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.

Screening-Level Ecological Risk Assessment Methods, Revision 3

Energy Technology Data Exchange (ETDEWEB)

Mirenda, Richard J. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

2012-08-16

This document provides guidance for screening-level assessments of potential adverse impacts to ecological resources from release of environmental contaminants at the Los Alamos National Laboratory (LANL or the Laboratory). The methods presented are based on two objectives, namely: to provide a basis for reaching consensus with regulators, managers, and other interested parties on how to conduct screening-level ecological risk investigations at the Laboratory; and to provide guidance for ecological risk assessors under the Environmental Programs (EP) Directorate. This guidance promotes consistency, rigor, and defensibility in ecological screening investigations and in reporting those investigation results. The purpose of the screening assessment is to provide information to the risk managers so informed riskmanagement decisions can be made. This document provides examples of recommendations and possible risk-management strategies.

Hanford Site Risk Assessment Methodology. Revision 3

International Nuclear Information System (INIS)

1995-05-01

This methodology has been developed to prepare human health and ecological evaluations of risk as part of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) remedial investigations (RI) and the Resource conservation and Recovery Act of 1976 (RCRA) facility investigations (FI) performed at the Hanford Site pursuant to the hanford Federal Facility Agreement and Consent Order (Ecology et al. 1994), referred to as the Tri-Party Agreement. Development of the methodology has been undertaken so that Hanford Site risk assessments are consistent with current regulations and guidance, while providing direction on flexible, ambiguous, or undefined aspects of the guidance. The methodology identifies site-specific risk assessment considerations and integrates them with approaches for evaluating human and ecological risk that can be factored into the risk assessment program supporting the Hanford Site cleanup mission. Consequently, the methodology will enhance the preparation and review of individual risk assessments at the Hanford Site

Hanford Site baseline risk assessment methodology. Revision 2

Energy Technology Data Exchange (ETDEWEB)

1993-03-01

This methodology has been developed to prepare human health and environmental evaluations of risk as part of the Comprehensive Environmental Response, Compensation, and Liability Act remedial investigations (RIs) and the Resource Conservation and Recovery Act facility investigations (FIs) performed at the Hanford Site pursuant to the Hanford Federal Facility Agreement and Consent Order referred to as the Tri-Party Agreement. Development of the methodology has been undertaken so that Hanford Site risk assessments are consistent with current regulations and guidance, while providing direction on flexible, ambiguous, or undefined aspects of the guidance. The methodology identifies Site-specific risk assessment considerations and integrates them with approaches for evaluating human and environmental risk that can be factored into the risk assessment program supporting the Hanford Site cleanup mission. Consequently, the methodology will enhance the preparation and review of individual risk assessments at the Hanford Site.

Framework for ecological risk assessment

International Nuclear Information System (INIS)

Rodier, D.; Norton, S.

1992-02-01

Increased interest in ecological issues such as global climate change, habitat loss, acid deposition, reduced biological diversity, and the ecological impacts of pesticides and toxic chemicals prompts this U.S. Environmental Protection Agency (EPA) report, A Framework for Ecological Risk Assessment ('Framework Report'). The report describes basic elements, or a framework, for evaluating scientific information on the adverse effects of physical and chemical stressors on the environment. The framework offers starting principles and a simple structure as guidance for current ecological risk assessments and as a foundation for future EPA proposals for risk assessment guidelines

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.

Climate risk screening tools and their application: A guide to the guidance

Energy Technology Data Exchange (ETDEWEB)

Traerup, S.; Olhoff, A.

2011-07-01

Climate risk screening is an integral part of efforts to ascertain current and future vulnerabilities and risks related to climate change. It is a prerequisite for identifying and designing adaptation measures, and an important element in the process of integrating, or mainstreaming, climate change adaptation into development project, planning and policy processes. There is an increasing demand and attention among national stakeholders in developing countries to take into account potential implications of climate variability and change for planning and prioritizing of development strategies and activities. Subsequently, there is a need for user friendly guidance on climate risk screening tools and their potentials for application that targets developing country stakeholders. This need is amplified by the sheer volume of climate change mainstreaming guidance documents and risk screening and assessment tools available and currently under development. Against this background, this paper sets out to provide potential users in developing countries, including project and programme developers and managers, with an informational entry point to climate risk screening tools. The emphasis in this report is on providing: 1) An overview of available climate risk screening and assessment tools along with indications of the tools available and relevant for specific purposes and contexts (Section 3). 2) Examples of application of climate risk screening and assessment tools along with links to further information (Section 4). Before turning to the respective sections on available climate risk screening tools and examples of their application, a delimitation of the tools included in this paper is included in Section 2. This section also provides a brief overview of how climate screening and related tools fit into decision making steps at various planning and decision making levels in conjunction with an outline of overall considerations to make when choosing a tool. The paper is

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.

D & D screening risk evaluation guidance

Energy Technology Data Exchange (ETDEWEB)

Robers, S.K.; Golden, K.M.; Wollert, D.A.

1995-09-01

The Screening Risk Evaluation (SRE) guidance document is a set of guidelines provided for the uniform implementation of SREs performed on decontamination and decommissioning (D&D) facilities. Although this method has been developed for D&D facilities, it can be used for transition (EM-60) facilities as well. The SRE guidance produces screening risk scores reflecting levels of risk through the use of risk ranking indices. Five types of possible risk are calculated from the SRE: current releases, worker exposures, future releases, physical hazards, and criticality. The Current Release Index (CRI) calculates the current risk to human health and the environment, exterior to the building, from ongoing or probable releases within a one-year time period. The Worker Exposure Index (WEI) calculates the current risk to workers, occupants and visitors inside contaminated D&D facilities due to contaminant exposure. The Future Release Index (FRI) calculates the hypothetical risk of future releases of contaminants, after one year, to human health and the environment. The Physical Hazards Index (PHI) calculates the risks to human health due to factors other than that of contaminants. Criticality is approached as a modifying factor to the entire SRE, due to the fact that criticality issues are strictly regulated under DOE. Screening risk results will be tabulated in matrix form, and Total Risk will be calculated (weighted equation) to produce a score on which to base early action recommendations. Other recommendations from the screening risk scores will be made based either on individual index scores or from reweighted Total Risk calculations. All recommendations based on the SRE will be made based on a combination of screening risk scores, decision drivers, and other considerations, as determined on a project-by-project basis.

Risk assessment guidance document for the UMTRA project groundwater remediation phase

International Nuclear Information System (INIS)

1992-05-01

The purpose of the groundwater remedial activities at the Uranium Mill Tailings Remedial Action (UMTRA) sites is to reduce, control, or eliminate risks to human health and the environment. This is in accordance with Subpart B of 40 CFR 192. According to this regulation, the need for groundwater restoration is based upon US Environmental Protection Agency (EPA)-defined groundwater cleanup standards and must be consistent with the National Environmental Policy Act (NEPA) process. Risk assessments will be used in the UMTRA Groundwater Program to aid in the evaluation of sites. Risk assessments are conducted for four purposes: (1) Preliminary risk assessments are used to aid in prioritizing sites, scope data collection, end determine if a site presents immediate health risks. (2) Baseline risk assessments provide a comprehensive integration and interpretation of demographic, geographic, physical, chemical, and biological factors at a site to determine the extent of actual or potential harm. This information Is used to determine the need for remedial action. (3) Risk evaluation of remedial alternatives is performed to evaluate risks to humans or the environment associated with the various remedial strategies. (4) After remediation, an evaluation of residual risks is conducted. The information gathered for each of these risk evaluations is used to determine the need for subsequent evaluation. Several sites may be eliminated after a preliminary risk assessment if there is no current or future threat to humans or the environment. Likewise, much of the data from a baseline risk assessment can be used to support alternate concentration limits or supplemental standards demonstrations, or identify sensitive habitats or receptors that may be of concern in selecting a remedy

Human Health Toxicity Values in Superfund Risk Assessments

Science.gov (United States)

This memorandum revises the hierarchy of human health toxicity values generally recommended for use inr isk assessments, originally presented in Risk Assessment Guidance for Superfund Volume I, Part A.

Safety analysis and risk assessment handbook

International Nuclear Information System (INIS)

Peterson, V.L.; Colwell, R.G.; Dickey, R.L.

1997-01-01

This Safety Analysis and Risk Assessment Handbook (SARAH) provides guidance to the safety analyst at the Rocky Flats Environmental Technology Site (RFETS) in the preparation of safety analyses and risk assessments. Although the older guidance (the Rocky Flats Risk Assessment Guide) continues to be used for updating the Final Safety Analysis Reports developed in the mid-1980s, this new guidance is used with all new authorization basis documents. With the mission change at RFETS came the need to establish new authorization basis documents for its facilities, whose functions had changed. The methodology and databases for performing the evaluations that support the new authorization basis documents had to be standardized, to avoid the use of different approaches and/or databases for similar accidents in different facilities. This handbook presents this new standardized approach. The handbook begins with a discussion of the requirements of the different types of authorization basis documents and how to choose the one appropriate for the facility to be evaluated. It then walks the analyst through the process of identifying all the potential hazards in the facility, classifying them, and choosing the ones that need to be analyzed further. It then discusses the methods for evaluating accident initiation and progression and covers the basic steps in a safety analysis, including consequence and frequency binning and risk ranking. The handbook lays out standardized approaches for determining the source terms of the various accidents (including airborne release fractions, leakpath factors, etc.), the atmospheric dispersion factors appropriate for Rocky Flats, and the methods for radiological and chemical consequence assessments. The radiological assessments use a radiological open-quotes templateclose quotes, a spreadsheet that incorporates the standard values of parameters, whereas the chemical assessments use the standard codes ARCHIE and ALOHA

Explaining probalistic risk assessment in common language

International Nuclear Information System (INIS)

Wong, J.W.

1994-01-01

Probabilistic human health risk assessment is explained in ordinary language using a hypothetical example and the ingestion equation from EPA's Risk Assessment Guidance for Superfund. A section on understanding probabilities and probability distributions used in a Monte Carlo simulation is included as well as an appendix showing the computer run and the technical assumptions behind it

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 ...

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

International Conference on Harmonisation; guidance on Q9 Quality Risk Management; availability. Notice.

Science.gov (United States)

2006-06-02

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q9 Quality Risk Management."' 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 provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions.

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

Mixtures and their risk assessment in toxicology.

Science.gov (United States)

Mumtaz, Moiz M; Hansen, Hugh; Pohl, Hana R

2011-01-01

For communities generally and for persons living in the vicinity of waste sites specifically, potential exposures to chemical mixtures are genuine concerns. Such concerns often arise from perceptions of a site's higher than anticipated toxicity due to synergistic interactions among chemicals. This chapter outlines some historical approaches to mixtures risk assessment. It also outlines ATSDR's current approach to toxicity risk assessment. The ATSDR's joint toxicity assessment guidance for chemical mixtures addresses interactions among components of chemical mixtures. The guidance recommends a series of steps that include simple calculations for a systematic analysis of data leading to conclusions regarding any hazards chemical mixtures might pose. These conclusions can, in turn, lead to recommendations such as targeted research to fill data gaps, development of new methods using current science, and health education to raise awareness of residents and health care providers. The chapter also provides examples of future trends in chemical mixtures assessment.

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

Assessment of health risks of policies

International Nuclear Information System (INIS)

Ádám, Balázs; Molnár, Ágnes; Ádány, Róza; Bianchi, Fabrizio; Bitenc, Katarina; Chereches, Razvan; Cori, Liliana; Fehr, Rainer; Kobza, Joanna; Kollarova, Jana

2014-01-01

The assessment of health risks of policies is an inevitable, although challenging prerequisite for the inclusion of health considerations in political decision making. The aim of our project was to develop a so far missing methodological guide for the assessment of the complex impact structure of policies. The guide was developed in a consensual way based on experiences gathered during the assessment of specific national policies selected by the partners of an EU project. Methodological considerations were discussed and summarized in workshops and pilot tested on the EU Health Strategy for finalization. The combined tool, which includes a textual guidance and a checklist, follows the top-down approach, that is, it guides the analysis of causal chains from the policy through related health determinants and risk factors to health outcomes. The tool discusses the most important practical issues of assessment by impact level. It emphasises the transparent identification and prioritisation of factors, the consideration of the feasibility of exposure and outcome assessment with special focus on quantification. The developed guide provides useful methodological instructions for the comprehensive assessment of health risks of policies that can be effectively used in the health impact assessment of policy proposals. - Highlights: • Methodological guide for the assessment of health risks of policies is introduced. • The tool is developed based on the experiences from several case studies. • The combined tool consists of a textual guidance and a checklist. • The top-down approach is followed through the levels of the full impact chain. • The guide provides assistance for the health impact assessment of policy proposals

Assessment of health risks of policies

Energy Technology Data Exchange (ETDEWEB)

Ádám, Balázs, E-mail: badam@cmss.sdu.dk [Unit for Health Promotion Research, Faculty of Health Sciences, University of Southern Denmark, Niels Bohrs Vej 9, DK-6700 Esbjerg (Denmark); Department of Preventive Medicine, Faculty of Public Health, University of Debrecen, P.O. Box 9, H-4012 Debrecen (Hungary); Molnár, Ágnes, E-mail: MolnarAg@smh.ca [Department of Preventive Medicine, Faculty of Public Health, University of Debrecen, P.O. Box 9, H-4012 Debrecen (Hungary); Centre for Research on Inner City Health, Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael' s Hospital, Victoria 209, Rm. 3-26.22, M5B 1C6 Toronto, Ontario (Canada); Ádány, Róza, E-mail: adany.roza@sph.unideb.hu [Department of Preventive Medicine, Faculty of Public Health, University of Debrecen, P.O. Box 9, H-4012 Debrecen (Hungary); Bianchi, Fabrizio, E-mail: Fabriepi@ifc.cnr.it [Unit of Environmental Epidemiology, Institute of Clinical Physiology, National Council of Research, Moruzzi 1, 56124 Pisa (Italy); Bitenc, Katarina, E-mail: katarina.bitenc@ivz-rs.si [National Institute of Public Health, Trubarjeva 2, SI-1000 Ljubljana (Slovenia); Chereches, Razvan, E-mail: razvan.m.chereches@gmail.com [Faculty of Political, Administrative and Communication Sciences, Babes-Bolyai University, Strada Mihail Kogalniceanu 1, 3400 Cluj (Romania); Cori, Liliana, E-mail: liliana.cori@ifc.cnr.it [Unit of Environmental Epidemiology, Institute of Clinical Physiology, National Council of Research, Moruzzi 1, 56124 Pisa (Italy); Fehr, Rainer, E-mail: rainer.fehr@uni-bielefeld.de [NRW Centre for Health, Westerfeldstr. 35-37, 33611 Bielefeld (Germany); Kobza, Joanna, E-mail: koga1@poczta.onet.pl [Public Health Department, Silesian Medical University, 18 Medykow Street, 40-752 Katowice (Poland); Kollarova, Jana, E-mail: janakollarova@yahoo.com [Department of Health Promotion, Regional Public Health Authority, Ipelska 1, 04011 Kosice (Slovakia); and others

2014-09-15

The assessment of health risks of policies is an inevitable, although challenging prerequisite for the inclusion of health considerations in political decision making. The aim of our project was to develop a so far missing methodological guide for the assessment of the complex impact structure of policies. The guide was developed in a consensual way based on experiences gathered during the assessment of specific national policies selected by the partners of an EU project. Methodological considerations were discussed and summarized in workshops and pilot tested on the EU Health Strategy for finalization. The combined tool, which includes a textual guidance and a checklist, follows the top-down approach, that is, it guides the analysis of causal chains from the policy through related health determinants and risk factors to health outcomes. The tool discusses the most important practical issues of assessment by impact level. It emphasises the transparent identification and prioritisation of factors, the consideration of the feasibility of exposure and outcome assessment with special focus on quantification. The developed guide provides useful methodological instructions for the comprehensive assessment of health risks of policies that can be effectively used in the health impact assessment of policy proposals. - Highlights: • Methodological guide for the assessment of health risks of policies is introduced. • The tool is developed based on the experiences from several case studies. • The combined tool consists of a textual guidance and a checklist. • The top-down approach is followed through the levels of the full impact chain. • The guide provides assistance for the health impact assessment of policy proposals.

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, ...

Comparison of the guidance documents in support of EU risk assessments with those for the derivation of EU water quality standards

NARCIS (Netherlands)

Vos JH; Janssen MPM; SEC

2005-01-01

Risks of both new and existing substances and of biocides in Europe are being evaluated using the Technical Guidance Document (TGD). The European Water Framework Directive refers to this document for establishing Environmental Quality Standards (EQSs) for water. Another guidance document for the

D ampersand D screening risk evaluation guidance

International Nuclear Information System (INIS)

Robers, S.K.; Golden, K.M.; Wollert, D.A.

1995-09-01

The Screening Risk Evaluation (SRE) guidance document is a set of guidelines provided for the uniform implementation of SREs performed on decontamination and decommissioning (D ampersand D) facilities. Although this method has been developed for D ampersand D facilities, it can be used for transition (EM-60) facilities as well. The SRE guidance produces screening risk scores reflecting levels of risk through the use of risk ranking indices. Five types of possible risk are calculated from the SRE: current releases, worker exposures, future releases, physical hazards, and criticality. The Current Release Index (CRI) calculates the current risk to human health and the environment, exterior to the building, from ongoing or probable releases within a one-year time period. The Worker Exposure Index (WEI) calculates the current risk to workers, occupants and visitors inside contaminated D ampersand D facilities due to contaminant exposure. The Future Release Index (FRI) calculates the hypothetical risk of future releases of contaminants, after one year, to human health and the environment. The Physical Hazards Index (PHI) calculates the risks to human health due to factors other than that of contaminants. Criticality is approached as a modifying factor to the entire SRE, due to the fact that criticality issues are strictly regulated under DOE. Screening risk results will be tabulated in matrix form, and Total Risk will be calculated (weighted equation) to produce a score on which to base early action recommendations. Other recommendations from the screening risk scores will be made based either on individual index scores or from reweighted Total Risk calculations. All recommendations based on the SRE will be made based on a combination of screening risk scores, decision drivers, and other considerations, as determined on a project-by-project basis

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.

Guidance on the European Framework for Psychosocial Risk Management: a resource for employers and worker representatives

NARCIS (Netherlands)

Leka, S.; Cox, T.; Jain, A.; Hassard, J.; Ertel, M.; Stilijanow, U.; Cvitkovic, J.; Lenhardt, U.; Lavicoli, S.; Deitinger, P.; Petyx, C.; Natali, E.; Houtman, I.L.D.; Zwetsloot, G.I.J.M.; Bakhuys Roozeboom, M.M.C.; Bossche, S.M.J. van den; Widerszal-Bazyl, M.; Zolmierczyk-Zreda, D.; Vartia, M.; Pahkin, K.; Lindstrom, K.; Sutela, S.

2008-01-01

The overarching aim of this document is the promotion of the translation of policy and knowledge into practice. As such, guidance is provided in relation to key issues including risk assessment, social dialogue and employee participation, key indicators, best practice interventions and corporate

Critical elements for human health risk assessment of less than lifetime exposures.

Science.gov (United States)

Geraets, Liesbeth; Nijkamp, Monique M; Ter Burg, Wouter

2016-11-01

Less than lifetime exposure has confronted risk assessors as to how to interpret the risks for human health in case a chronic health-based limit is exceeded. Intermittent, fluctuating and peak exposures do not match with the basis of the chronic limit values possibly leading to conservative outcomes. This paper presents guidance on how to deal with human risk assessment of less than lifetime exposure. Important steps to be considered are characterization of the human exposure situation, evaluation whether the human less than lifetime exposure scenario corresponds to a non-chronic internal exposure: toxicokinetic and toxicodynamic considerations, and, finally, re-evaluation of the risk assessment. Critical elements for these steps are the mode of action, Haber's rule, and toxicokinetics (ADME) amongst others. Previous work for the endpoints non-genotoxic carcinogenicity and developmental toxicity is included in the guidance. The guidance provides a way to consider the critical elements, without setting default factors to correct for the less than lifetime exposure in risk assessment. Copyright © 2016 Elsevier Inc. All rights reserved.

Using toxicokinetic-toxicodynamic modeling as an acute risk assessment refinement approach in vertebrate ecological risk assessment.

Science.gov (United States)

Ducrot, Virginie; Ashauer, Roman; Bednarska, Agnieszka J; Hinarejos, Silvia; Thorbek, Pernille; Weyman, Gabriel

2016-01-01

Recent guidance identified toxicokinetic-toxicodynamic (TK-TD) modeling as a relevant approach for risk assessment refinement. Yet, its added value compared to other refinement options is not detailed, and how to conduct the modeling appropriately is not explained. This case study addresses these issues through 2 examples of individual-level risk assessment for 2 hypothetical plant protection products: 1) evaluating the risk for small granivorous birds and small omnivorous mammals of a single application, as a seed treatment in winter cereals, and 2) evaluating the risk for fish after a pulsed treatment in the edge-of-field zone. Using acute test data, we conducted the first tier risk assessment as defined in the European Food Safety Authority (EFSA) guidance. When first tier risk assessment highlighted a concern, refinement options were discussed. Cases where the use of models should be preferred over other existing refinement approaches were highlighted. We then practically conducted the risk assessment refinement by using 2 different models as examples. In example 1, a TK model accounting for toxicokinetics and relevant feeding patterns in the skylark and in the wood mouse was used to predict internal doses of the hypothetical active ingredient in individuals, based on relevant feeding patterns in an in-crop situation, and identify the residue levels leading to mortality. In example 2, a TK-TD model accounting for toxicokinetics, toxicodynamics, and relevant exposure patterns in the fathead minnow was used to predict the time-course of fish survival for relevant FOCUS SW exposure scenarios and identify which scenarios might lead to mortality. Models were calibrated using available standard data and implemented to simulate the time-course of internal dose of active ingredient or survival for different exposure scenarios. Simulation results were discussed and used to derive the risk assessment refinement endpoints used for decision. Finally, we compared the

Guidance for addressing the Australian Weed Risk Assessment questions

Czech Academy of Sciences Publication Activity Database

Gordon, D. R.; Mitterdorfer, B.; Pheloung, P. C.; Ansari, S.; Buddehagen, C.; Chimera, C.; Daehler, C. C.; Dawson, G.; Denslow, J. S.; La Rosa, A. M.; Nishida, T.; Onderdonk, D. A.; Panetta, F. D.; Pyšek, Petr; Randall, R. P.; Richardson, D. M.; Tshidada, N. J.; Virtue, J. G.; Williams, P. A.

2010-01-01

Roč. 25, č. 2 (2010), s. 56-74 ISSN 0815-2195 R&D Projects: GA MŠk 7E09053 Institutional research plan: CEZ:AV0Z60050516 Keywords : plant invasions * risk assessment * prevention Subject RIV: EF - Botanics

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...

Proposals to overcome limitations in the EU chemical risk assessment scheme

DEFF Research Database (Denmark)

Trapp, Stefan; Schwartz, S.

2000-01-01

The noti®cation of new chemicals in the European Union requires a risk assessment. A Technical Guidance Document (TGD) was prepared for assistance. The TGD proposes QSARs, regressions and models from various sources. Each method has its own range of applicability and its own restrictions. Regress......The noti®cation of new chemicals in the European Union requires a risk assessment. A Technical Guidance Document (TGD) was prepared for assistance. The TGD proposes QSARs, regressions and models from various sources. Each method has its own range of applicability and its own restrictions...

A survey of ecological risk assessment at DOE facilities

International Nuclear Information System (INIS)

Barnthouse, L.W.; Bascietto, J.; Joseph, T.; Bilyard, G.

1992-01-01

The US Department of Energy (DOE) Risk-Based Standards Working Group is studying standard-setting and remedial action based on realistic estimates of human health and ecological risks. Federal and state regulations require DOE to assess ecological risks due to present and past operation of DOE facilities and ecological damage caused by remedial actions. Unfortunately, little technical guidance has been provided by regulatory agencies about how these assessments should be performed or what constitutes an adequate assessment. Active ecological research, environmental characterization, and ecological risk assessment programs are already underway at many locations. Some of these programs were established more than 30 years ago. Because of the strength of its existing programs and the depth of expertise available within the DOE complex, the agency is in a position to lead in developing ecological risk assessment procedures that are fully consistent with the general principles defined by EPA and that will ensure environmentally sound and cost-effective restoration of its sites. As a prelude to guidance development, the working group conducted a survey of ecological risk assessment activities at a subset of major DOE facilities. The survey was intended to (1) identify approaches now being used in ecological risk assessments performed by DOE staff and contractors at each site, (2) record successes and failures of these approaches, (3) identify new technical developments with potential for general application to many DOE facilities, and (4) identify major data needs, data resources, and methodological deficiencies

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.

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

Risk assessment of Short and Medium Chain Chlorinated Paraffin’s (SCCP and MCCP)

DEFF Research Database (Denmark)

Christensen, Frans Møller; Olsen, Stig Irving

2002-01-01

findings of the Short Chain Chlorinated Paraffin (SCCP) and the draft Medium Chain Chlorinated Paraffin (MCCP) risk assessments. The political actions taken as a consequence of the assessments are also described. The risk assessments have been prepared according to the EU Technical Guidance Document (TGD...

Approach and strategy for performing ecological risk assessments for the Department of Energy Oak Ridge Field Office Environmental Restoration Program

International Nuclear Information System (INIS)

Suter, G.W. II; Redfearn, A.; White, R.K.; Shaw, R.A.

1992-07-01

This document is intended to supplement exiting US Environmental Protection Agency (EPA) guidance for ecological risk assessment at hazardous waste sites by providing guidance that is more specific and more tailored to US Department of Energy sites than the guidance available from the EPA. However, it is a conceptual strategy document and does not include specific guidance on data, assumptions, and models. That detailed guidance is under development and will be presented in subsequent documents. Ecological risk assessments are equal to human health risk assessments in regulatory importance and can use many of the same data and some of the same estimation methods. However, they also have peculiar data needs and methods. Ecological risk assessments begin with an initial scoping phase, termed hazard definition, that characterizes the sources, the potentially environment, and the assessment endpoints. In the subsequent measurement and estimation phase, in which data are obtained concerning source of the endpoint biota to the contaminants and the effects of those exposures, and assumptions and models are used to relate the data to the desired exposure and effects parameters. Finally, in an integration phase, termed risk characterization, the various exposure and effects estimates are combined to infer the existence, cause, magnitude, and extent of effects of contaminants on the ecological endpoints. This phase is much more complicated for ecological risk assessments than for human health assessments because more types of data are available. Ecological risk assessments estimate effects using laboratory toxicity test results, like human health assessments, but also use results of ambient toxicity tests and biological surveys

Toxicity assessment strategies, data requirements, and risk assessment approaches to derive health based guidance values for non-relevant metabolites of plant protection products.

Science.gov (United States)

Dekant, Wolfgang; Melching-Kollmuss, Stephanie; Kalberlah, Fritz

2010-03-01

In Europe, limits for tolerable concentrations of "non-relevant metabolites" for active ingredients (AI) of plant protection products in drinking water between 0.1 and 10 microg/L are discussed depending on the toxicological information available. "Non-relevant metabolites" are degradation products of AIs, which do not or only partially retain the targeted toxicities of AIs. For "non-relevant metabolites" without genotoxicity (to be confirmed by testing in vitro), the application of the concept of "thresholds of toxicological concern" results in a health-based drinking water limit of 4.5 microg/L even for Cramer class III compounds, using the TTC threshold of 90 microg/person/day (divided by 10 and 2). Taking into account the thresholds derived from two reproduction toxicity data bases a drinking water limit of 3.0 microg/L is proposed. Therefore, for "non-relevant metabolites" whose drinking water concentration is below 3.0 microg/L, no toxicity testing is necessary. This work develops a toxicity assessment strategy as a basis to delineate health-based limits for "non-relevant metabolites" in ground and drinking water. Toxicological testing is recommended to investigate, whether the metabolites are relevant or not, based on the hazard properties of the parent AIs, as outlined in the SANCO Guidance document. Also, genotoxicity testing of the water metabolites is clearly recommended. In this publication, tiered testing strategies are proposed for non-relevant metabolites, when drinking water concentrations >3.0 microg/L will occur. Conclusions based on structure-activity relationships and the detailed toxicity database on the parent AI should be included. When testing in animals is required for risk assessment, key aspects are studies along OECD-testing guidelines with "enhanced" study designs addressing additional endpoints such as reproductive toxicity and a developmental screening test to derive health-based tolerable drinking water limits with a limited number

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...

Assessment of accident risks from german nuclear plants

International Nuclear Information System (INIS)

Heuser, F.W.

1979-01-01

The German risk study are presented. The main objectives can be summed up as follows: (a) An assessment of the societal risk due to accidents in nuclear power plants with reference to German conditions; (b) To get experience in the field of risk analysis and to provide a basis for estimation of uncertainties; (c) To provide guidance for future activities in the German Reactor Safety Research Program. Finally several conclusions reached by this study are discussed. (author)

Risk assessment handbook

International Nuclear Information System (INIS)

Farmer, F.G.; Jones, J.L.; Hunt, R.N.; Roush, M.L.; Wierman, T.E.

1990-09-01

The Probabilistic Risk Assessment Unit at EG ampersand G Idaho has developed this handbook to provide guidance to a facility manager exploring the potential benefit to be gained by performance of a risk assessment properly scoped to meet local needs. This document is designed to help the manager control the resources expended commensurate with the risks being managed and to assure that the products can be used programmatically to support future needs in order to derive maximum beneflt from the resources expended. We present a logical and functional mapping scheme between several discrete phases of project definition to ensure that a potential customer, working with an analyst, is able to define the areas of interest and that appropriate methods are employed in the analysis. In addition the handbook is written to provide a high-level perspective for the analyst. Previously, the needed information was either scattered or existed only in the minds of experienced analysts. By compiling this information and exploring the breadth of knowledge which exists within the members of the PRA Unit, the functional relationships between the customers' needs and the product have been established

The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials.

Science.gov (United States)

Bos, Peter M J; Gottardo, Stefania; Scott-Fordsmand, Janeck J; van Tongeren, Martie; Semenzin, Elena; Fernandes, Teresa F; Hristozov, Danail; Hund-Rinke, Kerstin; Hunt, Neil; Irfan, Muhammad-Adeel; Landsiedel, Robert; Peijnenburg, Willie J G M; Sánchez Jiménez, Araceli; van Kesteren, Petra C E; Oomen, Agnes G

2015-11-27

An engineered nanomaterial (ENM) may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA) a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing) a base set of information is considered, relevant exposure scenarios (RESs) are identified and the scope for Phase 2 (Risk assessment) is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy.

The MARINA Risk Assessment Strategy: A Flexible Strategy for Efficient Information Collection and Risk Assessment of Nanomaterials

Directory of Open Access Journals (Sweden)

Peter M. J. Bos

2015-11-01

Full Text Available An engineered nanomaterial (ENM may actually consist of a population of primary particles, aggregates and agglomerates of various sizes. Furthermore, their physico-chemical characteristics may change during the various life-cycle stages. It will probably not be feasible to test all varieties of all ENMs for possible health and environmental risks. There is therefore a need to further develop the approaches for risk assessment of ENMs. Within the EU FP7 project Managing Risks of Nanoparticles (MARINA a two-phase risk assessment strategy has been developed. In Phase 1 (Problem framing a base set of information is considered, relevant exposure scenarios (RESs are identified and the scope for Phase 2 (Risk assessment is established. The relevance of an RES is indicated by information on exposure, fate/kinetics and/or hazard; these three domains are included as separate pillars that contain specific tools. Phase 2 consists of an iterative process of risk characterization, identification of data needs and integrated collection and evaluation of data on the three domains, until sufficient information is obtained to conclude on possible risks in a RES. Only data are generated that are considered to be needed for the purpose of risk assessment. A fourth pillar, risk characterization, is defined and it contains risk assessment tools. This strategy describes a flexible and efficient approach for data collection and risk assessment which is essential to ensure safety of ENMs. Further developments are needed to provide guidance and make the MARINA Risk Assessment Strategy operational. Case studies will be needed to refine the strategy.

Subjective risk assessment for planning conservation projects

International Nuclear Information System (INIS)

Game, Edward T; Fitzsimons, James A; Lipsett-Moore, Geoff; McDonald-Madden, Eve

2013-01-01

Conservation projects occur under many types of uncertainty. Where this uncertainty can affect achievement of a project’s objectives, there is risk. Understanding risks to project success should influence a range of strategic and tactical decisions in conservation, and yet, formal risk assessment rarely features in the guidance or practice of conservation planning. We describe how subjective risk analysis tools can be framed to facilitate the rapid identification and assessment of risks to conservation projects, and how this information should influence conservation planning. Our approach is illustrated with an assessment of risks to conservation success as part of a conservation plan for the work of The Nature Conservancy in northern Australia. Risks can be both internal and external to a project, and occur across environmental, social, economic and political systems. Based on the relative importance of a risk and the level of certainty in its assessment we propose a series of appropriate, project level responses including research, monitoring, and active amelioration. Explicit identification, prioritization, and where possible, management of risks are important elements of using conservation resources in an informed and accountable manner. (letter)

Approach and strategy for performing ecological risk assessments for the U.S. Department of Energy's Oak Ridge Reservation: 1994 revision

International Nuclear Information System (INIS)

Suter, G.W. II; Sample, B.E.; Jones, D.S.; Ashwood, T.L.

