action Plan to improve global nuclear safety.''(IAEA)

Procedures for self-assessment of operational safety

International Nuclear Information System (INIS)

1997-08-01

Self-assessment processes have been continuously developed by nuclear organizations, including nuclear power plants. Currently, the nuclear industry and governmental organizations are showing an increasing interest in the implementation of this process as an effective way for improving safety performance. Self-assessment involves the use of different types of tools and mechanisms to assist the organizations in assessing their own safety performance against given standards. This helps to enhance the understanding of the need for improvements, the feeling of ownership in achieving them and and the safety culture as a whole. The concepts developed in this report present the basic approach to self-assessment taking into consideration experience gained during Operational Safety Review Team (OSART) missions, from organizations and utilities which have successfully implemented parts of a self-assessment programme and from meetings organized to discuss the subject

Development of Safety Review Guide for the Periodic Safety Review of Reactor Vessel Internals

International Nuclear Information System (INIS)

Park, Jeongsoon; Ko, Hanok; Kim, Seonjae; Jhung, Myungjo

2013-01-01

Aging management of the reactor vessel internals (RVIs) is one of the important issues for long-term operation of nuclear power plants (NPPs). Safety review on the assessment and management of the RVI aging is conducted through the process of a periodic safety review (PSR). The regulatory body should check that reactor facilities sustain safety functions in light of degradation due to aging and that the operator of a nuclear power reactor establishes and implements management program to deal with degradation due to aging in order to guarantee the safety functions and the safety margin as a result of PSR. KINS(Korea Institute of Nuclear Safety) has utilized safety review guides (SRG) which provide guidance to KINS staffs in performing safety reviews in order to assure the quality and uniformity of staff safety reviews. The KINS SRGs for the continued operation of pressurized water reactors (PWRs) published in 2006 contain areas of review regarding aging management of RVIs in chapter 2 (III.2.15, Appendix 2.0.1). However unlike the SRGs for the continued operation, KINS has not officially published the SRGs for the PSR of PWRs, but published them as a form of the research report. In addition to that, the report provides almost same review procedures for aging assessment and management of RVIs with the ones provided in the SRGs for the continued operation, it cannot provide review guidance specific to PSRs. Therefore, a PSR safety review guide should be developed for RVIs in PWRs. In this study, a draft PSR safety review guide for reactor vessel internals in PWRs is developed and provided. In this paper, a draft PSR safety review guide for reactor vessel internals (PSR SRG-RVIs) in PWRs is introduced and main contents of the draft are provided. However, since the PSR safety review guides for areas other than RVIs in the pressurized water reactors (PWRs) are expected to be developed in the near future, the draft PSR SRG-RVIs should be revisited to be compatible with

Uncertainty analysis in safety assessment

International Nuclear Information System (INIS)

Lemos, Francisco Luiz de; Sullivan, Terry

1997-01-01

Nuclear waste disposal is a very complex subject which requires the study of many different fields of science, like hydro geology, meteorology, geochemistry, etc. In addition, the waste disposal facilities are designed to last for a very long period of time. Both of these conditions make safety assessment projections filled with uncertainty. This paper addresses approaches for treatment of uncertainties in the safety assessment modeling due to the variability of data and some current approaches used to deal with this problem. (author)

Guidance on the import and export of radioactive sources

International Nuclear Information System (INIS)

2005-03-01

The IAEA Code of Conduct on the Safety and Security of Radioactive Sources, published in January 2004 with the symbol IAEA/CODEOC/2004, provides guidance on how States can safely and securely manage radioactive sources that may pose a significant risk. The concept of such an international undertaking on the safety and security of radioactive sources was highlighted in the major findings of the International Conference on the Safety of Radiation Sources and Security of Radioactive Materials held in Dijon, France, in September 1998. Following that conference, the IAEA Board of Governors requested the Director General to initiate exploratory discussions relating to an international undertaking in the areas of the safety and security of radiation sources. This request was reflected in an Action Plan on the Safety of Radiation Sources and Security of Radioactive Materials, with the Secretariat organizing a series of open-ended meetings of technical and legal experts nominated by Member States to further explore the concept of such an undertaking. Noting comments made in the Board of Governors, the experts agreed that any international undertaking should, for the present, be in the form of a 'code of conduct'. The text of a Code of Conduct on the Safety and Security of Radioactive Sources was accordingly developed. Steps to strengthen the provisions of the Code were subsequently initiated following the International Conference of National Regulatory Authorities with Competence in the Safety of Radiation Sources and the Security of Radioactive Material held in Buenos Aires in December 2000. Moreover, growing international concern about the security of radioactive sources after the events of 11 September 2001 led to a number of issues being considered further by technical and legal experts. Furthermore, the International Conference on Security of Radioactive Sources held in Vienna in March 2003 made recommendations regarding additional actions that might be needed. In June

NUMO's approach for long-term safety assessment - 59404

International Nuclear Information System (INIS)

Ebashi, Takeshi; Kaku, Kenichi; Ishiguro, Katsuhiko

2012-01-01

One of NUMO's policies for ensuring safety is staged and flexible project implementation and decision-making based on iterative confirmation of safety. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; a key aspect is uncertainty management. This paper presents NUMO's basic strategies for long-term safety assessment based on the above policy. NUMO's approach considering Japanese boundary conditions is demonstrated as a starting-point for evaluating the long-term safety of an actual site. In Japan, the Act on Final Disposal of Specified Radioactive Waste states that the siting process shall consist of three stages. The Nuclear Waste Management Organization of Japan (NUMO) is responsible for geological disposal of vitrified high-level waste and some types of TRU waste. NUMO has chosen to implement a volunteer approach to siting. NUMO decided to prepare the so-called 2010 technical report, which sets out three safety policies, one of which is staged project implementation and decision-making based on iterative confirmation of safety. Based on this policy, NUMO will gradually integrate relevant interdisciplinary knowledge to build a safety case when a formal volunteer application is received that would allow site investigations to be initiated. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; one of a key aspect is uncertainty management. This paper presents the basic strategies for NUMO's long-term safety assessment based on the above policy. In concrete terms, the common procedures involved in safety assessment are applied in a stepwise manner, based on integration of knowledge obtained from site investigations/evaluations and engineered measures. The results of the safety assessment are then reflected in the planning of site investigations and engineered

Accident Analysis Guidance for Completion of 10 CFR 830-Compliant DSAs

International Nuclear Information System (INIS)

Vincent, A.

2002-01-01

Safety analysis contractors responsible for existing nuclear facilities are required to submit a Documented Safety Analysis to the Department of Energy for approval by April 2003. Recognizing that schedule and resource limitations may be significant, an initiative is underway to make available a set of guidance tools. The guidance is in the form of a peer-reviewed Accident Analysis Guidebook, a series of application guides for ''safe harbor'' computer codes, establishment of a configuration-controlled collection of safety analysis software and a central registry to maintain it, and periodic analytical training on accident analysis methods. Delivery of the majority of these products is scheduled to be in FY 2003

Probabilistic safety assessment

International Nuclear Information System (INIS)

Hoertner, H.; Schuetz, B.

1982-09-01

For the purpose of assessing applicability and informativeness on risk-analysis methods in licencing procedures under atomic law, the choice of instruments for probabilistic analysis, the problems in and experience gained in their application, and the discussion of safety goals with respect to such instruments are of paramount significance. Naturally, such a complex field can only be dealt with step by step, making contribution relative to specific problems. The report on hand shows the essentials of a 'stocktaking' of systems relability studies in the licencing procedure under atomic law and of an American report (NUREG-0739) on 'Quantitative Safety Goals'. (orig.) [de

Assessment of Adaptive Guidance for Responsive Launch Vehicles and Spacecraft

Science.gov (United States)

2009-04-29

Figures 1 Earth centered inertial and launch plumbline coordinate systems . . . . . . . 7 2 Geodetic and geocentric latitude...Dramatically reduced reoccurring costs related to guidance. The same features of the closed-loop ascent guidance that provide operational flexibility...also result in greatly reduced need for human intervention. Thus the operational costs related to ascent guidance could be reduced to minimum

Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283

DEFF Research Database (Denmark)

Poulsen, Morten

2016-01-01

. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the novel food. The application should be comprehensive and complete. This guidance outlined the data needed......Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of novel foods...... for the safety assessments of novel foods. Requirements which should be covered in all applications relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use...

Non-cable vehicle guidance

Energy Technology Data Exchange (ETDEWEB)

Daugela, G.C.; Willott, A.M.; Chopiuk, R.G.; Thornton, S.E.

1988-06-01

The purpose is to determine the most promising driverless mine vehicle guidance systems that are not dependent on buried cables, and to plan their development. The project is presented in two phases: a preliminary study and literature review to determine whether suitable technologies exist to justify further work; and an in-depth assessment and selection of technologies for vehicle guidance. A large number of guidance elements are involved in a completely automated vehicle. The technologies that hold the best potential for development of guidance systems for mine vehicles are ultrasonics, radar, lasers, dead reckoning, and guidance algorithms. The best approach to adaptation of these technologies is on a step by step basis. Guidance modules that are complete in themselves and are designed to be integrated with other modules can provide short term benefits. Two modules are selected for development: the dragline operations monitor and automated machine control for optimized mining (AMCOM). 99 refs., 20 figs., 40 tabs.

A Methodology To Incorporate The Safety Culture Into Probabilistic Safety Assessments

Energy Technology Data Exchange (ETDEWEB)

Park, Sunghyun; Kim, Namyeong; Jae, Moosung [Hanyang University, Seoul (Korea, Republic of)

2015-10-15

In order to incorporate organizational factors into PSA, a methodology needs to be developed. Using the AHP to weigh organizational factors as well as the SLIM to rate those factors, a methodology is introduced in this study. The safety issues related to nuclear safety culture have occurred increasingly. The quantification tool has to be developed in order to include the organizational factor into Probabilistic Safety Assessments. In this study, the state-of-the-art for the organizational evaluation methodologies has been surveyed. This study includes the research for organizational factors, maintenance process, maintenance process analysis models, a quantitative methodology using Analytic Hierarchy Process, Success Likelihood Index Methodology. The purpose of this study is to develop a methodology to incorporate the safety culture into PSA for obtaining more objective risk than before. The organizational factor considered in nuclear safety culture might affect the potential risk of human error and hardware-failure. The safety culture impact index to monitor the plant safety culture can be assessed by applying the developed methodology into a nuclear power plant.