1994-08-01

This report provides guidance for planning and performing ecological risk assessments on the Oak Ridge Reservation (ORR). The tiered approach to ecological risk assessment has been implemented, generic conceptual models have been developed, and a general approach for developing ecological assessment endpoints and measurement endpoints has been agreed upon. The document also includes changes in terminology to agree with the terminology in the US Environmental Protection Agency's (EPA's) framework for ecological risk assessment. Although ecological risks are equal in regulatory importance to human health risks, formal procedures for ecological risk assessment are poorly developed. This report will provide specific guidance and promote the use of consistent approaches for ecological risk assessments at individual sites on the ORR. The strategy discussed in this report is consistent with the overall strategy for site management and Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) compliance and with relevant EPA guidance. The general approach and strategy presented herein was developed for the ORR, but it should be applicable to other complex CERCLA sites that possess significant ecological resources

Quadrant III RFI draft report: Appendix J, Baseline risk assessment

International Nuclear Information System (INIS)

1992-12-01

In accordance with the Risk Assessment Guidance for Superfund (U. S.EPA 1989), which states that background risk should be calculated separately from site-related risk in order to provide important information to the risk manager, this appendix assesses the human health risks associated with background levels of naturally occurring compounds in soil at the Portsmouth Gaseous Diffusion Plant (PORTS). This appendix is organized as follows: Background Conditions, in which the results of Geraghty ampersand Miller's work on characterizing background levels of naturally occurring compounds in soils is summarized; Identification of Exposure Pathways; Estimation of Environmental Concentrations; Estimation of Human Intake; Toxicity Assessment, and Risk Characterization, in which numerical estimates of carcinogenic and noncarcinogenic risk are calculated for each naturally occurring compound and potential exposure pathway

Approach and strategy for performing ecological risk assessments for the U.S. Department of Energy`s Oak Ridge Reservation: 1994 revision

Energy Technology Data Exchange (ETDEWEB)

Suter, G.W. II; Sample, B.E.; Jones, D.S.; Ashwood, T.L.

1994-08-01

This report provides guidance for planning and performing ecological risk assessments on the Oak Ridge Reservation (ORR). The tiered approach to ecological risk assessment has been implemented, generic conceptual models have been developed, and a general approach for developing ecological assessment endpoints and measurement endpoints has been agreed upon. The document also includes changes in terminology to agree with the terminology in the US Environmental Protection Agency`s (EPA`s) framework for ecological risk assessment. Although ecological risks are equal in regulatory importance to human health risks, formal procedures for ecological risk assessment are poorly developed. This report will provide specific guidance and promote the use of consistent approaches for ecological risk assessments at individual sites on the ORR. The strategy discussed in this report is consistent with the overall strategy for site management and Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) compliance and with relevant EPA guidance. The general approach and strategy presented herein was developed for the ORR, but it should be applicable to other complex CERCLA sites that possess significant ecological resources.

Development of regulatory guidance for risk-informing digital system reviews

International Nuclear Information System (INIS)

Arndt, S. A.

2006-01-01

In 1995, the U.S. Nuclear Regulatory Commission (NRC) issued the Probabilistic Risk Assessment (PRA) Policy Statement, which encourages the increased use of PRA and associated analyses in all regulatory matters to the extent supported by the state-of-the-art in PRA and the data. This policy applies, in part, to the review of digital systems, which offer the potential to improve plant safety and reliability through such features as increased hardware reliability and stability and improved failure detection capability. However, there are presently no universally accepted methods for modeling digital systems in current-generation PRAs. Further, there are ongoing debates among the PRA technical community regarding the level of detail that any digital system reliability model must have to adequately model the complex system interactions that can contribute to digital system failure modes. Moreover, for PRA modeling of digital reactor protection and control systems, direct interactions between system components and indirect interactions through controlled/supervised plant processes may necessitate the use of dynamic PRA methodologies. This situation has led the NRC to consider developing performance based rather than prescriptive regulatory guidance in this area. This paper will discuss the development of this guidance and some preliminary concepts. (authors)

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

Probabilistic risk assessment (PRA) reference document. Final report

International Nuclear Information System (INIS)

Murphy, J.A.

1984-09-01

This document describes the current status of probabilistic risk assessment (PRA) as practiced in the nuclear reactor regulatory process. The PRA studies that have been completed or are under way are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed. This document was issued for comment in February 1984 entitled Probabilistic Risk Assessment (PRA): Status Report and Guidance for Regulatory Application. The comments received on the draft have been considered for this final version of the report

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...

Euro Chlor risk assessment for the marine environment Osparcom region, North Sea

International Nuclear Information System (INIS)

Garny, V.; Lecloux, A.; Boutonnet, J.C.; Papp, R.; De Rooij, C.; Thompson, R.S.; Wijk, D. van

1999-01-01

Euro Chlor has voluntarily agreed to carry out environmental risk assessments of 25 chemicals, related to the chlorine industry. The assessments were carried out specifically for the marine environment, according to the methodology laid down in the EU risk assessment Regulation (1488/94) and the Guidance Document of the EU New and Existing Substances Regulation (TGD, 1997). The study consists of the collection and evaluation of data on effects and environmental concentrations

Information resources used in health risk assessment by the New Jersey Department of Environmental Protection

Energy Technology Data Exchange (ETDEWEB)

Post, G.B.; Baratta, M.; Wolfson, S.; McGeorge, L. [New Jersey Department of Environmental Protection, Trenton (United States)

1990-12-31

The New Jersey Department of Environmental Protection`s responsibilities related to health-based risk assessment are described, including its research projects and its development of health based compound specific standards and guidance levels. The resources used by the agency to support health risk assessment work are outlined.

Environmental risk assessment of the polycyclic musks AHTN and HHCB according to the EU-TGD

NARCIS (Netherlands)

Plassche EJ van de; Balk F; CSR

1997-01-01

An environmental risk assessment has been carried out for the polycyclic musks AHTN and HHCB according to the EU Technical Guidance Document for Environmental Risk Assessment for New and Existing Substances. AHTN and HHCB are used in fragrances for cosmetics and detergents. Both substances are high

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...

Medical homes for at-risk children: parental reports of clinician-parent relationships, anticipatory guidance, and behavior changes.

Science.gov (United States)

Nelson, Catherine S; Higman, Susan M; Sia, Calvin; McFarlane, Elizabeth; Fuddy, Loretta; Duggan, Anne K

2005-01-01

Family-centeredness, compassion, and trust are 3 attributes of the clinician-parent relationship in the medical home. Among adults, these attributes are associated with patients' adherence to clinicians' advice. The objectives were (1) to measure medical home attributes related to the clinician-parent relationship, (2) to measure provision of anticipatory guidance regarding injury and illness prevention, (3) to relate anticipatory guidance to parental behavior changes, and (4) to relate medical home attributes to anticipatory guidance and parental behavior changes. A cross-sectional study of data collected among at-risk families when children were 1 year of age, in a randomized, controlled trial of a home-visiting program to prevent child abuse and neglect, was performed. Modified subscales of the Primary Care Assessment Survey were used to measure parental ratings of clinicians' family-centeredness, compassion, and trust. Parental reports of provision of anticipatory guidance regarding injury and illness prevention topics (smoke alarms, infant walkers, car seats, hot water temperature, stair guards, sunscreen, firearm safety, and bottle propping) and behavior changes were recorded. Of the 564 mothers interviewed when their children were 1 year of age, 402 (71%) had a primary care provider and had complete data for anticipatory guidance items. By definition, poverty, partner violence, poor maternal mental health, and maternal substance abuse were common in the study sample. Maternal ratings of clinicians' family-centeredness, compassion, and trust were fairly high but ranged widely and varied among population subgroups. Families reported anticipatory guidance for a mean of 4.6 +/- 2.2 topics relevant for discussion. Each medical home attribute was positively associated with parental reports of completeness of anticipatory guidance, ie, family-centeredness (beta = .026, SE = .004), compassion (beta = .019, SE = .005), and trust (beta = .016, SE = .005). Parents

Risk Scan: A Review of Risk Assessment Capability and Maturity within the Canadian Safety and Security Program

Science.gov (United States)

2014-06-01

SCADA / ICS Cyber Test Lab initiated in 2013 Psychosocial – academic research exists,; opportunity for sharing and developing impact assessment...ecosystems and species at risk), accidents / system failure (rail; pipelines ; ferries CSSP strategy for the North Focus on regional l(and local) problem...Guidance; business planning; environmental scan; proposal evaluation; and performance measurement Program Risk Management – Guidelines for project

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...

Qualitative risk assessment as a remediation management tool

International Nuclear Information System (INIS)

Knutson, D.E.

1991-01-01

The technique used to complete this thesis utilizes existing NRC and EPA guidance on health-based risk to qualitatively prioritize preliminary assessments and provide a tool for the direction and management of remediation activities. This method is intended as a decision making tool to aid in prioritizing the remediation effort and manage the remedial investigation and feasibility study (RI/FS) process. It is not a replacement for the RI/FS. The methodology for qualitative risk assessment utilizes data gathered in preliminary assessments and calculates the health-based hazards and consequences from contaminants found at each individual location. The health-based qualitative risk indicated that number-sign 6 fuel oil, carbon tetrachloride, depleted uranium, and enriched uranium were the contaminants of major concern, in that order. Plutonium ranked approximately sixth in the contaminant of concern priority. 38 refs., 1 fig., 9 tabs

The MCRA model for probabilistic single-compound and cumulative risk assessment of pesticides.

Science.gov (United States)

van der Voet, Hilko; de Boer, Waldo J; Kruisselbrink, Johannes W; Goedhart, Paul W; van der Heijden, Gerie W A M; Kennedy, Marc C; Boon, Polly E; van Klaveren, Jacob D

2015-05-01

Pesticide risk assessment is hampered by worst-case assumptions leading to overly pessimistic assessments. On the other hand, cumulative health effects of similar pesticides are often not taken into account. This paper describes models and a web-based software system developed in the European research project ACROPOLIS. The models are appropriate for both acute and chronic exposure assessments of single compounds and of multiple compounds in cumulative assessment groups. The software system MCRA (Monte Carlo Risk Assessment) is available for stakeholders in pesticide risk assessment at mcra.rivm.nl. We describe the MCRA implementation of the methods as advised in the 2012 EFSA Guidance on probabilistic modelling, as well as more refined methods developed in the ACROPOLIS project. The emphasis is on cumulative assessments. Two approaches, sample-based and compound-based, are contrasted. It is shown that additional data on agricultural use of pesticides may give more realistic risk assessments. Examples are given of model and software validation of acute and chronic assessments, using both simulated data and comparisons against the previous release of MCRA and against the standard software DEEM-FCID used by the Environmental Protection Agency in the USA. It is shown that the EFSA Guidance pessimistic model may not always give an appropriate modelling of exposure. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

Focus on Chronic Exposure for Deriving Drinking Water Guidance Underestimates Potential Risk to Infants

Directory of Open Access Journals (Sweden)

Helen Goeden

2018-03-01

Full Text Available In 2007, the Minnesota Department of Health (MDH developed new risk assessment methods for deriving human health-based water guidance (HBG that incorporated the assessment of multiple exposure durations and life stages. The methodology is based on US Environmental Protection Agency recommendations for protecting children’s health (US EPA 2002. Over the last 10 years, the MDH has derived multiple duration (e.g., short-term, subchronic, and chronic water guidance for over 60 chemicals. This effort involved derivation of multiple duration reference doses (RfDs and selection of corresponding water intake rates (e.g., infant, child, and lifetime. As expected, RfDs typically decreased with increasing exposure duration. However, the corresponding HBG frequently did not decrease with increasing duration. For more than half of the chemicals, the shorter duration HBG was lower than chronic HBG value. Conventional wisdom has been that chronic-based values will be the most conservative and will therefore be protective of less than chronic exposures. However, the MDH’s experience highlights the importance of evaluating short-term exposures. For many chemicals, elevated intake rates early in life, coupled with short-term RfDs, resulted in the lowest HBG. Drinking water criteria based on chronic assessments may not be protective of short-term exposures in highly exposed populations such as formula-fed infants.

Regulatory Forum commentary: alternative mouse models for future cancer risk assessment.

Science.gov (United States)

Morton, Daniel; Sistare, Frank D; Nambiar, Prashant R; Turner, Oliver C; Radi, Zaher; Bower, Nancy

2014-07-01

International regulatory and pharmaceutical industry scientists are discussing revision of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) S1 guidance on rodent carcinogenicity assessment of small molecule pharmaceuticals. A weight-of-evidence approach is proposed to determine the need for rodent carcinogenicity studies. For compounds with high human cancer risk, the product may be labeled appropriately without conducting rodent carcinogenicity studies. For compounds with minimal cancer risk, only a 6-month transgenic mouse study (rasH2 mouse or p53+/- mouse) or a 2-year mouse study would be needed. If rodent carcinogenicity testing may add significant value to cancer risk assessment, a 2-year rat study and either a 6-month transgenic mouse or a 2-year mouse study is appropriate. In many cases, therefore, one rodent carcinogenicity study could be sufficient. The rasH2 model predicts neoplastic findings relevant to human cancer risk assessment as well as 2-year rodent models, produces fewer irrelevant neoplastic outcomes, and often will be preferable to a 2-year rodent study. Before revising ICH S1 guidance, a prospective evaluation will be conducted to test the proposed weight-of-evidence approach. This evaluation offers an opportunity for a secondary analysis comparing the value of alternative mouse models and 2-year rodent studies in the proposed ICH S1 weight-of-evidence approach for human cancer risk assessment. © 2014 by The Author(s).

Multi-Hazard Advanced Seismic Probabilistic Risk Assessment Tools and Applications

International Nuclear Information System (INIS)

Coleman, Justin L.; Bolisetti, Chandu; Veeraraghavan, Swetha; Parisi, Carlo; Prescott, Steven R.; Gupta, Abhinav

2016-01-01

Design of nuclear power plant (NPP) facilities to resist natural hazards has been a part of the regulatory process from the beginning of the NPP industry in the United States (US), but has evolved substantially over time. The original set of approaches and methods was entirely deterministic in nature and focused on a traditional engineering margins-based approach. However, over time probabilistic and risk-informed approaches were also developed and implemented in US Nuclear Regulatory Commission (NRC) guidance and regulation. A defense-in-depth framework has also been incorporated into US regulatory guidance over time. As a result, today, the US regulatory framework incorporates deterministic and probabilistic approaches for a range of different applications and for a range of natural hazard considerations. This framework will continue to evolve as a result of improved knowledge and newly identified regulatory needs and objectives, most notably in response to the NRC activities developed in response to the 2011 Fukushima accident in Japan. Although the US regulatory framework has continued to evolve over time, the tools, methods and data available to the US nuclear industry to meet the changing requirements have not kept pace. Notably, there is significant room for improvement in the tools and methods available for external event probabilistic risk assessment (PRA), which is the principal assessment approach used in risk-informed regulations and risk-informed decision-making applied to natural hazard assessment and design. This is particularly true if PRA is applied to natural hazards other than seismic loading. Development of a new set of tools and methods that incorporate current knowledge, modern best practice, and state-of-the-art computational resources would lead to more reliable assessment of facility risk and risk insights (e.g., the SSCs and accident sequences that are most risk-significant), with less uncertainty and reduced conservatisms.

Multi-Hazard Advanced Seismic Probabilistic Risk Assessment Tools and Applications

Energy Technology Data Exchange (ETDEWEB)

Coleman, Justin L. [Idaho National Lab. (INL), Idaho Falls, ID (United States); Bolisetti, Chandu [Idaho National Lab. (INL), Idaho Falls, ID (United States); Veeraraghavan, Swetha [Idaho National Lab. (INL), Idaho Falls, ID (United States); Parisi, Carlo [Idaho National Lab. (INL), Idaho Falls, ID (United States); Prescott, Steven R. [Idaho National Lab. (INL), Idaho Falls, ID (United States); Gupta, Abhinav [Idaho National Lab. (INL), Idaho Falls, ID (United States)

2016-09-01

Design of nuclear power plant (NPP) facilities to resist natural hazards has been a part of the regulatory process from the beginning of the NPP industry in the United States (US), but has evolved substantially over time. The original set of approaches and methods was entirely deterministic in nature and focused on a traditional engineering margins-based approach. However, over time probabilistic and risk-informed approaches were also developed and implemented in US Nuclear Regulatory Commission (NRC) guidance and regulation. A defense-in-depth framework has also been incorporated into US regulatory guidance over time. As a result, today, the US regulatory framework incorporates deterministic and probabilistic approaches for a range of different applications and for a range of natural hazard considerations. This framework will continue to evolve as a result of improved knowledge and newly identified regulatory needs and objectives, most notably in response to the NRC activities developed in response to the 2011 Fukushima accident in Japan. Although the US regulatory framework has continued to evolve over time, the tools, methods and data available to the US nuclear industry to meet the changing requirements have not kept pace. Notably, there is significant room for improvement in the tools and methods available for external event probabilistic risk assessment (PRA), which is the principal assessment approach used in risk-informed regulations and risk-informed decision-making applied to natural hazard assessment and design. This is particularly true if PRA is applied to natural hazards other than seismic loading. Development of a new set of tools and methods that incorporate current knowledge, modern best practice, and state-of-the-art computational resources would lead to more reliable assessment of facility risk and risk insights (e.g., the SSCs and accident sequences that are most risk-significant), with less uncertainty and reduced conservatisms.

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...

Transportation System Risk Assessment on DOE Defense Program shipments

International Nuclear Information System (INIS)

Brumburgh, G.P.; Kimura, C.Y.; Alesso, H.P.; Prassinos, P.G.

1992-01-01

Substantial effort has been expended concerning the level of safety provided to persons, property, and the environment from the hazards associated with transporting radioactive material. This work provided an impetus for the Department of Energy to investigate the use of probabilistic risk assessment techniques to supplement the deterministic approach to transportation safety. The DOE recently decided to incorporate the methodologies associated with PRAs in the process for authorizing the transportation of nuclear components, special assemblies, and radioactive materials affiliated with the DOE Defense Program. Accordingly, the LLNL, sponsored by the DOE/AL, is tasked with developing a safety guide series to provide guidance to preparers performing a transportation system risk assessment

European Psychiatric Association (EPA) guidance on forensic psychiatry: Evidence based assessment and treatment of mentally disordered offenders.

Science.gov (United States)

Völlm, Birgit A; Clarke, Martin; Herrando, Vicenç Tort; Seppänen, Allan O; Gosek, Paweł; Heitzman, Janusz; Bulten, Erik

2018-03-20

Forensic psychiatry in Europe is a specialty primarily concerned with individuals who have either offended or present a risk of doing so, and who also suffer from a psychiatric condition. These mentally disordered offenders (MDOs) are often cared for in secure psychiatric environments or prisons. In this guidance paper we first present an overview of the field of forensic psychiatry from a European perspective. We then present a review of the literature summarising the evidence on the assessment and treatment of MDOs under the following headings: The forensic psychiatrist as expert witness, risk, treatment settings for mentally disordered offenders, and what works for MDOs. We undertook a rapid review of the literature with search terms related to: forensic psychiatry, review articles, randomised controlled trials and best practice. We searched the Medline, Embase, PsycINFO, and Cochrane library databases from 2000 onwards for adult groups only. We scrutinised publications for additional relevant literature, and searched the websites of relevant professional organisations for policies, statements or guidance of interest. We present the findings of the scientific literature as well as recommendations for best practice drawing additionally from the guidance documents identified. We found that the evidence base for forensic-psychiatric practice is weak though there is some evidence to suggest that psychiatric care produces better outcomes than criminal justice detention only. Practitioners need to follow general psychiatric guidance as well as that for offenders, adapted for the complex needs of this patient group, paying particular attention to long-term detention and ethical issues. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

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

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

Screening Level Risk Assessment for the New Waste Calcining Facility

Energy Technology Data Exchange (ETDEWEB)

M. L. Abbott; K. N. Keck; R. E. Schindler; R. L. VanHorn; N. L. Hampton; M. B. Heiser

1999-05-01

This screening level risk assessment evaluates potential adverse human health and ecological impacts resulting from continued operations of the calciner at the New Waste Calcining Facility (NWCF) at the Idaho Nuclear Technology and Engineering Center (INTEC), Idaho National Engineering and Environmental Laboratory (INEEL). The assessment was conducted in accordance with the Environmental Protection Agency (EPA) report, Guidance for Performing Screening Level Risk Analyses at Combustion Facilities Burning Hazardous Waste. This screening guidance is intended to give a conservative estimate of the potential risks to determine whether a more refined assessment is warranted. The NWCF uses a fluidized-bed combustor to solidify (calcine) liquid radioactive mixed waste from the INTEC Tank Farm facility. Calciner off volatilized metal species, trace organic compounds, and low-levels of radionuclides. Conservative stack emission rates were calculated based on maximum waste solution feed samples, conservative assumptions for off gas partitioning of metals and organics, stack gas sampling for mercury, and conservative measurements of contaminant removal (decontamination factors) in the off gas treatment system. Stack emissions were modeled using the ISC3 air dispersion model to predict maximum particulate and vapor air concentrations and ground deposition rates. Results demonstrate that NWCF emissions calculated from best-available process knowledge would result in maximum onsite and offsite health and ecological impacts that are less then EPA-established criteria for operation of a combustion facility.

Application of Risk Assessment Tools in the Continuous Risk Management (CRM) Process

Science.gov (United States)

Ray, Paul S.

2002-01-01

Marshall Space Flight Center (MSFC) of the National Aeronautics and Space Administration (NASA) is currently implementing the Continuous Risk Management (CRM) Program developed by the Carnegie Mellon University and recommended by NASA as the Risk Management (RM) implementation approach. The four most frequently used risk assessment tools in the center are: (a) Failure Modes and Effects Analysis (FMEA), Hazard Analysis (HA), Fault Tree Analysis (FTA), and Probabilistic Risk Analysis (PRA). There are some guidelines for selecting the type of risk assessment tools during the project formulation phase of a project, but there is not enough guidance as to how to apply these tools in the Continuous Risk Management process (CRM). But the ways the safety and risk assessment tools are used make a significant difference in the effectiveness in the risk management function. Decisions regarding, what events are to be included in the analysis, to what level of details should the analysis be continued, make significant difference in the effectiveness of risk management program. Tools of risk analysis also depends on the phase of a project e.g. at the initial phase of a project, when not much data are available on hardware, standard FMEA cannot be applied; instead a functional FMEA may be appropriate. This study attempted to provide some directives to alleviate the difficulty in applying FTA, PRA, and FMEA in the CRM process. Hazard Analysis was not included in the scope of the study due to the short duration of the summer research project.

Focal species candidates for pesticide risk assessment in European rice fields: A review.

Science.gov (United States)

Vallon, Martin; Dietzen, Christian; Laucht, Silke; Ludwigs, Jan-Dieter

2018-04-25

An assessment of potential risks of pesticides on wildlife is required during the process of product registration within Europe because of the importance of agricultural landscapes as wildlife habitats. Despite their peculiarity and their specific role as artificial wetlands, rice paddies are to date pooled with cereals in guidance documents on how to conduct risk assessments for birds and mammals in Europe. Hence, the focal species currently considered in risk assessments for rice paddies are those known from cereal fields and can therefore be expected to differ significantly from the species actually occurring in the wet environments of rice paddies. We present results of a comprehensive review on bird and mammal species regularly occurring in rice paddies during a time of potential pesticide exposure to identify appropriate focal species candidates for ecotoxicological pesticide risk assessment according to the European Food Safety Authority (EFSA). In addition, we present data on rice cultivation areas and agricultural practices in Europe to give background information supporting the species selection process. Our literature search identified a general scarcity of relevant data, particularly for mammals, which highlights the need for crop-specific focal species studies. However, our results clearly indicate that the relevant bird and mammal species in rice fields indeed differ strongly from the focal species used for the cereal risk assessment. They can thus be used as a baseline for more realistic wildlife risk assessments specific to rice and the development of a revised guidance document to bridge the gap for regulatory decision makers. Integr Environ Assess Manag 2018;00:000-000. © 2018 SETAC. © 2018 SETAC.

Developing RESRAD-BASELINE for environmental baseline risk assessment

International Nuclear Information System (INIS)

Cheng, Jing-Jy.

1995-01-01

RESRAD-BASELINE is a computer code developed at Argonne developed at Argonne National Laboratory for the US Department of Energy (DOE) to perform both radiological and chemical risk assessments. The code implements the baseline risk assessment guidance of the US Environmental Protection Agency (EPA 1989). The computer code calculates (1) radiation doses and cancer risks from exposure to radioactive materials, and (2) hazard indexes and cancer risks from exposure to noncarcinogenic and carcinogenic chemicals, respectively. The user can enter measured or predicted environmental media concentrations from the graphic interface and can simulate different exposure scenarios by selecting the appropriate pathways and modifying the exposure parameters. The database used by PESRAD-BASELINE includes dose conversion factors and slope factors for radionuclides and toxicity information and properties for chemicals. The user can modify the database for use in the calculation. Sensitivity analysis can be performed while running the computer code to examine the influence of the input parameters. Use of RESRAD-BASELINE for risk analysis is easy, fast, and cost-saving. Furthermore, it ensures in consistency in methodology for both radiological and chemical risk analyses

Actual problems of environmental factors risk assessment on human health and ways to improve it

Directory of Open Access Journals (Sweden)

Y.A. Rakhmanin

2015-06-01

Full Text Available The article provides an analysis of global trends and new areas of health risk assessment and analysis methodology caused by exposure to chemicals, environmental pollutants, and the contemporary issues of national assessment methodology. Most details are considered: risk assessment evidence base, modern methods and problems of carcinogenic risk assessment, hygienic regulation based on risk assessment, the economic aspects of the methodology. Particular attention is paid to reasons of recent years perceived gaps in the Russian methodological basis of the best foreign samples. The urgent measures to improve the national risk assessment methodology are proposed, the main of which are: legislative consolidation of the basic concepts of risk assessment, a further update of the methodology and the practice of hygienic regulation on the basis of risk assessment, improving the valuation of damage to human health, the tightening of the requirements to the developed regulatory guidance documents on risk assessment, as well as to the training and retraining of personnel in the risk assessment.

Uncertainties in Cancer Risk Coefficients for Environmental Exposure to Radionuclides. An Uncertainty Analysis for Risk Coefficients Reported in Federal Guidance Report No. 13

Energy Technology Data Exchange (ETDEWEB)

Pawel, David [U.S. Environmental Protection Agency; Leggett, Richard Wayne [ORNL; Eckerman, Keith F [ORNL; Nelson, Christopher [U.S. Environmental Protection Agency

2007-01-01

Federal Guidance Report No. 13 (FGR 13) provides risk coefficients for estimation of the risk of cancer due to low-level exposure to each of more than 800 radionuclides. Uncertainties in risk coefficients were quantified in FGR 13 for 33 cases (exposure to each of 11 radionuclides by each of three exposure pathways) on the basis of sensitivity analyses in which various combinations of plausible biokinetic, dosimetric, and radiation risk models were used to generate alternative risk coefficients. The present report updates the uncertainty analysis in FGR 13 for the cases of inhalation and ingestion of radionuclides and expands the analysis to all radionuclides addressed in that report. The analysis indicates that most risk coefficients for inhalation or ingestion of radionuclides are determined within a factor of 5 or less by current information. That is, application of alternate plausible biokinetic and dosimetric models and radiation risk models (based on the linear, no-threshold hypothesis with an adjustment for the dose and dose rate effectiveness factor) is unlikely to change these coefficients by more than a factor of 5. In this analysis the assessed uncertainty in the radiation risk model was found to be the main determinant of the uncertainty category for most risk coefficients, but conclusions concerning the relative contributions of risk and dose models to the total uncertainty in a risk coefficient may depend strongly on the method of assessing uncertainties in the risk model.

Bioavailability in ecological risk. Assessment for radionuclides

International Nuclear Information System (INIS)

Garnier-Laplace, J.; Gilbin, R.; Della-Vedova, C.; Adam, C.; Simon, O.; Denison, F.; Beaugelin, K.

2005-01-01

The guidance for performing Ecological Risk Assessments (ERA) in Europe has been published in 2003 in the EC's Technical Guidance Document. This document constitutes the official reference in which current water quality standards and risk assessment approach for metals/metalloids are still mainly based on total or dissolved concentrations. However, it has been recognized that accurate assessment of the bio-available metal fraction is crucial, even if the way to incorporate bioavailability into these procedures is still under discussion. The speciation of a pollutant in the exposure medium is the first factor that regulates its bioavailability and consequently its bioaccumulation and the induced biological effects. Therefore, within any ecological risk assessment, bioavailability has obvious implications: firstly in exposure analysis which aim is to determine Predicted Exposure Concentration (PEC); secondly in effect analysis while deriving the so-called Predicted No-Effect Concentrations (PNEC) as toxicity is often linked to the amount of the contaminant incorporated into the tissues of biota. Similarities between metals/metalloids and radionuclides are limited to the biogeochemical behaviour of the element considered and to the need to use bioavailability models. In addition, for radionuclides, emitted ionising radiations (type and energy) need to be taken into account for both exposure and effect analyses whilst performing dosimetric calculations appropriate to the exposure scenarios. A methodology for properly implementing bioavailability models is explained and illustrated for aqueous U(VI), starting from a comprehensive review of the thermodynamic data relevant to environmentally-realistic physico-chemical conditions. Then, the use of thermodynamic equilibrium modelling as a tool for interpreting the bioavailability of U(VI) is presented. Using a systematic approach, different bioavailability models of increasing complexity were tested to model U bio

OPP Guidance for Submission of State and Tribal Water Quality Monitoring Data

Science.gov (United States)

This guidance describes the process to submit state and tribal surface and groundwater monitoring data for consideration in exposure characterizations for ecological and and human health risk assessments and in risk management decisions for pesticides.

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...

Chemical Exposure Assessment Program at Los Alamos National Laboratory: A risk based approach

International Nuclear Information System (INIS)

Stephenson, D.J.

1996-01-01

The University of California Contract And DOE Order 5480.10 require that Los Alamos National Laboratory (LANL) perform health hazard assessments/inventories of all employee workplaces. In response to this LANL has developed the Chemical Exposure Assessment Program. This program provides a systematic risk-based approach to anticipation, recognition, evaluation and control of chemical workplace exposures. Program implementation focuses resources on exposures with the highest risks for causing adverse health effects. Implementation guidance includes procedures for basic characterization, qualitative risk assessment, quantitative validation, and recommendations and reevaluation. Each component of the program is described. It is shown how a systematic method of assessment improves documentation, retrieval, and use of generated exposure information

Remedial Investigation/Feasibility Study (RI/FS) process, elements and techniques guidance

Energy Technology Data Exchange (ETDEWEB)

1993-12-01

This manual provides detailed guidance on Remedial Investigation/Feasibility Studies (RI/FSs) conducted pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) at Department of Energy (DOE) facilities. The purpose of the RI/FS, to assess the risk posed by a hazardous waste site and to determine the best way to reduce that risk, and its structure (site characterization, risk assessment, screening and detailed analysis of alternatives, etc.) is defined in the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) and further explained in the Environmental Protection Agency`s (EPA`s) Guidance for Conducting Remedial Investigations and Feasibility Studies Under CERCLA (Interim Final) 540/G-89/004, OSWER Directive 9355.3-01, October 1988. Though issued in 1988, the EPA guidance remains an excellent source of information on the conduct and structure of an RI/FS. This document makes use of supplemental RI/FS-related guidance that EPA has developed since its initial document was issued in 1988, incorporates practical lessons learned in more than 12 years of experience in CERCLA hazardous site remediation, and drawing on those lessons, introduces the Streamlined Approach For Environmental Restoration (SAFER), developed by DOE as a way to proceed quickly and efficiently through the RI/FS process at DOE facilities. Thus as its title implies, this guidance is intended to describe in detail the process and component elements of an RI/FS, as well as techniques to manage the RI/FS effectively.

Hazard waste risk assessment

International Nuclear Information System (INIS)

Hawley, K.A.; Napier, B.A.

1986-01-01

Pacific Northwest Laboratory continued to provide technical assistance to the Department of Energy (DOE) Office of Operational Safety (OOS) in the area of risk assessment for hazardous and radioactive-mixed waste management. The overall objective is to provide technical assistance to OOS in developing cost-effective risk assessment tools and strategies for bringing DOE facilities into compliance with the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) and the Resource Conservation and Recovery Act (RCRA). Major efforts during FY 1985 included (1) completing the modification of the Environmental Protection Agency (EPA) Hazard Ranking System (HRS) and developing training manuals and courses to assist in field office implementation of the modified Hazard Ranking System (mHRS); (2) initiating the development of a system for reviewing field office HRS/mHRS evaluations for appropriate use of data and appropriate application of the methodology; (3) initiating the development of a data base management system to maintain all field office HRS/mHRS scoring sheets and to support the master OOS environmental data base system; (4) developing implementation guidance for Phase I of the DOE CERCLA Program, Installation Assessment; (5) continuing to develop an objective, scientifically based methodology for DOE management to use in establishing priorities for conducting site assessments under Phase II of the DOE CERCLA Program, Confirmation; and (6) participating in developing the DOE response to EPA on the proposed listing of three sites on the National Priorities List

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...

A review of NRC staff uses of probabilistic risk assessment

Energy Technology Data Exchange (ETDEWEB)

1994-03-01

The NRC staff uses probabilistic risk assessment (PRA) and risk management as important elements its licensing and regulatory processes. In October 1991, the NRC`s Executive Director for Operations established the PRA Working Group to address concerns identified by the Advisory Committee on Reactor Safeguards with respect to unevenness and inconsistency in the staff`s current uses of PRA. After surveying current staff uses of PRA and identifying needed improvements, the Working Group defined a set of basic principles for staff PRA use and identified three areas for improvements: guidance development, training enhancements, and PRA methods development. For each area of improvement, the Working Group took certain actions and recommended additional work. The Working Group recommended integrating its work with other recent PRA-related activities the staff completed and improving staff interactions with PRA users in the nuclear industry. The Working Group took two key actions by developing general guidance for two uses of PRA within the NRC (that is, screening or prioritizing reactor safety issues and analyzing such issues in detail) and developing guidance on basic terms and methods important to the staff`s uses of PRA.

A review of NRC staff uses of probabilistic risk assessment

International Nuclear Information System (INIS)

1994-03-01

The NRC staff uses probabilistic risk assessment (PRA) and risk management as important elements its licensing and regulatory processes. In October 1991, the NRC's Executive Director for Operations established the PRA Working Group to address concerns identified by the Advisory Committee on Reactor Safeguards with respect to unevenness and inconsistency in the staff's current uses of PRA. After surveying current staff uses of PRA and identifying needed improvements, the Working Group defined a set of basic principles for staff PRA use and identified three areas for improvements: guidance development, training enhancements, and PRA methods development. For each area of improvement, the Working Group took certain actions and recommended additional work. The Working Group recommended integrating its work with other recent PRA-related activities the staff completed and improving staff interactions with PRA users in the nuclear industry. The Working Group took two key actions by developing general guidance for two uses of PRA within the NRC (that is, screening or prioritizing reactor safety issues and analyzing such issues in detail) and developing guidance on basic terms and methods important to the staff's uses of PRA

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.

Data validation and risk assessment -- some pitfalls when evaluating VOC measurements

International Nuclear Information System (INIS)

Korte, N.; Kearl, P.

1993-01-01

Data validation, as described in Environmental Protection Agency (EPA) protocols under the Contract Laboratory Program (CLP), yields false confidence in the data and drives up costs while providing little benefit (Korte and Brown 1992). Commonly, these data are then used to perform a risk assessment. Much of the published guidance for risk assessments in and arid soils is inadequate because it does not take into account vapor migration due to density-driven flow (Korte and others 1992). Investigations into both of these problems have been performed by personnel of Oak Ridge National Laboratory (ORNL) and are described in this presentation

Implications of applying cumulative risk assessment to the workplace.

Science.gov (United States)

Fox, Mary A; Spicer, Kristen; Chosewood, L Casey; Susi, Pam; Johns, Douglas O; Dotson, G Scott

2018-06-01

Multiple changes are influencing work, workplaces and workers in the US including shifts in the main types of work and the rise of the 'gig' economy. Work and workplace changes have coincided with a decline in unions and associated advocacy for improved safety and health conditions. Risk assessment has been the primary method to inform occupational and environmental health policy and management for many types of hazards. Although often focused on one hazard at a time, risk assessment frameworks and methods have advanced toward cumulative risk assessment recognizing that exposure to a single chemical or non-chemical stressor rarely occurs in isolation. We explore how applying cumulative risk approaches may change the roles of workers and employers as they pursue improved health and safety and elucidate some of the challenges and opportunities that might arise. Application of cumulative risk assessment should result in better understanding of complex exposures and health risks with the potential to inform more effective controls and improved safety and health risk management overall. Roles and responsibilities of both employers and workers are anticipated to change with potential for a greater burden of responsibility on workers to address risk factors both inside and outside the workplace that affect health at work. A range of policies, guidance and training have helped develop cumulative risk assessment for the environmental health field and similar approaches are available to foster the practice in occupational safety and health. Copyright © 2018 Elsevier Ltd. All rights reserved.

A microbial identification framework for risk assessment.

Science.gov (United States)

Bernatchez, Stéphane; Anoop, Valar; Saikali, Zeina; Breton, Marie

2018-06-01

Micro-organisms are increasingly used in a variety of products for commercial uses, including cleaning products. Such microbial-based cleaning products (MBCP) are represented as a more environmentally-friendly alternative to chemically based cleaning products. The identity of the micro-organisms formulated into these products is often considered confidential business information and is not revealed or it is only partly revealed (i.e., identification to the genus, not to the species). That paucity of information complicates the evaluation of the risk associated with their use. The accurate taxonomic identification of those micro-organisms is important so that a suitable risk assessment of the products can be conducted. To alleviate difficulties associated with adequate identification of micro-organisms in MBCP and other products containing micro-organisms, a microbial identification framework for risk assessment (MIFRA) has been elaborated. It serves to provide guidance on a polyphasic tiered approach, combining the data obtained from the use of various methods (i.e., polyphasic approach) combined with the sequential selection of the methods (i.e., tiered) to achieve a satisfactory identity of the micro-organism to an acceptable taxonomic level. The MIFRA is suitable in various risk assessment contexts for micro-organisms used in any commercial product. Copyright © 2018. Published by Elsevier Ltd.

Transparency in risk assessments - Presenting the 'expectation value' of post-closure risks from radioactive waste repositories

International Nuclear Information System (INIS)

Wilmot, R.D.; Galson, D.A.; Pollard, S.J.T.; Smith, R.E.; Yearsley, R.A.

1999-01-01

The Environment Agency of England and Wales (the 'Agency') has an extremely broad regulatory remit covering aspects of flood defence, integrated pollution control, water quality, waste management, abstraction control, navigation, fisheries, conservation and recreation. Risk assessment, as a regulatory and management tool plays an essential role in the targeting and prioritisation of this activity, as well as in aiding site-specific decisions on authorisations for abstraction, discharge and/or disposal. From a regulatory perspective, the majority of the Agency's risk assessment activity is focused on critically reviewing risk assessments submitted to the Agency in support of requests for authorisation. With increasing calls for openness in all areas of regulatory decision-making, new demands are being placed on risk assessments with a view to allowing far more transparency and traceability of 'process' and 'content' than has historically been the case. The Agency is responsible for the licensing of radioactive waste disposal facilities in England and Wales. It has issued guidance on what is expected of an application for an authorisation to dispose of low and intermediate level radioactive waste to land - the 'Guidance on Requirements for Authorisation' (the 'GRA'). The GRA includes a risk target and places a strong emphasis on confidence-building during the preparation and assessment of post-closure safety cases for such facilities. In this paper we discuss a recent study commissioned by the Agency which has examined the use of expectation value of risk in assessments and considered ways of improving transparency. The study has concluded that the expectation value is an appropriate measure of risk for comparison with a single-value criterion, provided that the scope of the assessment does not involve undue speculation regarding the FEPs (Features, Events and Processes) to be included. Low probability or speculative events and processes for which no data can be

Participatory Risk Assessment for Environmental Decision-Making

International Nuclear Information System (INIS)

Homan, Jacqueline; Petts, Judith

2001-01-01

Recent research, discussion and practice in the role environmental decision-making as an integral part of a democratic society have resulted in legislation, policy and guidance that encourage, and indeed may require, greater participation. The focus of this research paper is to explore these participatory ideas in the context of environmental risk assessment. Participation methods have generic application. However, the importance of fitting method to purpose requires that different contexts and issues relative to the objectives be addressed. In relation to environmental risk assessment these issues include: the complexity of risk issues per se; the inherent uncertainty that dominates any risk assessment; the quantitative nature of many risk assessments and the difficulty of dealing with low probability-high consequence outconies; the possibility of controversy in relation to decisions involving risk and thus the careful attention needed to the process and identification of participants; the traditional role and culture of experts in risk decisions and the challenge of reconciling this with the role of lay knowledge and the potential for the public to act as quality assurers in the risk decision process; the tendency for people to need reassurance when confronted with risk, even during a participation process; the need to acknowledge the public's ability to deal with complex technical issues and the need for information and data to respond to their questions, and the fact that 'risk' per se will often not be the only issue of public concern. The contributions to the risk debate from the social sciences are having considerable influence on the practice of environmental decision-making. Calls for increased stakeholder involvement in risk decisions are requiring greater access to and engagement with environmental risk assessments. Mechanisms for this level of involvement, however, are not well defined. For these aspirational calls to be realised in practice, decision

Participatory Risk Assessment for Environmental Decision-Making

Energy Technology Data Exchange (ETDEWEB)

Homan, Jacqueline; Petts, Judith [Univ. of Birmingham (United Kingdom). Centre for Environmental Research and Training; Pollard, Simon; Twigger-Ross, Clare [National Centre for Risk Analysis and Options Appraisal, London (United Kingdom)

2001-07-01

Recent research, discussion and practice in the role environmental decision-making as an integral part of a democratic society have resulted in legislation, policy and guidance that encourage, and indeed may require, greater participation. The focus of this research paper is to explore these participatory ideas in the context of environmental risk assessment. Participation methods have generic application. However, the importance of fitting method to purpose requires that different contexts and issues relative to the objectives be addressed. In relation to environmental risk assessment these issues include: the complexity of risk issues per se; the inherent uncertainty that dominates any risk assessment; the quantitative nature of many risk assessments and the difficulty of dealing with low probability-high consequence outconies; the possibility of controversy in relation to decisions involving risk and thus the careful attention needed to the process and identification of participants; the traditional role and culture of experts in risk decisions and the challenge of reconciling this with the role of lay knowledge and the potential for the public to act as quality assurers in the risk decision process; the tendency for people to need reassurance when confronted with risk, even during a participation process; the need to acknowledge the public's ability to deal with complex technical issues and the need for information and data to respond to their questions, and the fact that 'risk' per se will often not be the only issue of public concern. The contributions to the risk debate from the social sciences are having considerable influence on the practice of environmental decision-making. Calls for increased stakeholder involvement in risk decisions are requiring greater access to and engagement with environmental risk assessments. Mechanisms for this level of involvement, however, are not well defined. For these aspirational calls to be realised in

Improving the Clinical Pharmacologic Assessment of Abuse Potential: Part 1: Regulatory Context and Risk Management.

Science.gov (United States)

Sellers, Edward M

2018-02-01

This article brings to the attention of drug developers the Food and Drug Administration's (FDA's) recent final Guidance to Industry on Assessment of Abuse Potential and provides practical suggestions about compliance with the Guidance. The Guidance areas are reviewed, analyzed, and placed in the context of current scientific knowledge and best practices to mitigate regulatory risk. The Guidance provides substantial new detail on what needs to be done at all stages of drug development for central nervous system-active drugs. However, because many psychopharmacologic agents have unique preclinical and clinical features, the plan for each agent needs to be not only carefully prepared but also reviewed and approved by the FDA. Examples are provided where assumptions about interpretation of the Guidance can delay development. If the expertise and experience needed for assessing abuse potential during drug development do not exist within a company, external preclinical and clinical expert should be involved. Consultation with the FDA is encouraged and important because the specific requirements for each drug will vary.

Safety assessment guidance in the International Atomic Energy Agency RADWASS Program

Energy Technology Data Exchange (ETDEWEB)

Vovk, I.F.; Seitz, R.R.

1995-12-31

The IAEA RADWASS programme is aimed at establishing a coherent and comprehensive set of principles and standards for the safe management of waste and formulating the guidelines necessary for their application. A large portion of this programme has been devoted to safety assessments for various waste management activities. Five Safety Guides are planned to be developed to provide general guidance to enable operators and regulators to develop necessary framework for safety assessment process in accordance with international recommendations. They cover predisposal, near surface disposal, geological disposal, uranium/thorium mining and milling waste, and decommissioning and environmental restoration. The Guide on safety assessment for near surface disposal is at the most advanced stage of preparation. This draft Safety Guide contains guidance on description of the disposal system, development of a conceptual model, identification and description of relevant scenarios and pathways, consequence analysis, presentation of results and confidence building. The set of RADWASS publications is currently undergoing in-depth review to ensure a harmonized approach throughout the Safety Series.

GUIDANCE ON SELECTING AGE GROUPS FOR ...

Science.gov (United States)

This guidance document provides a set of early-lifestage age groups for Environmental Protection Agency scientists to consider when assessing children’s exposure to environmental contaminants and the resultant potential dose. These recommended age groups are based on current understanding of differences in behavior and physiology which may impact exposures in children. A consistent set of early-life age groups, supported by an underlying scientific rationale, is expected to improve Agency exposure and risk assessments for children by increasing the consistency and comparability of risk assessments across the Agency; by improving accuracy and transparency in assessments for those cases where current practice might too broadly combine behaviorally and physiologically disparate age groups; and by fostering a consistent approach to future exposure surveys and monitoring efforts to generate improved exposure factors for children. see description

Guidance for Identifying, Selecting and Evaluating Open Literature Studies

Science.gov (United States)

This guidance for Office of Pesticide Program staff will assist in their evaluation of open literature studies of pesticides. It also describes how we identify, select, and ensure that data we use in risk assessments is of sufficient scientific quality.

Risk-informed design guidance for future reactor systems

International Nuclear Information System (INIS)

Delaney, Michael J.; Apostolakis, George E.; Driscoll, Michael J.

2005-01-01

Future reactor designs face an uncertain regulatory environment. It is anticipated that there will be some level of probabilistic insights in the regulations and supporting regulatory documents for Generation-IV nuclear reactors. Central to current regulations are design basis accidents (DBAs) and the general design criteria (GDC), which were established before probabilistic risk assessments (PRAs) were developed. These regulations implement a structuralist approach to safety through traditional defense in depth and large safety margins. In a rationalist approach to safety, accident frequencies are quantified and protective measures are introduced to make these frequencies acceptably low. Both approaches have advantages and disadvantages and future reactor design and licensing processes will have to implement a hybrid approach. This paper presents an iterative four-step risk-informed methodology to guide the design of future-reactor systems using a gas-cooled fast reactor emergency core cooling system as an example. This methodology helps designers to analyze alternative designs under potential risk-informed regulations and to anticipate design justifications the regulator may require during the licensing process. The analysis demonstrated the importance of common-cause failures and the need for guidance on how to change the quantitative impact of these potential failures on the frequency of accident sequences as the design changes. Deliberation is an important part of the four-step methodology because it supplements the quantitative results by allowing the inclusion in the design choice of elements such as best design practices and ease of online maintenance, which usually cannot be quantified. The case study showed that, in some instances, the structuralist and the rationalist approaches were inconsistent. In particular, GDC 35 treats the double-ended break of the largest pipe in the reactor coolant system with concurrent loss of offsite power and a single

The role of satellite remote sensing in structured ecosystem risk assessments.

Science.gov (United States)

Murray, Nicholas J; Keith, David A; Bland, Lucie M; Ferrari, Renata; Lyons, Mitchell B; Lucas, Richard; Pettorelli, Nathalie; Nicholson, Emily

2018-04-01

The current set of global conservation targets requires methods for monitoring the changing status of ecosystems. Protocols for ecosystem risk assessment are uniquely suited to this task, providing objective syntheses of a wide range of data to estimate the likelihood of ecosystem collapse. Satellite remote sensing can deliver ecologically relevant, long-term datasets suitable for analysing changes in ecosystem area, structure and function at temporal and spatial scales relevant to risk assessment protocols. However, there is considerable uncertainty about how to select and effectively utilise remotely sensed variables for risk assessment. Here, we review the use of satellite remote sensing for assessing spatial and functional changes of ecosystems, with the aim of providing guidance on the use of these data in ecosystem risk assessment. We suggest that decisions on the use of satellite remote sensing should be made a priori and deductively with the assistance of conceptual ecosystem models that identify the primary indicators representing the dynamics of a focal ecosystem. Copyright © 2017 Elsevier B.V. All rights reserved.

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

An Approach for Integrating Toxicogenomic Data in Risk Assessment: The Dibutyl Phthalate Case Study

Science.gov (United States)

An approach for evaluating and integrating genomic data in chemical risk assessment was developed based on the lessons learned from performing a case study for the chemical dibutyl phthalate. A case study prototype approach was first developed in accordance with EPA guidance and ...

Framework for integrating human and animal data in chemical risk assessment.

Science.gov (United States)

Lavelle, Karlene S; Robert Schnatter, A; Travis, Kim Z; Swaen, Gerard M H; Pallapies, Dirk; Money, Chris; Priem, Peter; Vrijhof, Henk

2012-03-01

Although regulatory agencies formally encourage the integration of all available data in chemical risk assessment, consistent implementation of this practice has been constrained by the lack of a clear, systematic method for doing so. In this paper, we describe a methodology for evaluating, classifying and integrating human and animal data into the risk assessment process that incorporates: (1) a balanced appraisal of human and animal data, (2) relevance to different stages of the risk assessment process, and (3) accommodation for different data quality requirements. The proposed framework offers a flexible, step-wise approach for determining which set of available data best support the chemical risk assessment that involves the rating and relative ranking of human and animal data quality. The evaluation of human data incorporates seven data quality elements, nature and specificity of the lead effect; evaluation of animal data incorporates data quality and relevance to humans. Results of simulations with selected chemicals previously evaluated in a formal risk assessment generally agreed with existing regulatory guidance. Application of the proposed framework across a wider range of chemical agents will improve transparency of the risk assessment process and validity of results, while informing continuous refinements to this evolving methodology. Copyright © 2012 Elsevier Inc. All rights reserved.

Protection goals in environmental risk assessment: a practical approach.

Science.gov (United States)

Garcia-Alonso, Monica; Raybould, Alan

2014-12-01

Policy protection goals are set up in most countries to minimise harm to the environment, humans and animals caused by human activities. Decisions on whether to approve new agricultural products, like pesticides or genetically modified (GM) crops, take into account these policy protection goals. To support decision-making, applications for approval of commercial uses of GM crops usually comprise an environmental risk assessment (ERA). These risk assessments are analytical tools, based on science, that follow a conceptual model that includes a problem formulation step where policy protection goals are considered. However, in most countries, risk assessors face major problems in that policy protection goals set in the legislation are stated in very broad terms and are too ambiguous to be directly applicable in ERAs. This means that risk assessors often have to interpret policy protection goals without clear guidance on what effects would be considered harmful. In this paper we propose a practical approach that may help risk assessors to translate policy protection goals into unambiguous (i.e., operational) protection goals and to establish relevant assessment endpoints and risk hypotheses that can be used in ERAs. Examples are provided to show how this approach can be applied to two areas of environmental concern relevant to the ERAs of GM crops.

Waste area Grouping 2 Phase I task data report: Human health risk assessment

International Nuclear Information System (INIS)

Purucker, S.T.; Douthat, D.M.

1996-06-01

This report is one of five reports issued in 1996 that provide follow- up information to the Phase 1 Remedial Investigation (RI) Report for Waste Area Grouping (WAG) 2 at Oak Ridge National Laboratory (ORNL). The five reports address areas of concern that could cause potential human health risk and ecological risk within WAG2 at ORNL. The purpose of this report is to present a summary of the human health risk assessment results based on the data collected for the WAG 2 Phase 1 RI. Estimates of risk are provided based on measured concentrations in the surface water, floodplain soil, and sediment of White Oak Creek, Melton Branch, and their tributaries. The human health risk assessment methodology used in this risk assessment is based on Risk Assessment Guidance for Superfund (RAGS). First, the data for the different media are elevated to determine usability for risk assessment. Second, through the process of selecting chemicals of potential concern (COPCs), contaminants to be considered in the risk assessment are identified for each assessment of exposure potential is performed, and exposure pathways are identified. Subsequently, exposure is estimated quantitatively, and the toxicity of each of the COPCs is determined. The results of these analyses are combined and summarized in a risk characterization

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.

Qualitative risk assessment for 100-DR-1 source operable unit

International Nuclear Information System (INIS)

Naiknimbalkar, N.M.

1994-01-01

The Washington State Department of Ecology (Ecology), the US Environmental Protection Agency (EPA), and the US Department of Energy (DOE), signatories to the Hanford Federal Facility Agreement and Consent Order have developed the Hanford site Past-Practice Strategy to emphasize initiating and completing waste site cleanups with a bias for action. This strategy relies, in part, upon the use of a qualitative risk assessment (QRA) to assist in decision-making. The QRA is performed using the Hanford Site Baseline Risk Assessment Methodology (HSBRAM) as guidance (DOE-RL 1993a). The results will be used, along with other considerations, to make a recommendation for or against an interim remedial measure (IRM) at each high-priority waste site. The objective of conducting IRMs at Hanford, is to achieve cleanup and reduce risk in the shortest time possible and in a cost effective manner

Strategy for integrated CERCLA/NEPA risk assessments

International Nuclear Information System (INIS)

MacDonell, M.M.; Haroun, L.A.; Peterson, J.M.; Blunt, D.A.; Fingleton, D.J.; Picel, M.H.

1991-01-01

The US Department of Energy (DOE) has established a policy whereby, for remedial actions, the procedural and documentational requirements of the National Environmental Policy Act (NEPA) are integrated with those of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended. However, the objectives of risk assessment under NEPA and CERCLA differ somewhat. Until its recent application at contaminated sites, NEPA analysis has typically been applied to impacts from taking actions at clean sites (e.g., for construction activities), and a somewhat loosely structured process has historically been used to estimate relative risks for NEPA analyses. Decisions such as cleanup levels were not made on the basis of the risk estimates, and they therefore tended to be conservative and were not discussed in detail. In contrast, risks estimated for Superfund (CERCLA) sites are used to focus the decision-making process for those sites and support national prioritization for cleanup, and the US Environmental Protection Agency (EPA) has developed a detailed framework for preparing baseline health risk assessments for these sites. The purpose of this paper is to discuss issues related to intergrating the CERCLA and NEPA approaches into the risk assessments that have been prepared for a DOE remedial action project at the Weldon Spring site near St. Charles, Missouri. These issues are grouped into three basic categories: general assumptions for the impact evaluation, data management, and presentation of the methodology and results. This paper is not intended to represent DOE policy and guidance, nor does it represent the only approach that can be used for integrated risk assessments. It merely discusses the process that was used for the Weldon Spring project, articulating the issues that were encountered and how they were addressed

Ecological and human health sediment risk assessment for a hydrocarbon-impacted site in Lake Athabasca

International Nuclear Information System (INIS)

Mcdonald, B.; Wagenaar, A.; LaPorte, J.; Misfeldt, G.; Chatwell, I.

2009-01-01

The operation of a public port facility near Uranium City, Saskatchewan has resulted in elevated levels of hydrocarbons in soil, groundwater and sediment. Remedial action in the uplands portion of the site was successful and a risk management approach was initiated for the aquatic portion of the site in order to resolve human health and ecological issues. Ecological risks were assessed using a sediment weight-of-evidence approach involving chemistry, toxicity, bioaccumulation and benthic community structure. Human health risks were assessed via fish consumption, water ingestion and direct contact according to Health Canada guidance. This presentation included an overview of the general risk assessment approach as well as site-specific data and findings. The primary focus was on the challenges confronted during the risk assessment process, such as the need to include alkylated PAHs as a COPC in the human health risk assessment and to evaluate ongoing propeller wash and sediment resuspension for sediment risk management, even though the facility is no longer operational.

Multicriteria Decision Framework for Cybersecurity Risk Assessment and Management.

Science.gov (United States)

Ganin, Alexander A; Quach, Phuoc; Panwar, Mahesh; Collier, Zachary A; Keisler, Jeffrey M; Marchese, Dayton; Linkov, Igor

2017-09-05

Risk assessors and managers face many difficult challenges related to novel cyber systems. Among these challenges are the constantly changing nature of cyber systems caused by technical advances, their distribution across the physical, information, and sociocognitive domains, and the complex network structures often including thousands of nodes. Here, we review probabilistic and risk-based decision-making techniques applied to cyber systems and conclude that existing approaches typically do not address all components of the risk assessment triplet (threat, vulnerability, consequence) and lack the ability to integrate across multiple domains of cyber systems to provide guidance for enhancing cybersecurity. We present a decision-analysis-based approach that quantifies threat, vulnerability, and consequences through a set of criteria designed to assess the overall utility of cybersecurity management alternatives. The proposed framework bridges the gap between risk assessment and risk management, allowing an analyst to ensure a structured and transparent process of selecting risk management alternatives. The use of this technique is illustrated for a hypothetical, but realistic, case study exemplifying the process of evaluating and ranking five cybersecurity enhancement strategies. The approach presented does not necessarily eliminate biases and subjectivity necessary for selecting countermeasures, but provides justifiable methods for selecting risk management actions consistent with stakeholder and decisionmaker values and technical data. Published 2017. This article is a U.S. Government work and is in the public domain in the U.S.A.

Insights from Guideline for Performance of Internal Flooding Probabilistic Risk Assessment (IFPRA)

International Nuclear Information System (INIS)

Choi, Sun Yeong; Yang, Joo Eon

2009-01-01

An internal flooding (IF) risk assessment refers to the quantitative probabilistic safety assessment (PSA) treatment of flooding as a result of pipe and tank breaks inside the plants, as well as from other recognized flood sources. The industry consensus standard for Internal Events Probabilistic Risk Assessment (ASME-RA-Sb-2005) includes high-level and supporting technical requirements for developing internal flooding probabilistic risk assessment (IFPRA). This industry standard is endorsed in Regulatory Guide 1.200, Revision 1 as an acceptable approach for addressing the risk contribution from IF events for risk informed applications that require U.S. Nuclear Regulatory commission (NRC) approval. In 2006, EPRI published a draft report for IFPRA that addresses the requirements of the ASME PRA consensus standard and have made efforts to refine and update the final EPRI IFPRA guideline. Westinghouse has performed an IFPRA analysis for several nuclear power plants (NPPs), such as Watts Bar and Fort Calhoun, using the draft EPRI guidelines for development of an IFPRA. Proprietary methodologies have been developed to apply the EPRI guidelines. The objectives of the draft report for IFPRA guideline are to: · Provide guidance for PSA practitioners in the performance of the elements of a PRA associated with internal flooding events consistent with the current state of the art for internal flooding PRA · Provide guidance regarding acceptable approaches that is sufficient to meeting the requirements of the ASME PRA Standard associated with internal flooding · Incorporate lessons learned in the performance of internal flooding PRAs including those identified as pilot applications of earlier drafts of this procedures guide The purpose of this paper is to present a vision for domestic nuclear power plants' IFPRA by comparing the method of the draft EPRI guidelines with the existing IFPRA method for domestic NPPs

Insights from Guideline for Performance of Internal Flooding Probabilistic Risk Assessment (IFPRA)

Energy Technology Data Exchange (ETDEWEB)

Choi, Sun Yeong; Yang, Joo Eon [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2009-10-15

An internal flooding (IF) risk assessment refers to the quantitative probabilistic safety assessment (PSA) treatment of flooding as a result of pipe and tank breaks inside the plants, as well as from other recognized flood sources. The industry consensus standard for Internal Events Probabilistic Risk Assessment (ASME-RA-Sb-2005) includes high-level and supporting technical requirements for developing internal flooding probabilistic risk assessment (IFPRA). This industry standard is endorsed in Regulatory Guide 1.200, Revision 1 as an acceptable approach for addressing the risk contribution from IF events for risk informed applications that require U.S. Nuclear Regulatory commission (NRC) approval. In 2006, EPRI published a draft report for IFPRA that addresses the requirements of the ASME PRA consensus standard and have made efforts to refine and update the final EPRI IFPRA guideline. Westinghouse has performed an IFPRA analysis for several nuclear power plants (NPPs), such as Watts Bar and Fort Calhoun, using the draft EPRI guidelines for development of an IFPRA. Proprietary methodologies have been developed to apply the EPRI guidelines. The objectives of the draft report for IFPRA guideline are to: {center_dot} Provide guidance for PSA practitioners in the performance of the elements of a PRA associated with internal flooding events consistent with the current state of the art for internal flooding PRA {center_dot} Provide guidance regarding acceptable approaches that is sufficient to meeting the requirements of the ASME PRA Standard associated with internal flooding {center_dot} Incorporate lessons learned in the performance of internal flooding PRAs including those identified as pilot applications of earlier drafts of this procedures guide The purpose of this paper is to present a vision for domestic nuclear power plants' IFPRA by comparing the method of the draft EPRI guidelines with the existing IFPRA method for domestic NPPs.

Progress of environmental management and risk assessment of industrial chemicals in China

International Nuclear Information System (INIS)

Wang Hong; Yan Zhenguang; Li Hong; Yang Niyun; Leung, Kenneth M.Y.; Wang Yizhe; Yu Ruozhen; Zhang Lai; Wang Wanhua; Jiao Congying

2012-01-01

With China’s rapid economic growth, chemical-related environmental issues have become increasingly prominent, and the environmental management of chemicals has garnered increased attention from the government. This review focuses on the current situation and the application of risk assessment in China’s environmental management of industrial chemicals. The related challenges and research needs of the country are also discussed. The Chinese government promulgated regulations for the import and export of toxic chemicals in 1994. Regulations for new chemical substances came into force in 2003, and were revised in 2010 based on the concept of risk management. In order to support the implementation of new regulations, Guidance for Risk Assessment of Chemicals is under development in an attempt to provide the concepts and techniques of risk assessment. With increasing concern and financial support from Chinese government, China is embarking on the fast track of research and development in environmental management of industrial chemicals. - This paper reviews the current situation of industrial chemical management in China, and discusses the application of risk assessment and further research needs in this field.

Folate status in women of reproductive age as basis of neural tube defect risk assessment.

Science.gov (United States)

Bailey, Lynn B; Hausman, Dorothy B

2018-02-01

Reliable folate status data for women of reproductive age (WRA) to assess global risk for neural tube defects (NTDs) are needed. We focus on a recent recommendation by the World Health Organization that a specific "optimal" red blood cell (RBC) folate concentration be used as the sole indicator of NTD risk within a population and discuss how to best apply this guidance to reach the goal of assessing NTD risk globally. We also emphasize the importance of using the microbiologic assay (MBA) as the most reliable assay for obtaining comparable results for RBC folate concentration across time and countries, the need for harmonization of the MBA through use of consistent key reagents and procedures within laboratories, and the requirement to apply assay-matched cutoffs for folate deficiency and insufficiency. To estimate NTD risk globally, the ideal scenario would be to have country-specific population-based surveys of RBC folate in WRA determined utilizing a harmonized MBA, as was done in recent studies in Guatemala and Belize. We conclude with guidance on next steps to best navigate the road map toward the goal of generating reliable folate status data on which to assess NTD risk in WRA in low- and middle-income countries. © 2017 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals, Inc. on behalf of New York Academy of Sciences.

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

Challenges in Risk Assessment: Quantitative Risk Assessment

OpenAIRE

Jacxsens, Liesbeth; Uyttendaele, Mieke; De Meulenaer, Bruno

2016-01-01

The process of risk analysis consists out of three components, risk assessment, risk management and risk communication. These components are internationally well spread by Codex Alimentarius Commission as being the basis for setting science based standards, criteria on food safety hazards, e.g. setting maximum limits of mycotoxins in foodstuffs. However, the technical component risk assessment is hard to elaborate and to understand. Key in a risk assessment is the translation of biological or...

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

Progress of environmental management and risk assessment of industrial chemicals in China.

Science.gov (United States)

Wang, Hong; Yan, Zhen-Guang; Li, Hong; Yang, Ni-Yun; Leung, Kenneth M Y; Wang, Yi-Zhe; Yu, Ruo-Zhen; Zhang, Lai; Wang, Wan-Hua; Jiao, Cong-Ying; Liu, Zheng-Tao

2012-06-01

With China's rapid economic growth, chemical-related environmental issues have become increasingly prominent, and the environmental management of chemicals has garnered increased attention from the government. This review focuses on the current situation and the application of risk assessment in China's environmental management of industrial chemicals. The related challenges and research needs of the country are also discussed. The Chinese government promulgated regulations for the import and export of toxic chemicals in 1994. Regulations for new chemical substances came into force in 2003, and were revised in 2010 based on the concept of risk management. In order to support the implementation of new regulations, Guidance for Risk Assessment of Chemicals is under development in an attempt to provide the concepts and techniques of risk assessment. With increasing concern and financial support from Chinese government, China is embarking on the fast track of research and development in environmental management of industrial chemicals. Copyright © 2011 Elsevier Ltd. All rights reserved.

Demonstration of the Military Ecological Risk Assessment Framework (MERAF): Apache Longbow - Hell Missile Test at Yuma Proving Ground

Energy Technology Data Exchange (ETDEWEB)

Efroymson, R.A.

2002-05-09

This ecological risk assessment for a testing program at Yuma Proving Ground, Arizona, is a demonstration of the Military Ecological Risk Assessment Framework (MERAF; Suter et al. 2001). The demonstration is intended to illustrate how risk assessment guidance concerning-generic military training and testing activities and guidance concerning a specific type of activity (e.g., low-altitude aircraft overflights) may be implemented at a military installation. MERAF was developed with funding from the Strategic Research and Development Program (SERDP) of the Department of Defense. Novel aspects of MERAF include: (1) the assessment of risks from physical stressors using an ecological risk assessment framework, (2) the consideration of contingent or indirect effects of stressors (e.g., population-level effects that are derived from habitat or hydrological changes), (3) the integration of risks associated with different component activities or stressors, (4) the emphasis on quantitative risk estimates and estimates of uncertainty, and (5) the modularity of design, permitting components of the framework to be used in various military risk assessments that include similar activities. The particular subject of this report is the assessment of ecological risks associated with a testing program at Cibola Range of Yuma Proving Ground, Arizona. The program involves an Apache Longbow helicopter firing Hellfire missiles at moving targets, i.e., M60-A1 tanks. Thus, the three component activities of the Apache-Hellfire test were: (1) helicopter overflight, (2) missile firing, and (3) tracked vehicle movement. The demonstration was limited, to two ecological endpoint entities (i.e., potentially susceptible and valued populations or communities): woody desert wash communities and mule deer populations. The core assessment area is composed of about 126 km{sup 2} between the Chocolate and Middle Mountains. The core time of the program is a three-week period, including fourteen days of

Demonstration of the Military Ecological Risk Assessment Framework (MERAF): Apache Longbow - Hell Missile Test at Yuma Proving Ground

International Nuclear Information System (INIS)

Efroymson, R.A.