A Methodology To Incorporate The Safety Culture Into Probabilistic Safety Assessments

International Nuclear Information System (INIS)

Park, Sunghyun; Kim, Namyeong; Jae, Moosung

2015-01-01

In order to incorporate organizational factors into PSA, a methodology needs to be developed. Using the AHP to weigh organizational factors as well as the SLIM to rate those factors, a methodology is introduced in this study. The safety issues related to nuclear safety culture have occurred increasingly. The quantification tool has to be developed in order to include the organizational factor into Probabilistic Safety Assessments. In this study, the state-of-the-art for the organizational evaluation methodologies has been surveyed. This study includes the research for organizational factors, maintenance process, maintenance process analysis models, a quantitative methodology using Analytic Hierarchy Process, Success Likelihood Index Methodology. The purpose of this study is to develop a methodology to incorporate the safety culture into PSA for obtaining more objective risk than before. The organizational factor considered in nuclear safety culture might affect the potential risk of human error and hardware-failure. The safety culture impact index to monitor the plant safety culture can be assessed by applying the developed methodology into a nuclear power plant

Complementary safety assessments - Report by the French Nuclear Safety Authority

International Nuclear Information System (INIS)

2011-12-01

As an immediate consequence of the Fukushima accident, the French Authority of Nuclear Safety (ASN) launched a campaign of on-site inspections and asked operators (mainly EDF, AREVA and CEA) to make complementary assessments of the safety of the nuclear facilities they manage. The approach defined by ASN for the complementary safety assessments (CSA) is to study the behaviour of nuclear facilities in severe accidents situations caused by an off-site natural hazard according to accident scenarios exceeding the current baseline safety requirements. This approach can be broken into 2 phases: first conformity to current design and secondly an approach to the beyond design-basis scenarios built around the principle of defence in depth. 38 inspections were performed on issues linked to the causes of the Fukushima crisis. It appears that some sites have to reinforce the robustness of the heat sink. The CSA confirmed that the processes put into place at EDF to detect non-conformities were satisfactory. The complementary safety assessments demonstrated that the current seismic margins on the EDF nuclear reactors are satisfactory. With regard to flooding, the complementary safety assessments show that the complete reassessment carried out following the flooding of the Le Blayais nuclear power plant in 1999 offers the installations a high level of protection against the risk of flooding. Concerning the loss of electrical power supplies and the loss of cooling systems, the analysis of EDF's CSA reports showed that certain heat sink and electrical power supply loss scenarios can, if nothing is done, lead to core melt in just a few hours in the most unfavourable circumstances. As for nuclear facilities that are not power or experimental reactors, some difficulties have appeared to implement the CSA approach that was initially devised for reactors. Generally speaking, ASN considers that the safety of nuclear facilities must be made more robust to improbable risks which are not

Risk prediction, safety analysis and quantitative probability methods - a caveat

International Nuclear Information System (INIS)

Critchley, O.H.

1976-01-01

Views are expressed on the use of quantitative techniques for the determination of value judgements in nuclear safety assessments, hazard evaluation, and risk prediction. Caution is urged when attempts are made to quantify value judgements in the field of nuclear safety. Criteria are given the meaningful application of reliability methods but doubts are expressed about their application to safety analysis, risk prediction and design guidances for experimental or prototype plant. Doubts are also expressed about some concomitant methods of population dose evaluation. The complexities of new designs of nuclear power plants make the problem of safety assessment more difficult but some possible approaches are suggested as alternatives to the quantitative techniques criticized. (U.K.)

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.

Development and applications of a safety assessment system for promoting safety culture in nuclear power plants

International Nuclear Information System (INIS)

Takano, Ken-ichi; Hasegawa, Naoko; Hirose, Ayako; Hayase, Ken-ichi

2004-01-01

For past five years, CRIEPI has been continuing efforts to develop and make applications of a 'safety assessment system' which enable to measure the safety level of organization. This report describe about frame of the system, assessment results and its reliability, and relation between labor accident rate in the site and total safety index (TSI), which can be obtained by the principal factors analysis. The safety assessment in this report is based on questionnaire survey of employee. The format and concrete questionnaires were developed using existing literatures including organizational assessment tools. The tailored questionnaire format involved 124 questionnaire items. The assessment results could be considered as a well indicator of the safety level of organization, safety management, and safety awareness of employee. (author)

Safety culture' is integrating 'human' into risk assessment

International Nuclear Information System (INIS)

Sugimoto, Taiji

2014-01-01

Significance of Fukushima nuclear power accident requested reconsideration of safety standards, of which we had usually no doubt. Risk assessment standard (JIS B 9702), Which was used for repetition of database preparation and cumulative assessment, defined allowable risk and residual risk. However, work site and immediate assessment was indispensable beside such assessment so as to ensure safety. Risk of casualties was absolutely not acceptable in principle and judgments to approve allowable risk needed accountability, which was reminded by safety culture proposed by IAEA and also identified by investigation of organizational cause of Columbia accident. Actor of safety culture would be organization and individual, and mainly individual. Realization of safety culture was conducted by personnel having moral consciousness and firm sense of mission in the course of jobs and working daily with sweat pouring. Safety engineering/technology should have framework integrating human as such totality. (T. Tanaka)

Report 6: Guidance document. Man-made hazards and Accidental Aircraft Crash hazards modelling and implementation in extended PSA

International Nuclear Information System (INIS)

Kahia, S.; Brinkman, H.; Bareith, A.; Siklossy, T.; Vinot, T.; Mateescu, T.; Espargilliere, J.; Burgazzi, L.; Ivanov, I.; Bogdanov, D.; Groudev, P.; Ostapchuk, S.; Zhabin, O.; Stojka, T.; Alzbutas, R.; Kumar, M.; Nitoi, M.; Farcasiu, M.; Borysiewicz, M.; Kowal, K.; Potempski, S.

2016-01-01

The goal of this report is to provide guidance on practices to model man-made hazards (mainly external fires and explosions) and accidental aircraft crash hazards and implement them in extended Level 1 PSA. This report is a joint deliverable of work package 21 (WP21) and work package 22 (WP22). The general objective of WP21 is to provide guidance on all of the individual hazards selected at the first ASAMPSA-E End Users Workshop (May 2014, Uppsala, Sweden). The objective of WP22 is to provide the solutions for purposes of different parts of man-made hazards Level 1 PSA fulfilment. This guidance is focusing on man-made hazards, namely: external fires and explosions, and accidental aircraft crash hazards. Guidance developed refers to existing guidance whenever possible. The initial part of guidance (WP21 part) reflects current practices to assess the frequencies for each type of hazards or combination of hazards (including correlated hazards) as initiating event for PSAs. The sources and quality of hazard data, the elements of hazard assessment methodologies and relevant examples are discussed. Classification and criteria to properly assess hazard combinations as well as examples and methods for assessment of these combinations are included in this guidance. In appendixes additional material is presented with the examples of practical approaches to aircraft crash and man-made hazard. The following issues are addressed: 1) Hazard assessment methodologies, including issues related to hazard combinations. 2) Modelling equipment of safety related SSC, 3) HRA, 4) Emergency response, 5) Multi-unit issues. Recommendations and also limitations, gaps identified in the existing methodologies and a list of open issues are included. At all stages of this guidance and especially from an industrial end-user perspective, one must keep in mind that the development of man-made hazards probabilistic analysis must be conditioned to the ability to ultimately obtain a representative risk

Percutaneous radiofrequency ablation of lung metastases from colorectal carcinoma under C-arm cone beam CT guidance.

Science.gov (United States)

Amouyal, G; Pernot, S; Déan, C; Cholley, B; Scotté, F; Sapoval, M; Pellerin, O

2017-11-01

The aim of this study was to assess the feasibility, safety and efficacy of percutaneous radiofrequency ablation of lung metastases from colorectal carcinoma using C-arm cone beam computed tomography (CBCT) guidance. This single-center prospective observational study was performed from August 2013 to August 2016, and included consecutive patients referred for radiofrequency ablation of lung metastases from colorectal cancer. Radiofrequency ablation procedures were performed under C-arm CBCT guidance. Feasibility was assessed by probe accuracy placement, time to accurate placement and number of C-arm CBCT acquisitions to reach the target lesion. Safety was assessed by the report of adverse event graded using the common terminology criteria for adverse events (CTCAE-V4.0). Efficacy was assessed by metastases response rate using RECIST 1.1 and 18 FDG-PET-CT tumor uptake at 6months. Fifty-four consecutive patients (32 men, 22 women) with a mean age of 63±8 (SD) years (range: 51-81years) with a total of 56 lung metastasis from colorectal metastases were treated in a single session. The mean tumor diameter was 25.6±4.5 (SD)mm (range: 17-31mm). Median time to insert the needle into the target lesion was 10min (range: 5-25min). Median number of needles repositioning and C-arm CBCT acquisition per patient was 1 (range: 0-3) and 4 (range: 3-6) respectively. The accuracy for radiofrequency ablation probe placement was 2±0.2 (SD)mm (range: 0-9mm). Pneumothorax requiring chest tube placement occurred in one patient (CTCAE-V4.0 grade 3). At 6months, all patients were alive with tumor response rate of -27% and had no significant activity on the 18 FDG-PET CT follow-up. Percutaneous radiofrequency ablation of lung metastases from colorectal cancer under C-arm CBCT guidance is feasible and safe, with immediate and short-term results similar to those obtained using conventional CT guidance. Copyright © 2017 Éditions françaises de radiologie. Published by Elsevier Masson SAS

International Review Team (IRT) Safety Case Recommendations for the Yucca Mountain Total System Performance Assessment (TSPA) Supporting the Site Recommendation

International Nuclear Information System (INIS)

Van Luik, Abraham E.

2004-01-01

The session started with Abe Van Luik (IGSC Chair, US-DOE-YM, USA) who presented the feedback of the international peer review of the US-DOE Yucca Mountain TSPA (Total System Performance Assessment) supporting the successful designation of the site by the Congress and the President of the U.S. In particular, he listed key implications of the IRT (International Review team) recommendations on the forthcoming US-DOE documentation of its case for safety to be submitted to the regulator, the U.S. Nuclear Regulatory Commission, mainly: - The documentation submitted to the licensing authority should address technical aspects and compliance with regulatory criteria. - That documentation should reflect sound science and good engineering practice; it should present detailed and rigorous modelling. - In addition, it should present both quantitative and qualitative arguments, make a statement on why there can be confidence in the face of uncertainty, acknowledge remaining issues and provide the strategy to resolve them. - Demonstrating understanding is as important as demonstrating compliance. - There is a need to provide a clear explanation of the case made to the regulator for more general audiences to complement the large amount of technical documents that will be produced. The US-DOE response to these recommendations for the License Application, which is under preparation, is that the recommendations will be implemented to the maximum extent possible. In subsequent discussion, with respect to the License Application, it was acknowledged that detailed guidance from the U.S. regulator was very useful, and guidance of this type would be generally useful. At the current time, the words 'safety case' are not mentioned in U.S. regulations, but if one reads both the regulation and guidance documents it becomes evident that all aspects of a safety case need to be provided in the License Application and its accompanying documents

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

Acute tier-1 and tier-2 effect assessment approaches in the EFSA Aquatic Guidance Diocument: are they sufficiently protective for insecticides?

NARCIS (Netherlands)

Wijngaarden, van R.P.A.; Maltby, L.; Brock, T.C.M.

2015-01-01

BACKGROUND The objective of this paper is to evaluate whether the acute tier-1 and tier-2 methods as proposed by the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) are appropriate for deriving regulatory acceptable concentrations (RACs) for insecticides.