2002-01-01

This ecological risk assessment for a testing program at Yuma Proving Ground, Arizona, is a demonstration of the Military Ecological Risk Assessment Framework (MERAF; Suter et al. 2001). The demonstration is intended to illustrate how risk assessment guidance concerning-generic military training and testing activities and guidance concerning a specific type of activity (e.g., low-altitude aircraft overflights) may be implemented at a military installation. MERAF was developed with funding from the Strategic Research and Development Program (SERDP) of the Department of Defense. Novel aspects of MERAF include: (1) the assessment of risks from physical stressors using an ecological risk assessment framework, (2) the consideration of contingent or indirect effects of stressors (e.g., population-level effects that are derived from habitat or hydrological changes), (3) the integration of risks associated with different component activities or stressors, (4) the emphasis on quantitative risk estimates and estimates of uncertainty, and (5) the modularity of design, permitting components of the framework to be used in various military risk assessments that include similar activities. The particular subject of this report is the assessment of ecological risks associated with a testing program at Cibola Range of Yuma Proving Ground, Arizona. The program involves an Apache Longbow helicopter firing Hellfire missiles at moving targets, i.e., M60-A1 tanks. Thus, the three component activities of the Apache-Hellfire test were: (1) helicopter overflight, (2) missile firing, and (3) tracked vehicle movement. The demonstration was limited, to two ecological endpoint entities (i.e., potentially susceptible and valued populations or communities): woody desert wash communities and mule deer populations. The core assessment area is composed of about 126 km 2 between the Chocolate and Middle Mountains. The core time of the program is a three-week period, including fourteen days of

Municipal solid waste management health risk assessment from air emissions for China by applying life cycle analysis.

Science.gov (United States)

Li, Hua; Nitivattananon, Vilas; Li, Peng

2015-05-01

This study is to quantify and objectively evaluate the extent of environmental health risks from three waste treatment options suggested by the national municipal solid waste management enhancing strategy (No [2011] 9 of the State Council, promulgated on 19 April 2011), which includes sanitary landfill, waste-to-energy incineration and compost, together with the material recovery facility through a case study in Zhangqiu City of China. It addresses potential chronic health risks from air emissions to residential receptors in the impacted area. It combines field survey, analogue survey, design documents and life cycle inventory methods in defining the source strength of chemicals of potential concern. The modelling of life cycle inventory and air dispersion is via integrated waste management(IWM)-2 and Screening Air Dispersion Model (Version 3.0) (SCREEN3). The health risk assessment is in accordance with United States Environmental Protection Agency guidance Risk Assessment Guidance for Superfund (RAGS), Volume I: Human Health Evaluation Manual (Part F, Supplemental Guidance for Inhalation Risk Assessment). The exposure concentration is based on long-term exposure to the maximum ground level contaminant in air under the 'reasonable worst situation' emissions and then directly compared with reference for concentration and unit risk factor/cancer slope factor derived from the national air quality standard (for a conventional pollutant) and toxicological studies (for a specific pollutant). Results from this study suggest that the option of compost with material recovery facility treatment may pose less negative health impacts than other options; the sensitivity analysis shows that the landfill integrated waste management collection rate has a great influence on the impact results. Further investigation is needed to validate or challenge the findings of this study. © The Author(s) 2015.

Drug interactions evaluation: An integrated part of risk assessment of therapeutics

International Nuclear Information System (INIS)

Zhang, Lei; Reynolds, Kellie S.; Zhao, Ping; Huang, Shiew-Mei

2010-01-01

Pharmacokinetic drug interactions can lead to serious adverse events or decreased drug efficacy. The evaluation of a new molecular entity's (NME's) drug-drug interaction potential is an integral part of risk assessment during drug development and regulatory review. Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). The recent Food and Drug Administration (FDA) draft drug interaction guidance ( (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf)) highlights the methodologies and criteria that may be used to guide drug interaction evaluation by industry and regulatory agencies and to construct informative labeling for health practitioner and patients. In addition, the Food and Drug Administration established a 'Drug Development and Drug Interactions' website to provide up-to-date information regarding evaluation of drug interactions ( (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm)). This review summarizes key elements in the FDA drug interaction guidance and new scientific developments that can guide the evaluation of drug-drug interactions during the drug development process.

Obsolescence Risk Assessment Process Best Practice

Science.gov (United States)

Romero Rojo, F. J.; Roy, R.; Kelly, S.

2012-05-01

A component becomes obsolete when it is no longer available from the original manufacturer to the original specification. In long-lifecycle projects, obsolescence has become a major problem as it prevents the maintenance of the system. This is the reason why obsolescence management is now an essential part of the product support activities in sectors such as defence, aerospace, nuclear and railway; where systems need to be supported for several decades. The obsolescence risk assessment for the bill of materials (BoM) is a paramount activity in order to manage obsolescence proactively and cost-effectively. This is the reason why it was necessary to undertake a benchmarking study to develop best practice in this process. A total of 22 obsolescence experts from 13 different organisations/projects from across UK and USA have participated in this study. Their current processes and experience have been taken into account in the development of the best practice process for obsolescence risk assessment. The key factors that have to be analysed in the risk assessment process for each component in the BoM are: number of manufacturers, years to end of life, stock available, consumption rate and operational impact criticality. For the very high risk components, a more detailed analysis is required to inform the decisions regarding the most suitable mitigation strategies. On the contrary, for the low risk components, a fully proactive approach is neither appropriate nor cost effective. Therefore, it is advised for these components that obsolescence issues are dealt with reactively. This process has been validated using case studies with several experts from industry and is currently being implemented by the UK Ministry of Defence as technical guidance within the JSP 886 Volume 7 Part 8.13 standards.

Obsolescence Risk Assessment Process Best Practice

International Nuclear Information System (INIS)

Rojo, F J Romero; Roy, R; Kelly, S

2012-01-01

A component becomes obsolete when it is no longer available from the original manufacturer to the original specification. In long-lifecycle projects, obsolescence has become a major problem as it prevents the maintenance of the system. This is the reason why obsolescence management is now an essential part of the product support activities in sectors such as defence, aerospace, nuclear and railway; where systems need to be supported for several decades. The obsolescence risk assessment for the bill of materials (BoM) is a paramount activity in order to manage obsolescence proactively and cost-effectively. This is the reason why it was necessary to undertake a benchmarking study to develop best practice in this process. A total of 22 obsolescence experts from 13 different organisations/projects from across UK and USA have participated in this study. Their current processes and experience have been taken into account in the development of the best practice process for obsolescence risk assessment. The key factors that have to be analysed in the risk assessment process for each component in the BoM are: number of manufacturers, years to end of life, stock available, consumption rate and operational impact criticality. For the very high risk components, a more detailed analysis is required to inform the decisions regarding the most suitable mitigation strategies. On the contrary, for the low risk components, a fully proactive approach is neither appropriate nor cost effective. Therefore, it is advised for these components that obsolescence issues are dealt with reactively. This process has been validated using case studies with several experts from industry and is currently being implemented by the UK Ministry of Defence as technical guidance within the JSP 886 Volume 7 Part 8.13 standards.

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)

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...

Deciding which chemical mixtures risk assessment methods work best for what mixtures

International Nuclear Information System (INIS)

Teuschler, Linda K.

2007-01-01

The most commonly used chemical mixtures risk assessment methods involve simple notions of additivity and toxicological similarity. Newer methods are emerging in response to the complexities of chemical mixture exposures and effects. Factors based on both science and policy drive decisions regarding whether to conduct a chemical mixtures risk assessment and, if so, which methods to employ. Scientific considerations are based on positive evidence of joint toxic action, elevated human exposure conditions or the potential for significant impacts on human health. Policy issues include legislative drivers that may mandate action even though adequate toxicity data on a specific mixture may not be available and risk assessment goals that impact the choice of risk assessment method to obtain the amount of health protection desired. This paper discusses three important concepts used to choose among available approaches for conducting a chemical mixtures risk assessment: (1) additive joint toxic action of mixture components; (2) toxicological interactions of mixture components; and (3) chemical composition of complex mixtures. It is proposed that scientific support for basic assumptions used in chemical mixtures risk assessment should be developed by expert panels, risk assessment methods experts, and laboratory toxicologists. This is imperative to further develop and refine quantitative methods and provide guidance on their appropriate applications. Risk assessors need scientific support for chemical mixtures risk assessment methods in the form of toxicological data on joint toxic action for high priority mixtures, statistical methods for analyzing dose-response for mixtures, and toxicological and statistical criteria for determining sufficient similarity of complex mixtures

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.

Formulation and Presentation of Risk Assessments to Address Risk Targets for Radioactive Waste Disposal

International Nuclear Information System (INIS)

Wilmot, R.D.

2002-10-01

. Supporting calculations to explore these issues quantitatively could provide additional support for conducting such a review. Regulatory guidance on these issues would be a further means of supporting the review process. In addition to a review of approaches to the calculation of risk, the report also examines alternative measures that have been proposed for assessing long-term performance of a disposal system. Such alternative performance measures include environmental concentrations, radionuclide fluxes and radiotoxicity. Such measures have been adopted in some regulatory regimes, but their use is not sufficiently widespread to draw definitive conclusions as to their usefulness. Alternative performance measures may be of value in developing an understanding of system performance, but stakeholders may find their use as regulatory criteria less easy to understand than measures of dose or risk. Additional work on developing a methodology for formulating and quantifying alternative performance measures is therefore suggested, together with consultation on the benefits and disadvantages associated with the adoption of such measures

Formulation and Presentation of Risk Assessments to Address Risk Targets for Radioactive Waste Disposal

Energy Technology Data Exchange (ETDEWEB)

Wilmot, R.D. [Galson Sciences Ltd, Oakham (United Kingdom)

2002-10-01

. Supporting calculations to explore these issues quantitatively could provide additional support for conducting such a review. Regulatory guidance on these issues would be a further means of supporting the review process. In addition to a review of approaches to the calculation of risk, the report also examines alternative measures that have been proposed for assessing long-term performance of a disposal system. Such alternative performance measures include environmental concentrations, radionuclide fluxes and radiotoxicity. Such measures have been adopted in some regulatory regimes, but their use is not sufficiently widespread to draw definitive conclusions as to their usefulness. Alternative performance measures may be of value in developing an understanding of system performance, but stakeholders may find their use as regulatory criteria less easy to understand than measures of dose or risk. Additional work on developing a methodology for formulating and quantifying alternative performance measures is therefore suggested, together with consultation on the benefits and disadvantages associated with the adoption of such measures.

Probabilistic risk assessment for the Sandia National Laboratories Technical Area V Liquid Waste Disposal System surface impoundments

International Nuclear Information System (INIS)

Dawson, L.A.; Eidson, A.F.

1996-01-01

A probabilistic risk assessment was completed for a former radioactive waste disposal site. The site, two unlined surface impoundment, was designed as part of the Liquid Waste Disposal System (LWDS) to receive radioactive effluent from nuclear reactors in Technical Area-V (TA-V) at Sandia National Laboratories/New Mexico (SNL/NM). First, a statistical comparison of site sampling results to natural background, using EPA methods, and a spatial distribution analysis were performed. Risk assessment was conducted with SNL/NM's Probabilistic Risk Evaluation and Characterization Investigation System model. The risk assessment indicated that contamination from several constituents might have been high enough to require remediation. However, further analysis based on expected site closure activities and recent EPA guidance indicated that No Further Action was acceptable

Risk Assessment and Decision-Making under Uncertainty in Tunnel and Underground Engineering

Directory of Open Access Journals (Sweden)

Yuanpu Xia

2017-10-01

Full Text Available The impact of uncertainty on risk assessment and decision-making is increasingly being prioritized, especially for large geotechnical projects such as tunnels, where uncertainty is often the main source of risk. Epistemic uncertainty, which can be reduced, is the focus of attention. In this study, the existing entropy-risk decision model is first discussed and analyzed, and its deficiencies are improved upon and overcome. Then, this study addresses the fact that existing studies only consider parameter uncertainty and ignore the influence of the model uncertainty. Here, focus is on the issue of model uncertainty and differences in risk consciousness with different decision-makers. The utility theory is introduced in the model. Finally, a risk decision model is proposed based on the sensitivity analysis and the tolerance cost, which can improve decision-making efficiency. This research can provide guidance or reference for the evaluation and decision-making of complex systems engineering problems, and indicate a direction for further research of risk assessment and decision-making issues.

ATEX explosive atmospheres : risk assessment, control and compliance

CERN Document Server

Jespen, Torben

2016-01-01

This book details how safety (i.e. the absence of unacceptable risks) is ensured in areas where potentially explosive atmospheres (ATEX) can arise. The book also offers readers essential information on how to comply with the newest (April 2016) EU legislation when the presence of ATEX cannot be avoided. By presenting general guidance on issues arising out of the EU ATEX legislation – especially on zone classification, explosion risk assessment, equipment categorization, Ex-marking and related technical/chemical aspects – the book provides equipment manufacturers, responsible employers, and others with the essential knowledge they need to be able to understand the different – and often complicated – aspects of ATEX and to implement the necessary safety precautions. As such, it represents a valuable resource for all those concerned with maintaining high levels of safety in ATEX environments.

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...

Molecular profiling--a tool for addressing emerging gaps in the comparative risk assessment of GMOs.

Science.gov (United States)

Heinemann, Jack A; Kurenbach, Brigitta; Quist, David

2011-10-01

Assessing the risks of genetically modified organisms (GMOs) is required by both international agreement and domestic legislation. Many view the use of the "omics" tools for profiling classes of molecules as useful in risk assessment, but no consensus has formed on the need or value of these techniques for assessing the risks of all GMOs. In this and many other cases, experts support case-by-case use of molecular profiling techniques for risk assessment. We review the latest research on the applicability and usefulness of molecular profiling techniques for GMO risk assessment. As more and more kinds of GMOs and traits are developed, broader use of molecular profiling in a risk assessment may be required to supplement the comparative approach to risk assessment. The literature-based discussions on the use of profiling appear to have settled on two findings: 1. profiling techniques are reliable and relevant, at least no less so than other techniques used in risk assessment; and 2. although not required routinely, regulators should be aware of when they are needed. The dismissal of routine molecular profiling may be confusing to regulators who then lack guidance on when molecular profiling might be worthwhile. Molecular profiling is an important way to increase confidence in risk assessments if the profiles are properly designed to address relevant risks and are applied at the correct stage of the assessment. Copyright © 2011 Elsevier Ltd. All rights reserved.

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...

Complementary use of life cycle assessment and risk assessment for engineered nanomaterials: Lessons learned from chemicals?

DEFF Research Database (Denmark)

Grieger, Khara D.; Laurent, Alexis; Miseljic, Mirko

2013-01-01

Successful strategies to handle the potential health and environmental risks of engineered nanomaterials (ENM) often rely upon the well-established frameworks of life cycle assessment (LCA) and risk assessment (RA). However, current research and specific guidance on how to actually apply these two...... scientific research efforts have taken into account some key lessons learned from past experiences with chemicals at the same time that many key challenges remain to applying these frameworks to ENM. In that setting, two main proposed approaches to use LCA and RA together for ENM are identified: i) LC......-based RA, similar to traditional RA applied in a life cycle perspective, and ii) RA-complemented LCA, similar to conventional LCA supplemented by RA in specific life cycle steps. This study finds that these two approaches for using LCA and RA together for ENM are similar to those made for chemicals...

An introductory guide to uncertainty analysis in environmental and health risk assessment

International Nuclear Information System (INIS)

Hoffman, F.O.; Hammonds, J.S.

1992-10-01

To compensate for the potential for overly conservative estimates of risk using standard US Environmental Protection Agency methods, an uncertainty analysis should be performed as an integral part of each risk assessment. Uncertainty analyses allow one to obtain quantitative results in the form of confidence intervals that will aid in decision making and will provide guidance for the acquisition of additional data. To perform an uncertainty analysis, one must frequently rely on subjective judgment in the absence of data to estimate the range and a probability distribution describing the extent of uncertainty about a true but unknown value for each parameter of interest. This information is formulated from professional judgment based on an extensive review of literature, analysis of the data, and interviews with experts. Various analytical and numerical techniques are available to allow statistical propagation of the uncertainty in the model parameters to a statement of uncertainty in the risk to a potentially exposed individual. Although analytical methods may be straightforward for relatively simple models, they rapidly become complicated for more involved risk assessments. Because of the tedious efforts required to mathematically derive analytical approaches to propagate uncertainty in complicated risk assessments, numerical methods such as Monte Carlo simulation should be employed. The primary objective of this report is to provide an introductory guide for performing uncertainty analysis in risk assessments being performed for Superfund sites

EVALUATION AND INTERPRETATION OF NEURODEVELOPMENTAL ENDPOINTS FOR HUMAN HEALTH RISK ASSESSMENT -- POSITIVE CONTROL STUDIES, NORMAL VARIABILITY AND STATISTICAL ISSUES.

Science.gov (United States)

ILSI Research Foundation/Risk Science Institute convened an expert working group to assess the lessons learned from the implementation of the EPA Developmental Neurotoxicity (DNT) Guideline and provide guidance for future use. The group prepared manuscripts in five areas: public ...

Twelve recommendations for integrating existing systematic reviews into new reviews: EPC guidance.

Science.gov (United States)

Robinson, Karen A; Chou, Roger; Berkman, Nancy D; Newberry, Sydne J; Fu, Rongwei; Hartling, Lisa; Dryden, Donna; Butler, Mary; Foisy, Michelle; Anderson, Johanna; Motu'apuaka, Makalapua; Relevo, Rose; Guise, Jeanne-Marie; Chang, Stephanie

2016-02-01

As time and cost constraints in the conduct of systematic reviews increase, the need to consider the use of existing systematic reviews also increases. We developed guidance on the integration of systematic reviews into new reviews. A workgroup of methodologists from Evidence-based Practice Centers developed consensus-based recommendations. Discussions were informed by a literature scan and by interviews with organizations that conduct systematic reviews. Twelve recommendations were developed addressing selecting reviews, assessing risk of bias, qualitative and quantitative synthesis, and summarizing and assessing body of evidence. We provide preliminary guidance for an efficient and unbiased approach to integrating existing systematic reviews with primary studies in a new review. Copyright © 2016 Elsevier Inc. All rights reserved.

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

Science.gov (United States)

Snodin, D J

2015-12-01

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

Principle considerations for the risk assessment of sprayed consumer products.

Science.gov (United States)

Steiling, W; Bascompta, M; Carthew, P; Catalano, G; Corea, N; D'Haese, A; Jackson, P; Kromidas, L; Meurice, P; Rothe, H; Singal, M

2014-05-16

In recent years, the official regulation of chemicals and chemical products has been intensified. Explicitly for spray products enhanced requirements to assess the consumers'/professionals' exposure to such product type have been introduced. In this regard the Aerosol-Dispensers-Directive (75/324/EEC) with obligation for marketing aerosol dispensers, and the Cosmetic-Products-Regulation (1223/2009/EC) which obliges the insurance of a safety assessment, have to be mentioned. Both enactments, similar to the REACH regulation (1907/2006/EC), require a robust chemical safety assessment. From such assessment, appropriate risk management measures may be identified to adequately control the risk of these chemicals/products to human health and the environment when used. Currently, the above-mentioned regulations lack the guidance on which data are needed for preparing a proper hazard analysis and safety assessment of spray products. Mandatory in the process of inhalation risk and safety assessment is the determination and quantification of the actual exposure to the spray product and more specifically, its ingredients. In this respect the current article, prepared by the European Aerosol Federation (FEA, Brussels) task force "Inhalation Toxicology", intends to introduce toxicological principles and the state of the art in currently available exposure models adapted for typical application scenarios. This review on current methodologies is intended to guide safety assessors to better estimate inhalation exposure by using the most relevant data. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

A Transparent Framework for guiding Radiological and Non-Radiological Contaminated Land Risk Assessments

International Nuclear Information System (INIS)

Lee, Alex; Mathers, Dan

2003-01-01

A framework is presented that may be used as a transparent guidance to both radiological and non-radiological risk assessments. This framework has been developed by BNFL, with external consultation, to provide a systematic approach for identifying key system drivers and to guide associated research packages in light of data deficiencies and sources of model uncertainty. The process presented represents an advance on existing working practices yet combines regulator philosophy to produce a robust, comprehensive, cost-effective and transparent work package. It aims at lending added confidence to risk models thereby adding value to the decision process

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

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.

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.

Use of product databases for risk assessment purposes

International Nuclear Information System (INIS)

Heinemeyer, Gerhard; Hahn, Axel

2005-01-01

Product information databases are important prerequisites for providing data to poison centers (PC) to give adequate advice in cases of poisonings and for preparation of statistics as annual reports. For risk assessment measures, they can help for exposure assessments and for priority setting. A product database is a set of information of product and substance names, compositions, and uses of products. Data are provided due to national regulations as well as to national and international agreements between industry, international associations, e.g. the European Association of Poison Centres and Clinical Toxicologists (EAPCCT), and clinical toxicology institutions. They have different contents, i.e. complete formulations, frame formulations, and material safety data sheets. For definite identification of products, the product name should be readily taken from the labels and must be similar to the names provided by electronic media as databases. Products should be classified according to their use. The first system that has been prepared for that purpose is the ATC classification for pharmaceuticals. For chemicals, several systems e.g. the WHO-IPCS classification code, exist; the EU technical guidance document for risk assessment of chemicals is mentioning use categories, and they are used on national levels as well. For risk assessment purposes, statistics of poisonings and other health hazards are important as well as information about exposure. Linking cases of poisonings with product data enables risk assessors to perform statistical evaluations about health effects due to product use categories which can be compared to product compositions. If products are categorized by their use, information about use characteristics, such as frequencies and durations, can be derived. Hence, product categories can be taken to characterize scenarios and thus help for model estimations of exposure and respective doses

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.

Risk assessment

International Nuclear Information System (INIS)

Kinchin, G.H.

1983-01-01

After defining risk and introducing the concept of individual and societal risk, the author considers each of these, restricting considerations to risk of death. Some probabilities of death arising from various causes are quoted, and attention drawn to the care necessary in making comparisons between sets of data and to the distinction between voluntary and involuntary categories and between early and delayed deaths. The presentation of information on societal risk is discussed and examples given. The history of quantified risk assessment is outlined, particularly related to the nuclear industry, the process of assessing risk discussed: identification of hazard causes, the development of accident chains and the use of event trees, the evaluation of probability through the collection of data and their use with fault trees, and the assessment of consequences of hazards in terms of fatalities. Reference is made to the human element and common-made failures, and to studies supporting the development of reliability assessment techniques. Acceptance criteria are discussed for individual and societal risk in the nuclear field, and it is shown that proposed criteria lead to risks conservative by comparison with risks from day-to-day accidents and other potentially hazardous industries. (U.K.)

Risk Assessment Overview

Science.gov (United States)

Prassinos, Peter G.; Lyver, John W., IV; Bui, Chinh T.

2011-01-01

Risk assessment is used in many industries to identify and manage risks. Initially developed for use on aeronautical and nuclear systems, risk assessment has been applied to transportation, chemical, computer, financial, and security systems among others. It is used to gain an understanding of the weaknesses or vulnerabilities in a system so modification can be made to increase operability, efficiency, and safety and to reduce failure and down-time. Risk assessment results are primary inputs to risk-informed decision making; where risk information including uncertainty is used along with other pertinent information to assist management in the decision-making process. Therefore, to be useful, a risk assessment must be directed at specific objectives. As the world embraces the globalization of trade and manufacturing, understanding the associated risk become important to decision making. Applying risk assessment techniques to a global system of development, manufacturing, and transportation can provide insight into how the system can fail, the likelihood of system failure and the consequences of system failure. The risk assessment can identify those elements that contribute most to risk and identify measures to prevent and mitigate failures, disruptions, and damaging outcomes. In addition, risk associated with public and environment impact can be identified. The risk insights gained can be applied to making decisions concerning suitable development and manufacturing locations, supply chains, and transportation strategies. While risk assessment has been mostly applied to mechanical and electrical systems, the concepts and techniques can be applied across other systems and activities. This paper provides a basic overview of the development of a risk assessment.

Introduction to risk assessment

International Nuclear Information System (INIS)

Raina, V.M.

2002-01-01

This paper gives an introduction to risk assessment. It discusses the basic concepts of risk assessment, nuclear risk assessment process and products, the role of risk assessment products in nuclear safety assurance, the relationship between risk assessment and other safety analysis and risk assessment and safe operating envelope

76 FR 53683 - Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...

Science.gov (United States)

2011-08-29

... 200N, Rockville, MD 20852-1448; or the Office of Communication, Education and Radiation Programs... describes a modern, risk-based approach to monitoring that focuses on critical study parameters and relies... appropriate, and other forms of information technology. Title: Draft Guidance for Industry: Oversight of...

Cumulative Risk Assessment (CRA): transforming the way we assess health risks.

Science.gov (United States)

Williams, Pamela R D; Dotson, G Scott; Maier, Andrew

2012-10-16

Human health risk assessments continue to evolve and now focus on the need for cumulative risk assessment (CRA). CRA involves assessing the combined risk from coexposure to multiple chemical and nonchemical stressors for varying health effects. CRAs are broader in scope than traditional chemical risk assessments because they allow for a more comprehensive evaluation of the interaction between different stressors and their combined impact on human health. Future directions of CRA include greater emphasis on local-level community-based assessments; integrating environmental, occupational, community, and individual risk factors; and identifying and implementing common frameworks and risk metrics for incorporating multiple stressors.

Motivators and barriers to incorporating climate change-related health risks in environmental health impact assessment.

Science.gov (United States)

Turner, Lyle R; Alderman, Katarzyna; Connell, Des; Tong, Shilu

2013-03-22

Climate change presents risks to health that must be addressed by both decision-makers and public health researchers. Within the application of Environmental Health Impact Assessment (EHIA), there have been few attempts to incorporate climate change-related health risks as an input to the framework. This study used a focus group design to examine the perceptions of government, industry and academic specialists about the suitability of assessing the health consequences of climate change within an EHIA framework. Practitioners expressed concern over a number of factors relating to the current EHIA methodology and the inclusion of climate change-related health risks. These concerns related to the broad scope of issues that would need to be considered, problems with identifying appropriate health indicators, the lack of relevant qualitative information that is currently incorporated in assessment and persistent issues surrounding stakeholder participation. It was suggested that improvements are needed in data collection processes, particularly in terms of adequate communication between environmental and health practitioners. Concerns were raised surrounding data privacy and usage, and how these could impact on the assessment process. These findings may provide guidance for government and industry bodies to improve the assessment of climate change-related health risks.

Critical infrastructures risk and vulnerability assessment in transportation of dangerous goods transportation by road and rail

CERN Document Server

Vamanu, Bogdan I; Katina, Polinpapilinho F

2016-01-01

This book addresses a key issue in today’s society: the safer transport of dangerous goods, taking into account people, the environment and economics. In particular, it offers a potential approach to identifying the issues, developing the models, providing the methods and recommending the tools to address the risks and vulnerabilities involved. We believe this can only be achieved by assessing those risks in a comprehensive, quantifiable and integrated manner. Examining both rail and road transportation, the book is divided into three sections, covering: the mature and accepted (by both academia and practitioners) methodology of risk assessment; the vulnerability assessment – a novel approach proposed as a vital complement to risk; guidance and support to build the tools that make methods and equations to yield: the Decision Support Systems. Throughout the book, the authors do not endeavor to provide THE solution. Instead, the book offers insightful food for thought for students, researchers, practitioner...

Public health guidance on cardiovascular benefits and risks related to fish consumption

Directory of Open Access Journals (Sweden)

Stern Alan H

2007-10-01

Full Text Available Abstract Historically, concerns with fish consumption have addressed risks from contaminants (e.g., methylmercury (MeHg, and PCBs. More recently public health concerns have widened in appreciation of the specific benefits of fish consumption such as those arising from polyunsaturated fatty acids (PUFAs in fish oil. Fish contains varying levels of PUFAs and MeHg. Since both address the same health outcomes (in opposite directions and occur together in fish, great care must be exercised in providing public health guidance. Mozaffarian and Rimm in a recent article (JAMA. 2006, 296:1885–99 have made a strong case for the beneficial effects of PUFAs in reducing the risk of coronary heart disease, but at the same time, have also broadly discounted the increased risks of coronary heart disease posed by MeHg in fish, stating that "... among adults... the benefits of fish intake exceed the potential risks." This conclusion appears to be based on an inaccurate and insufficiently critical analysis of the literature. This literature is re-examined in light of their conclusions, and the available and appropriate public health options are considered.

Risk assessment - The future trend

International Nuclear Information System (INIS)

Marks, G.A.

1991-01-01

Many organizations today are faced with cleaning a site or facility, selecting appropriate remedial alternatives, or explaining the potential effects on human health and the environment caused by the releases of toxic compounds into the air, soil, and water, The use of risk assessment (RA) as a management tool is increasing because it offers an integrated approach to the analysis of toxicological, geological, physio-chemical, meteorological, statistical, and biological parameters that must be evaluated in the assessment of potential impacts to human health. The regulatory atmosphere in the 1990s is leaning toward the adoption of further laws requiring the completion of the RA process. Any industry involved in submitting permit applications to Air Quality Management Districts or complying with California's Proposition 65 and AB 2588 will be required to prepare RAs. Several guidance documents are available that support the RA process including the California Site Mitigation Decision Tree Manual published by the State Department of Health Services (DHS), which bases its approach on developing cleanup objectives (Applied Action Levels) on RA. This presentation focuses on the applications RA can have to the petroleum industry and the kinds of data that each case should develop to make maximum use of the RA process

Guidance values for microcystins in water and cyanobacterial supplement products (blue-green algal supplements): a reasonable or misguided approach?

International Nuclear Information System (INIS)

Dietrich, Daniel; Hoeger, Stefan

2005-01-01

This article reviews current scientific knowledge on the toxicity and carcinogenicity of microcystins and compares this to the guidance values proposed for microcystins in water by the World Health Organization, and for blue-green algal food supplements by the Oregon State Department of Health. The basis of the risk assessment underlying these guidance values is viewed as being critical due to overt deficiencies in the data used for its generation: (i) use of one microcystin congener only (microcystin-LR), while the other presently known nearly 80 congeners are largely disregarded, (ii) new knowledge regarding potential neuro and renal toxicity of microcystins in humans and (iii) the inadequacies of assessing realistic microcystin exposures in humans and especially in children via blue-green algal food supplements. In reiterating the state-of-the-art toxicology database on microcystins and in the light of new data on the high degree of toxin contamination of algal food supplements, this review clearly demonstrates the need for improved kinetic data of microcystins in humans and for discussion concerning uncertainty factors, which may result in a lowering of the present guidance values and an increased routine control of water bodies and food supplements for toxin contamination. Similar to the approach taken previously by authorities for dioxin or PCB risk assessment, the use of a toxin equivalent approach to the risk assessment of microcystins is proposed

An approach for integrating toxicogenomic data in risk assessment: The dibutyl phthalate case study

Energy Technology Data Exchange (ETDEWEB)

Euling, Susan Y., E-mail: euling.susan@epa.gov [National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC (United States); Thompson, Chad M. [ToxStrategies, Inc., 23501 Cinco Ranch Blvd., Suite G265, Katy, TX 77494 (United States); Chiu, Weihsueh A. [National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC (United States); Benson, Robert [U.S. Environmental Protection Agency, Region 8, Mail code 8P-W, 1595 Wynkoop Street, Denver, CO 80202 (United States)

2013-09-15

An approach for evaluating and integrating genomic data in chemical risk assessment was developed based on the lessons learned from performing a case study for the chemical dibutyl phthalate. A case study prototype approach was first developed in accordance with EPA guidance and recommendations of the scientific community. Dibutyl phthalate (DBP) was selected for the case study exercise. The scoping phase of the dibutyl phthalate case study was conducted by considering the available DBP genomic data, taken together with the entire data set, for whether they could inform various risk assessment aspects, such as toxicodynamics, toxicokinetics, and dose–response. A description of weighing the available dibutyl phthalate data set for utility in risk assessment provides an example for considering genomic data for future chemical assessments. As a result of conducting the scoping process, two questions—Do the DBP toxicogenomic data inform 1) the mechanisms or modes of action?, and 2) the interspecies differences in toxicodynamics?—were selected to focus the case study exercise. Principles of the general approach include considering the genomics data in conjunction with all other data to determine their ability to inform the various qualitative and/or quantitative aspects of risk assessment, and evaluating the relationship between the available genomic and toxicity outcome data with respect to study comparability and phenotypic anchoring. Based on experience from the DBP case study, recommendations and a general approach for integrating genomic data in chemical assessment were developed to advance the broader effort to utilize 21st century data in risk assessment. - Highlights: • Performed DBP case study for integrating genomic data in risk assessment • Present approach for considering genomic data in chemical risk assessment • Present recommendations for use of genomic data in chemical risk assessment.

Principles for the risk assessment of genetically modified microorganisms and their food products in the European Union.

Science.gov (United States)

Aguilera, Jaime; Gomes, Ana R; Olaru, Irina

2013-10-01

Genetically modified microorganisms (GMMs) are involved in the production of a variety of food and feed. The release and consumption of these products can raise questions about health and environmental safety. Therefore, the European Union has different legislative instruments in place in order to ensure the safety of such products. A key requirement is to conduct a scientific risk assessment as a prerequisite for the product to be placed on the market. This risk assessment is performed by the European Food Safety Authority (EFSA), through its Scientific Panels. The EFSA Panel on Genetically Modified Organisms has published complete and comprehensive guidance for the risk assessment of GMMs and their products for food and/or feed use, in which the strategy and the criteria to conduct the assessment are explained, as well as the scientific data to be provided in applications for regulated products. This Guidance follows the main risk assessment principles developed by various international organisations (Codex Alimentarius, 2003; OECD, 2010). The assessment considers two aspects: the characterisation of the GMM and the possible effects of its modification with respect to safety, and the safety of the product itself. Due to the existing diversity of GMMs and their products, a categorisation is recommended to optimise the assessment and to determine the extent of the required data. The assessment starts with a comprehensive characterisation of the GMM, covering the recipient/parental organism, the donor(s) of the genetic material, the genetic modification, and the final GMM and its phenotype. Evaluation of the composition, potential toxicity and/or allergenicity, nutritional value and environmental impact of the product constitute further cornerstones of the process. The outcome of the assessment is reflected in a scientific opinion which indicates whether the product raises any safety issues. This opinion is taken into account by the different European regulatory

Qualitative risk assessment during polymer mortar test specimens preparation - methods comparison

Science.gov (United States)

Silva, F.; Sousa, S. P. B.; Arezes, P.; Swuste, P.; Ribeiro, M. C. S.; Baptista, J. S.