Uncertainty analysis in safety assessment

Energy Technology Data Exchange (ETDEWEB)

Lemos, Francisco Luiz de [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN), Belo Horizonte, MG (Brazil); Sullivan, Terry [Brookhaven National Lab., Upton, NY (United States)

1997-12-31

Nuclear waste disposal is a very complex subject which requires the study of many different fields of science, like hydro geology, meteorology, geochemistry, etc. In addition, the waste disposal facilities are designed to last for a very long period of time. Both of these conditions make safety assessment projections filled with uncertainty. This paper addresses approaches for treatment of uncertainties in the safety assessment modeling due to the variability of data and some current approaches used to deal with this problem. (author) 13 refs.; e-mail: lemos at bnl.gov; sulliva1 at bnl.gov

Model review and evaluation for application in DOE safety basis documentation of chemical accidents - modeling guidance for atmospheric dispersion and consequence assessment

Energy Technology Data Exchange (ETDEWEB)

Lazaro, M. A. [Argonne National Lab. (ANL), Argonne, IL (United States); Woodarad, K. [Argonne National Lab. (ANL), Argonne, IL (United States); Hanna, S. R. [Argonne National Lab. (ANL), Argonne, IL (United States); Hesse, D. J. [Argonne National Lab. (ANL), Argonne, IL (United States); Huang, J. -C. [Argonne National Lab. (ANL), Argonne, IL (United States); Lewis, J. [Argonne National Lab. (ANL), Argonne, IL (United States); Mazzola, C. A. [Argonne National Lab. (ANL), Argonne, IL (United States)

1997-09-01

The U.S. Department of Energy (DOE), through its Defense Programs (DP), Office of Engineering and Operations Suppon, established the Accident Phenomenology and Consequence (AP AC) Methodology Evaluation Program to identify and evaluate methodologies and computer codes to support accident phenomenological and consequence calculations for both radiological and nonradiological materials at DOE facilities and to identify development needs. The program is also intended to define and recommend "best or good engineering/safety analysis practices" to be followed in preparing ''design or beyond design basis" assessments to be included in DOE nuclear and nonnuclear facility safety documents. The AP AC effort is intended to provide scientifically sound and more consistent analytical approaches, by identifying model selection procedures and application methodologies, in order to enhance safety analysis activities throughout the DOE complex.

Adaptation of the ToxRTool to Assess the Reliability of Toxicology Studies Conducted with Genetically Modified Crops and Implications for Future Safety Testing.

Science.gov (United States)

Koch, Michael S; DeSesso, John M; Williams, Amy Lavin; Michalek, Suzanne; Hammond, Bruce

2016-01-01

To determine the reliability of food safety studies carried out in rodents with genetically modified (GM) crops, a Food Safety Study Reliability Tool (FSSRTool) was adapted from the European Centre for the Validation of Alternative Methods' (ECVAM) ToxRTool. Reliability was defined as the inherent quality of the study with regard to use of standardized testing methodology, full documentation of experimental procedures and results, and the plausibility of the findings. Codex guidelines for GM crop safety evaluations indicate toxicology studies are not needed when comparability of the GM crop to its conventional counterpart has been demonstrated. This guidance notwithstanding, animal feeding studies have routinely been conducted with GM crops, but their conclusions on safety are not always consistent. To accurately evaluate potential risks from GM crops, risk assessors need clearly interpretable results from reliable studies. The development of the FSSRTool, which provides the user with a means of assessing the reliability of a toxicology study to inform risk assessment, is discussed. Its application to the body of literature on GM crop food safety studies demonstrates that reliable studies report no toxicologically relevant differences between rodents fed GM crops or their non-GM comparators.

Safety assessment of foods derived from genetically modified crops

NARCIS (Netherlands)

Kleter, G.A.; Kuiper, H.A.

2003-01-01

The pre-market safety assessment of foods derived from genetically modified crops is carried out according to the consensus approach of "substantial equivalence", in other words: the comparative safety assessment. Currently, the safety assessment of genetically modified foods is harmonized at the

National Waste Repository Novi Han operational safety analysis report. Safety assessment methodology

International Nuclear Information System (INIS)

2003-01-01

The scope of the safety assessment (SA), presented includes: waste management functions (acceptance, conditioning, storage, disposal), inventory (current and expected in the future), hazards (radiological and non-radiological) and normal and accidental modes. The stages in the development of the SA are: criteria selection, information collection, safety analysis and safety assessment documentation. After the review the facilities functions and the national and international requirements, the criteria for safety level assessment are set. As a result from the 2nd stage actual parameters of the facility, necessary for safety analysis are obtained.The methodology is selected on the base of the comparability of the results with the results of previous safety assessments and existing standards and requirements. The procedure and requirements for scenarios selection are described. A radiological hazard categorisation of the facilities is presented. Qualitative hazards and operability analysis is applied. The resulting list of events are subjected to procedure for prioritization by method of 'criticality analysis', so the estimation of the risk is given for each event. The events that fall into category of risk on the boundary of acceptability or are unacceptable are subjected to the next steps of the analysis. As a result the lists with scenarios for PSA and possible design scenarios are established. PSA logical modeling and quantitative calculations of accident sequences are presented

Wide-Area Haptic Guidance: Taking the User by the Hand

OpenAIRE

Pérez Arias, Antonia; Hanebeck, Uwe D.

2010-01-01

In this paper, we present a novel use of haptic information in extended range telepresence, the wide-area haptic guidance. It consists of force and position signals applied to the user's hand in order to improve safety, accuracy, and speed in some telepresent tasks. Wide-area haptic guidance assists the user in reaching a desired position in a remote environment of arbitrary size without degrading the feeling of presence. Several methods for haptic guidance are analyzed. With active haptic gu...

Recommendations of the Oligonucleotide Safety Working Group's Formulated Oligonucleotide Subcommittee for the Safety Assessment of Formulated Oligonucleotide-Based Therapeutics.

Science.gov (United States)

Marlowe, Jennifer L; Akopian, Violetta; Karmali, Priya; Kornbrust, Douglas; Lockridge, Jennifer; Semple, Sean

2017-08-01

The use of lipid formulations has greatly improved the ability to effectively deliver oligonucleotides and has been instrumental in the rapid expansion of therapeutic development programs using oligonucleotide drugs. However, the development of such complex multicomponent therapeutics requires the implementation of unique, scientifically sound approaches to the nonclinical development of these drugs, based upon a hybrid of knowledge and experiences drawn from small molecule, protein, and oligonucleotide therapeutic drug development. The relative paucity of directly applicable regulatory guidance documents for oligonucleotide therapeutics in general has resulted in the generation of multiple white papers from oligonucleotide drug development experts and members of the Oligonucleotide Safety Working Group (OSWG). The members of the Formulated Oligonucleotide Subcommittee of the OSWG have utilized their collective experience working with a variety of formulations and their associated oligonucleotide payloads, as well as their insights into regulatory considerations and expectations, to generate a series of consensus recommendations for the pharmacokinetic characterization and nonclinical safety assessment of this unique class of therapeutics. It should be noted that the focus of Subcommittee discussions was on lipid nanoparticle and other types of particulate formulations of therapeutic oligonucleotides and not on conjugates or other types of modifications of oligonucleotide structure intended to facilitate delivery.

Assessment of safety culture: Changing regulatory approach in Hungary

International Nuclear Information System (INIS)

Ronaky, Jozsef; Toth, Andras

2002-01-01

Hungarian Atomic Energy Authority (HAEA) is changing its inspection practice and assessment methods of safety performance and safety culture in operating nuclear facilities. The new approach emphasises integrated team inspection of safety cornerstones and systematic assessment of safety performance of operators. (author)

Tolerability of risk, safety assessment principles and their implications for probabilistic safety analysis

International Nuclear Information System (INIS)

Ewing, D.J.F.; Campbell, J.F.

1994-01-01

This paper gives a regulatory view of probabilistic safety assessment as seen by the Nuclear Installations Inspectorate (NII) and in the light of the general regulatory risk aims set out in the Health and Safety Executive's (HSE) The tolerability of risk from nuclear power stations (TOR) and in Safety assessment principles for nuclear plants (SAPs), prepared by NII on behalf of the HSE. Both of these publications were revised and republished in 1992. This paper describes the SAPs, together with the historical background, the motivation for review, the effects of the Sizewell and Hinkley Point C public inquiries, changes since the original versions, comparison with international standards and use in assessment. For new plant, probabilistic safety analysis (PSA) is seen as an essential tool in balancing the safety of the design and in demonstrating compliance with TOR and the SAPs. (Author)

The radiation safety self-assessment program of Ontario Hydro

International Nuclear Information System (INIS)

Armitage, G.; Chase, W.J.

1987-01-01

Ontario Hydro has developed a self-assessment program to ensure that high quality in its radiation safety program is maintained. The self-assessment program has three major components: routine ongoing assessment, accident/incident investigation, and detailed assessments of particular radiation safety subsystems or of the total radiation safety program. The operation of each of these components is described

Modifications to nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2004-01-01

control and that the modified configuration conforms to the approved basis for granting a nuclear power plant operating licence. The main purpose of the recommendations concerning changes of management is to give general guidance on performing those changes in such a way that the safety of the plant is not compromised. This Safety Guide deals with the intended modification of structures, systems and components, operational limits and conditions, procedures and software, and the management systems and tools for the operation of a nuclear power plant. The recommendations made cover the whole modification process, from conception to completion. The justification for undertaking modifications is outside the scope of this Safety Guide. The modification and/or refurbishment of nuclear power plants for the purpose of extending the design lifetime could necessitate many major design modifications and special re-evaluation of plant safety (see Ref. [2]), and is therefore outside the scope of this publication. Section 2 gives guidance on general methods for modifications that could be implemented at nuclear power plants. Section 3 identifies the roles and responsibilities of various organizations involved in the modification process. Sections 4 and 5 give guidance on the different types of modification and their assessment in respect of safety aspects, and Section 4 provides guidelines on subsequent categorization. Section 6 deals with aspects of temporary modifications. Sections 7 and 8 give guidance on implementation of different types of modifications. Sections 9, 10 and 11 give basic recommendations on quality assurance, training and management of documentation. Comprehensive guidance on these matters can be found in the appropriate Safety Guides

Modifications to nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2007-01-01

control and that the modified configuration conforms to the approved basis for granting a nuclear power plant operating licence. The main purpose of the recommendations concerning changes of management is to give general guidance on performing those changes in such a way that the safety of the plant is not compromised. This Safety Guide deals with the intended modification of structures, systems and components, operational limits and conditions, procedures and software, and the management systems and tools for the operation of a nuclear power plant. The recommendations made cover the whole modification process, from conception to completion. The justification for undertaking modifications is outside the scope of this Safety Guide. The modification and/or refurbishment of nuclear power plants for the purpose of extending the design lifetime could necessitate many major design modifications and special re-evaluation of plant safety, and is therefore outside the scope of this publication. Section 2 gives guidance on general methods for modifications that could be implemented at nuclear power plants. Section 3 identifies the roles and responsibilities of various organizations involved in the modification process. Sections 4 and 5 give guidance on the different types of modification and their assessment in respect of safety aspects, and Section 4 provides guidelines on subsequent categorization. Section 6 deals with aspects of temporary modifications. Sections 7 and 8 give guidance on implementation of different types of modifications. Sections 9, 10 and 11 give basic recommendations on quality assurance, training and management of documentation. Comprehensive guidance on these matters can be found in the appropriate Safety Guides

Probabilistic safety assessment for seismic events

International Nuclear Information System (INIS)

1993-10-01

This Technical Document on Probabilistic Safety Assessment for Seismic Events is mainly associated with the Safety Practice on Treatment of External Hazards in PSA and discusses in detail one specific external hazard, i.e. earthquakes

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

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

Construction for Nuclear Installations. Specific Safety Guide

International Nuclear Information System (INIS)

2015-01-01

This Safety Guide provides recommendations and guidance based on international good practices in the construction of nuclear installations, which will enable construction to proceed with high quality. It can be applied to support the development, implementation and assessment of construction methods and procedures and the identification of good practices for ensuring the quality of the construction to meet the design intent and ensure safety. It will be a useful tool for regulatory bodies, licensees and new entrant countries for nuclear power plants and other nuclear installations

Chemical process safety at fuel cycle facilities

International Nuclear Information System (INIS)

Ayres, D.A.