2015-05-01

Polymer binder modification with inorganic nanomaterials (NM) could be a potential and efficient solution to control matrix flammability of polymer concrete (PC) materials without sacrificing other important properties. Occupational exposures can occur all along the life cycle of a NM and “nanoproducts” from research through scale-up, product development, manufacturing, and end of life. The main objective of the present study is to analyse and compare different qualitative risk assessment methods during the production of polymer mortars (PM) with NM. The laboratory scale production process was divided in 3 main phases (pre-production, production and post-production), which allow testing the assessment methods in different situations. The risk assessment involved in the manufacturing process of PM was made by using the qualitative analyses based on: French Agency for Food, Environmental and Occupational Health & Safety method (ANSES); Control Banding Nanotool (CB Nanotool); Ecole Polytechnique Fédérale de Lausanne method (EPFL); Guidance working safely with nanomaterials and nanoproducts (GWSNN); Istituto Superiore per la Prevenzione e la Sicurezza del Lavoro, Italy method (ISPESL); Precautionary Matrix for Synthetic Nanomaterials (PMSN); and Stoffenmanager Nano. It was verified that the different methods applied also produce different final results. In phases 1 and 3 the risk assessment tends to be classified as medium-high risk, while for phase 2 the more common result is medium level. It is necessary to improve the use of qualitative methods by defining narrow criteria for the methods selection for each assessed situation, bearing in mind that the uncertainties are also a relevant factor when dealing with the risk related to nanotechnologies field.

Qualitative risk assessment during polymer mortar test specimens preparation - methods comparison

International Nuclear Information System (INIS)

Silva, F; Sousa, S P B; Ribeiro, M C S; Arezes, P; Swuste, P; Baptista, J S

2015-01-01

Polymer binder modification with inorganic nanomaterials (NM) could be a potential and efficient solution to control matrix flammability of polymer concrete (PC) materials without sacrificing other important properties. Occupational exposures can occur all along the life cycle of a NM and “nanoproducts” from research through scale-up, product development, manufacturing, and end of life. The main objective of the present study is to analyse and compare different qualitative risk assessment methods during the production of polymer mortars (PM) with NM. The laboratory scale production process was divided in 3 main phases (pre-production, production and post-production), which allow testing the assessment methods in different situations. The risk assessment involved in the manufacturing process of PM was made by using the qualitative analyses based on: French Agency for Food, Environmental and Occupational Health and Safety method (ANSES); Control Banding Nanotool (CB Nanotool); Ecole Polytechnique Fédérale de Lausanne method (EPFL); Guidance working safely with nanomaterials and nanoproducts (GWSNN); Istituto Superiore per la Prevenzione e la Sicurezza del Lavoro, Italy method (ISPESL); Precautionary Matrix for Synthetic Nanomaterials (PMSN); and Stoffenmanager Nano. It was verified that the different methods applied also produce different final results. In phases 1 and 3 the risk assessment tends to be classified as medium-high risk, while for phase 2 the more common result is medium level. It is necessary to improve the use of qualitative methods by defining narrow criteria for the methods selection for each assessed situation, bearing in mind that the uncertainties are also a relevant factor when dealing with the risk related to nanotechnologies field. (paper)

Selecting and applying indicators of ecosystem collapse for risk assessments.

Science.gov (United States)

Rowland, Jessica A; Nicholson, Emily; Murray, Nicholas J; Keith, David A; Lester, Rebecca E; Bland, Lucie M

2018-03-12

Ongoing ecosystem degradation and transformation are key threats to biodiversity. Measuring ecosystem change towards collapse relies on monitoring indicators that quantify key ecological processes. Yet little guidance is available on selecting and implementing indicators for ecosystem risk assessment. Here, we reviewed indicator use in ecological studies of decline towards collapse in marine pelagic and temperate forest ecosystems. We evaluated the use of indicator selection methods, indicator types (geographic distribution, abiotic, biotic), methods of assessing multiple indicators, and temporal quality of time series. We compared these ecological studies to risk assessments in the International Union for the Conservation of Nature Red List of Ecosystems (RLE), where indicators are used to estimate ecosystem collapse risk. We found that ecological studies and RLE assessments rarely reported how indicators were selected, particularly in terrestrial ecosystems. Few ecological studies and RLE assessments quantified ecosystem change with all three indicator types, and indicators types used varied between marine and terrestrial ecosystem. Several studies used indices or multivariate analyses to assess multiple indicators simultaneously, but RLE assessments did not, as RLE guidelines advise against them. Most studies and RLE assessments used time series spanning at least 30 years, increasing the chance of reliably detecting change. Limited use of indicator selection protocols and infrequent use of all three indicator types may hamper the ability to accurately detect changes. To improve the value of risk assessments for informing policy and management, we recommend using: (i) explicit protocols, including conceptual models, to identify and select indicators; (ii) a range of indicators spanning distributional, abiotic and biotic features; (iii) indices and multivariate analyses with extreme care until guidelines are developed; (iv) time series with sufficient data to

Visual Impairment/Intracranial Pressure Risk Assessment

Science.gov (United States)

Fogarty, Jennifer A.; Durham, T.; Otto, C.; Grounds, D.; Davis, J. R.

2010-01-01

Since 2006 there have been 6 reported cases of altered visual acuity and intracranial pressure (ICP) in long duration astronauts. In order to document this risk and develop an integrated approach to its mitigation, the NASA Space Life Sciences Directorate (SLSD) and Human Research Program (HRP) have chosen to use the Human System Risk Board (HSRB) and the risk management analysis tool (RMAT). The HSRB is the venue in which the stakeholders and customers discuss and vet the evidence and the RMAT is the tool that facilitates documentation and comparison of the evidence across mission profiles as well as identification of risk factors, and documentation of mitigation strategies. This process allows for information to be brought forward and dispositioned so that it may be properly incorporated into the RMAT and contribute to the design of the research and mitigation plans. The evidence thus far has resulted in the identification of a visual impairment/intracranial pressure (VIIP) project team, updating of both short and long duration medical requirements designed to assess visual acuity, and a research plan to characterize this issue further. In order to understand this issue more completely, a plan to develop an Accelerated Research Collaboration (ARC) has been approved by the HSRB. The ARC is a novel research model pioneered by the Myelin Repair Foundation. It is a patient centered research model that brings together researchers and clinicians, under the guidance of a scientific advisory panel, to collaborate and produce results much quickly than accomplished through traditional research models. The data and evidence from the updated medical requirements and the VIIP ARC will be reviewed at the HSRB on a regular basis. Each review package presented to the HSRB will include an assessment and recommendation with respect to continuation of research, countermeasure development, occupational surveillance modalities, selection criteria, etc. This process will determine the

Pesticide Cumulative Risk Assessment: Framework for Screening Analysis

Science.gov (United States)

This document provides guidance on how to screen groups of pesticides for cumulative evaluation using a two-step approach: begin with evaluation of available toxicological information and, if necessary, follow up with a risk-based screening approach.

Integration of existing systematic reviews into new reviews: identification of guidance needs

Science.gov (United States)

2014-01-01

Background An exponential increase in the number of systematic reviews published, and constrained resources for new reviews, means that there is an urgent need for guidance on explicitly and transparently integrating existing reviews into new systematic reviews. The objectives of this paper are: 1) to identify areas where existing guidance may be adopted or adapted, and 2) to suggest areas for future guidance development. Methods We searched documents and websites from healthcare focused systematic review organizations to identify and, where available, to summarize relevant guidance on the use of existing systematic reviews. We conducted informational interviews with members of Evidence-based Practice Centers (EPCs) to gather experiences in integrating existing systematic reviews, including common issues and challenges, as well as potential solutions. Results There was consensus among systematic review organizations and the EPCs about some aspects of incorporating existing systematic reviews into new reviews. Current guidance may be used in assessing the relevance of prior reviews and in scanning references of prior reviews to identify studies for a new review. However, areas of challenge remain. Areas in need of guidance include how to synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews. For instance, empiric evidence is needed regarding how to quality check data abstraction and when and how to use study-level risk of bias assessments from prior reviews. Conclusions There remain areas of uncertainty for how to integrate existing systematic reviews into new reviews. Methods research and consensus processes among systematic review organizations are needed to develop guidance to address these challenges. PMID:24956937

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.

WODA Technical Guidance on Underwater Sound from Dredging.

Science.gov (United States)

Thomsen, Frank; Borsani, Fabrizio; Clarke, Douglas; de Jong, Christ; de Wit, Pim; Goethals, Fredrik; Holtkamp, Martine; Martin, Elena San; Spadaro, Philip; van Raalte, Gerard; Victor, George Yesu Vedha; Jensen, Anders

2016-01-01

The World Organization of Dredging Associations (WODA) has identified underwater sound as an environmental issue that needs further consideration. A WODA Expert Group on Underwater Sound (WEGUS) prepared a guidance paper in 2013 on dredging sound, including a summary of potential impacts on aquatic biota and advice on underwater sound monitoring procedures. The paper follows a risk-based approach and provides guidance for standardization of acoustic terminology and methods for data collection and analysis. Furthermore, the literature on dredging-related sounds and the effects of dredging sounds on marine life is surveyed and guidance on the management of dredging-related sound risks is provided.

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

Operational risk assessment.

Science.gov (United States)

McKim, Vicky L

2017-06-01

In the world of risk management, which encompasses the business continuity disciplines, many types of risk require evaluation. Financial risk is most often the primary focus, followed by product and market risks. Another critical area, which typically lacks a thorough review or may be overlooked, is operational risk. This category encompasses many risk exposure types including those around building structures and systems, environmental issues, nature, neighbours, clients, regulatory compliance, network, data security and so on. At times, insurance carriers will assess internal hazards, but seldom do these assessments include more than a cursory look at other types of operational risk. In heavily regulated environments, risk assessments are required but may not always include thorough assessments of operational exposures. Vulnerabilities may linger or go unnoticed, only to become the catalyst for a business disruption at a later time, some of which are so severe that business recovery becomes nearly impossible. Businesses may suffer loss of clients as the result of a prolonged disruption of services. Comprehensive operational risk assessments can assist in identifying such vulnerabilities, exposures and threats so that the risk can be minimised or removed. This paper lays out how an assessment of this type can be successfully conducted.

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.

Guidance for Facilities on Risk Management Programs (RMP)

Science.gov (United States)

Includes supplemental guidance specific to ammonia refrigeration, wastewater treatment, propane storage, warehouses, chemical distributors, offsite consequence analysis, retail agriculture, applicability of program levels, prevention, emergency response.

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...

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...

Review of guidance on recurrence risk management for general practitioners in breast cancer, colorectal cancer and melanoma guidelines.

NARCIS (Netherlands)

Spronk, I.; Korevaar, J.C.; Burgers, J.S.; Albreht, T.; Schellevis, F.G.

2017-01-01

Background. General practitioners (GPs) will face cancer recurrences more frequently due to the rising number of cancer survivors and greater involvement of GPs in the follow-up care. Currently, GPs are uncertain about managing recurrence risks and may need more guidance. Objective. To explore what

78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-08-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

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...

Hepatitis Risk Assessment

Science.gov (United States)

... please visit this page: About CDC.gov . Hepatitis Risk Assessment Recommend on Facebook Tweet Share Compartir Viral Hepatitis. Are you at risk? Take this 5 minute Hepatitis Risk Assessment developed ...

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.

GM Risk Assessment

Science.gov (United States)

Sparrow, Penny A. C.

GM risk assessments play an important role in the decision-making process surrounding the regulation, notification and permission to handle Genetically Modified Organisms (GMOs). Ultimately the role of a GM risk assessment will be to ensure the safe handling and containment of the GMO; and to assess any potential impacts on the environment and human health. A risk assessment should answer all ‘what if’ scenarios, based on scientific evidence.

Management of mediastinal syndromes in pediatrics: a new challenge of ultrasound guidance to avoid high-risk general anesthesia.

Science.gov (United States)

Sola, Chrystelle; Choquet, Olivier; Prodhomme, Olivier; Capdevila, Xavier; Dadure, Christophe

2014-05-01

Adverse events associated with anesthetic management of anterior mediastinal masses in pediatrics are common. To avoid an extremely hazardous general anesthesia, the use of real-time ultrasonography offers an effective alternative in high-risk cases. We report the anesthetic management including a light sedation and ultrasound guidance for regional anesthesia, surgical node biopsy, and placement of a central venous line in two children with an anterior symptomatic mediastinal mass. For pediatric patients with clinical and/or radiologic signs of airway compression, ultrasound guidance provides safety technical assistance to avoid general anesthesia and should be performed for the initial diagnostic and therapeutic procedures. © 2013 John Wiley & Sons Ltd.

Motivators and Barriers to Incorporating Climate Change-Related Health Risks in Environmental Health Impact Assessment

Directory of Open Access Journals (Sweden)

Shilu Tong

2013-03-01

Full Text Available Climate change presents risks to health that must be addressed by both decision-makers and public health researchers. Within the application of Environmental Health Impact Assessment (EHIA, there have been few attempts to incorporate climate change-related health risks as an input to the framework. This study used a focus group design to examine the perceptions of government, industry and academic specialists about the suitability of assessing the health consequences of climate change within an EHIA framework. Practitioners expressed concern over a number of factors relating to the current EHIA methodology and the inclusion of climate change-related health risks. These concerns related to the broad scope of issues that would need to be considered, problems with identifying appropriate health indicators, the lack of relevant qualitative information that is currently incorporated in assessment and persistent issues surrounding stakeholder participation. It was suggested that improvements are needed in data collection processes, particularly in terms of adequate communication between environmental and health practitioners. Concerns were raised surrounding data privacy and usage, and how these could impact on the assessment process. These findings may provide guidance for government and industry bodies to improve the assessment of climate change-related health risks.

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

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

EPA guidance on the early detection of clinical high risk states of psychoses

DEFF Research Database (Denmark)

Schultze-Lutter, F; Michel, C; Schmidt, S J

2015-01-01

The aim of this guidance paper of the European Psychiatric Association is to provide evidence-based recommendations on the early detection of a clinical high risk (CHR) for psychosis in patients with mental problems. To this aim, we conducted a meta-analysis of studies reporting on conversion rates...... to psychosis in non-overlapping samples meeting any at least any one of the main CHR criteria: ultra-high risk (UHR) and/or basic symptoms criteria. Further, effects of potential moderators (different UHR criteria definitions, single UHR criteria and age) on conversion rates were examined. Conversion rates...... in the identified 42 samples with altogether more than 4000 CHR patients who had mainly been identified by UHR criteria and/or the basic symptom criterion 'cognitive disturbances' (COGDIS) showed considerable heterogeneity. While UHR criteria and COGDIS were related to similar conversion rates until 2-year follow...

Exposure Assessment Tools by Tiers and Types - Deterministic and Probabilistic Assessments

Science.gov (United States)

EPA ExpoBox is a toolbox for exposure assessors. Its purpose is to provide a compendium of exposure assessment and risk characterization tools that will present comprehensive step-by-step guidance and links to relevant exposure assessment data bases

Offshore risk assessment

CERN Document Server

Vinnem, Jan-Erik

2014-01-01

  Offshore Risk Assessment was the first book to deal with quantified risk assessment (QRA) as applied specifically to offshore installations and operations. Risk assessment techniques have been used for more than three decades in the offshore oil and gas industry, and their use is set to expand increasingly as the industry moves into new areas and faces new challenges in older regions.   This updated and expanded third edition has been informed by a major R&D program on offshore risk assessment in Norway and summarizes research from 2006 to the present day. Rooted with a thorough discussion of risk metrics and risk analysis methodology,  subsequent chapters are devoted to analytical approaches to escalation, escape, evacuation and rescue analysis of safety and emergency systems.   Separate chapters analyze the main hazards of offshore structures: fire, explosion, collision, and falling objects as well as structural and marine hazards. Risk mitigation and control are discussed, as well as an illustrat...

Development of a Standardized Approach for Assessing Potential Risks to Amphibians Exposed to Sediment and Hydric Soils

Science.gov (United States)

2004-05-01

different foods in amphibian tests. Possible foods considered for this study included boiled spinach, boiled lettuce , fish flakes, TetraMin...other foods such as boiled spinach or lettuce . • Sediment tests in flow-through chambers are preferable over static-renewal systems because of... hybridization may be possible. Amphibian Ecological Risk Assessment Guidance Manual Q:\\mw97\\Projects\\9070045\\419\\Appendix C\\appC-1

76 FR 71577 - Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication...

Science.gov (United States)

2011-11-18

...] Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in... guidance for industry entitled ``Medication Guides-- Distribution Requirements and Inclusion in Risk... Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).'' This guidance provides...

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.

76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Science.gov (United States)

2011-03-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...

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

Science.gov (United States)

Johnson, F Reed; Zhou, Mo

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

Risk assessment of exposure to volatile organic compounds in groundwater in Taiwan

Energy Technology Data Exchange (ETDEWEB)

Fan Chihhao [Department of Safety, Health, and Environmental Engineering, Mingchi University of Technology, Taipei County, Taiwan (China); Wang, G.-S. [Department of Public Health, National Taiwan University, Taipei, Taiwan (China); Chen, Y.-C. [Energy and Environment Research Laboratories, Industrial Technology Research Institute, Hsinchu County, Taiwan (China); Ko, C.-H. [School of Forest and Resources Conservation, National Taiwan University, Taipei, Taiwan (China)], E-mail: chunhank@ntu.edu.tw

2009-03-15

The purpose of this study is to assess the risks from exposure to 14 volatile organic compounds (VOCs) in selected groundwater sites in Taiwan. The study employs the multimedia environment pollutant assessment system (MEPAS) model to calculate the specific non-cancer and cancer risks at an exposure level of 1 {mu}g/L of each VOC for a variety of exposure pathways. The results show that the highest specific non-cancer risk is associated with water ingestion of vinyl chloride (VC) and that the highest specific cancer risk is associated with indoor breathing of VC. The three most important exposure pathways for risk assessment for both non-cancer and cancer risks are identified as water ingestion, dermal absorption when showering, and indoor breathing. Excess tetrachloroethylene (PCE), trichloroethylene (TCE), dichloroethylene (DCE), and VC are detected in the groundwater aquifers of one dump site and one factory. However, the study suggests that the pollutants in the contaminated groundwater aquifers do not travel extensively with groundwater flow and that the resulting VOC concentrations are below detectable levels for most of the sampled drinking-water treatment plants. Nevertheless, the non-cancer and cancer risks resulting from use of the contaminated groundwater are found to be hundred times higher than the general risk guidance values. To ensure safe groundwater utilisation, remediation initiatives for soil and groundwater are required. Finally, the study suggests that the current criteria for VOCs in drinking water might not be capable of ensuring public safety when groundwater is used as the primary water supply; more stringent quality criteria for drinking water are proposed for selected VOCs.

Pollution prevention opportunity assessments. Guidance for the Hanford Site

International Nuclear Information System (INIS)

Engel, J.A.

1994-10-01

The purpose of this document is to provide help to you, Hanford waste generators, in finding ways to reduce waste through Pollution Prevention (P2) and Pollution Prevention Opportunity Assessments (P2OAs). It is based on guidance from other sites, and serves to compliment the Hanford-specific training on P2OAs offered by the Pollution Prevention group at Westinghouse Hanford Company (WHC). The chapters of this document include help on how to choose major waste generating activities, how to conduct a P2OA, how to get results, and how to show progress. There is also a chapter on special situations and problems your facility may encounter. This first chapter tells you why you should consider conducting P2OAs and why they may be required

Concept of risk: risk assessment and nuclear safety

International Nuclear Information System (INIS)

Thompson, P.B.

1980-01-01

The dissertation is a critical examination of risk assessment and its role in public policy. Nuclear power safety safety issues are selected as the primary source of illustrations and examples. The dissertation examines how risk assessment studies develop a concept of risk which becomes decisive for policy choices. Risk-assessment techniques are interpreted as instruments which secure an evaluation of risk which, in turn, figures prominently in technical reports on nuclear power. The philosophical critique is mounted on two levels. First, an epistemological critique surveys distinctions between the technical concept of risk and more familiar senses of risk. The critique shows that utilization of risk assessment re-structures the concept of risk. The technical concept is contrasted to the function of risk within a decision-maker's conceptual agenda and hierarchy of values. Second, an ethical critique exposes the value commitments of risk assessment recommendations. Although some of these values might be defended for policy decisions, the technical character of risk assessment obfuscates normative issues. Risk assessment is shown to be a form of factual enquiry which, nonetheless, represents a commitment to a specific selection of ethical and social values. Risk assessment should not be interpreted as a primary guide to decision unless the specific values incorporated into its concept of risk are stated explicitly and justified philosophically. Such a statement would allow value questions which have been sublimated by the factual tone of the analytic techniques to be debated on clear, social and ethical grounds

Dutch Risk Assessment tools

NARCIS (Netherlands)

Venema, A.

2015-01-01

The ‘Risico- Inventarisatie- en Evaluatie-instrumenten’ is the name for the Dutch risk assessment (RA) tools. A RA tool can be used to perform a risk assessment including an evaluation of the identified risks. These tools were among the first online risk assessment tools developed in Europe. The

European Universities' Guidance on Research Integrity and Misconduct.

Science.gov (United States)

Aubert Bonn, Noémie; Godecharle, Simon; Dierickx, Kris

2017-02-01

Research integrity is imperative to good science. Nonetheless, many countries and institutions develop their own integrity guidance, thereby risking incompatibilities with guidance of collaborating institutions. We retrieved guidance for academic integrity and misconduct of 18 universities from 10 European countries and investigated accessibility, general content, principles endorsed, and definitions of misconduct. Accessibility and content differ substantially between institutions. There are general trends of common principles of integrity and definitions of misconduct, yet differences remain. Parallel with previous research, we distinguish different approaches in integrity guidance; one emphasizes broad values of integrity, and the other details negative behaviors of misconduct. We propose that a balance between both approaches is necessary to preserve trust, meaning, and realism of guidance on research integrity.

Information risk management a practitioner's guide

CERN Document Server

Sutton, David

2014-01-01

Information risk management (IRM) is about identifying, assessing and prioritising risks to keep information secure and available. This accessible book provides practical guidance to the principles and development of a strategic approach to an IRM programme. The only textbook for the BCS Practitioner Certificate in Information Risk Management.

Incorporating climate and ocean change into extinction risk assessments for 82 coral species.

Science.gov (United States)

Brainard, Russell E; Weijerman, Mariska; Eakin, C Mark; McElhany, Paul; Miller, Margaret W; Patterson, Matt; Piniak, Gregory A; Dunlap, Matthew J; Birkeland, Charles

2013-12-01

Many marine invertebrate species facing potential extinction have uncertain taxonomies and poorly known demographic and ecological traits. Uncertainties are compounded when potential extinction drivers are climate and ocean changes whose effects on even widespread and abundant species are only partially understood. The U.S. Endangered Species Act mandates conservation management decisions founded on the extinction risk to species based on the best available science at the time of consideration-requiring prompt action rather than awaiting better information. We developed an expert-opinion threat-based approach that entails a structured voting system to assess extinction risk from climate and ocean changes and other threats to 82 coral species for which population status and threat response information was limited. Such methods are urgently needed because constrained budgets and manpower will continue to hinder the availability of desired data for many potentially vulnerable marine species. Significant species-specific information gaps and uncertainties precluded quantitative assessments of habitat loss or population declines and necessitated increased reliance on demographic characteristics and threat vulnerabilities at genus or family levels. Adapting some methods (e.g., a structured voting system) used during other assessments and developing some new approaches (e.g., integrated assessment of threats and demographic characteristics), we rated the importance of threats contributing to coral extinction risk and assessed those threats against population status and trend information to evaluate each species' extinction risk over the 21st century. This qualitative assessment resulted in a ranking with an uncertainty range for each species according to their estimated likelihood of extinction. We offer guidance on approaches for future biological extinction risk assessments, especially in cases of data-limited species likely to be affected by global-scale threats

State of risk assessment

International Nuclear Information System (INIS)

Conrad, J.

1978-03-01

In view of the growing importance assumed in recent years by scientific work on the calculation, quantification, evaluation and acceptance as well as behavior in the face of risks in general and more specifically, the risks of large industrial plants, the report attempts to provide a survey of the current situation, results and evaluation of this new branch of research, risk assessment. The emphasis of the report is on the basic discussion and criticism of the theoretical and methodological approaches used in the field of risk assessment (section 3). It is concerned above all with - methodical problems of determining and quantifying risks (3.1) - questions of the possibility of risk evaluation and comp arison (3.1, 3.2) - the premises of normative and empirical studies on decision making under risk (3.2, 3.3) - investigations into society's acceptance of risks involved in the introduction of new technologies (3.4) - attempts to combine various aspects of the field of risk assessment in a unified concept (3.5, 3.6, 3.7). Because risk assessment is embedded in the framework of decision theory and technology assessment, it can be implicitly evaluated at a more general level within this framework, as far as its possibilities and weaknesses of method and application are concerned (section 4). Sections 2 and 5 deal with the social context of origin and utilization of risk assessment. Finally, an attempt is made at a summary indicating the possible future development of risk assessment. (orig./HP) [de

Radon: guidance on protective measures for new dwellings

International Nuclear Information System (INIS)

1991-01-01

This report gives guidance for reducing the presence of radon in new dwellings and hence reducing the risk to occupants of exposure to radon. This is a follow-up to the interim guidance of 1988. The report provides comprehensive practical details on the methods of protection including both primary and secondary measures. (UK)

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.

Risk assessment and risk management of mycotoxins.

Science.gov (United States)

2012-01-01

Risk assessment is the process of quantifying the magnitude and exposure, or probability, of a harmful effect to individuals or populations from certain agents or activities. Here, we summarize the four steps of risk assessment: hazard identification, dose-response assessment, exposure assessment, and risk characterization. Risk assessments using these principles have been conducted on the major mycotoxins (aflatoxins, fumonisins, ochratoxin A, deoxynivalenol, and zearalenone) by various regulatory agencies for the purpose of setting food safety guidelines. We critically evaluate the impact of these risk assessment parameters on the estimated global burden of the associated diseases as well as the impact of regulatory measures on food supply and international trade. Apart from the well-established risk posed by aflatoxins, many uncertainties still exist about risk assessments for the other major mycotoxins, often reflecting a lack of epidemiological data. Differences exist in the risk management strategies and in the ways different governments impose regulations and technologies to reduce levels of mycotoxins in the food-chain. Regulatory measures have very little impact on remote rural and subsistence farming communities in developing countries, in contrast to developed countries, where regulations are strictly enforced to reduce and/or remove mycotoxin contamination. However, in the absence of the relevant technologies or the necessary infrastructure, we highlight simple intervention practices to reduce mycotoxin contamination in the field and/or prevent mycotoxin formation during storage.

Safety of magnetic fusion facilities: Guidance

International Nuclear Information System (INIS)

1996-05-01

This document provides guidance for the implementation of the requirements identified in DOE-STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While the requirements in DOE-STD-6002-96 are generally applicable to a wide range of fusion facilities, this Standard, DOE-STD-6003-96, is concerned mainly with the implementation of those requirements in 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 Standard is oriented toward regulation in the Department of Energy (DOE) environment as opposed to regulation by other regulatory agencies. As the need for guidance involving other types of fusion facilities or other regulatory environments emerges, additional guidance volumes should be prepared. The concepts, processes, and recommendations set forth here are for guidance only. They will contribute to safety at magnetic fusion facilities

77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

Science.gov (United States)

2012-10-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical... certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs...

2007 TOXICOLOGY AND RISK ASSESSMENT ...

Science.gov (United States)

EPA has announced The 2007 Toxicology and Risk Assessment Conference Cincinnati Marriott North, West Chester (Cincinnati), OHApril 23- 26, 2007 - Click to register!The Annual Toxicology and Risk Assessment Conference is a unique meeting where several Government Agencies come together to discuss toxicology and risk assessment issues that are not only of concern to the government, but also to a broader audience including academia and industry. The theme of this year's conference is Emerging Issues and Challenges in Risk Assessment and the preliminary agenda includes: Plenary Sessions and prominent speakers (tentative) include: Issues of Emerging Chemical ContaminantsUncertainty and Variability in Risk Assessment Use of Mechanistic data in IARC evaluationsParallel Sessions:Uncertainty and Variability in Dose-Response Assessment Recent Advances in Toxicity and Risk Assessment of RDX The Use of Epidemiologic Data for Risk Assessment Applications Cumulative Health Risk Assessment:

Risk Assessment

Science.gov (United States)

How the EPA conducts risk assessment to protect human health and the environment. Several assessments are included with the guidelines, models, databases, state-based RSL Tables, local contacts and framework documents used to perform these assessments.

Exploration Health Risks: Probabilistic Risk Assessment

Science.gov (United States)

Rhatigan, Jennifer; Charles, John; Hayes, Judith; Wren, Kiley

2006-01-01

Maintenance of human health on long-duration exploration missions is a primary challenge to mission designers. Indeed, human health risks are currently the largest risk contributors to the risks of evacuation or loss of the crew on long-duration International Space Station missions. We describe a quantitative assessment of the relative probabilities of occurrence of the individual risks to human safety and efficiency during space flight to augment qualitative assessments used in this field to date. Quantitative probabilistic risk assessments will allow program managers to focus resources on those human health risks most likely to occur with undesirable consequences. Truly quantitative assessments are common, even expected, in the engineering and actuarial spheres, but that capability is just emerging in some arenas of life sciences research, such as identifying and minimize the hazards to astronauts during future space exploration missions. Our expectation is that these results can be used to inform NASA mission design trade studies in the near future with the objective of preventing the higher among the human health risks. We identify and discuss statistical techniques to provide this risk quantification based on relevant sets of astronaut biomedical data from short and long duration space flights as well as relevant analog populations. We outline critical assumptions made in the calculations and discuss the rationale for these. Our efforts to date have focussed on quantifying the probabilities of medical risks that are qualitatively perceived as relatively high risks of radiation sickness, cardiac dysrhythmias, medically significant renal stone formation due to increased calcium mobilization, decompression sickness as a result of EVA (extravehicular activity), and bone fracture due to loss of bone mineral density. We present these quantitative probabilities in order-of-magnitude comparison format so that relative risk can be gauged. We address the effects of

Career Guidance and Social Exclusion: A Cautionary Tale.

Science.gov (United States)

Watts, A. G.

2001-01-01

Examines the relationship of career guidance to public-policy interventions designed to address social exclusion. Analyzes the nature and origin of the concept of social exclusion and reviews the roles of career guidance in response to it, particularly in relation to young people who have dropped out of formal education or are at high risk of…

Risk assessment and optimization (ALARA) analysis for the environmental remediation of Brookhaven National Laboratory's hazardous waste management facility

International Nuclear Information System (INIS)

Dionne, B.J.; Morris, S. III; Baum, J.W.

1998-03-01

The Department of Energy's (DOE) Office of Environment, Safety, and Health (EH) sought examples of risk-based approaches to environmental restoration to include in their guidance for DOE nuclear facilities. Extensive measurements of radiological contamination in soil and ground water have been made at Brookhaven National Laboratory's Hazardous Waste Management Facility (HWMF) as part of a Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) remediation process. This provided an ideal opportunity for a case study. This report provides a risk assessment and an open-quotes As Low as Reasonably Achievableclose quotes (ALARA) analysis for use at other DOE nuclear facilities as an example of a risk-based decision technique

Psycho-Educational Assessment of Specific Learning Disabilities: Views and Practices of Australian Psychologists and Guidance Counsellors

Science.gov (United States)

Meteyard, John D.; Gilmore, Linda

2015-01-01

This article reports an investigation of the views and practices of 203 Australian psychologists and guidance counsellors with respect to psycho-educational assessment of students with specific learning disabilities (SLDs). Results from an online survey indicated that practitioners draw upon a wide range of theoretical perspectives when…

Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

Energy Technology Data Exchange (ETDEWEB)

Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A. [Nuclear Regulatory Commission, Washington, DC (United States). Div. of Industrial and Medical Nuclear Safety; Tingle, W. [Dept. of Environment, Health, and Natural Resources, Raleigh, NC (United States). Div. of Radiation Protection

1997-05-01

As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ``Applications for the Use of Sealed Sources in Portable Gauging Devices,`` and in NMSs Policy and guidance Directive 2-07, ``Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.`` This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications.

Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

International Nuclear Information System (INIS)

Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A.; Tingle, W.

1997-05-01

As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ''Applications for the Use of Sealed Sources in Portable Gauging Devices,'' and in NMSs Policy and guidance Directive 2-07, ''Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.'' This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications

Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

Directory of Open Access Journals (Sweden)

Melanie Calvert

Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

Mesocosm soil ecological risk assessment tool for GMO 2nd tier studies

DEFF Research Database (Denmark)

D'Annibale, Alessandra; Maraldo, Kristine; Larsen, Thomas

Ecological Risk Assessment (ERA) of GMO is basically identical to ERA of chemical substances, when it comes to assessing specific effects of the GMO plant material on the soil ecosystem. The tiered approach always includes the option of studying more complex but still realistic ecosystem level...... effects in 2nd tier caged experimental systems, cf. the new GMO ERA guidance: EFSA Journal 2010; 8(11):1879. We propose to perform a trophic structure analysis, TSA, and include the trophic structure as an ecological endpoint to gain more direct insight into the change in interactions between species, i.......e. the food-web structure, instead of relying only on the indirect evidence from population abundances. The approach was applied for effect assessment in the agro-ecosystem where we combined factors of elevated CO2, viz. global climate change, and GMO plant effects. A multi-species (Collembola, Acari...

Design Guidance for New Windows | Efficient Windows Collaborative

Science.gov (United States)

Foundry Foundry New Construction Windows Window Selection Tool Selection Process Design Guidance Installation Replacement Windows Window Selection Tool Assessing Options Selection Process Design Guidance Installation Understanding Windows Benefits Design Considerations Measuring Performance Performance Standards

Design Guidance for Replacement Windows | Efficient Windows Collaborative

Science.gov (United States)

Foundry Foundry New Construction Windows Window Selection Tool Selection Process Design Guidance Installation Replacement Windows Window Selection Tool Assessing Options Selection Process Design Guidance Installation Understanding Windows Benefits Design Considerations Measuring Performance Performance Standards

Guidance for a harmonized emission scenario document (ESD) on ballast water discharge

Energy Technology Data Exchange (ETDEWEB)

Zipperle, Andreas [BIS - Beratungszentrum fuer integriertes Sedimentmanagement, Hamburg (Germany); Gils, Jos van [DELTARES, Delft (Netherlands); Hattum, Bert van [Amsterdam Univ. (Netherlands). IVM - Institute for Environmental Studies; Heise, Susanne [BIS - Beratungszentrum fuer integriertes Sedimentmanagement, Hamburg (Germany); Hamburg Univ. of Applied Sciences (Germany)

2011-05-15

The present report provides guidance for a harmonized Emission Scenario Document (ESD) for the exposure assessment as part of the environmental risk assessment process which applicants seeking approval of a ballast water management system (BWMS) need to perform prior to notification and authorisation procedures. Despite the global variability of the marine environment, ballast water discharges and treatment methods, exposure assessments need to be comparable between different applications. In order to achieve this, this ESD points out the following aspects: - Applicants should use standardized scenarios in order to predict mean exposure. These should reflect generic situations, independent of region or port so that results are widely applicable. In addition to a harbour scenario, a standardized shipping lane scenario should be considered, - During or right after ballast water discharge, high concentrations may persist in a water body for a certain length of time until extensive mixing results in mean concentrations. Not taking exposure to peak concentrations within gradients into account could lead to an underestimation of risk, especially for rapidly degrading substances. Efforts have been made to approximate maximum exposure concentration with simple dilution factors. Their applicability was checked by near-field-evaluations. - Chemical properties determine the environmental fate of substances. If they are ambiguous, selection of a specific set of data strongly influences the result of an exposure assessment. Guidance is given on what to do about lacking data. - In order to harmonize the exposure assessments, reliable chemical model software should be used. A discussion on the requirements of suitable software and an evaluation of MAMPEC is given in this report. (orig.)

Current approaches to cyanotoxin risk assessment and risk management around the globe

Science.gov (United States)

Ibelings, Bas W.; Backer, Lorraine C.; Kardinaal, W. Edwin A.; Chorus, Ingrid

2015-01-01

Toxic cyanobacteria became more widely recognized as a potential health hazard in the 1990s, and in 1998 the World Health Organization (WHO) first published a provisional Guideline Value of 1 μg L−1 for microcystin-LR in drinking-water. In this publication we compare risk assessment and risk management of toxic cyanobacteria in 17 countries across all five continents. We focus on the three main (oral) exposure vehicles to cyanotoxins: drinking-water, water related recreational and freshwater seafood. Most countries have implemented the provisional WHO Guideline Value, some as legally binding standard, to ensure the distribution of safe drinking-water with respect to microcystins. Regulation, however, also needs to address the possible presence of a wide range of other cyanotoxins and bioactive compounds, for which no guideline values can be derived due to insufficient toxicological data. The presence of microcystins (commonly expressed as microcystin-LR equivalents) may be used as proxy for overall guidance on risk management, but this simplification may miss certain risks, for instance from dissolved fractions of cylindrospermopsin and cyanobacterial neurotoxins. An alternative approach, often taken for risk assessment and management in recreational waters, is to regulate cyanobacterial presence – as cell numbers or biomass – rather than individual toxins. Here, many countries have implemented a two or three tier alert level system with incremental severity. These systems define the levels where responses are switched from Surveillance to Alert and finally to Action Mode and they specify the short-term actions that follow. Surface bloom formation is commonly judged to be a significant risk because of the elevated concentration of microcystins in a scum. Countries have based their derivations of legally binding standards, guideline values, maximally allowed concentrations (or limits named otherwise) on very similar scientific methodology, but underlying

Current approaches to cyanotoxin risk assessment and risk management around the globe.

Science.gov (United States)

Ibelings, Bas W; Backer, Lorraine C; Kardinaal, W Edwin A; Chorus, Ingrid

2015-12-01

Toxic cyanobacteria became more widely recognized as a potential health hazard in the 1990s, and in 1998 the World Health Organization (WHO) first published a provisional Guideline Value of 1 μg L -1 for microcystin-LR in drinking-water. In this publication we compare risk assessment and risk management of toxic cyanobacteria in 17 countries across all five continents. We focus on the three main (oral) exposure vehicles to cyanotoxins: drinking-water, water related recreational and freshwater seafood. Most countries have implemented the provisional WHO Guideline Value, some as legally binding standard, to ensure the distribution of safe drinking-water with respect to microcystins. Regulation, however, also needs to address the possible presence of a wide range of other cyanotoxins and bioactive compounds, for which no guideline values can be derived due to insufficient toxicological data. The presence of microcystins (commonly expressed as microcystin-LR equivalents) may be used as proxy for overall guidance on risk management, but this simplification may miss certain risks, for instance from dissolved fractions of cylindrospermopsin and cyanobacterial neurotoxins. An alternative approach, often taken for risk assessment and management in recreational waters, is to regulate cyanobacterial presence - as cell numbers or biomass - rather than individual toxins. Here, many countries have implemented a two or three tier alert level system with incremental severity. These systems define the levels where responses are switched from Surveillance to Alert and finally to Action Mode and they specify the short-term actions that follow. Surface bloom formation is commonly judged to be a significant risk because of the elevated concentration of microcystins in a scum. Countries have based their derivations of legally binding standards, guideline values, maximally allowed concentrations (or limits named otherwise) on very similar scientific methodology, but underlying

Tank waste remediation system risk management plan

International Nuclear Information System (INIS)

Zimmerman, B.D.

1998-01-01

The purpose of the Tank Waste Remediation System (TWRS) Risk Management Plan is to describe a consistent approach to risk management such that TWRS Project risks are identified and managed to achieve TWRS Project success. The Risk Management Plan implements the requirements of the Tank Waste Remediation System Systems Engineering Management Plan in the area of risk management. Figure ES-1 shows the relationship of the TWRS Risk Management Plan to other major TWRS Project documents. As the figure indicates, the Risk Management Plan is a tool used to develop and control TWRS Project work. It provides guidance on how TWRS Project risks will be assessed, analyzed, and handled, and it specifies format and content for the risk management lists, which are a primary product of the risk management process. In many instances, the Risk Management Plan references the TWRS Risk Management Procedure, which provides more detailed discussion of many risk management activities. The TWRS Risk Management Plan describes an ongoing program within the TWRS Project. The Risk Management Plan also provides guidance in support of the TWRS Readiness To-Proceed (RTP) assessment package

NanoSafer vs. 1.1 - Nanomaterial risk assessment using first order modeling

DEFF Research Database (Denmark)

Jensen, Keld A.; Saber, Anne T.; Kristensen, Henrik V.

2013-01-01

Currently, there are no nanospecific safety data sheets (SDS) fo r manufactured nanomaterials (MN) and there is only limited data available on nanomaterial exposure levels. We have established an advanced control banding tool, NanoSafer, which enables alternative risk assessm ent and guidance...... in the SDS for the closest analogue bulk material for which the requested occupational exposure limit (OEL) is given as well. The emission potential is either given by a constant release rate or the dustiness level determined us ing the EN15051 rotating drum or similar. The exposure assessment is estimated...... of the nearest analogue bulk material a nd the specific surface area. The NanoSafer control banding tool is now available in Danish and English and contains help tools, including a data library with dustiness data and an inspirational nanosafety e learning tool for companies’ risk management. The ability...

[Differences in attachment and personality in children from child guidance centers, child psychiatry units, and control families].

Science.gov (United States)

Zimmermann, Peter; Scheuerer-Englisch, Hermann

2013-01-01

Insecure attachment and deficits in self-regulation as personality traits are risk factors for the development of psychopathological symptoms from infancy on. This study examines differences in attachment and personality in late childhood, comparing children from non-clinical families, from a child guidance center, and child psychiatry units with in-patient care. Children's attachment representations, their attachment behavior strategy, reported distressing parental behavior, their emotional openness, and attachment coherency were assessed with the Late Childhood Attachment Interview (LCAI). Ego-resiliency, ego-undercontrol, field-independence, aggressiveness, and anxiety were assessed by means of the California Child Q-Sort. The results show clear attachment differences, with the child guidance group showing more attachment insecurity in the LCAI compared to the control group, and the psychiatric in-patient group even more attachment insecurity, more distressing parenting from both mother and father, and more attachment disorganization than the other two groups. Whereas children from the child guidance center and the child psychiatry unit did not differ in personality, both groups were significantly different from the control group in all personality dimensions. The results suggest that personality differences may be a risk factor for behaviour problems, however problem severity and the choice of the treatment institution seem to be influenced by attachment security.

Hanford Site's Integrated Risk Assessment Program: No-intervention risk assessment

International Nuclear Information System (INIS)

Mahaffey, J.A.; Dukelow, J.S. Jr.; Stenner, R.D.

1994-08-01

The long-term goal of the Integrated Risk Assessment program (IRAP) is to estimate risks to workers, the public, organizations, and groups with reserved rights to Site access, the ecosystem, and natural resources to aid in managing environmental restoration and waste management at the Hanford Site. For each of these, information is needed about current risks, risks during cleanup, and endstate risks. The objective is three-fold: to determine if and when to remediate, and to what extent; to identify information unavailable but needed to make better cleanup decisions; to establish technology performance criteria for achieving desired cleanup levels; to understand costs and benefits of activities from a Site-wide perspective. The no-intervention risk, assessment is the initial evaluation of public health risks conducted under IRAP. The objective is to identify types of activities that the US Department of Energy (DOE) must accomplish for closure of the Hanford Site, defined as no further DOE intervention. There are two primary conclusions from the no-intervention risk assessment. First, some maintenance and operations activities at Hanford must be continued to protect the public from grave risks. However, when large Hanford expenditures are compared to cleanup progress, funds expended for maintenance and operations must be put in proper perspective. Second, stakeholder's emphasis on public risks at Hanford, as indicated by remediation priorities, are not in line with those estimated. The focus currently is on compliance with regulations, and on dealing with issues which are visible to stakeholders

SPAR-H Step-by-Step Guidance

Energy Technology Data Exchange (ETDEWEB)

April M. Whaley; Dana L. Kelly; Ronald L. Boring; William J. Galyean

2012-06-01

Step-by-step guidance was developed recently at Idaho National Laboratory for the US Nuclear Regulatory Commission on the use of the Standardized Plant Analysis Risk-Human Reliability Analysis (SPAR-H) method for quantifying Human Failure Events (HFEs). This work was done to address SPAR-H user needs, specifically requests for additional guidance on the proper application of various aspects of the methodology. This paper overviews the steps of the SPAR-H analysis process and highlights some of the most important insights gained during the development of the step-by-step directions. This supplemental guidance for analysts is applicable when plant-specific information is available, and goes beyond the general guidance provided in existing SPAR-H documentation. The steps highlighted in this paper are: Step-1, Categorizing the HFE as Diagnosis and/or Action; Step-2, Rate the Performance Shaping Factors; Step-3, Calculate PSF-Modified HEP; Step-4, Accounting for Dependence, and; Step-5, Minimum Value Cutoff.

Chemical Risk Assessment

Science.gov (United States)

This course is aimed at providing an overview of the fundamental guiding principles and general methods used in chemical risk assessment. Chemical risk assessment is a complex and ever-evolving process. These principles and methods have been organized by the National Research Cou...

An integrated risk assessment approach: Risk assessment in the programmatic environmental impact statement

International Nuclear Information System (INIS)

Morris, J.M.

1994-01-01

The following paper is an informal summary of salient points made in the presentation entitled open-quotes An Integrated Risk Assessment Approach: Risk Assessment in the Programmatic Environmental Impact Statement (PEIS).close quotes. This presentation was given at the U.S. DOE Integrated Planning Workshop in Denver, Colorado on June 2, 1994. Integrated decision analysis is very important in environmental restoration and waste management in the evaluation of such things as land use planning, waste load forecasting, cost analyses, and technology development activities. Integrated risk assessment is an approach that addresses multiple components of risk, including: risks from surplus facilities as well as typical environmental restoration sites, risks to the public, risks to workers, ecological risk, risks before, during and after remediation activities, and others

The relation of risk assessment and health impact assessment

DEFF Research Database (Denmark)

Ádám, Balázs; Gulis, Gabriel

2013-01-01

than assessing a present situation. As part of this process, however, methods applied in risk assessment are used. Risk assessment typically characterises relation of a well-defined risk factor to a well-defined health outcome. Within HIA usually several individual risk assessments are needed...... of the causal chain from the proposal through related health determinants and risk factors to health outcomes. The stepwise analysis, systematic prioritization and consideration of horizontal interactions between the causal pathways make it feasible to use widely recognized risk assessment methods in the HIA......The level and distribution of health risks in a society is substantially influenced by measures of various policies, programmes or projects. Risk assessment can evaluate the nature, likelihood and severity of an adverse effect. Health impact assessment (HIA) provides similar function when used...

Assessment of cardiovascular risk.

LENUS (Irish Health Repository)

Cooney, Marie Therese

2010-10-01

Atherosclerotic cardiovascular disease (CVD) is the most common cause of death worldwide. Usually atherosclerosis is caused by the combined effects of multiple risk factors. For this reason, most guidelines on the prevention of CVD stress the assessment of total CVD risk. The most intensive risk factor modification can then be directed towards the individuals who will derive the greatest benefit. To assist the clinician in calculating the effects of these multiple interacting risk factors, a number of risk estimation systems have been developed. This review address several issues regarding total CVD risk assessment: Why should total CVD risk be assessed? What risk estimation systems are available? How well do these systems estimate risk? What are the advantages and disadvantages of the current systems? What are the current limitations of risk estimation systems and how can they be resolved? What new developments have occurred in CVD risk estimation?

Smart Ultrasound Remote Guidance Experiment (SURGE) Preliminary Findings

Science.gov (United States)

Hurst, Victor; Dulchavsky, Scott; Garcia, Kathleen; Sargsyan, Ashot; Ebert, Doug

2009-01-01

To date, diagnostic quality ultrasound images were obtained aboard the International Space Station (ISS) using the ultrasound of the Human Research Facility (HRF) rack in the Laboratory module. Through the Advanced Diagnostic Ultrasound in Microgravity (ADUM) and the Braslet-M Occlusion Cuffs (BRASLET SDTO) studies, non-expert ultrasound operators aboard the ISS have performed cardiac, thoracic, abdominal, vascular, ocular, and musculoskeletal ultrasound assessments using remote guidance from ground-based ultrasound experts. With exploration class missions to the lunar and Martian surfaces on the horizon, crew medical officers will necessarily need to operate with greater autonomy given communication delays (round trip times of up to 5 seconds for the Moon and 90 minutes for Mars) and longer periods of communication blackouts (due to orbital constraints of communication assets). The SURGE project explored the feasibility and training requirements of having non-expert ultrasound operators perform autonomous ultrasound assessments in a simulated exploration mission outpost. The project aimed to identify experience, training, and human factors requirements for crew medical officers to perform autonomous ultrasonography. All of these aims pertained to the following risks from the NASA Bioastronautics Road Map: 1) Risk 18: Major Illness and Trauna; 2) Risk 20) Ambulatory Care; 3) Risk 22: Medical Informatics, Technologies, and Support Systems; and 4) Risk 23: Medical Skill Training and Maintenance.

Screening Assessment of Potential Human-Health Risk from Future Natural-Gas Drilling Near Project Rulison in Western Colorado

Energy Technology Data Exchange (ETDEWEB)

Daniels Jeffrey I.,Chapman Jenny B.

2012-01-01

The Project Rulison underground nuclear test was conducted in 1969 at a depth of 8,400 ft in the Williams Fork Formation of the Piceance Basin, west-central Colorado (Figure 1). The U.S. Department of Energy Office of Legacy Management (LM) is the steward of the site. Their management is guided by data collected from past site investigations and current monitoring, and by the results of calculations of expected behavior of contaminants remaining in the deep subsurface. The purpose of this screening risk assessment is to evaluate possible health risks from current and future exposure to Rulison contaminants so the information can be factored into LM's stewardship decisions. For example, these risk assessment results can inform decisions regarding institutional controls at the site and appropriate monitoring of nearby natural-gas extraction activities. Specifically, the screening risk analysis can provide guidance for setting appropriate action levels for contaminant monitoring to ensure protection of human health.

Screening Assessment of Potential Human-Health Risk from Future Natural-Gas Drilling Near Project Rulison in Western Colorado

International Nuclear Information System (INIS)

Daniels, Jeffrey I.; Chapman, Jenny B.

2012-01-01

The Project Rulison underground nuclear test was conducted in 1969 at a depth of 8,400 ft in the Williams Fork Formation of the Piceance Basin, west-central Colorado (Figure 1). The U.S. Department of Energy Office of Legacy Management (LM) is the steward of the site. Their management is guided by data collected from past site investigations and current monitoring, and by the results of calculations of expected behavior of contaminants remaining in the deep subsurface. The purpose of this screening risk assessment is to evaluate possible health risks from current and future exposure to Rulison contaminants so the information can be factored into LM's stewardship decisions. For example, these risk assessment results can inform decisions regarding institutional controls at the site and appropriate monitoring of nearby natural-gas extraction activities. Specifically, the screening risk analysis can provide guidance for setting appropriate action levels for contaminant monitoring to ensure protection of human health.

Allergenicity assessment strategy for novel food proteins and protein sources.

Science.gov (United States)

Verhoeckx, Kitty; Broekman, Henrike; Knulst, André; Houben, Geert

2016-08-01

To solve the future food insecurity problem, alternative and sustainable protein sources (e.g. insects, rapeseed, fava bean and algae) are now being explored for the production of food and feed. To approve these novel protein sources for future food a comprehensive risk assessment is needed according to the European food legislation. Allergenicity risk assessment might pose some major difficulties, since detailed guidance on how to assess the allergenic potential of novel foods is not available. At present, the approach relies mostly on the guidance of allergenicity assessment for genetically modified (GM) plant foods. The most recent one was proposed by EFSA (2010 and 2011); "weight-of-evidence approach". However this guidance is difficult to interpret, not completely applicable or validated for novel foods and therefore needs some adjustments. In this paper we propose a conceptual strategy which is based on the "weight-of-evidence approach" for food derived from GM plants and other strategies that were previously published in the literature. This strategy will give more guidance on how to assess the allergenicity of novel food proteins and protein sources. Copyright © 2016 Elsevier Inc. All rights reserved.

Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance.

Science.gov (United States)

Sveistrup, Joen; af Rosenschöld, Per Munck; Deasy, Joseph O; Oh, Jung Hun; Pommer, Tobias; Petersen, Peter Meidahl; Engelholm, Svend Aage

2014-02-04

Image-guided radiotherapy (IGRT) facilitates the delivery of a very precise radiation dose. In this study we compare the toxicity and biochemical progression-free survival between patients treated with daily image-guided intensity-modulated radiotherapy (IG-IMRT) and 3D conformal radiotherapy (3DCRT) without daily image guidance for high risk prostate cancer (PCa). A total of 503 high risk PCa patients treated with radiotherapy (RT) and endocrine treatment between 2000 and 2010 were retrospectively reviewed. 115 patients were treated with 3DCRT, and 388 patients were treated with IG-IMRT. 3DCRT patients were treated to 76 Gy and without daily image guidance and with 1-2 cm PTV margins. IG-IMRT patients were treated to 78 Gy based on daily image guidance of fiducial markers, and the PTV margins were 5-7 mm. Furthermore, the dose-volume constraints to both the rectum and bladder were changed with the introduction of IG-IMRT. The 2-year actuarial likelihood of developing grade > = 2 GI toxicity following RT was 57.3% in 3DCRT patients and 5.8% in IG-IMRT patients (p analysis, 3DCRT was associated with a significantly increased risk of developing grade > = 2 GI toxicity compared to IG-IMRT (p analysis there was no difference in biochemical progression-free survival between 3DCRT and IG-IMRT. The difference in toxicity can be attributed to the combination of the IMRT technique with reduced dose to organs-at-risk, daily image guidance and margin reduction.

Risk-based and deterministic regulation

International Nuclear Information System (INIS)

Fischer, L.E.; Brown, N.W.

1995-07-01

Both risk-based and deterministic methods are used for regulating the nuclear industry to protect the public safety and health from undue risk. The deterministic method is one where performance standards are specified for each kind of nuclear system or facility. The deterministic performance standards address normal operations and design basis events which include transient and accident conditions. The risk-based method uses probabilistic risk assessment methods to supplement the deterministic one by (1) addressing all possible events (including those beyond the design basis events), (2) using a systematic, logical process for identifying and evaluating accidents, and (3) considering alternative means to reduce accident frequency and/or consequences. Although both deterministic and risk-based methods have been successfully applied, there is need for a better understanding of their applications and supportive roles. This paper describes the relationship between the two methods and how they are used to develop and assess regulations in the nuclear industry. Preliminary guidance is suggested for determining the need for using risk based methods to supplement deterministic ones. However, it is recommended that more detailed guidance and criteria be developed for this purpose

UV DISINFECTION GUIDANCE MANUAL FOR THE ...

Science.gov (United States)

Provides technical information on selection, design and operation of UV systems; provides regulatory agencies with guidance and the necessary tools to assess UV systems at the design, start-up, and routine operation phase; provides manufacturers with the testing and performance standards for UV components and systems for treating drinking water. Provide guidance to water systems, regulators and manufacturers on UV disinfection of drinking water.

Approach and Strategy for Performing Ecological Risk Assessments for the Department of Energy Oak Ridge Field Office Environmental Restoration Program

Energy Technology Data Exchange (ETDEWEB)

Suter, G.W. II

1992-01-01

This technical memorandum provides guidance for planning and performing ecological risk assessments (ERAs) on the Oak Ridge Reservation (ORR). This work was performed under Work Breakdown Structure 1.4.12.2.3.04.07.02 (Activity Data Sheet 8304) and meets an Environmental Restoration Program milestone for FY 95. The strategy discussed in this report is consistent with the overall strategy for site management and Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) compliance developed for the ORR and relevant U.S. Environmental Protection Agency documents and guidance. The general approach and strategy presented herein was developed for the ORR, but it could be applicable to other complex CERCLA sites that possess significant ecological resources.

Risk assessment and optimization (ALARA) analysis for the environmental remediation of Brookhaven National Laboratory's hazardous waste management facility

International Nuclear Information System (INIS)

Dionne, B.J.; Morris, S.C. III; Baum, J.W.

1998-01-01

The Department of Energy's (DOE) Office of Environment, Safety, and Health (EH) sought examples of risk-based approaches to environmental restoration to include in their guidance for DOE nuclear facilities. Extensive measurements of radiological contamination in soil and ground water have been made at Brookhaven National Laboratory's Hazardous Waste Management Facility (HWMF) as part of a Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) remediation process. This provided an ideal opportunity for a case study. This report provides a risk assessment and an open-quotes As Low as Reasonably Achievableclose quotes (ALARA) analysis for use at other DOE nuclear facilities as an example of a risk-based decision technique. This document contains the Appendices for the report

The Apache Longbow-Hellfire Missile Test at Yuma Proving Ground: Introduction and Problem Formulation for a Multiple Stressor Risk Assessment

International Nuclear Information System (INIS)

Efroymson, Rebecca Ann; Peterson, Mark J.; Jones, Daniel Steven; Suter, Glenn

2008-01-01

An ecological risk assessment was conducted at Yuma Proving Ground, Arizona, as a demonstration of the Military Ecological Risk Assessment Framework (MERAF). The focus of the assessment was a testing program at Cibola Range, which involved an Apache Longbow helicopter firing Hellfire missiles at moving targets, i.e., M60-A1 tanks. The problem formulation for the assessment included conceptual models for three component activities of the test, helicopter overflight, missile firing, and tracked vehicle movement, and two ecological endpoint entities, woody desert wash communities and desert mule deer (Odocoileus hemionus crooki) populations. An activity-specific risk assessment framework was available to provide guidance for assessing risks associated with aircraft overflights. Key environmental features of the study area include barren desert pavement and tree-lined desert washes. The primary stressors associated with helicopter overflights were sound and the view of the aircraft. The primary stressor associated with Hellfire missile firing was sound. The principal stressor associated with tracked vehicle movement was soil disturbance, and a resulting, secondary stressor was hydrological change. Water loss to washes and wash vegetation was expected to result from increased ponding, infiltration and/or evaporation associated with disturbances to desert pavement. A plan for estimating integrated risks from the three military activities was included in the problem formulation

Information needs for risk assessment

Energy Technology Data Exchange (ETDEWEB)

DeRosa, C.T.; Choudhury, H.; Schoeny, R.S.

1990-12-31

Risk assessment can be thought of as a conceptual approach to bridge the gap between the available data and the ultimate goal of characterizing the risk or hazard associated with a particular environmental problem. To lend consistency to and to promote quality in the process, the US Environmental Protection Agency (EPA) published Guidelines for Risk Assessment of Carcinogenicity, Developmental Toxicity, Germ Cell Mutagenicity and Exposure Assessment, and Risk Assessment of Chemical Mixtures. The guidelines provide a framework for organizing the information, evaluating data, and for carrying out the risk assessment in a scientifically plausible manner. In the absence of sufficient scientific information or when abundant data are available, the guidelines provide alternative methodologies that can be employed in the risk assessment. 4 refs., 3 figs., 2 tabs.

Genetically modified crops and aquatic ecosystems: considerations for environmental risk assessment and non-target organism testing.

Science.gov (United States)

Carstens, Keri; Anderson, Jennifer; Bachman, Pamela; De Schrijver, Adinda; Dively, Galen; Federici, Brian; Hamer, Mick; Gielkens, Marco; Jensen, Peter; Lamp, William; Rauschen, Stefan; Ridley, Geoff; Romeis, Jörg; Waggoner, Annabel

2012-08-01

Environmental risk assessments (ERA) support regulatory decisions for the commercial cultivation of genetically modified (GM) crops. The ERA for terrestrial agroecosystems is well-developed, whereas guidance for ERA of GM crops in aquatic ecosystems is not as well-defined. The purpose of this document is to demonstrate how comprehensive problem formulation can be used to develop a conceptual model and to identify potential exposure pathways, using Bacillus thuringiensis (Bt) maize as a case study. Within problem formulation, the insecticidal trait, the crop, the receiving environment, and protection goals were characterized, and a conceptual model was developed to identify routes through which aquatic organisms may be exposed to insecticidal proteins in maize tissue. Following a tiered approach for exposure assessment, worst-case exposures were estimated using standardized models, and factors mitigating exposure were described. Based on exposure estimates, shredders were identified as the functional group most likely to be exposed to insecticidal proteins. However, even using worst-case assumptions, the exposure of shredders to Bt maize was low and studies supporting the current risk assessments were deemed adequate. Determining if early tier toxicity studies are necessary to inform the risk assessment for a specific GM crop should be done on a case by case basis, and should be guided by thorough problem formulation and exposure assessment. The processes used to develop the Bt maize case study are intended to serve as a model for performing risk assessments on future traits and crops.

Comprehensive multipathway risk assessment of chemicals associated with recycled ("crumb") rubber in synthetic turf fields.

Science.gov (United States)

Peterson, Michael K; Lemay, Julie C; Pacheco Shubin, Sara; Prueitt, Robyn L

2018-01-01

Thousands of synthetic turf fields in the US are regularly used by millions of individuals (particularly children and adolescents). Although many safety assessments have concluded that there are low or negligible risks related to exposure to chemicals found in the recycled rubber used to make these fields, concerns remain about the safety of this product. Existing studies of recycled rubber's potential health risks have limitations such as small sample sizes and limited evaluation of relevant exposure pathways and scenarios. Conduct a comprehensive multipathway human health risk assessment (HHRA) of exposure to chemicals found in recycled rubber. All available North American data on the chemical composition of recycled rubber, as well as air sampling data collected on or near synthetic turf fields, were identified via a literature search. Ingestion, dermal contact, and inhalation pathways were evaluated according to US Environmental Protection Agency (US EPA) guidance, and exposure scenarios for adults, adolescents, and children were considered. Estimated non-cancer hazards and cancer risks for all the evaluated scenarios were within US EPA guidelines. In addition, cancer risk levels for users of synthetic turf field were comparable to or lower than those associated with natural soil fields. This HHRA's results add to the growing body of literature that suggests recycled rubber infill in synthetic turf poses negligible risks to human health. This comprehensive assessment provides data that allow stakeholders to make informed decisions about installing and using these fields. Copyright © 2017 Elsevier Inc. All rights reserved.

Probabilistic risk assessment as an aid to risk management

International Nuclear Information System (INIS)

Garrick, B.J.

1982-01-01

Probabilistic risk assessments are providing important insights into nuclear power plant safety. Their value is two-fold: first as a means of quantifying nuclear plant risk including contributors to risk, and second as an aid to risk management. A risk assessment provides an analytical plant model that can be the basis for performing meaningful decision analyses for controlling safety. It is the aspect of quantitative risk management that makes probabilistic risk assessment an important technical discipline of the future

Methodology of environmental risk assessment management

Directory of Open Access Journals (Sweden)

Saša T. Bakrač

2012-04-01

Full Text Available Successful protection of environment is mostly based on high-quality assessment of potential and present risks. Environmental risk management is a complex process which includes: identification, assessment and control of risk, namely taking measures in order to minimize the risk to an acceptable level. Environmental risk management methodology: In addition to these phases in the management of environmental risk, appropriate measures that affect the reduction of risk occurrence should be implemented: - normative and legal regulations (laws and regulations, - appropriate organizational structures in society, and - establishing quality monitoring of environment. The emphasis is placed on the application of assessment methodologies (three-model concept, as the most important aspect of successful management of environmental risk. Risk assessment methodology - European concept: The first concept of ecological risk assessment methodology is based on the so-called European model-concept. In order to better understand this ecological risk assessment methodology, two concepts - hazard and risk - are introduced. The European concept of environmental risk assessment has the following phases in its implementation: identification of hazard (danger, identification of consequences (if there is hazard, estimate of the scale of consequences, estimate of consequence probability and risk assessment (also called risk characterization. The European concept is often used to assess risk in the environment as a model for addressing the distribution of stressors along the source - path - receptor line. Risk assessment methodology - Canadian concept: The second concept of the methodology of environmental risk assessment is based on the so-called Canadian model-concept. The assessment of ecological risk includes risk arising from natural events (floods, extreme weather conditions, etc., technological processes and products, agents (chemical, biological, radiological, etc

Defining the role of risk assessment in the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) remedial investigation process at the DOE-OR

International Nuclear Information System (INIS)

Miller, P.D.; McGinn, C.W.; Purucker, S.T.; White, R.K.

1994-08-01

The risk assessment strategy that will be implemented on the Oak Ridge Reservation has been standardized to ensure consistency and technical defensibility in all risk assessment activities and is presented within this document. The strategy emphasizes using existing environmental data in screening risk analyses to aid in identifying chemicals of potential concern, operable units that could pursue a no further investigation determination, and operable units that may warrant early response actions. The screening risk analyses include a comparison of measured chemical concentrations to preliminary remediation goals, performing a most likely exposure and integration point assessment, and performing a screening ecological risk assessment. This document focuses heavily on the screening risk analyses and relies on existing U.S. Environmental Protection Agency risk assessment guidance to provide specific details on conducting baseline risk assessments. However, the document does contain a section on the baseline risk assessment process that details the exposure pathways to be evaluated on the Oak Ridge Reservation. This document will be used in conjunction with existing Martin Marietta Energy Systems, Inc. Environmental Restoration risk assessment standards, policies, procedures, and technical memoranda. The material contained herein will be periodically updated as the strategy is tried and tested and as the risk assessment methodology is revised. The primary purpose for this document is to present the proposed strategy to the Tennessee Department of Environment and Conservation and the U.S. Environmental Protection Agency, Region IV and receive concurrence or additional comments on the material presented herein

UK regulatory standards - the 'Guidance on requirements for authorisation'

International Nuclear Information System (INIS)

Williams, C.R.

1999-01-01

In the United Kingdom, disposal of radioactive waste requires an authorisation under the Radioactive Substances Act 1993. The power to grant such authorisations rests with the Environment Agency for disposals in England and Wales, and with similar Agencies in Scotland and Northern Ireland - namely the Scottish Environment Protection Agency (SEPA) and the Environment and Heritage Service (EHS) of the Department of the Environment for Northern Ireland. In 1997, following two rounds of consultation, the Environment Agency jointly with SEPA and EHS published a document 'Disposal Facilities on Land for Low and Intermediate Level Radioactive Wastes: Guidance on Requirements for Authorisation' - the GRA document. The GRA document outlines the regulatory framework governing the disposal of radioactive waste, general guidance on procedures, the principles and criteria against which proposals for a disposal facility will be assessed, and the radiological and technical requirements which a facility will be expected to meet. In particular, the document states that, in the period after control is withdrawn, the assessed radiological risk from a facility to a representative member of the potentially exposed group at greatest risk should be consistent with a risk target of 10 -6 per year. The document also specifies the information which a developer will need to provide, to demonstrate that a proposal is consistent with the principles and requirements, and identifies other, non-risk-based, criteria. In March 1997, the Secretary of State for the Environment rejected a planning appeal by United Kingdom Nirex Ltd for an underground Rock Characterisation Facility located near Sellafield in Cumbria. That decision has effectively delayed the construction of any deep repository in the UK. Subsequently a House of Lords Select Committee has commenced a major review of nuclear waste management. The Environment Agency continues to be responsible for the authorisation of the shallow

Strategic Risk Assessment

Science.gov (United States)

Derleth, Jason; Lobia, Marcus

2009-01-01

This slide presentation provides an overview of the attempt to develop and demonstrate a methodology for the comparative assessment of risks across the entire portfolio of NASA projects and assets. It includes information about strategic risk identification, normalizing strategic risks, calculation of relative risk score, and implementation options.