1997-08-01

This NUREG provides broad guidance on chemical safety issues relevant to fuel cycle facilities. It describes an approach acceptable to the NRC staff, with examples that are not exhaustive, for addressing chemical process safety in the safe storage, handling, and processing of licensed nuclear material. It expounds to license holders and applicants a general philosophy of the role of chemical process safety with respect to NRC-licensed materials; sets forth the basic information needed to properly evaluate chemical process safety; and describes plausible methods of identifying and evaluating chemical hazards and assessing the adequacy of the chemical safety of the proposed equipment and facilities. Examples of equipment and methods commonly used to prevent and/or mitigate the consequences of chemical incidents are discussed in this document

Living probabilistic safety assessment (LPSA)

International Nuclear Information System (INIS)

1999-08-01

Over the past few years many nuclear power plant organizations have performed probabilistic safety assessments (PSAs) to identify and understand key plant vulnerabilities. As a result of the availability of these PSA studies, there is a desire to use them to enhance plant safety and to operate the nuclear stations in the most efficient manner. PSA is an effective tool for this purpose as it assists plant management to target resources where the largest benefit to plant safety can be obtained. However, any PSA which is to be used in this way must have a credible and defensible basis. Thus, it is very important to have a high quality 'living PSA' accepted by the plant and the regulator. With this background in mind, the IAEA has prepared this report on Living Probabilistic Safety Assessment (LPSA) which addresses the updating, documentation, quality assurance, and management and organizational requirements for LPSA. Deficiencies in the areas addressed in this report would seriously reduce the adequacy of the LPSA as a tool to support decision making at NPPs. This report was reviewed by a working group during a Technical Committee Meeting on PSA Applications to Improve NPP Safety held in Madrid, Spain, from 23 to 27 February 1998

Criticality Safety in the Handling of Fissile Material. Specific Safety Guide

Energy Technology Data Exchange (ETDEWEB)

NONE

2014-05-15

This Safety Guide provides guidance and recommendations on how to meet the relevant requirements for ensuring subcriticality when dealing with fissile material and for planning the response to criticality accidents. The guidance and recommendations are applicable to both regulatory bodies and operating organizations. The objectives of criticality safety are to prevent a self-sustained nuclear chain reaction and to minimize the consequences of this if it were to occur. The Safety Guide makes recommendations on how to ensure subcriticality in systems involving fissile materials during normal operation, anticipated operational occurrences, and, in the case of accident conditions, within design basis accidents, from initial design through commissioning, operation, and decommissioning and disposal.

Probabilistic safety assessment in nuclear power plant management

International Nuclear Information System (INIS)

Holloway, N.J.

1989-06-01

Probabilistic Safety Assessment (PSA) techniques have been widely used over the past few years to assist in understanding how engineered systems respond to abnormal conditions, particularly during a severe accident. The use of PSAs in the design and operation of such systems thus contributes to the safety of nuclear power plants. Probabilistic safety assessments can be maintained to provide a continuous up-to-date assessment (Living PSA), supporting the management of plant operations and modifications

Development of a harmonized approach to safety assessment of decommissioning: Lessons learned from international experience (DeSa project)

International Nuclear Information System (INIS)

Percival, K.; Nokhamzon, J.-G.; Ferch, R.; Batandjieva, B.

2006-01-01

comprehensive approach to identification of radiological and non-radiological hazards needs to be applied, as in most decommissioning projects non-radiological hazards are predominant; (iv) there is limited experience worldwide on procedures for review of decommissioning safety assessments; (v) a graded approach is being applied on the basis of various criteria and there is no internationally agreed common approach; (vi) engineering evaluation of systems and components remains a challenge due to the gradual elimination of engineering barriers, aging of a facility and dynamic decommissioning activities; (vii) more clarity and guidance is needed on the interface between safety assessment for waste management and decommissioning. It is envisaged that consolidation of the knowledge, experience and lessons learned from decommissioning in over thirty Member States will provide a useful tool for the successful performance and regulation of decommissioning and for the release of sites from regulatory control consistent with international safety standards and good international practice. (author)

Commissioning of research reactors. Safety guide

International Nuclear Information System (INIS)

2006-01-01

The objective of this Safety Guide is to provide recommendations on meeting the requirements for the commissioning of research reactors on the basis of international best practices. Specifically, it provides recommendations on fulfilling the requirements established in paras 6.44 and 7.42-7.50 of International Atomic Energy Agency, Safety of Research Reactors, IAEA Safety Standards Series No. NS-R-4, IAEA, Vienna (2005) and guidance and specific and consequential recommendations relating to the recommendations presented in paras 615-621 of International Atomic Energy Agency, Safety in the Utilization and Modification of Research Reactors, Safety Series No. 35-G2, IAEA, Vienna (1994) and paras 228-229 of International Atomic Energy Agency, Safety Assessment of Research Reactors and Preparation of the Safety Analysis Report, Safety Series No. 35-G1, IAEA, Vienna (1994). This Safety Guide is intended for use by all organizations involved in commissioning for a research reactor, including the operating organization, the regulatory body and other organizations involved in the research reactor project

Track 2 sites: Guidance for assessing low probability hazard sites at the INEL. Revision 6

Energy Technology Data Exchange (ETDEWEB)

1994-01-01

This document presents guidance for assessment of Track 2 low probability hazard sites (LPHS) at the Idaho National Engineering Laboratory (INEL). The Track 2 classification was developed specifically for the INEL to streamline the implementation of Comprehensive Environmental Response, Compensation, and Liability Act. Track 2 LPHSs are described as sites where insufficient data are available to make a decision concerning the risk level or to select or design a remedy. As such, these types of sites are not described in the National Contingency Plan or existing regulatory guidance. The goal of the Track 2 process is to evaluate LPHSs using existing qualitative and quantitative data to minimize the collection of new environmental data. To this end, this document presents a structured format consisting of a series of questions and tables. A qualitative risk assessment is used. The process is iterative, and addresses an LPHS from multiple perspectives (i.e., historical, empirical, process) in an effort to generate a reproducible and defensible method. This rigorous approach follows the data quality objective process and establishes a well organized, logical approach to consolidate and assess existing data, and set decision criteria. If necessary, the process allows for the design of a sampling and analysis strategy to obtain new environmental data of appropriate quality to support decisions for each LPHS. Finally, the guidance expedites consensus between regulatory parties by emphasizing a team approach to Track 2 investigations.

Review of SKB's interim report of SR-Can: SKI's and SSI's evaluation of SKB's up-dated methodology for safety assessment

Energy Technology Data Exchange (ETDEWEB)

Dverstorp, Bjoern; Moberg, Leif; Wiebert, Anders; Xu Shulan [Swedish Radiation Protection Authority, Stockholm (Sweden); Stroemberg, Bo; Kautsky, Fritz; Lilja, Christina; Simic, Eva; Sundstroem, Benny; Toverud, Oeivind [Swedish Nuclear Power Inspectorate, Stockholm (Sweden)

2005-07-01

This report presents the findings of a review of the Swedish Nuclear Fuel and Waste Management Co.'s (SKB) interim report of the safety assessment SR-Can (SKB TR 04-11), conducted by the Swedish Radiation Protection Authority (SSI) and the Swedish Nuclear Power Inspectorate (SKI). SKB's interim report describes and exemplifies the safety assessment methodology that SKB plans to use in the oncoming licence applications for an encapsulation plant and a final repository for spent nuclear fuel. The authorities' review takes into account the findings of an international peer review of SKB's interim report. The authorities conclude that SKB has improved its safety assessment methodology in several aspects compared to earlier safety reports. Among other things the authorities commend SKB for giving a comprehensive account of relevant regulations and guidance, and for the systematic approach to identification and documentation of features, events and processes that need to be considered in the safety assessment. However, the authorities also conclude that important parts of SKB's method need to be further developed before they are mature enough to be used as a basis for a license application. The authorities' overall assessment is summarised in chapter 8 of this report.

Types of safety assessments of near surface repository for radioactive waste

International Nuclear Information System (INIS)

Mateeva, M.

2004-01-01

The purpose of this article is to presents the classification of different types safety assessments of near surface repository for low and intermediate level radioactive waste substantiated with results of safety assessments generated in Bulgaria. The different approach of safety assessments applied for old existing repository as well as for site selection for construction new repository is outlined. The regulatory requirements in Bulgaria define three main types of assessments: Safety assessment; Technical substation of repository safety; Assessment of repository influence on environment that is in form of report prepared from the Ministry of environment and waters on the base of results obtained in two first types of assessments. Additionally first type is subdivided in three categories - preliminary safety assessment, safety assessment and post closure safety assessment, which are generated using deterministic approach. The technical substation of repository safety is generated using probabilistic approach. Safety assessment results that are presented here are based on evaluation of existing old repository type 'Radon' in Novi Han and real site selection procedure for new near surface repository for low and intermediate level radioactive waste from nuclear power station in Kozloduy. The important role of safety assessment for improvement the repository safety as well as for repository licensing, correct site selection and right choice of engineer barriers and repository design is discussed using generated results. (author)

Data used for safety assessment of reprocessing facilities

International Nuclear Information System (INIS)

Nomura, Yasushi; Suzuki, Atsuyuki; Kanagawa, Akira

1990-08-01

For safety assessment of a reprocessing facility, it is important to know performance of radioactive materials in their accidental release and transfer. Accordingly, it is necessary to collect and prepare data for use in analyses for their performance. In JAERI, experiments such as for data acquisition, for source-term evaluation and for radioactive material transfer, are now planned to be performed. Prior to these experiments, it is decided to investigate data in use for accidental safety assessment of reprocessing plants and their based experimental data, thus to make it possible to recommend reasonable values for safety analysis parameters by evaluating the investigated results, to select the experimental items, to edit a safety assessment handbook and so on. In this line of objectives, JAERI rewarded a two-year contract of investigation to Nuclear Safety Research Association, to make a working group under a special committee on data investigation for reprocessing facility safety assessment. This report is a collection of results reviewed and checked by the working group. The contents consist of two parts, one for investigation and review of data used for safety assessment of domestic or oversea reprocessing facilities, and the other for investigation, review and evaluation of ANSI recommended American standard data reported by E. Walker together with their based experimental data resorting to the original referred reports. (author)