Overview of risk assessment

International Nuclear Information System (INIS)

Rimington, J.D.

1992-01-01

The paper begins by defining some terms, and then refer to a number of technical and other difficulties. Finally it attempts to set out why risk assessment is important and what its purposes are. 2) First, risk and risk assessment - what are they?. 3) Risk is a subject of universal significance. Life is very uncertain, and we can achieve no object or benefit in it except by approaching nearer to particular hazards which lie between us and our objects. That approach represents acceptance of risk. 4) Risk assessment is a way of systematising our approach to hazard with a view to determining what is more and what is less risky. It helps us in the end to diminish our exposure while obtaining whatever benefits we have in mind, or to optimise the risks and the benefits

Overview of risk assessment

Energy Technology Data Exchange (ETDEWEB)

Rimington, J D [Health and Safety Executive (United Kingdom)

1992-07-01

The paper begins by defining some terms, and then refer to a number of technical and other difficulties. Finally it attempts to set out why risk assessment is important and what its purposes are. 2) First, risk and risk assessment - what are they?. 3) Risk is a subject of universal significance. Life is very uncertain, and we can achieve no object or benefit in it except by approaching nearer to particular hazards which lie between us and our objects. That approach represents acceptance of risk. 4) Risk assessment is a way of systematising our approach to hazard with a view to determining what is more and what is less risky. It helps us in the end to diminish our exposure while obtaining whatever benefits we have in mind, or to optimise the risks and the benefits.

75 FR 8412 - Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of...

Science.gov (United States)

2010-02-24

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0047] Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of Accidental Radionuclide Releases; Solicitation of Public... ground water flow and transport of accidental radionuclide releases necessary to demonstrate compliance...

[Urban ecological risk assessment: a review].

Science.gov (United States)

Wang, Mei-E; Chen, Wei-Ping; Peng, Chi

2014-03-01

With the development of urbanization and the degradation of urban living environment, urban ecological risks caused by urbanization have attracted more and more attentions. Based on urban ecology principles and ecological risk assessment frameworks, contents of urban ecological risk assessment were reviewed in terms of driven forces, risk resources, risk receptors, endpoints and integrated approaches for risk assessment. It was suggested that types and degrees of urban economical and social activities were the driven forces for urban ecological risks. Ecological functional components at different levels in urban ecosystems as well as the urban system as a whole were the risk receptors. Assessment endpoints involved in changes of urban ecological structures, processes, functional components and the integrity of characteristic and function. Social-ecological models should be the major approaches for urban ecological risk assessment. Trends for urban ecological risk assessment study should focus on setting a definite protection target and criteria corresponding to assessment endpoints, establishing a multiple-parameter assessment system and integrative assessment approaches.

[Forensic assessment of violence risk].

Science.gov (United States)

Pujol Robinat, Amadeo; Mohíno Justes, Susana; Gómez-Durán, Esperanza L

2014-03-01

Over the last 20 years there have been steps forward in the field of scientific research on prediction and handling different violent behaviors. In this work we go over the classic concept of "criminal dangerousness" and the more current of "violence risk assessment". We analyze the evolution of such assessment from the practice of non-structured clinical expert opinion to current actuarial methods and structured clinical expert opinion. Next we approach the problem of assessing physical violence risk analyzing the HCR-20 (Assessing Risk for Violence) and we also review the classic and complex subject of the relation between mental disease and violence. One of the most problematic types of violence, difficult to assess and predict, is sexual violence. We study the different actuarial and sexual violence risk prediction instruments and in the end we advise an integral approach to the problem. We also go through partner violence risk assessment, describing the most frequently used scales, especially SARA (Spouse Assault Risk Assessment) and EPV-R. Finally we give practical advice on risk assessment, emphasizing the importance of having maximum information about the case, carrying out a clinical examination, psychopathologic exploration and the application of one of the described risk assessment scales. We'll have to express an opinion about the dangerousness/risk of future violence from the subject and some recommendations on the conduct to follow and the most advisable treatment. Copyright © 2014 Elsevier España, S.L. All rights reserved.

Health effects of fine particulate matter in life cycle impact assessment: findings from the Basel Guidance Workshop

DEFF Research Database (Denmark)

Fantke, Peter; Jolliet, Olivier; Evans, John S.

2015-01-01

Purpose Fine particulate matter (PM2.5) is considered to be one of the most important environmental factors contributing to the global human disease burden. However, due to the lack of broad consensus and harmonization in the life cycle assessment (LCA) community, there is no clear guidance on ho...

Human exposure assessment for biocides in the EU development of step by step guidance and worked examples

NARCIS (Netherlands)

Gerritsen-Ebben, R.M.G.; Hemmen, J.J. van

2007-01-01

Directive 98/8/EC(1) concerns EU harmonisation of placing biocidal products on the market. In the present short paper the preliminary results of an ongoing project are presented in which step by step guidance on human exposure assessment with worked examples is developed. For all 23 biocidal product

Risk Assessment and Integration Team (RAIT) Portfolio Risk Analysis Strategy

Science.gov (United States)

Edwards, Michelle

2010-01-01

Impact at management level: Qualitative assessment of risk criticality in conjunction with risk consequence, likelihood, and severity enable development of an "investment policy" towards managing a portfolio of risks. Impact at research level: Quantitative risk assessments enable researchers to develop risk mitigation strategies with meaningful risk reduction results. Quantitative assessment approach provides useful risk mitigation information.

[Risk Assessment and Risk Management of Chemicals in China].

Science.gov (United States)

Wang, Tie-yu; Zhou, Yun-qiao; Li, Qi-feng; Lü, Yong-long

2016-02-15

Risk assessment and risk management have been increasingly approved as an effective approach for appropriate disposal and scientific management of chemicals. This study systematically analyzed the risk assessment methods of chemicals from three aspects including health risk, ecological risk and regional risk. Based on the current situation of classification and management towards chemicals in China, a specific framework of risk management on chemicals was proposed by selecting target chemicals, predominant industries and related stakeholders as the objects. The results of the present study will provide scientific support for improving risk assessment and reasonable management of chemicals in China.

Integrated risk information system (IRIS)

Energy Technology Data Exchange (ETDEWEB)

Tuxen, L. [Environmental Protection Agency, Washington, DC (United States)

1990-12-31

The Integrated Risk Information System (IRIS) is an electronic information system developed by the US Environmental Protection Agency (EPA) containing information related to health risk assessment. IRIS is the Agency`s primary vehicle for communication of chronic health hazard information that represents Agency consensus following comprehensive review by intra-Agency work groups. The original purpose for developing IRIS was to provide guidance to EPA personnel in making risk management decisions. This original purpose for developing IRIS was to guidance to EPA personnel in making risk management decisions. This role has expanded and evolved with wider access and use of the system. IRIS contains chemical-specific information in summary format for approximately 500 chemicals. IRIS is available to the general public on the National Library of Medicine`s Toxicology Data Network (TOXNET) and on diskettes through the National Technical Information Service (NTIS).

Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

DEFF Research Database (Denmark)

Satya, Sneha; Wade, Mike; Hass, Ulla

This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing and Asses......This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing...... on testing and assessment of endocrine disrupters (EDTA AG). In November 2010, comments were requested from the WNT, the EDTA AG, the Task Force on Hazard Assessment and experts involved in the assessment of chemicals. The EDTA AG addressed the comments from the WNT at a meeting held in April 2011...... the conclusions and next steps recommended in the draft guidance document are sensible and helpful when assessed in light of comprehensive datasets. The draft guidance document and the three case studies were reviewed again and revised at a meeting of the EDTA AG in December 2011. The draft guidance document...

77 FR 29458 - Supervisory Guidance on Stress Testing for Banking Organizations With More Than $10 Billion in...

Science.gov (United States)

2012-05-17

... of risk management, the final guidance provides principles that a banking organization should follow... integrated into overall risk management.\\8\\ The agencies expect such companies would follow the principles... risk management program. The guidance outlines broad principles for a [[Page 29464

Assessing and Managing Knowledge Loss Risk

International Nuclear Information System (INIS)

Dermarkar, Fred

2013-01-01

Summary: • Sustaining Design Basis Knowledge is a strategic need for long term safe and reliable operation; • Utilities need to manage knowledge in a systematic manner, based on identifying areas of risk, developing and implementing plans to mitigate the risk, and exercising oversight of those plans; • Approaches will differ depending upon organizational functions and needs; • Individual utility efforts are not sufficient: they need to be complemented by a larger scale infrastructure in the academic and research communities; • The Canadian nuclear industry has been collaborating to actively support and expand the academic infrastructure to sustain design basis knowledge; • KM initiatives require constant nurturing for sustainability; • Internationally recognized guidance on Characteristics, Attributes and Best Practices for governmental, industrial and academic contributions to KM is important to sustainability

Risk assessment and optimization (ALARA) analysis for the environmental remediation of Brookhaven National Laboratory`s hazardous waste management facility

Energy Technology Data Exchange (ETDEWEB)

Dionne, B.J.; Morris, S. III; Baum, J.W. [and others

1998-03-01

The Department of Energy`s (DOE) Office of Environment, Safety, and Health (EH) sought examples of risk-based approaches to environmental restoration to include in their guidance for DOE nuclear facilities. Extensive measurements of radiological contamination in soil and ground water have been made at Brookhaven National Laboratory`s Hazardous Waste Management Facility (HWMF) as part of a Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) remediation process. This provided an ideal opportunity for a case study. This report provides a risk assessment and an {open_quotes}As Low as Reasonably Achievable{close_quotes} (ALARA) analysis for use at other DOE nuclear facilities as an example of a risk-based decision technique.

Patient caries risk assessment

DEFF Research Database (Denmark)

Twetman, Svante; Fontana, Margherita

2009-01-01

Risk assessment is an essential component in the decision-making process for the correct prevention and management of dental caries. Multiple risk factors and indicators have been proposed as targets in the assessment of risk of future disease, varying sometimes based on the age group at which...... they are targeted. Multiple reviews and systematic reviews are available in the literature on this topic. This chapter focusses primarily on results of reviews based on longitudinal studies required to establish the accuracy of caries risk assessment. These findings demonstrate that there is a strong body...... of evidence to support that caries experience is still, unfortunately, the single best predictor for future caries development. In young children, prediction models which include a variety of risk factors seem to increase the accuracy of the prediction, while the usefulness of additional risk factors...

Generic Assessment Criteria for human health risk assessment of potentially contaminated land in China.

Science.gov (United States)

Cheng, Yuanyuan; Nathanail, Paul C

2009-12-20

Generic Assessment Criteria (GAC) are derived using widely applicable assumptions about the characteristics and behaviour of contaminant sources, pathways and receptors. GAC provide nationally consistent guidance, thereby saving money and time. Currently, there are no human health based Generic Assessment Criteria (GAC) for contaminated sites in China. Protection of human health is therefore difficult to ensure and demonstrate; and the lack of GAC makes it difficult to tell if there is potential significant risk to human health unless site-specific criteria are derived. This paper derived Chinese GAC (GAC) for five inorganic and eight organic substances for three regions in China for three land uses: urban residential without plant uptake, Chinese cultivated land, and commercial/industrial using the SNIFFER model. The SNIFFER model has been further implemented with a dermal absorption algorithm and the model default input values have been changed to reflect the Chinese exposure scenarios. It is envisaged that the modified SNIFFER model could be used to derive GAC for more contaminants, more Regions, and more land uses. Further research to enhance the reliability and acceptability of the GAC is needed in regional/national surveys in diet and working patterns.

Building better environmental risk assessments

Directory of Open Access Journals (Sweden)

Raymond eLayton

2015-08-01

Full Text Available Risk assessment is a reasoned, structured approach to address uncertainty based on scientific and technical evidence. It forms the foundation for regulatory decision making, which is bound by legislative and policy requirements, as well as the need for making timely decisions using available resources. In order to be most useful, environmental risk assessments (ERA for genetically modified (GM crops should provide consistent, reliable, and transparent results across all types of GM crops, traits, and environments. The assessments must also separate essential information from scientific or agronomic data of marginal relevance or value for evaluating risk and complete the assessment in a timely fashion. Challenges in conducting ERAs differ across regulatory systems – examples are presented from Canada, Malaysia, and Argentina. One challenge faced across the globe is the conduct of risk assessments with limited resources. This challenge can be overcome by clarifying risk concepts, placing greater emphasis on data critical to assess environmental risk (for example, phenotypic and plant performance data rather than molecular data, and adapting advances in risk analysis from other relevant disciplines.

Building Better Environmental Risk Assessments

Science.gov (United States)

Layton, Raymond; Smith, Joe; Macdonald, Phil; Letchumanan, Ramatha; Keese, Paul; Lema, Martin

2015-01-01

Risk assessment is a reasoned, structured approach to address uncertainty based on scientific and technical evidence. It forms the foundation for regulatory decision-making, which is bound by legislative and policy requirements, as well as the need for making timely decisions using available resources. In order to be most useful, environmental risk assessments (ERAs) for genetically modified (GM) crops should provide consistent, reliable, and transparent results across all types of GM crops, traits, and environments. The assessments must also separate essential information from scientific or agronomic data of marginal relevance or value for evaluating risk and complete the assessment in a timely fashion. Challenges in conducting ERAs differ across regulatory systems – examples are presented from Canada, Malaysia, and Argentina. One challenge faced across the globe is the conduct of risk assessments with limited resources. This challenge can be overcome by clarifying risk concepts, placing greater emphasis on data critical to assess environmental risk (for example, phenotypic and plant performance data rather than molecular data), and adapting advances in risk analysis from other relevant disciplines. PMID:26301217

Building Better Environmental Risk Assessments.

Science.gov (United States)

Layton, Raymond; Smith, Joe; Macdonald, Phil; Letchumanan, Ramatha; Keese, Paul; Lema, Martin

2015-01-01

Risk assessment is a reasoned, structured approach to address uncertainty based on scientific and technical evidence. It forms the foundation for regulatory decision-making, which is bound by legislative and policy requirements, as well as the need for making timely decisions using available resources. In order to be most useful, environmental risk assessments (ERAs) for genetically modified (GM) crops should provide consistent, reliable, and transparent results across all types of GM crops, traits, and environments. The assessments must also separate essential information from scientific or agronomic data of marginal relevance or value for evaluating risk and complete the assessment in a timely fashion. Challenges in conducting ERAs differ across regulatory systems - examples are presented from Canada, Malaysia, and Argentina. One challenge faced across the globe is the conduct of risk assessments with limited resources. This challenge can be overcome by clarifying risk concepts, placing greater emphasis on data critical to assess environmental risk (for example, phenotypic and plant performance data rather than molecular data), and adapting advances in risk analysis from other relevant disciplines.

Risk Assessment Stability: A Revalidation Study of the Arizona Risk/Needs Assessment Instrument

Science.gov (United States)

Schwalbe, Craig S.

2009-01-01

The actuarial method is the gold standard for risk assessment in child welfare, juvenile justice, and criminal justice. It produces risk classifications that are highly predictive and that may be robust to sampling error. This article reports a revalidation study of the Arizona Risk/Needs Assessment instrument, an actuarial instrument for juvenile…

Integrate life-cycle assessment and risk analysis results, not methods.

Science.gov (United States)

Linkov, Igor; Trump, Benjamin D; Wender, Ben A; Seager, Thomas P; Kennedy, Alan J; Keisler, Jeffrey M

2017-08-04

Two analytic perspectives on environmental assessment dominate environmental policy and decision-making: risk analysis (RA) and life-cycle assessment (LCA). RA focuses on management of a toxicological hazard in a specific exposure scenario, while LCA seeks a holistic estimation of impacts of thousands of substances across multiple media, including non-toxicological and non-chemically deleterious effects. While recommendations to integrate the two approaches have remained a consistent feature of environmental scholarship for at least 15 years, the current perception is that progress is slow largely because of practical obstacles, such as a lack of data, rather than insurmountable theoretical difficulties. Nonetheless, the emergence of nanotechnology presents a serious challenge to both perspectives. Because the pace of nanomaterial innovation far outstrips acquisition of environmentally relevant data, it is now clear that a further integration of RA and LCA based on dataset completion will remain futile. In fact, the two approaches are suited for different purposes and answer different questions. A more pragmatic approach to providing better guidance to decision-makers is to apply the two methods in parallel, integrating only after obtaining separate results.

Exposure Assessment Tools by Chemical Classes - Nanomaterials

Science.gov (United States)

EPA ExpoBox is a toolbox for exposure assessors. Its purpose is to provide a compendium of exposure assessment and risk characterization tools that will present comprehensive step-by-step guidance and links to relevant exposure assessment data bases

Moisture Control Guidance for Commercial and Public ...

Science.gov (United States)

This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled

RISK MANAGEMENT: AN INTEGRATED APPROACH TO RISK MANAGEMENT AND ASSESSMENT

Directory of Open Access Journals (Sweden)

Szabo Alina

2012-12-01

Full Text Available Purpose: The objective of this paper is to offer an overview over risk management cycle by focusing on prioritization and treatment, in order to ensure an integrated approach to risk management and assessment, and establish the ‘top 8-12’ risks report within the organization. The interface with Internal Audit is ensured by the implementation of the scoring method to prioritize risks collected from previous generated risk report. Methodology/approach: Using evidence from other research in the area and the professional expertise, this article outlines an integrated approach to risk assessment and risk management reporting processes, by separating the risk in two main categories: strategic and operational risks. The focus is on risk prioritization and scoring; the final output will comprise a mix of strategic and operational (‘top 8-12’ risks, which should be used to establish the annual Internal Audit plan. Originality/value: By using an integrated approach to risk assessment and risk management will eliminate the need for a separate Internal Audit risk assessment over prevailing risks. It will reduce the level of risk assessment overlap by different functions (Tax, Treasury, Information System over the same risk categories as a single methodology, is used and will align timings of risk assessment exercises. The risk prioritization by usage of risk and control scoring criteria highlights the combination between financial and non-financial impact criteria allowing risks that do not naturally lend themselves to a financial amount to be also assessed consistently. It is emphasized the usage of score method to prioritize the risks included in the annual audit plan in order to increase accuracy and timelines.

Applicable value of real time interventional ultrasound guidance in family planning reproduction operation

International Nuclear Information System (INIS)

Wu Guoping; Zou Dongfang; Sun Jian; Dong Weihua

2007-01-01

Objective: To determine the clinical value of real time interventional ultrasound guidance in family planning reproduction operation. Methods: Under the guidance of ultrasound monitoring, 522 cases with high risk and difficult uterine operation were undertaken in our department. Results: The abdominal endoscopic contraceptive uterine operation under real time ultrasound monitoring was carried out for 522 cases in 4 years, with successful rates for high risk pregnancy as 287/289 cases, high risk troublesome withdrawal of contraceptive ring as 129/130 cases and puzzling uterine operation as 103/103 cases. The total successful rate reached 99.42%, without uterine rupture and other complications. Conclusion: The former complex, blind and difficult uterine operations turn to be simple, safe and reliable under the guidance of real time ultrasound. (authors)

Career Guidance Books Assess the Value of Journalism Education.

Science.gov (United States)

Steiner, Linda

1994-01-01

Examines the advice given about journalism preparation and education in 100 career guidance books and general inventories of careers published over the last century. Discusses educating journalists, the special case of women, and shifting assumptions. (SR)

76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

Science.gov (United States)

2011-02-28

...] Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication... a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion... Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance is...

Risk assessment: 'A consumer's perspective'

International Nuclear Information System (INIS)

Waterhouse, Rachel

1992-01-01

The paper assesses the concept of risk, risk assessment and tolerability of risk from consumer point of view. Review of existing UK and EC directives on certain products and appliances is also covered

Risk assessment: 'A consumer's perspective'

Energy Technology Data Exchange (ETDEWEB)

Waterhouse, Rachel [Consumer' s Association, Health and Safety Commission (United Kingdom)

1992-07-01

The paper assesses the concept of risk, risk assessment and tolerability of risk from consumer point of view. Review of existing UK and EC directives on certain products and appliances is also covered.

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

Using risk assessment in periodontics.

Science.gov (United States)

Woodman, Alan J

2014-08-01

Risk assessment has become a regular feature in both dental practice and society as a whole, and principles used to assess risk in society are similar to those used in a clinical setting. Although the concept of risk assessment as a prognostic indicator for periodontal disease incidence and activity is well established in the management of periodontitis, the use of risk assessment to manage the practical treatment of periodontitis and its sequelae appears to have less foundation. A simple system of initial risk assessment - building on the use of the Basic Periodontal Examination (BPE), clinical, medical and social factors - is described, linked to protocols for delivering care suited to general dental practice and stressing the role of long-term supportive care. The risks of not treating the patient are considered, together with the possible causes of failure, and the problems of successful treatment are illustrated by the practical management of post-treatment recession.

Improvement in toxicity in high risk prostate cancer patients treated with image-guided intensity-modulated radiotherapy compared to 3D conformal radiotherapy without daily image guidance

International Nuclear Information System (INIS)

Sveistrup, Joen; Rosenschöld, Per Munck af; Deasy, Joseph O; Oh, Jung Hun; Pommer, Tobias; Petersen, Peter Meidahl; Engelholm, Svend Aage

2014-01-01

Image-guided radiotherapy (IGRT) facilitates the delivery of a very precise radiation dose. In this study we compare the toxicity and biochemical progression-free survival between patients treated with daily image-guided intensity-modulated radiotherapy (IG-IMRT) and 3D conformal radiotherapy (3DCRT) without daily image guidance for high risk prostate cancer (PCa). A total of 503 high risk PCa patients treated with radiotherapy (RT) and endocrine treatment between 2000 and 2010 were retrospectively reviewed. 115 patients were treated with 3DCRT, and 388 patients were treated with IG-IMRT. 3DCRT patients were treated to 76 Gy and without daily image guidance and with 1–2 cm PTV margins. IG-IMRT patients were treated to 78 Gy based on daily image guidance of fiducial markers, and the PTV margins were 5–7 mm. Furthermore, the dose-volume constraints to both the rectum and bladder were changed with the introduction of IG-IMRT. The 2-year actuarial likelihood of developing grade > = 2 GI toxicity following RT was 57.3% in 3DCRT patients and 5.8% in IG-IMRT patients (p < 0.001). For GU toxicity the numbers were 41.8% and 29.7%, respectively (p = 0.011). On multivariate analysis, 3DCRT was associated with a significantly increased risk of developing grade > = 2 GI toxicity compared to IG-IMRT (p < 0.001, HR = 11.59 [CI: 6.67-20.14]). 3DCRT was also associated with an increased risk of developing GU toxicity compared to IG-IMRT. The 3-year actuarial biochemical progression-free survival probability was 86.0% for 3DCRT and 90.3% for IG-IMRT (p = 0.386). On multivariate analysis there was no difference in biochemical progression-free survival between 3DCRT and IG-IMRT. The difference in toxicity can be attributed to the combination of the IMRT technique with reduced dose to organs-at-risk, daily image guidance and margin reduction

A total risk assessment methodology for security assessment

International Nuclear Information System (INIS)

Auilar, Richard; Pless, Daniel J.; Kaplan, Paul Garry; Silva, Consuelo Juanita; Rhea, Ronald Edward; Wyss, Gregory Dane; Conrad, Stephen Hamilton

2009-01-01

Sandia National Laboratories performed a two-year Laboratory Directed Research and Development project to develop a new collaborative risk assessment method to enable decision makers to fully consider the interrelationships between threat, vulnerability, and consequence. A five-step Total Risk Assessment Methodology was developed to enable interdisciplinary collaborative risk assessment by experts from these disciplines. The objective of this process is promote effective risk management by enabling analysts to identify scenarios that are simultaneously achievable by an adversary, desirable to the adversary, and of concern to the system owner or to society. The basic steps are risk identification, collaborative scenario refinement and evaluation, scenario cohort identification and risk ranking, threat chain mitigation analysis, and residual risk assessment. The method is highly iterative, especially with regard to scenario refinement and evaluation. The Total Risk Assessment Methodology includes objective consideration of relative attack likelihood instead of subjective expert judgment. The 'probability of attack' is not computed, but the relative likelihood for each scenario is assessed through identifying and analyzing scenario cohort groups, which are groups of scenarios with comparable qualities to the scenario being analyzed at both this and other targets. Scenarios for the target under consideration and other targets are placed into cohort groups under an established ranking process that reflects the following three factors: known targeting, achievable consequences, and the resources required for an adversary to have a high likelihood of success. The development of these target cohort groups implements, mathematically, the idea that adversaries are actively choosing among possible attack scenarios and avoiding scenarios that would be significantly suboptimal to their objectives. An adversary who can choose among only a few comparable targets and scenarios (a

UK guidance for assessing the impact of radioactive substances on wildlife inhabiting Natura 2000 sites

International Nuclear Information System (INIS)

Merrill, P.; Copplestone, D.; Zinger, I.; Allot, R.; Williams, C.

2004-01-01

The UK has a duty to comply with the EU Birds and Habitats Directives when planning and undertaking all of its regulatory and operational activities. These European Directives were introduced into UK legislation by the Conservation (Natural Habitats) Regulations 1994, as amended by the Conservation (Natural Habitats) (England) Regulations 2000. Under these Regulations, the Environment Agency has obligations in England and Wales to review all existing environmental licences to ensure that no Agency authorised activity results in an adverse effect, either directly or indirectly, on the integrity of identified European Sites. In this context European Sites consist of classified or Special Protection Areas (SPA) created under the Wild Birds Directive and candidate or designated Special Areas of Conservation (SAC) under the Habitats Directive. These sites are collectively referred to as Natura 2000 sites. Working in partnership with English Nature and the Countryside Council for Wales, who select Natura 2000 sites, the Agency has put in place a staged approach to the assessment of the impact of ionising radiation on the environment. - Stage 1: Identifying whether the Habitats Regulations are applicable. - Stage 2: Identifying whether authorisations to discharge radioactive substances present a potential risk of significant effect on wildlife and habitats. - Stage 3: Identifying issues to consider when carrying out a more detailed assessment of the potential impact of radioactive discharges for sites identified as presenting a potential risk. - Stage 4: Grant or deny authorisation for regulated discharge purposes, following Stage 3 Assessment. The developed methodology, described in R and D Publication 128 and presented at the IAEA Darwin Symposium in 2003, was used in screening authorisations (Stage 2), and is now needed by practitioners to carry out detailed impact assessments under Stage 3. The current paper will describe how the methodology was used to apply the

Supporting Risk Assessment: Accounting for Indirect Risk to Ecosystem Components.

Directory of Open Access Journals (Sweden)

Cathryn Clarke Murray

Full Text Available The multi-scalar complexity of social-ecological systems makes it challenging to quantify impacts from human activities on ecosystems, inspiring risk-based approaches to assessments of potential effects of human activities on valued ecosystem components. Risk assessments do not commonly include the risk from indirect effects as mediated via habitat and prey. In this case study from British Columbia, Canada, we illustrate how such "indirect risks" can be incorporated into risk assessments for seventeen ecosystem components. We ask whether (i the addition of indirect risk changes the at-risk ranking of the seventeen ecosystem components and if (ii risk scores correlate with trophic prey and habitat linkages in the food web. Even with conservative assumptions about the transfer of impacts or risks from prey species and habitats, the addition of indirect risks in the cumulative risk score changes the ranking of priorities for management. In particular, resident orca, Steller sea lion, and Pacific herring all increase in relative risk, more closely aligning these species with their "at-risk status" designations. Risk assessments are not a replacement for impact assessments, but-by considering the potential for indirect risks as we demonstrate here-they offer a crucial complementary perspective for the management of ecosystems and the organisms within.

Guidance document on practices to model and implement Earthquake hazards in extended PSA (final version). Volume 1

International Nuclear Information System (INIS)

Decker, K.; Hirata, K.; Groudev, P.

2016-01-01

The current report provides guidance for the assessment of seismo-tectonic hazards in level 1 and 2 PSA. The objective is to review existing guidance, identify methodological challenges, and to propose novel guidance on key issues. Guidance for the assessment of vibratory ground motion and fault capability comprises the following: - listings of data required for the hazard assessment and methods to estimate data quality and completeness; - in-depth discussion of key input parameters required for hazard models; - discussions on commonly applied hazard assessment methodologies; - references to recent advances of science and technology. Guidance on the assessment of correlated or coincident hazards comprises of chapters on: - screening of correlated hazards; - assessment of correlated hazards (natural and man-made); - assessment of coincident hazards. (authors)

24 CFR 35.315 - Risk assessment.

Science.gov (United States)

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Risk assessment. 35.315 Section 35... Provided by a Federal Agency Other Than HUD § 35.315 Risk assessment. Each owner shall complete a risk assessment in accordance with 40 CFR 745.227(d). Each risk assessment shall be completed in accordance with...

Chance-Constrained Guidance With Non-Convex Constraints

Science.gov (United States)

Ono, Masahiro

2011-01-01

Missions to small bodies, such as comets or asteroids, require autonomous guidance for descent to these small bodies. Such guidance is made challenging by uncertainty in the position and velocity of the spacecraft, as well as the uncertainty in the gravitational field around the small body. In addition, the requirement to avoid collision with the asteroid represents a non-convex constraint that means finding the optimal guidance trajectory, in general, is intractable. In this innovation, a new approach is proposed for chance-constrained optimal guidance with non-convex constraints. Chance-constrained guidance takes into account uncertainty so that the probability of collision is below a specified threshold. In this approach, a new bounding method has been developed to obtain a set of decomposed chance constraints that is a sufficient condition of the original chance constraint. The decomposition of the chance constraint enables its efficient evaluation, as well as the application of the branch and bound method. Branch and bound enables non-convex problems to be solved efficiently to global optimality. Considering the problem of finite-horizon robust optimal control of dynamic systems under Gaussian-distributed stochastic uncertainty, with state and control constraints, a discrete-time, continuous-state linear dynamics model is assumed. Gaussian-distributed stochastic uncertainty is a more natural model for exogenous disturbances such as wind gusts and turbulence than the previously studied set-bounded models. However, with stochastic uncertainty, it is often impossible to guarantee that state constraints are satisfied, because there is typically a non-zero probability of having a disturbance that is large enough to push the state out of the feasible region. An effective framework to address robustness with stochastic uncertainty is optimization with chance constraints. These require that the probability of violating the state constraints (i.e., the probability of

Clarification of the Use of Biological Data and Information in the 2002 Integrated Water Quality Monitoring and Assessment Report Guidance

Science.gov (United States)

The memorandum modifies the 2002 Integrated Water Quality Monitoring and Assessment Report Guidance to provide clarity and promote consistency in the manner in which states use biological data and information in developing their 2002 submissions.

Exploring the uncertainties in cancer risk assessment using the integrated probabilistic risk assessment (IPRA) approach.

Science.gov (United States)

Slob, Wout; Bakker, Martine I; Biesebeek, Jan Dirk Te; Bokkers, Bas G H

2014-08-01

Current methods for cancer risk assessment result in single values, without any quantitative information on the uncertainties in these values. Therefore, single risk values could easily be overinterpreted. In this study, we discuss a full probabilistic cancer risk assessment approach in which all the generally recognized uncertainties in both exposure and hazard assessment are quantitatively characterized and probabilistically evaluated, resulting in a confidence interval for the final risk estimate. The methodology is applied to three example chemicals (aflatoxin, N-nitrosodimethylamine, and methyleugenol). These examples illustrate that the uncertainty in a cancer risk estimate may be huge, making single value estimates of cancer risk meaningless. Further, a risk based on linear extrapolation tends to be lower than the upper 95% confidence limit of a probabilistic risk estimate, and in that sense it is not conservative. Our conceptual analysis showed that there are two possible basic approaches for cancer risk assessment, depending on the interpretation of the dose-incidence data measured in animals. However, it remains unclear which of the two interpretations is the more adequate one, adding an additional uncertainty to the already huge confidence intervals for cancer risk estimates. © 2014 Society for Risk Analysis.

Supporting Risk Assessment: Accounting for Indirect Risk to Ecosystem Components

Science.gov (United States)

Mach, Megan E.; Martone, Rebecca G.; Singh, Gerald G.; O, Miriam; Chan, Kai M. A.

2016-01-01

The multi-scalar complexity of social-ecological systems makes it challenging to quantify impacts from human activities on ecosystems, inspiring risk-based approaches to assessments of potential effects of human activities on valued ecosystem components. Risk assessments do not commonly include the risk from indirect effects as mediated via habitat and prey. In this case study from British Columbia, Canada, we illustrate how such “indirect risks” can be incorporated into risk assessments for seventeen ecosystem components. We ask whether (i) the addition of indirect risk changes the at-risk ranking of the seventeen ecosystem components and if (ii) risk scores correlate with trophic prey and habitat linkages in the food web. Even with conservative assumptions about the transfer of impacts or risks from prey species and habitats, the addition of indirect risks in the cumulative risk score changes the ranking of priorities for management. In particular, resident orca, Steller sea lion, and Pacific herring all increase in relative risk, more closely aligning these species with their “at-risk status” designations. Risk assessments are not a replacement for impact assessments, but—by considering the potential for indirect risks as we demonstrate here—they offer a crucial complementary perspective for the management of ecosystems and the organisms within. PMID:27632287

Avalanche risk assessment in Russia

Science.gov (United States)

Komarov, Anton; Seliverstov, Yury; Sokratov, Sergey; Glazovskaya, Tatiana; Turchaniniva, Alla

2017-04-01

The avalanche prone area covers about 3 million square kilometers or 18% of total area of Russia and pose a significant problem in most mountain regions of the country. The constant growth of economic activity, especially in the North Caucasus region and therefore the increased avalanche hazard lead to the demand of the large-scale avalanche risk assessment methods development. Such methods are needed for the determination of appropriate avalanche protection measures as well as for economic assessments during all stages of spatial planning of the territory. The requirement of natural hazard risk assessments is determined by the Federal Law of Russian Federation. However, Russian Guidelines (SP 11-103-97; SP 47.13330.2012) are not clearly presented concerning avalanche risk assessment calculations. A great size of Russia territory, vast diversity of natural conditions and large variations in type and level of economic development of different regions cause significant variations in avalanche risk values. At the first stage of research the small scale avalanche risk assessment was performed in order to identify the most common patterns of risk situations and to calculate full social risk and individual risk. The full social avalanche risk for the territory of country was estimated at 91 victims. The area of territory with individual risk values lesser then 1×10(-6) covers more than 92 % of mountain areas of the country. Within these territories the safety of population can be achieved mainly by organizational activities. Approximately 7% of mountain areas have 1×10(-6) - 1×10(-4) individual risk values and require specific mitigation measures to protect people and infrastructure. Territories with individual risk values 1×10(-4) and above covers about 0,1 % of the territory and include the most severe and hazardous mountain areas. The whole specter of mitigation measures is required in order to minimize risk. The future development of such areas is not recommended

Risk assessment in international operations

International Nuclear Information System (INIS)

Stricklin, Daniela L.