Guidance for treatment of variability and uncertainty in ecological risk assessments of contaminated sites

International Nuclear Information System (INIS)

1998-06-01

Uncertainty is a seemingly simple concept that has caused great confusion and conflict in the field of risk assessment. This report offers guidance for the analysis and presentation of variability and uncertainty in ecological risk assessments, an important issue in the remedial investigation and feasibility study processes. This report discusses concepts of probability in terms of variance and uncertainty, describes how these concepts differ in ecological risk assessment from human health risk assessment, and describes probabilistic aspects of specific ecological risk assessment techniques. The report ends with 17 points to consider in performing an uncertainty analysis for an ecological risk assessment of a contaminated site

Regulatory Control of Radiation Sources. Safety Guide

International Nuclear Information System (INIS)

2009-01-01

This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

Guidance on the Technology Performance Level (TPL) Assessment Methodology

Energy Technology Data Exchange (ETDEWEB)

Weber, Jochem [National Renewable Energy Lab. (NREL), Golden, CO (United States); Roberts, Jesse D. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Babarit, Aurelien [Ecole Centrale de Nantes (France). Lab. of Research in Hydrodynamics, Energetics and Atmospheric Environment (LHEEA); Costello, Ronan [Wave Venture, Penstraze (United Kingdom); Bull, Diana L. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Neilson, Kim [Ramboll, Copenhagen (Denmark); Bittencourt, Claudio [DNV GL, London (United Kingdom); Kennedy, Ben [Wave Venture, Penstraze (United Kingdom); Malins, Robert Joseph [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Dykes, Katherine [National Renewable Energy Lab. (NREL), Golden, CO (United States)

2016-09-01

This document presents the revised Technology Performance Level (TPL) assessment methodology. There are three parts to this revised methodology 1) the Stakeholder Needs and Assessment Guidance (this document), 2) the Technical Submission form, 3) the TPL scoring spreadsheet. The TPL assessment is designed to give a technology neutral or agnostic assessment of any wave energy converter technology. The focus of the TPL is on the performance of the technology in meeting the customer’s needs. The original TPL is described in [1, 2] and those references also detail the critical differences in the nature of the TPL when compared to the more widely used technology readiness level (TRL). (Wave energy TRL is described in [3]). The revised TPL is particularly intended to be useful to investors and also to assist technology developers to conduct comprehensive assessments in a way that is meaningful and attractive to investors. The revised TPL assessment methodology has been derived through a structured Systems Engineering approach. This was a formal process which involved analyzing customer and stakeholder needs through the discipline of Systems Engineering. The results of the process confirmed the high level of completeness of the original methodology presented in [1] (as used in the Wave Energy Prize judging) and now add a significantly increased level of detail in the assessment and an improved more investment focused structure. The revised TPL also incorporates the feedback of the Wave Energy Prize judges.

Safety functions and safety function indicators - key elements in SKB'S methodology for assessing long-term safety of a KBS-3 repository

International Nuclear Information System (INIS)

Hedin, A.

2008-01-01

The application of so called safety function indicators in SKB safety assessment of a KBS-3 repository for spent nuclear fuel is presented. Isolation and retardation are the two main safety functions of the KBS-3 concept. In order to quantitatively evaluate safety on a sub-system level, these functions need to be differentiated, associated with quantitative measures and, where possible, with quantitative criteria relating to the fulfillment of the safety functions. A safety function is defined as a role through which a repository component contributes to safety. A safety function indicator is a measurable or calculable property of a repository component that allows quantitative evaluation of a safety function. A safety function indicator criterion is a quantitative limit such that if the criterion is fulfilled, the corresponding safety function is upheld. The safety functions and their associated indicators and criteria developed for the KBS-3 repository are primarily related to the isolating potential and to physical states of the canister and the clay buffer surrounding the canister. They are thus not directly related to release rates of radionuclides. The paper also describes how the concepts introduced i) aid in focussing the assessment on critical, safety related issues, ii) provide a framework for the accounting of safety throughout the different time frames of the assessment and iii) provide key information in the selection of scenarios for the safety assessment. (author)

Safety and reliability assessment

International Nuclear Information System (INIS)

1979-01-01

This report contains the papers delivered at the course on safety and reliability assessment held at the CSIR Conference Centre, Scientia, Pretoria. The following topics were discussed: safety standards; licensing; biological effects of radiation; what is a PWR; safety principles in the design of a nuclear reactor; radio-release analysis; quality assurance; the staffing, organisation and training for a nuclear power plant project; event trees, fault trees and probability; Automatic Protective Systems; sources of failure-rate data; interpretation of failure data; synthesis and reliability; quantification of human error in man-machine systems; dispersion of noxious substances through the atmosphere; criticality aspects of enrichment and recovery plants; and risk and hazard analysis. Extensive examples are given as well as case studies

Improving nuclear regulation. NEA regulatory guidance booklets volumes 1-14

International Nuclear Information System (INIS)

2011-01-01

A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are continuously maintained and operated in an acceptably safe manner. In meeting this objective the regulator must bear in mind that it is the operator that has responsibility for safely operating the nuclear facility; the role of the regulator is to assess and to provide assurance regarding the operator's activities in terms of assuming that responsibility. The full series of these reports was brought together in one edition for the first time in 2009 and was widely found to be a useful resource. This second edition comprises 14 volumes, including the latest on The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services. The reports address various challenges that could apply throughout the lifetime of a nuclear facility, including design, siting, manufacturing, construction, commissioning, operation, maintenance and decommissioning. The compilation is intended to serve as a knowledge management tool both for current regulators and the new nuclear professionals and organisations entering the regulatory field. Contents: Executive Summary; Regulatory Challenges: 1. The Role of the Nuclear Regulator in Promoting and Evaluating Safety Culture; 2. Regulatory Response Strategies for Safety Culture Problems; 3. Nuclear Regulatory Challenges Related to Human Performance; 4. Regulatory Challenges in Using Nuclear Operating Experience; 5. Nuclear Regulatory Review of Licensee Self-assessment (LSA); 6. Nuclear Regulatory Challenges Arising from Competition in Electricity Markets; 7. The Nuclear Regulatory Challenge of Judging Safety Back-fits; 8. The Regulatory Challenges of Decommissioning Nuclear Reactors; 9. The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services

Strategic Environmental Assessment as catalyst of healthier spatial planning: The Danish guidance and practice

DEFF Research Database (Denmark)

Kørnøv, Lone

2009-01-01

and guidance. This paper examines the inclusion of health as a formal component in impact assessment of spatial plans. Based upon a documentary study of 100 environmental reports, the paper analyses and discusses how health impact considerations are incorporated in SEA practice. It is found that health impacts...

Nuclear criticality safety guide

International Nuclear Information System (INIS)

Pruvost, N.L.; Paxton, H.C.

1996-09-01

This technical reference document cites information related to nuclear criticality safety principles, experience, and practice. The document also provides general guidance for criticality safety personnel and regulators

Nuclear criticality safety guide

Energy Technology Data Exchange (ETDEWEB)

Pruvost, N.L.; Paxton, H.C. [eds.

1996-09-01

This technical reference document cites information related to nuclear criticality safety principles, experience, and practice. The document also provides general guidance for criticality safety personnel and regulators.

Safety assessment as basis for the decision making process

International Nuclear Information System (INIS)

Ilie, P.; Didita, L.; Danchiv, A.

2005-01-01

This paper deals with the safety assessment for a new near surface repository, particularly for the early stage of repository development using ISAM (Improvement of Safety Assessment Methodologies for Near Surface Disposal Facilities) safety assessment methodology. In this stage of the repository life cycle the main purpose of the safety assessment is to demonstrate that the plant is capable to be constructed and operated safely. The paper is based on development of the ASAM (Application of the Safety Assessment Methodologies for Near-Surface Disposal Facilities) Decision Support Subgroup of the Common Aspects Working Group. The implications of decision making for the application of the ISAM methodology on post-closure safety assessment are analysed. Some important elements of the decision-making process with impact on key components of the ISAM process are described. Following the development of Decision Support Subgroup of the ASAM Common Aspects Working Group the proposed change of ISAM methodology is analysed. This approach puts all activities in a decision context where the first iteration of the safety assessment is based on the existing state of knowledge and the initial engineering design. Confidence in the process is accomplished through the direct inclusion of all decision makers and stakeholders in the formulation of decisions, the definition of the state of knowledge, and decision making activities. The decision process is developed in context of undertaking assessments with little site-specific information, this situation is specifically for new planned repository. Limited site-specific information can result in a high degree of uncertainty, therefore it is important first of all to identify the sources of uncertainty arising from the limited nature of the site-specific information and then to apply appropriate approaches to manage the uncertainties and to determine whether the uncertainties are important to the overall safety of the disposal facility

Assessment of safety culture at INPP

International Nuclear Information System (INIS)

Lesin, S.

2002-01-01

Safety Culture covers all main directions of plant activities and the plant departments involved through integration into the INPP Quality Assurance System. Safety Culture is represented by three components. The first is the clear INPP Safety and Quality Assurance Policy. Based on the Policy INPP is safely operated and managers' actions firstly aim at safety assurance. The second component is based on personal responsibility for safety and attitude of each employee of the plant. The third component is based on commitment to safety and competence of managers and employees of the plant. This component links the first two to ensure efficient management of safety at the plant. The above mentioned components including the elements which may significantly affect Safety Culture are also presented in the attachment. The concept of such model implies understanding of effect of different factors on the level of Safety Culture in the organization. In order to continuously correct safety problems, self-assessment of the Safety Culture level is performed at regular intervals. (author)

EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

NARCIS (Netherlands)

Arnold, G.; Boesten, J.J.T.I.; Clook, M.

2013-01-01

The Guidance Document is intended to provide guidance for notifiers and authorities in the context of the review of plant protection products (PPPs) and their active substances under Regulation (EC) 1107/2009. The scientific opinion on the science behind the development of a risk assessment of plant

Safety assessment for radioactive waste disposal facility

International Nuclear Information System (INIS)

Thanaletchumy Karuppiah; Mohd Abdul Wahab Yusof; Nik Marzuki Nik Ibrahim; Nurul Wahida Ahmad Khairuddin

2008-08-01

Safety assessments are used to evaluate the performance of a radioactive waste disposal facility and its impact on human health and the environment. This paper presents the overall information and methodology to carry out the safety assessment for a long term performance of a disposal system. A case study was also conducted to gain hands-on experience in the development and justification of scenarios, the formulation and implementation of models and the analysis of results. AMBER code using compartmental modeling approach was used to represent the migration and fate of contaminants in this training. This safety assessment is purely illustrative and it serves as a starting point for each development stage of a disposal facility. This assessment ultimately becomes more detail and specific as the facility evolves. (Author)

Preliminary safety assessment of the WIPP facility

International Nuclear Information System (INIS)

Balestri, R.J.; Torres, B.W.; Pahwa, S.B.; Brannen, J.P.

1979-01-01

This paper summarizes the efforts to perform a safety assessment of the Waste Isolation Pilot Plant (WIPP) facility being proposed for southeastern New Mexico. This preliminary safety assessment is limited to a consequence assessment in terms of the dose to a maximally exposed individual as a result of introducing the radionuclides into the biosphere. The extremely low doses to the organs as a result of the liquid breach scenarios are contrasted with the background radiation

LNG Safety Assessment Evaluation Methods

Energy Technology Data Exchange (ETDEWEB)

Muna, Alice Baca [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); LaFleur, Angela Christine [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

2015-05-01

Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods were evaluated for their potential applicability for use in the LNG railroad application. After reviewing the documents included in this report, as well as others not included because of repetition, the Department of Energy (DOE) Hydrogen Safety Plan Checklist is most suitable to be adapted to the LNG railroad application. This report was developed to survey industries related to rail transportation for methodologies and tools that can be used by the FRA to review and evaluate safety assessments submitted by the railroad industry as a part of their implementation plans for liquefied or compressed natural gas storage ( on-board or tender) and engine fueling delivery systems. The main sections of this report provide an overview of various methods found during this survey. In most cases, the reference document is quoted directly. The final section provides discussion and a recommendation for the most appropriate methodology that will allow efficient and consistent evaluations to be made. The DOE Hydrogen Safety Plan Checklist was then revised to adapt it as a methodology for the Federal Railroad Administration’s use in evaluating safety plans submitted by the railroad industry.

Promoting and assessment of safety culture within regulatory body

International Nuclear Information System (INIS)

Awasthi, Sumit; Bhattacharya, D.; Koley, J.; Krishnamurthy, P.R.

2015-01-01

Regulators have an important role to play in assisting organizations under their jurisdiction to develop positive safety cultures. It is therefore essential for the regulator to have a robust safety culture as an inherent strategy and communication of this strategy to the organizations it supervises. Atomic Energy Regulatory Board (AERB) emphasizes every utility to institute a good safety culture during various stages of a NPP. The regulatory requirement for establishing organisational safety culture within utility at different stages are delineated in the various AERB safety codes which are presented in the paper. Although the review and assessment of the safety culture is a part of AERB’s continual safety supervision through existing review mechanism, AERB do not use any specific indicators for safety culture assessment. However, establishing and nurturing a good safety culture within AERB helps in encouraging the utility to institute the same. At the induction level AERB provides training to its staffs for regulatory orientation which include a specific course on safety culture. Subsequently, the junior staffs are mentored by seniors while involving them in various regulatory processes and putting them as observers during regulatory decision making process. Further, AERB established a formal procedure for assessing and improving safety culture within its staff as a management system process. The paper describes as a case study the above safety culture assessment process established within AERB

Probabilistic safety assessment for research reactors

International Nuclear Information System (INIS)

1986-12-01

Increasing interest in using Probabilistic Safety Assessment (PSA) methods for research reactor safety is being observed in many countries throughout the world. This is mainly because of the great ability of this approach in achieving safe and reliable operation of research reactors. There is also a need to assist developing countries to apply Probabilistic Safety Assessment to existing nuclear facilities which are simpler and therefore less complicated to analyse than a large Nuclear Power Plant. It may be important, therefore, to develop PSA for research reactors. This might also help to better understand the safety characteristics of the reactor and to base any backfitting on a cost-benefit analysis which would ensure that only necessary changes are made. This document touches on all the key aspects of PSA but placed greater emphasis on so-called systems analysis aspects rather than the in-plant or ex-plant consequences

Safety assessment of radioactive wastes storage 'Mironova Gora'

International Nuclear Information System (INIS)

Serbryakov, B.; Karamushka, V.; Ostroborodov, V.

2000-01-01

A project of transforming the radioactive wastes storage 'Mironova Gora' is under development. A safety assessment of this storage facility was performed to gain assurance on the design decision. The assessment, which was based on the safety assessment methods developed for radioactive wastes repositories, is presented in this paper. (author)

78 FR 9702 - Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products...

Science.gov (United States)

2013-02-11

... approach in both the preclinical and clinical phases of the development of therapeutic protein products to... you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency... entitled ``Immunogenicity Assessment for Therapeutic Protein Products.'' The purpose of this document is to...

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

Science.gov (United States)

Ponce, Rafael; Abad, Leslie; Amaravadi, Lakshmi; Gelzleichter, Thomas; Gore, Elizabeth; Green, James; Gupta, Shalini; Herzyk, Danuta; Hurst, Christopher; Ivens, Inge A; Kawabata, Thomas; Maier, Curtis; Mounho, Barbara; Rup, Bonita; Shankar, Gopi; Smith, Holly; Thomas, Peter; Wierda, Dan

2009-07-01

An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.

Development and Presentation of the Drigg Post-Closure Safety Case

International Nuclear Information System (INIS)

Kelly, Eugene; Watts, Len; Grimwood, Paul

2001-01-01

Drigg is an operational facility for the near-surface disposal of solid low level radioactive waste (LLW). The disposal facility is located in Cumbria, north-west England, near the Sellafield nuclear site, and is owned and operated by British Nuclear Fuels plc (BNFL). Disposals at Drigg are carried out under the terms of an authorisation granted by the UK Environment Agency. Periodically the Drigg authorisation is subject to formal regulatory review. The current regulatory guidance, 'Disposal Facilities on Land for Low and Intermediate Level Radioactive Wastes: Guidance on Requirements for Authorisation' (the GRA) was published in 1997 and contains guidance on the principles and requirements against which the Environment Agency will consider applications for disposal authorisation. BNFL has undertaken to produce an updated Drigg postclosure safety case (PCSC) in September 2002 to support the next authorisation review. In preparation for this, BNFL published a 'Status Report on the Development of the 2002 Drigg PCSC' in March 2000. This paper discusses the main components of the Drigg PCSC and how they relate to each other. Central to the safety case will be a systematic, post-closure radiological safety assessment (PCRSA). However the main focus of this paper is on the other main components of the PCSC which are presented in conjunction with the PCRSA to make a complete and integrated safety case. In addition other confidence building activities which are key to developing and presenting the safety case are discussed, in particular communications with the stakeholders

Highway Safety Program Manual: Volume 8: Alcohol in Relation to Highway Safety.

Science.gov (United States)

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 8 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on alcohol in relation to highway safety. The purpose and objectives of the alcohol program are outlined. Federal authority in the area of highway safety and general policies regarding…

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

International Nuclear Information System (INIS)

2010-12-01

authorities in their review of SR-Can /Dverstorp and Stroemberg 2008/ maintain that the state, rather than SKB, is expected to be responsible for the supervision and monitoring of the repository after sealing. Man is dependent on, and influences, the environment in which he lives. After the repository has been closed, future generations should be able to utilise the repository site according to their needs without jeopardising their health. In the case of a final repository of the KBS-3 type, there are, however, inevitably examples of activities that, if carried out carelessly or without knowledge of the repository, could result in exposure to radiotoxic elements from the spent fuel. Therefore, there is an international consensus that future human activities shall be considered in safety assessments of deep geological repositories. Based on generally accepted principles and the Swedish Radiation Safety Authority's, SSM's, regulations SSM FS 2008:21 and SSM FS 2008:37, the future human actions considered in this part of the safety assessment are restricted to global pollution and actions that: - are carried out after the sealing of the repository, - take place at or close to the repository site, - are unintentional, i.e. are carried out when the location of the repository is unknown, its purpose forgotten or the consequences of the action are unknown, - impair the safety functions of the repository's barriers. However, in line with SSM's general guidance /SSM 2008a/, future human actions and their impact on the repository are evaluated separately, and are not included in the main scenario reference evolution or in the risk summation

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

Energy Technology Data Exchange (ETDEWEB)

2010-12-15

authorities in their review of SR-Can /Dverstorp and Stroemberg 2008/ maintain that the state, rather than SKB, is expected to be responsible for the supervision and monitoring of the repository after sealing. Man is dependent on, and influences, the environment in which he lives. After the repository has been closed, future generations should be able to utilise the repository site according to their needs without jeopardising their health. In the case of a final repository of the KBS-3 type, there are, however, inevitably examples of activities that, if carried out carelessly or without knowledge of the repository, could result in exposure to radiotoxic elements from the spent fuel. Therefore, there is an international consensus that future human activities shall be considered in safety assessments of deep geological repositories. Based on generally accepted principles and the Swedish Radiation Safety Authority's, SSM's, regulations SSM FS 2008:21 and SSM FS 2008:37, the future human actions considered in this part of the safety assessment are restricted to global pollution and actions that: - are carried out after the sealing of the repository, - take place at or close to the repository site, - are unintentional, i.e. are carried out when the location of the repository is unknown, its purpose forgotten or the consequences of the action are unknown, - impair the safety functions of the repository's barriers. However, in line with SSM's general guidance /SSM 2008a/, future human actions and their impact on the repository are evaluated separately, and are not included in the main scenario reference evolution or in the risk summation

Reporting, Visualization, and Modeling of Immunogenicity Data to Assess Its Impact on Pharmacokinetics, Efficacy, and Safety of Monoclonal Antibodies.

Science.gov (United States)

Passey, Chaitali; Suryawanshi, Satyendra; Sanghavi, Kinjal; Gupta, Manish

2018-02-26

The rapidly increasing number of therapeutic biologics in development has led to a growing recognition of the need for improvements in immunogenicity assessment. Published data are often inadequate to assess the impact of an antidrug antibody (ADA) on pharmacokinetics, safety, and efficacy, and enable a fully informed decision about patient management in the event of ADA development. The recent introduction of detailed regulatory guidance for industry should help address many past inadequacies in immunogenicity assessment. Nonetheless, careful analysis of gathered data and clear reporting of results are critical to a full understanding of the clinical relevance of ADAs, but have not been widely considered in published literature to date. Here, we review visualization and modeling of immunogenicity data. We present several relatively simple visualization techniques that can provide preliminary information about the kinetics and magnitude of ADA responses, and their impact on pharmacokinetics and clinical endpoints for a given therapeutic protein. We focus on individual sample- and patient-level data, which can be used to build a picture of any trends, thereby guiding analysis of the overall study population. We also discuss methods for modeling ADA data to investigate the impact of immunogenicity on pharmacokinetics, efficacy, and safety.

Self-assessment of operational safety for nuclear power plants

International Nuclear Information System (INIS)

1999-12-01

Self-assessment processes have been continuously developed by nuclear organizations, including nuclear power plants. Currently, the nuclear industry and governmental organizations are showing an increasing interest in the implementation of this process as an effective way for improving safety performance. Self-assessment involves the use of different types of tools and mechanisms to assist the organizations in assessing their own safety performance against given standards. This helps to enhance the understanding of the need for improvements, the feeling of ownership in achieving them and the safety culture as a whole. Although the primary beneficiaries of the self-assessment process are the plant and operating organization, the results of the self-assessments are also used, for example, to increase the confidence of the regulator in the safe operation of an installation, and could be used to assist in meeting obligations under the Convention on Nuclear Safety. Such considerations influence the form of assessment, as well as the type and detail of the results. The concepts developed in this report present the basic approach to self-assessment, taking into consideration experience gained during Operational Safety Review Team (OSART) missions, from organizations and utilities which have successfully implemented parts of a self-assessment programme and from meetings organized to discuss the subject. This report will be used in IAEA sponsored workshops and seminars on operational safety that include the topic of self-assessment

Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-15

This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.

Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.

Analysis of truncation limit in probabilistic safety assessment

International Nuclear Information System (INIS)

Cepin, Marko

2005-01-01

A truncation limit defines the boundaries of what is considered in the probabilistic safety assessment and what is neglected. The truncation limit that is the focus here is the truncation limit on the size of the minimal cut set contribution at which to cut off. A new method was developed, which defines truncation limit in probabilistic safety assessment. The method specifies truncation limits with more stringency than presenting existing documents dealing with truncation criteria in probabilistic safety assessment do. The results of this paper indicate that the truncation limits for more complex probabilistic safety assessments, which consist of larger number of basic events, should be more severe than presently recommended in existing documents if more accuracy is desired. The truncation limits defined by the new method reduce the relative errors of importance measures and produce more accurate results for probabilistic safety assessment applications. The reduced relative errors of importance measures can prevent situations, where the acceptability of change of equipment under investigation according to RG 1.174 would be shifted from region, where changes can be accepted, to region, where changes cannot be accepted, if the results would be calculated with smaller truncation limit

Risk assessment of safety violations for coal mines

Energy Technology Data Exchange (ETDEWEB)

Megan Orsulaka; Vladislav Kecojevicb; Larry Graysona; Antonio Nietoa [Pennsylvania State University, University Park, PA (United States). Dept of Energy and Mineral Engineering

2010-09-15

This article presents an application of a risk assessment approach in characterising the risks associated with safety violations in underground bituminous mines in Pennsylvania using the Mine Safety and Health Administration (MSHA) citation database. The MSHA database on citations provides an opportunity to assess risks in mines through scrutiny of violations of mandatory safety standards. In this study, quantitative risk assessment is performed, which allows determination of the frequency of occurrence of safety violations (through associated citations) as well as the consequences of them in terms of penalty assessments. Focus is on establishing risk matrices on citation experiences of mines, which can give early indication of emerging potentially serious problems. The resulting frequency, consequence and risk rankings present valuable tools for prioritising resource allocations, determining control strategies, and could potentially contribute to more proactive prevention of incidents and injuries.

Healthcare professionals’ views of feedback on patient safety culture assessment.

OpenAIRE

Zwijnenberg, N.C.; Hendriks, M.; Hoogervorst-Schilp, J.; Wagner, C.

2016-01-01

Background: By assessing patient safety culture, healthcare providers can identify areas for improvement in patient safety culture. To achieve this, these assessment outcomes have to be relevant and presented clearly. The aim of our study was to explore healthcare professionals’ views on the feedback of a patient safety culture assessment. Methods: Twenty four hospitals participated in a patient safety culture assessment in 2012. Hospital departments received feedback in a report and on a web...

Safety assessment of research reactors and preparation of the safety analysis report

International Nuclear Information System (INIS)

1994-01-01

This Safety Guide presents guidelines, approved by international consensus, for the preparation, review and assessment of safety documentation for research reactors such as the Safety Analysis Report. While the Guide is most applicable to research reactors in the design and construction stage, it is also recommended for use during relicensing or reassessment of existing reactors

Use of toxicity assessment to develop site specific remediation criteria for oil and gas facilities : guidance manual

International Nuclear Information System (INIS)

1996-01-01

The results of a two year study into the evaluation of toxicity-based methods to develop site-specific, risk-based cleanup objectives for the decommissioning of oil and gas facilities were compiled into a manual of guidance. The two basic approaches used in determining remediation criteria for contaminated sites are: (1) comparison of the concentrations of chemicals found on-site with broad regional or national soil and water quality objectives developed for the chemicals involved, and (2) site-specific risk assessment. Toxicity tests are used to test organisms such as earthworms, lettuce seeds, or larval fish directly in the soil, water or sediment suspected of being contaminated. The effects of any contamination on the survival, growth, reproduction, and behaviour of the test organisms are then evaluated. The manual provides guidance in: (1) using toxicity assessments within the regulatory framework of site decommissioning, (2) performing a toxicity assessment, and (3) developing site-specific criteria for a risk assessment. 18 refs., 3 tabs., 5 figs

A systematic review of the safety information contained within the Summaries of Product Characteristics of medications licensed in the United Kingdom for Attention Deficit Hyperactivity Disorder. how does the safety prescribing advice compare with national guidance?

Directory of Open Access Journals (Sweden)

Savill Nicola

2012-01-01

Full Text Available Abstract Background The safety of paediatric medications is paramount and contraindications provide clear pragmatic advice. Further advice may be accessed through Summaries of Product Characteristics (SPCs and relevant national guidelines. The SPC can be considered the ultimate independent guideline and is regularly updated. In 2008, the authors undertook a systematic review of the SPC contraindications of medications licensed in the United Kingdom (UK for the treatment of Attention Deficit Hyperactivity Disorder (ADHD. At that time, there were fewer contraindications reported in the SPC for atomoxetine than methylphenidate and the specific contraindications varied considerably amongst methylphenidate formulations. In 2009, the European Medicines Agency (EMA mandated harmonisation of methylphenidate SPCs. Between September and November 2011, there were three changes to the atomoxetine SPC that resulted in revised prescribing information. In addition, Clinical Guidance has also been produced by the National Institute for Health and Clinical Excellence (NICE (2008, the Scottish Intercollegiate Guidelines Network (SIGN (2009 and the British National Formulary for Children (BNFC. Methods An updated systematic review of the Contraindications sections of the SPCs of all medications currently licensed for treatment of ADHD in the UK was undertaken and independent statements regarding contraindications and relevant warnings and precautions were then compared with UK national guidance with the aim of assessing any disparity and potential areas of confusion for prescribers. Results As of November 2011, there were seven medications available in the UK for the treatment of ADHD. There are 15 contraindications for most formulations of methylphenidate, 14 for dexamfetamine and 5 for atomoxetine. Significant differences exist between the SPCs and national guidance part due to the ongoing reactive process of amending the former as new information becomes known

Safety Assessment of Polyether Lanolins as Used in Cosmetics.

Science.gov (United States)

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan; Heldreth, Bart

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 39 polyether lanolin ingredients as used in cosmetics. These ingredients function mostly as hair conditioning agents, skin conditioning agent-emollients, and surfactant-emulsifying agents. The Panel reviewed available animal and clinical data, from previous CIR safety assessments of related ingredients and components. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group. The Panel concluded that these polyether lanolin ingredients are safe in the practices of use and concentration as given in this safety assessment.

Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment; Evaluacion mediante examen por pares de la efectividad de un programa regulador para la seguridad radiologica. Informe provisional para formular comentarios

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-06-01

This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State.

Probabilistic safety assessment as a standpoint for decision making

International Nuclear Information System (INIS)

Cepin, M.

2001-01-01

This paper focuses on the role of probabilistic safety assessment in decision-making. The prerequisites for use of the results of probabilistic safety assessment and the criteria for the decision-making based on probabilistic safety assessment are discussed. The decision-making process is described. It provides a risk evaluation of impact of the issue under investigation. Selected examples are discussed, which highlight the described process. (authors)

Guidance on methodology for evaluation of the effectiveness of options for reducing the risk of introduction and spread of organisms harmful to plant health in the EU territory

DEFF Research Database (Denmark)

Baker, R.; Candresse, T.; Dormannsné Simon, E.

2012-01-01

The European Food Safety Authority (EFSA) requested the Panel on Plant Health (PLH Panel) to provide guidance for the evaluation of the effectiveness of the options for plants and plant products for reducing the risk of introduction and spread of harmful organisms in the European Union territory...... and guidance documents for assessing a proposed RRO. In addition, the current document provides recommendations for assessing RROs, specifically: on experimental design; on the use of statistical methods including approaches for studying uncertainty; on the use of quantitative pathway analysis and spread...

The Safety Assessment Framework Tool (SAFRAN) - Description, Overview and Applicability

International Nuclear Information System (INIS)

Alujevic, Luka

2014-01-01

The SAFRAN tool (Safety Assessment Framework) is a user-friendly software application that incorporates the methodologies developed in the SADRWMS (Safety Assessment Driven Radioactive Waste Management Solutions) project. The International Atomic Energy Agency (IAEA) organized the International Project on Safety Assessment Driving Radioactive Waste Management Solutions (SADRWMS) to examine international approaches to safety assessment for predisposal management of all types of radioactive waste, including disused sources, small volumes, legacy and decommissioning waste, operational waste, and large volume naturally occurring radioactive material residues. SAFRAN provides aid in: Describing the predisposal RW management activities in a systematic way, Conducting the SA (safety assessment) with clear documentation of the methodology, assumptions, input data and models, Establishing a traceable and transparent record of the safety basis for decisions on the proposed RW management solutions, Demonstrating clear consideration of and compliance with national and international safety standards and recommendations. The SAFRAN tool allows the user to visibly, systematically and logically address predisposal radioactive waste management and decommissioning challenges in a structured way. It also records the decisions taken in such a way that it constitutes a justifiable safety assessment of the proposed management solutions. The objective of this paper is to describe the SAFRAN architecture and features, properly define the terms safety case and safety assessment, and to predict the future development of the SAFRAN tool and assess its applicability to the construction of a future LILW (Low and Intermediate Level Waste) storage facility and repository in Croatia, taking into account all the capabilities and modelling features of the SAFRAN tool. (author)

77 FR 8879 - Agency Information Collection Activities; Proposed Collection; Comment Request: Guidance for...

Science.gov (United States)

2012-02-15

... report will alert FDA to trends or clusters of events that might be a safety issue otherwise unreported...] Agency Information Collection Activities; Proposed Collection; Comment Request: Guidance for Industry and... of information technology. Guidance for Industry and Food and Drug Administration Staff; Class II...

Environment, safety and Health Progress Assessment of the Rocky Flats Plant

International Nuclear Information System (INIS)

1993-05-01

This report documents the result of the US Department of Energy's (DOE) Environment, Safety and Health (ES ampersand H) Progress Assessment of the DOE Rocky Flats Plant (RFP) in Golden, Colorado. The assessment, which was conducted during the period of May 17 through May 28, 1993, included a selective review of the ES ampersand H management systems and programs of the responsible DOE Headquarters Program Offices (Defense Programs (DP) and Environmental Restoration and Waste Management (EM)), the DOE Rocky Flats Office (RFO), and the site contractor, EG ampersand G Rocky Flats, Inc. (EG ampersand G). Despite the near constant state of flux under which RFP has been required to operate, the Progress Assessment Team has concluded that significant progress has been made in correcting the deficiencies identified in the 1989 Assessment and in responding responsibly to regulations, and DOE directives and guidance that have been issued since that time. The Team concluded that the improvements have been concentrated in the activities associated with plutonium facilities and in regulatory driven programs. Much remains to be done with respect to implementing on a sitewide basis those management systems that anchor an organization's pursuit of continuous ES ampersand H improvement. Furthermore the Team concluded that the pace of improvement has been constrained by a combination of factors that have limited the site's ability to manage change in the pursuit of sitewide ES ampersand H excellence

Communication Services and Supports for Individuals with Severe Disabilities: Guidance for Assessment and Intervention

Science.gov (United States)

Brady, Nancy C.; Bruce, Susan; Goldman, Amy; Erickson, Karen; Mineo, Beth; Ogletree, Bill T.; Paul, Diane; Romski, Mary Ann; Sevcik, Rose; Siegel, Ellin; Schoonover, Judith; Snell, Marti; Sylvester, Lorraine; Wilkinson, Krista

2015-01-01

The National Joint Committee for the Communication Needs of People with Severe Disabilities (NJC) reviewed literature regarding practices for people with severe disabilities in order to update guidance provided in documents originally published in 1992. Changes in laws, definitions, and policies that affect communication attainments by persons with severe disabilities are presented, along with guidance regarding assessment and intervention practices. A revised version of the Communication Bill of Rights, a powerful document that describes the communication rights of all individuals, including those with severe disabilities is included in this article. The information contained within this article is intended to be used by professionals, family members, and individuals with severe disabilities to inform and advocate for effective communication services and opportunities. PMID:26914467

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

Implementation of IAEA Code of Conduct and Guidance – Exporting State Perspective

International Nuclear Information System (INIS)

Hayes, T.

2010-01-01

Canadian Nuclear Safety Commission (CNSC) is a federal agency reporting to Parliament through Natural Resources Minister It Regulates all nuclear facilities and activities to protect the health, safety and security of persons and the environment, assure that Canada meets its international commitments and obligations on the peaceful use of nuclear energy by Implementation of the IAEA Code and Guidance. There were 99 States committed to the IAEA Code of Conduct (as of July 2010) while 59 States committed to the IAEA Guidance on Import and Export (as of July 2010) Use of risk-informed regulatory processes to optimize resource allocation and decision-making. Canadian Nuclear Safety Commission Control of Radioactive Sources. As such, the Canadian Government is a strong proponent of the establishment and maintenance of an effective, efficient and harmonized international regime for ensuring the safety and security of such sources

Safety factors for neutron fluences in NPP safety assessment

International Nuclear Information System (INIS)

Demekhin, V.L.; Bukanov, V.N.; Il'kovich, V.V.; Pugach, A.M.

2016-01-01

In accordance with global practice and a number of existing regulations, the use of conservative approach is required for the calculations related to nuclear safety assessment of NPP. It implies the need to consider the determination of neutron fluence errors that is rather complicated. It is proposed to carry out the consideration by the way of multiplying the neutron fluences obtained with transport calculations by safety factors. The safety factor values are calculated by the developed technique based on the theory of errors, features of the neutron transport calculation code and the results obtained with the code. It is shown that the safety factor value is equal 1.18 with the confidence level of not less than 0.95 for the majority of VVER-1000 reactor places where neutron fluences are determined by MCPV code, and its maximum value is 1.25

Need for an "integrated safety assessment" of GMOs, linking food safety and environmental considerations.

Science.gov (United States)

Haslberger, Alexander G

2006-05-03

Evidence for substantial environmental influences on health and food safety comes from work with environmental health indicators which show that agroenvironmental practices have direct and indirect effects on human health, concluding that "the quality of the environment influences the quality and safety of foods" [Fennema, O. Environ. Health Perspect. 1990, 86, 229-232). In the field of genetically modified organisms (GMOs), Codex principles have been established for the assessment of GM food safety and the Cartagena Protocol on Biosafety outlines international principles for an environmental assessment of living modified organisms. Both concepts also contain starting points for an assessment of health/food safety effects of GMOs in cases when the environment is involved in the chain of events that could lead to hazards. The environment can act as a route of unintentional entry of GMOs into the food supply, such as in the case of gene flow via pollen or seeds from GM crops, but the environment can also be involved in changes of GMO-induced agricultural practices with relevance for health/food safety. Examples for this include potential regional changes of pesticide uses and reduction in pesticide poisonings resulting from the use of Bt crops or influences on immune responses via cross-reactivity. Clearly, modern methods of biotechnology in breeding are involved in the reasons behind the rapid reduction of local varieties in agrodiversity, which constitute an identified hazard for food safety and food security. The health/food safety assessment of GM foods in cases when the environment is involved needs to be informed by data from environmental assessment. Such data might be especially important for hazard identification and exposure assessment. International organizations working in these areas will very likely be needed to initiate and enable cooperation between those institutions responsible for the different assessments, as well as for exchange and analysis of

Ensuring the quality of occupational safety risk assessment.

Science.gov (United States)

Pinto, Abel; Ribeiro, Rita A; Nunes, Isabel L

2013-03-01

In work environments, the main aim of occupational safety risk assessment (OSRA) is to improve the safety level of an installation or site by either preventing accidents and injuries or minimizing their consequences. To this end, it is of paramount importance to identify all sources of hazards and assess their potential to cause problems in the respective context. If the OSRA process is inadequate and/or not applied effectively, it results in an ineffective safety prevention program and inefficient use of resources. An appropriate OSRA is an essential component of the occupational safety risk management process in industries. In this article, we performed a survey to elicit the relative importance for identified OSRA tasks to enable an in-depth evaluation of the quality of risk assessments related to occupational safety aspects on industrial sites. The survey involved defining a questionnaire with the most important elements (tasks) for OSRA quality assessment, which was then presented to safety experts in the mining, electrical power production, transportation, and petrochemical industries. With this work, we expect to contribute to the main question of OSRA in industries: "What constitutes a good occupational safety risk assessment?" The results obtained from the questionnaire showed that experts agree with the proposed OSRA process decomposition in steps and tasks (taxonomy) and also with the importance of assigning weights to obtain knowledge about OSRA task relevance. The knowledge gained will enable us, in the near future, to build a framework to evaluate OSRA quality for industrial sites. © 2012 Society for Risk Analysis.

Safety assessment in plant layout design using indexing approach: Implementing inherent safety perspective

International Nuclear Information System (INIS)

Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

2008-01-01

The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design

Exploiting data from safety investigations and processes to assess performance of safety management aspects

NARCIS (Netherlands)

Karanikas, Nektarios

2016-01-01

This paper presents an alternative way to use records from safety investigations as a means to support the evaluation of safety management (SM) aspects. Datasets from safety investigation reports and progress records of an aviation organization were analyzed with the scope of assessing safety

Individual plant examination: Submittal guidance

International Nuclear Information System (INIS)

1989-08-01

Based on a Policy Statement on Severe Accidents Regarding Future Designs and Existing Plants, the performance of a plant examination is requested from the licensee of each nuclear power plant. The plant examination looks for vulnerabilities to severe accidents and cost-effective safety improvements that reduce or eliminate the important vulnerabilities. This document delineates guidance for reporting the results of that plant examination. 38 refs., 2 tabs

NPP Krsko periodic safety review. Safety assessment and analyses

International Nuclear Information System (INIS)

Basic, I.; Spiler, J.; Thaulez, F.

2002-01-01

Definition of a PSR (Periodic Safety Review) project is a comprehensive safety review of a plant after ten years of operation. The objective is a verification by means of a comprehensive review using current methods that the plant remains safe when judged against current safety objectives and practices and that adequate arrangements are in place to maintain plant safety. The overall goals of the NEK PSR Program are defined in compliance with the basic role of a PSR and the current practice typical for most of the countries in EU. This practice is described in the related guides and good practice documents issued by international organizations. The overall goals of the NEK PSR are formulated as follows: to demonstrate that the plant is as safe as originally intended; to evaluate the actual plant status with respect to aging and wear-out identifying any structures, systems or components that could limit the life of the plant in the foreseeable future, and to identify appropriate corrective actions, where needed; to compare current level of safety in the light of modern standards and knowledge, and to identify where improvements would be beneficial for minimizing deviations at justifiable costs. The Krsko PSR will address the following safety factors: Operational Experience, Safety Assessment, EQ and Aging Management, Safety Culture, Emergency Planning, Environmental Impact and Radioactive Waste.(author)

Safety assessment of a lithium target

International Nuclear Information System (INIS)

Burgazzi, Luciano; Roberta, Ferri; Barbara, Giannone

2006-01-01

This paper addresses the safety assessment of the lithium target of the International Fusion Materials Irradiation Facility (IFMIF) through evaluating the most important risk factors related to system operation and verifying the fulfillment of the safety criteria. The hazard assessment is based on using a well-structured Failure Mode and Effect Analysis (FMEA) procedure by detailing on a component-by-component basis all the possible failure modes and identifying their effects on the plant. Additionally, a systems analysis, applying the fault tree technique, is performed in order to evaluate, from a probabilistic standpoint, all the relevant and possible failures of each component required for safe system operation and assessing the unavailability of the lithium target system. The last task includes the thermal-hydraulic transient analysis of the target lithium loop, including operational and accident transients. A lithium target loop model is developed, using the RELAP5/Mod3.2 thermal-hydraulic code, which has been modified to include specific features of IFMIF itself. The main conclusions are that target safety is fulfilled, the hazards associated with lithium operation are confined within the IFMIF security boundaries, the environmental impact is negligible, and the plant responds to the simulated transients by being able to reach steady conditions in a safety situation

Environment, safety and health progress assessment manual

International Nuclear Information System (INIS)

1992-12-01

On June 27, 1989, the Secretary of Energy announced a 1O-Point Initiative to strengthen environment,safety, and health (ES ampersand H) programs, and waste management activities at involved conducting DOE production, research, and testing facilities. One of the points independent Tiger Team Assessments of DOE operating facilities. The Office of Special Projects (OSP), EH-5, in the Office of the Assistant Secretary for Environment, Safety and Health, EH-1, was assigned the responsibility to conduct the Tiger Team Assessments. Through June 1992, a total of 35 Tiger Team Assessments were completed. The Secretary directed that Corrective Action Plans be developed and implemented to address the concerns identified by the Tiger Teams. In March 1991, the Secretary approved a plan for assessments that are ''more focused, concentrating on ES ampersand H management, ES ampersand H corrective actions, self-assessment programs, and root-cause related issues.'' In July 1991, the Secretary approved the initiation of ES ampersand H Progress Assessments, as a followup to the Tiger Team Assessments, and in the continuing effort to institutionalize the self-assessment process and line management accountability in the ES ampersand H areas. This volume contains appendices to the Environment, Safety and Health Progress Assessment Manual