2008-01-01

During international peace-keeping missions, a diverse number of non-battle hazards may be encountered, which range from heavily polluted areas, endemic disease, toxic industrial materials, local violence, traffic, and even psychological factors. Hence, elevated risk levels from a variety of sources are encountered during deployments. With the emphasis within the Swedish military moving from national defense towards prioritization of international missions in atypical environments, the risk of health consequences, including long term health effects, has received greater consideration. The Swedish military is interested in designing an optimal approach for assessment of health threats during deployments. The Medical Intelligence group at FOI CBRN Security and Defence in Umea has, on request from and in collaboration with the Swedish Armed Forces, reviewed a variety of international health threat and risk assessment models for military operations. Application of risk assessment methods used in different phases of military operations will be reviewed. An overview of different international approaches used in operational risk management (ORM) will be presented as well as a discussion of the specific needs and constraints for health risk assessment in military operations. This work highlights the specific challenges of risk assessment that are unique to the deployment setting such as the assessment of exposures to a variety of diverse hazards concurrently

Implications of probabilistic risk assessment

International Nuclear Information System (INIS)

Cullingford, M.C.; Shah, S.M.; Gittus, J.H.

1987-01-01

Probabilistic risk assessment (PRA) is an analytical process that quantifies the likelihoods, consequences and associated uncertainties of the potential outcomes of postulated events. Starting with planned or normal operation, probabilistic risk assessment covers a wide range of potential accidents and considers the whole plant and the interactions of systems and human actions. Probabilistic risk assessment can be applied in safety decisions in design, licensing and operation of industrial facilities, particularly nuclear power plants. The proceedings include a review of PRA procedures, methods and technical issues in treating uncertainties, operating and licensing issues and future trends. Risk assessment for specific reactor types or components and specific risks (eg aircraft crashing onto a reactor) are used to illustrate the points raised. All 52 articles are indexed separately. (U.K.)

Independent Orbiter Assessment (IOA): Assessment of the guidance, navigation, and control subsystem FMEA/CIL

Science.gov (United States)

Trahan, W. H.; Odonnell, R. A.; Pietz, K. C.; Drapela, L. J.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Guidance, Navigation, and Control System (GNC) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. The results of that comparison for the Orbiter GNC hardware is documented. The IOA product for the GNC analysis consisted of 141 failure mode worksheets that resulted in 24 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 148 FMEAs and 36 CIL items. This comparison produced agreement on all but 56 FMEAs which caused differences in zero CIL items.

Uncertainties in risk assessment at USDOE facilities

Energy Technology Data Exchange (ETDEWEB)

Hamilton, L.D.; Holtzman, S.; Meinhold, A.F.; Morris, S.C.; Rowe, M.D.

1994-01-01

The United States Department of Energy (USDOE) has embarked on an ambitious program to remediate environmental contamination at its facilities. Decisions concerning cleanup goals, choices among cleanup technologies, and funding prioritization should be largely risk-based. Risk assessments will be used more extensively by the USDOE in the future. USDOE needs to develop and refine risk assessment methods and fund research to reduce major sources of uncertainty in risk assessments at USDOE facilities. The terms{open_quote} risk assessment{close_quote} and{open_quote} risk management{close_quote} are frequently confused. The National Research Council (1983) and the United States Environmental Protection Agency (USEPA, 1991a) described risk assessment as a scientific process that contributes to risk management. Risk assessment is the process of collecting, analyzing and integrating data and information to identify hazards, assess exposures and dose responses, and characterize risks. Risk characterization must include a clear presentation of {open_quotes}... the most significant data and uncertainties...{close_quotes} in an assessment. Significant data and uncertainties are {open_quotes}...those that define and explain the main risk conclusions{close_quotes}. Risk management integrates risk assessment information with other considerations, such as risk perceptions, socioeconomic and political factors, and statutes, to make and justify decisions. Risk assessments, as scientific processes, should be made independently of the other aspects of risk management (USEPA, 1991a), but current methods for assessing health risks are based on conservative regulatory principles, causing unnecessary public concern and misallocation of funds for remediation.

Uncertainties in risk assessment at USDOE facilities

International Nuclear Information System (INIS)

Hamilton, L.D.; Holtzman, S.; Meinhold, A.F.; Morris, S.C.; Rowe, M.D.

1994-01-01

The United States Department of Energy (USDOE) has embarked on an ambitious program to remediate environmental contamination at its facilities. Decisions concerning cleanup goals, choices among cleanup technologies, and funding prioritization should be largely risk-based. Risk assessments will be used more extensively by the USDOE in the future. USDOE needs to develop and refine risk assessment methods and fund research to reduce major sources of uncertainty in risk assessments at USDOE facilities. The terms open-quote risk assessment close-quote and open-quote risk management close-quote are frequently confused. The National Research Council (1983) and the United States Environmental Protection Agency (USEPA, 1991a) described risk assessment as a scientific process that contributes to risk management. Risk assessment is the process of collecting, analyzing and integrating data and information to identify hazards, assess exposures and dose responses, and characterize risks. Risk characterization must include a clear presentation of open-quotes... the most significant data and uncertainties...close quotes in an assessment. Significant data and uncertainties are open-quotes...those that define and explain the main risk conclusionsclose quotes. Risk management integrates risk assessment information with other considerations, such as risk perceptions, socioeconomic and political factors, and statutes, to make and justify decisions. Risk assessments, as scientific processes, should be made independently of the other aspects of risk management (USEPA, 1991a), but current methods for assessing health risks are based on conservative regulatory principles, causing unnecessary public concern and misallocation of funds for remediation

Advanced Test Reactor outage risk assessment

International Nuclear Information System (INIS)

Thatcher, T.A.; Atkinson, S.A.

1997-01-01

Beginning in 1997, risk assessment was performed for each Advanced Test Reactor (ATR) outage aiding the coordination of plant configuration and work activities (maintenance, construction projects, etc.) to minimize the risk of reactor fuel damage and to improve defense-in-depth. The risk assessment activities move beyond simply meeting Technical Safety Requirements to increase the awareness of risk sensitive configurations, to focus increased attention on the higher risk activities, and to seek cost-effective design or operational changes that reduce risk. A detailed probabilistic risk assessment (PRA) had been performed to assess the risk of fuel damage during shutdown operations including heavy load handling. This resulted in several design changes to improve safety; however, evaluation of individual outages had not been performed previously and many risk insights were not being utilized in outage planning. The shutdown PRA provided the necessary framework for assessing relative and absolute risk levels and assessing defense-in-depth. Guidelines were written identifying combinations of equipment outages to avoid. Screening criteria were developed for the selection of work activities to receive review. Tabulation of inherent and work-related initiating events and their relative risk level versus plant mode has aided identification of the risk level the scheduled work involves. Preoutage reviews are conducted and post-outage risk assessment is documented to summarize the positive and negative aspects of the outage with regard to risk. The risk for the outage is compared to the risk level that would result from optimal scheduling of the work to be performed and to baseline or average past performance

Risk assessment and optimization (ALARA) analysis for the environmental remediation of Brookhaven National Laboratory`s hazardous waste management facility

Energy Technology Data Exchange (ETDEWEB)

Dionne, B.J.; Morris, S.C. III; Baum, J.W. [and others

1998-01-01

The Department of Energy`s (DOE) Office of Environment, Safety, and Health (EH) sought examples of risk-based approaches to environmental restoration to include in their guidance for DOE nuclear facilities. Extensive measurements of radiological contamination in soil and ground water have been made at Brookhaven National Laboratory`s Hazardous Waste Management Facility (HWMF) as part of a Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) remediation process. This provided an ideal opportunity for a case study. This report provides a risk assessment and an {open_quotes}As Low as Reasonably Achievable{close_quotes} (ALARA) analysis for use at other DOE nuclear facilities as an example of a risk-based decision technique. This document contains the Appendices for the report.

GAR Global Risk Assessment

Science.gov (United States)

Maskrey, Andrew; Safaie, Sahar

2015-04-01

Disaster risk management strategies, policies and actions need to be based on evidence of current disaster loss and risk patterns, past trends and future projections, and underlying risk factors. Faced with competing demands for resources, at any level it is only possible to priorities a range of disaster risk management strategies and investments with adequate understanding of realised losses, current and future risk levels and impacts on economic growth and social wellbeing as well as cost and impact of the strategy. The mapping and understanding of the global risk landscape has been greatly enhanced by the latest iteration of the GAR Global Risk Assessment and the objective of this submission is to present the GAR global risk assessment which contributed to Global Assessment Report (GAR) 2015. This initiative which has been led by UNISDR, was conducted by a consortium of technical institutions from around the world and has covered earthquake, cyclone, riverine flood, and tsunami probabilistic risk for all countries of the world. In addition, the risks associated with volcanic ash in the Asia-Pacific region, drought in various countries in sub-Saharan Africa and climate change in a number of countries have been calculated. The presentation will share thee results as well as the experience including the challenges faced in technical elements as well as the process and recommendations for the future of such endeavour.

Deterministic quantitative risk assessment development

Energy Technology Data Exchange (ETDEWEB)

Dawson, Jane; Colquhoun, Iain [PII Pipeline Solutions Business of GE Oil and Gas, Cramlington Northumberland (United Kingdom)

2009-07-01

Current risk assessment practice in pipeline integrity management is to use a semi-quantitative index-based or model based methodology. This approach has been found to be very flexible and provide useful results for identifying high risk areas and for prioritizing physical integrity assessments. However, as pipeline operators progressively adopt an operating strategy of continual risk reduction with a view to minimizing total expenditures within safety, environmental, and reliability constraints, the need for quantitative assessments of risk levels is becoming evident. Whereas reliability based quantitative risk assessments can be and are routinely carried out on a site-specific basis, they require significant amounts of quantitative data for the results to be meaningful. This need for detailed and reliable data tends to make these methods unwieldy for system-wide risk k assessment applications. This paper describes methods for estimating risk quantitatively through the calibration of semi-quantitative estimates to failure rates for peer pipeline systems. The methods involve the analysis of the failure rate distribution, and techniques for mapping the rate to the distribution of likelihoods available from currently available semi-quantitative programs. By applying point value probabilities to the failure rates, deterministic quantitative risk assessment (QRA) provides greater rigor and objectivity than can usually be achieved through the implementation of semi-quantitative risk assessment results. The method permits a fully quantitative approach or a mixture of QRA and semi-QRA to suit the operator's data availability and quality, and analysis needs. For example, consequence analysis can be quantitative or can address qualitative ranges for consequence categories. Likewise, failure likelihoods can be output as classical probabilities or as expected failure frequencies as required. (author)

Evaluation of thermal risk assessment

International Nuclear Information System (INIS)

Loos, J.J.; Perry, E.S.

1993-01-01

Risk assessment was done in 1983 to estimate the ecological hazard of increasing the generating load and thermal output of an electric generating station. Subsequently, long-term monitoring in the vicinity of the station allowed verification of the predictions made in the risk assessment. This presentation will review the efficacy of early risk assessment methods in producing useful predictions from a resource management point of view. In 1984, the Chalk Point Generating facility of the Potomac Electric Power Company increased it's median generating load by 100%. Prior to this operational change, the Academy of Natural Sciences of Philadelphia synthesized site specific data, model predictions, and results from literature to assess the risk of additional waste heat to the Patuxent River subestuary of Chesapeake Bay. Risk was expressed as the number of days per year that various species of fish and the blue crab would be expected to avoid the discharge vicinity. Accuracy of these predictions is assessed by comparing observed fish and crab distributions and their observed frequencies of avoidance to those predicted. It is concluded that the predictions of this early risk assessment were sufficiently accurate to produce a reliable resource management decision

Developing an in vivo toxicity assay for RNAi risk assessment in honey bees, Apis mellifera L.

Science.gov (United States)

Vélez, Ana María; Jurzenski, Jessica; Matz, Natalie; Zhou, Xuguo; Wang, Haichuan; Ellis, Marion; Siegfried, Blair D

2016-02-01

Maize plants expressing dsRNA for the management of Diabrotica virgifera virgifera are likely to be commercially available by the end of this decade. Honey bees, Apis mellifera, can potentially be exposed to pollen from transformed maize expressing dsRNA. Consequently, evaluation of the biological impacts of RNAi in honey bees is a fundamental component for ecological risk assessment. The insecticidal activity of a known lethal dsRNA target for D. v. virgifera, the vATPase subunit A, was evaluated in larval and adult honey bees. Activity of both D. v. virgifera (Dvv)- and A. mellifera (Am)-specific dsRNA was tested by dietary exposure to dsRNA. Larval development, survival, adult eclosion, adult life span and relative gene expression were evaluated. The results of these tests indicated that Dvv vATPase-A dsRNA has limited effects on larval and adult honey bee survival. Importantly, no effects were observed upon exposure of Am vATPase-A dsRNA suggesting that the lack of response involves factors other than sequence specificity. The results from this study provide guidance for future RNAi risk analyses and for the development of a risk assessment framework that incorporates similar hazard assessments. Copyright © 2015 Elsevier Ltd. All rights reserved.

Liquid Pipeline Operator's Control Room Human Factors Risk Assessment and Management Guide

Science.gov (United States)

2008-11-26

The purpose of this guide is to document methodologies, tools, procedures, guidance, and instructions that have been developed to provide liquid pipeline operators with an efficient and effective means of managing the human factors risks in their con...

On risk assessment of energy production

International Nuclear Information System (INIS)

Kunii, Katsuhiko

2005-07-01

Today we cannot ignore the risk of health and/or environment by energy production such as power generation since the risk has been made large enough. In this report an information survey has been done in order to know the outline and points of risk assessment. Based on the information of reports and literature about risk assessment, have been surveyed mainly the external cost assessment of power generation (in which quantification of health and/or environment risk has been done), in addition, risks of disasters, accidents, investments, finance etc. and impacts of those risks on social activities. The remarks obtained by the survey are as follows: 1) Some of external cost assessment of power generation show different results even if the assessment conditions of technology, site, etc. are mostly the same. It is necessary to remark on the information such as basic data, model, background, application limit of assessment considering the reliability. 2) Especially it is considered that the reliability of risk assessment is not enough at present because of the lack of basic data. (author)

Simulation of enteric pathogen concentrations in locally-collected greywater and wastewater for microbial risk assessments

Science.gov (United States)

As decentralized water reuse continues to gain popularity, risk-based treatment guidance is increasingly sought for the protection of public health. However, efforts to evaluate pathogen risks and log-reduction requirements have been hindered by an incomplete understanding of pat...

Defense Programs Transportation Risk Assessment

International Nuclear Information System (INIS)

Clauss, D.B.

1994-01-01

This paper provides an overview of the methodology used in a probabilistic transportation risk assessment conducted to assess the probabilities and consequences of inadvertent dispersal of radioactive materials arising from severe transportation accidents. The model was developed for the Defense Program Transportation Risk Assessment (DPTRA) study. The analysis incorporates several enhancements relative to previous risk assessments of hazardous materials transportation including newly-developed statistics on the frequencies and severities of tractor semitrailer accidents and detailed route characterization using the 1990 Census data

Risk Factor Assessment Branch (RFAB)

Science.gov (United States)

The Risk Factor Assessment Branch (RFAB) focuses on the development, evaluation, and dissemination of high-quality risk factor metrics, methods, tools, technologies, and resources for use across the cancer research continuum, and the assessment of cancer-related risk factors in the population.

Ecological models in support of regulatory risk assessments of pesticides: developing a strategy for the future.

Science.gov (United States)

Forbes, Valery E; Hommen, Udo; Thorbek, Pernille; Heimbach, Fred; Van den Brink, Paul J; Wogram, Jörn; Thulke, Hans-Hermann; Grimm, Volker

2009-01-01

This brief communication reports on the main findings of the LEMTOX workshop, held from 9 to 12 September 2007, at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. The workshop brought together a diverse group of stakeholders from academia, regulatory authorities, contract research organizations, and industry, representing Europe, the United States, and Asia, to discuss the role of ecological modeling in risk assessments of pesticides, particularly under the European regulatory framework. The following questions were addressed: What are the potential benefits of using ecological models in pesticide registration and risk assessment? What obstacles prevent ecological modeling from being used routinely in regulatory submissions? What actions are needed to overcome the identified obstacles? What recommendations should be made to ensure good modeling practice in this context? The workshop focused exclusively on population models, and discussion was focused on those categories of population models that link effects on individuals (e.g., survival, growth, reproduction, behavior) to effects on population dynamics. The workshop participants concluded that the overall benefits of ecological modeling are that it could bring more ecology into ecological risk assessment, and it could provide an excellent tool for exploring the importance of, and interactions among, ecological complexities. However, there are a number of challenges that need to be overcome before such models will receive wide acceptance for pesticide risk assessment, despite having been used extensively in other contexts (e.g., conservation biology). The need for guidance on Good Modeling Practice (on model development, analysis, interpretation, evaluation, documentation, and communication), as well as the need for case studies that can be used to explore the added value of ecological models for risk assessment, were identified as top priorities. Assessing recovery potential of exposed

A Best Practices Notebook for Disaster Risk Reduction and Climate Change Adaptation: Guidance and Insights for Policy and Practice from the CATALYST Project

NARCIS (Netherlands)

Hare, M.; Bers, van C.; Mysiak, J.; Calliari, E.; Haque, A.; Warner, K.; Yuzva, K.; Zissener, M.; Jaspers, A.M.J.; Timmerman, J.G.

2014-01-01

This publication, A Best Practices Notebook for Disaster Risk Reduction and Climate Change Adaptation: Guidance and Insights for Policy and Practice from the CATALYST Project is one of two main CATALYST knowledge products that focus on the transformative approaches and measures that can support

Risk assessments ensure safer power

Energy Technology Data Exchange (ETDEWEB)

1982-02-19

A growth industry is emerging devoted to the study and comparison of the economic, social and health risks posed by large industrial installations. Electricity generation is one area coming under particularly close scrutiny. Types of risk, ways of assessing risk and the difference between experts' analyses and the public perception of risk are given. An example of improved risk assessment helping to reduce deaths and injuries in coal mining is included.

78 FR 76297 - Social Media: Consumer Compliance Risk Management Guidance

Science.gov (United States)

2013-12-17

... encourage the application of uniform examination principles and standards by state and federal supervisory... marketing, providing incentives, facilitating applications for new accounts, inviting feedback from the... responsibilities. The revised Guidance clarifies and points to the longstanding principle that financial...

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)

Risk assessment

DEFF Research Database (Denmark)

Pedersen, Liselotte; Rasmussen, Kirsten; Elsass, Peter

2010-01-01

International research suggests that using formalized risk assessment methods may improve the predictive validity of professionals' predictions of risk of future violence. This study presents data on forensic psychiatric patients discharged from a forensic unit in Denmark in year 2001-2002 (n=107...... and the individual dynamic items strengthen the use of this scheme in clinical practice. (PsycINFO Database Record (c) 2010 APA, all rights reserved) (journal abstract)...

A novel approach for navigational guidance of ships using onboard monitoring systems

DEFF Research Database (Denmark)

Nielsen, Ulrik Dam; Jensen, Jørgen Juncher

2011-01-01

A novel approach and conceptual ideas are outlined for risk-based navigational guidance of ships using decision support systems in combination with onboard, in-service monitoring systems. The guidance has as the main objective to advise on speed and/or course changes; in particular with focus...

Sudden Cardiac Arrest (SCA) Risk Assessment

Science.gov (United States)

... HRS Find a Specialist Share Twitter Facebook SCA Risk Assessment Sudden Cardiac Arrest (SCA) occurs abruptly and without ... people of all ages and health conditions. Start Risk Assessment The Sudden Cardiac Arrest (SCA) Risk Assessment Tool ...

Syncope: Assessment of risk and an approach to evaluation in the emergency department and urgent care clinic

Directory of Open Access Journals (Sweden)

Baris Akdemir

2015-03-01

Full Text Available Syncope is among the most frequent forms of transient loss of consciousness (TLOC, and is characterized by a relatively brief and self-limited loss of consciousness that by definition is triggered by transient cerebral hypoperfusion. Most often, syncope is caused by a temporary drop of systemic arterial pressure below that required to maintain cerebral function, but brief enough not to cause permanent structural brain injury. Currently, approximately one-third of syncope/collapse patients seen in the emergency department (ED or urgent care clinic are admitted to hospital for evaluation. The primary objective of developing syncope/TLOC risk stratification schemes is to provide guidance regarding the immediate prognostic risk of syncope patients presenting to the ED or clinic; thereafter, based on that risk assessment physicians may be better equipped to determine which patients can be safely evaluated as outpatients, and which require hospital care. In general, the need for hospitalization is determined by several key issues: i the patient's immediate (usually considered 1 week to 1 month mortality risk and risk for physical injury (e.g., falls risk, ii the patient's ability to care for him/herself, and iii whether certain treatments inherently require in-hospital initiation (e.g., pacemaker implantation. However, at present no single risk assessment protocol appears to be satisfactory for universal application, and development of a consensus recommendation is an essential next step.

Integrated climate change risk assessment:

DEFF Research Database (Denmark)

Kaspersen, Per Skougaard; Halsnæs, Kirsten

2017-01-01

Risk assessments of flooding in urban areas during extreme precipitation for use in, for example, decision-making regarding climate adaptation, are surrounded by great uncertainties stemming from climate model projections, methods of downscaling and the assumptions of socioeconomic impact models...... to address the complex linkages between the different kinds of data required in assessing climate adaptation. It emphasizes that the availability of spatially explicit data can reduce the overall uncertainty of the risk assessment and assist in identifying key vulnerable assets. The usefulness...... of such a framework is demonstrated by means of a risk assessment of flooding from extreme precipitation for the city of Odense, Denmark. A sensitivity analysis shows how the presence of particularly important assets, such as cultural and historical heritage, may be addressed in assessing such risks. The output...

Criteria for guidance in the safety assessment of nuclear installations in the United Kingdom

International Nuclear Information System (INIS)

Gausden, R.; Fryer, D.R.H.

1977-01-01

There is an increasing appreciation of the need for a consistent approach to nuclear safety between various groups having an interest in safety and between various types of installation. Licensing for construction and ultimate approval to operate any nuclear installation depend in the United Kingdom upon a searching assessment of the design, construction and operation of the proposed plant. Criteria of the kind discussed in this paper have been used by the Nuclear Installations Inspectorate in this assessment process. From time to time they are subject to comments from other bodies in the U.K. One aim of the criteria is to set out the broad objectives that should be met regarding the magnitude of radiological consequences of accidents or normal operation. In addition, the criteria give guidance on the design philosophy for nuclear safety and the principles of fault evaluation. Criteria must be conceived so that while maintaining safety standards their application does not frustrate design and development. It is also important that undue formalism is not induced in the assessment process at the expense of inhibiting the judgement of safety assessors. A balance must, therefore, be struck between detailed and generalised guidance. It is also accepted that experience in the use and interpretation of criteria will indicate a need for improvement and additions: the criteria are, therefore, regarded as living rather than fixed statements which are expected to develop in response to any need for change in a safe direction that may arise. In developing them, the Inspectorate has drawn heavily upon the experience accumulated during its 16 years of operation and has also referred to criteria published by other organisations. The paper deals specifically with certain of the most important sections of the criteria and indicates the total range of subjects which need to be included in such criteria

77 FR 55510 - Guidance on Performing a Seismic Margin Assessment

Science.gov (United States)

2012-09-10

... Guidance for the Individual Plant Examination of External Events (IPEEE) for Severe Accident...-Term Task Force Review of Insights from the Fukushima Dai-ichi Accident,'' hereafter called the ``March...

Assessing Your Weight and Health Risk

Science.gov (United States)

... Health Professional Resources Assessing Your Weight and Health Risk Assessment of weight and health risk involves using ... risk for developing obesity-associated diseases or conditions. Risk Factors for Health Topics Associated With Obesity Along ...

Description of codes and models to be used in risk assessment

International Nuclear Information System (INIS)

1991-09-01

Human health and environmental risk assessments will be performed as part of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) remedial investigation/feasibility study (RI/FS) activities at the Hanford Site. Analytical and computer encoded numerical models are commonly used during both the remedial investigation (RI) and feasibility study (FS) to predict or estimate the concentration of contaminants at the point of exposure to humans and/or the environment. This document has been prepared to identify the computer codes that will be used in support of RI/FS human health and environmental risk assessments at the Hanford Site. In addition to the CERCLA RI/FS process, it is recommended that these computer codes be used when fate and transport analyses is required for other activities. Additional computer codes may be used for other purposes (e.g., design of tracer tests, location of observation wells, etc.). This document provides guidance for unit managers in charge of RI/FS activities. Use of the same computer codes for all analytical activities at the Hanford Site will promote consistency, reduce the effort required to develop, validate, and implement models to simulate Hanford Site conditions, and expedite regulatory review. The discussion provides a description of how models will likely be developed and utilized at the Hanford Site. It is intended to summarize previous environmental-related modeling at the Hanford Site and provide background for future model development. The modeling capabilities that are desirable for the Hanford Site and the codes that were evaluated. The recommendations include the codes proposed to support future risk assessment modeling at the Hanford Site, and provides the rational for the codes selected. 27 refs., 3 figs., 1 tab

Exposure Assessment Tools by Lifestages and Populations - General Population

Science.gov (United States)

EPA ExpoBox is a toolbox for exposure assessors. Its purpose is to provide a compendium of exposure assessment and risk characterization tools that will present comprehensive step-by-step guidance and links to relevant exposure assessment data bases

National Environmental Policy Act guidance: A model process

International Nuclear Information System (INIS)

Angle, B.M.; Lockhart, V.A.T.; Sema, B.; Tuott, L.C.; Irving, J.S.

1995-04-01

The ''Model National Environmental Policy Act (NEPA) Process'' includes: References to regulations, guidance documents, and plans; training programs; procedures; and computer databases. Legislative Acts and reference documents from Congress, US Department of Energy, and Lockheed Idaho Technologies Company provide the bases for conducting NEPA at the Idaho National Engineering Laboratory (INEL). Lockheed Idaho Technologies Company (LITCO) NEPA / Permitting Department, the Contractor Environmental Organization (CEO) is responsible for developing and maintaining LITCO NEPA and permitting policies, guidance, and procedures. The CEO develops procedures to conduct environmental evaluations based on NEPA, Council on Environmental Quality (CEQ) regulations, and DOE guidance. This procedure includes preparation or support of environmental checklists, categorical exclusion determinations, environmental assessment determinations, environmental assessments, and environmental impact statements. In addition, the CEO uses this information to train personnel conducting environmental evaluations at the INEL. Streamlining these procedures fosters efficient use of resources, quality documents, and better decisions on proposed actions

Risk assessment theory, methods, and applications

CERN Document Server

Rausand, Marvin

2011-01-01

With its balanced coverage of theory and applications along with standards and regulations, Risk Assessment: Theory, Methods, and Applications serves as a comprehensive introduction to the topic. The book serves as a practical guide to current risk analysis and risk assessment, emphasizing the possibility of sudden, major accidents across various areas of practice from machinery and manufacturing processes to nuclear power plants and transportation systems. The author applies a uniform framework to the discussion of each method, setting forth clear objectives and descriptions, while also shedding light on applications, essential resources, and advantages and disadvantages. Following an introduction that provides an overview of risk assessment, the book is organized into two sections that outline key theory, methods, and applications. * Introduction to Risk Assessment defines key concepts and details the steps of a thorough risk assessment along with the necessary quantitative risk measures. Chapters outline...

The issue of risk dilution in risk assessments

International Nuclear Information System (INIS)

Wilmot, R.; Robinson, P.

2004-01-01

This paper explores an issue that was first highlighted more than 20 years ago during an inquiry concerning the Sizeweli B nuclear power station in the UK. In the probabilistic safety assessment for this plant, the proponent had apparently reduced its estimates of risk by admitting to increased uncertainty about the timing of certain events. This situation is counter-intuitive, since an increase in uncertainty about the factors contributing to safety would be expected to lead to less confidence and hence to greater risk. This paradoxical situation was termed 'risk dilution' and it has been a topic of interest to reviewers of safety cases since. The recent international peer review of the Yucca Mountain performance assessments concluded that there was a potential for risk dilution in the assumptions and calculations presented. The next section describes how assumptions about the timing of events and other aspects of an assessment may lead to risk dilution, and this is followed by two examples based on recent performance assessments. The final section discusses how potential problems can be identified in safety cases, and the types of response that a regulator might adopt as a result. (authors)

Identifying important life stages for monitoring and assessing risks from exposures to environmental contaminants: results of a World Health Organization review.

Science.gov (United States)

Cohen Hubal, Elaine A; de Wet, Thea; Du Toit, Lilo; Firestone, Michael P; Ruchirawat, Mathuros; van Engelen, Jacqueline; Vickers, Carolyn

2014-06-01

In this paper, we summarize exposure-related issues to consider in determining the most appropriate age ranges and life stages for risk assessment. We then propose a harmonized set of age bins for monitoring and assessing risks from exposures to chemicals for global use. The focus is on preconception through adolescence, though the approach should be applicable to additional life stages. A two-tiered set of early life age groups is recommended. The first tier involves the adoption of guidance similar to the childhood age groups recommended by the U.S. Environmental Protection Agency, whereas the second tier consolidates some of those age groups to reduce the burden of developing age-specific exposure factors for different regions. While there is no single "correct" means of choosing a common set of age groups to use internationally in assessing early life exposure and risk, use of a set of defined age groups is recommended to facilitate comparisons of potential exposures and risks around the globe, the collection of data and analyses of aggregate exposure and cumulative risk. Application of these age groups for robust assessment of exposure and risk for specific populations will require region-specific exposure factors as well as local environmental monitoring data. Copyright © 2013 World Health Organization. Published by Elsevier Inc. All rights reserved.

Rodent sperm analysis in field-based ecological risk assessment: pilot study at Ravenna army ammunition plant, Ravenna, Ohio

International Nuclear Information System (INIS)

Tannenbaum, L.V.; Bazar, M.; Hawkins, M.S.; Cornaby, B.W.; Ferguson, E.A.; Chantelle Carroll, L.; Ryan, P.F.

2003-01-01

Rodent sperm analysis is a visable method for use in field studies of risk at contaminated sites. - Ecological risk assessment (ERA) guidance recommends that field-truthing efforts proceed when modeled hazard quotients (HQs) suggest that toxicological effects are occurring to site receptors. To date, no field methods have been proposed by the regulatory community that can lead to definitive determinations of acceptable or unacceptable risk for birds and mammals, the two terrestrial classes of receptors that are commonly assessed using the HQ method. This paper describes rodent sperm analysis (RSA) as a viable method to be applied in the field at sites with historical contamination. RSA is capable of detecting biological differences that bear on reproduction, a highly regarded toxicological endpoint of concern in USEPA Superfund-type ERAs. The results of RSA's first application at a study site are reported and discussed. The paper also provides the rationale for RSA's efficacy in the context of Superfund and other environmental cleanup programs, where limited time and money are available to determine and evaluate the field condition

Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.

Science.gov (United States)

Zannad, Faiez; Stough, Wendy Gattis; Lipicky, Raymond J; Tamargo, Juan; Bakris, George L; Borer, Jeffrey S; Alonso García, Maria de Los Angeles; Hadjadj, Samy; Koenig, Wolfgang; Kupfer, Stuart; McCullough, Peter A; Mosenzon, Ofri; Pocock, Stuart; Scheen, André J; Sourij, Harald; Van der Schueren, Bart; Stahre, Christina; White, William B; Calvo, Gonzalo

2016-07-01

The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Gender-Sensitive Post-Disaster Assessments

OpenAIRE

World Bank

2012-01-01

This note on gender-sensitive post-disaster assessments is the eighth in a series of guidance notes on gender issues in disaster risk management (DRM) in the East Asia and the Pacific region. Targeting World Bank staff, clients and development partners, this note gives an overview of the main reasons for assessing gender impacts as part of a post-disaster needs assessment, identifies the k...

Risk Assessment in the Maritime Industry

Directory of Open Access Journals (Sweden)

M. Mousavi

2017-02-01

Full Text Available Risk assessment is a well-developed field which many operators are currently applying to improve their operations and reduce their risk exposure. This paper is intended to provide an overview of the risk assessment for mariners in the Maritime transportation. The risks addressed are primarily those affecting the safety of a vessel, facility or operation. The concept of risk is defined, and the methods available to assess the risks associated with an operation are described. Regulatory requirements that have prompted the development of modern risk assessment practices are described, and future regulatory trends are discussed. There are many different analysis techniques and models that have been developed to aid in conducting risk assessments. A key to any successful risk analysis is choosing the right method (or combination of methods for the situation at hand. This is achieved through critical analysis of the available data concerning marine crises. This paper provides a brief introduction to some of the analysis methods available and suggests risk analysis approaches to support different types of decision making within the maritime transportation to cope with crises. Finally, as awareness of risk assessment increases, the benefits which can be realized through its application will continue to increase. Organizations in both the public and the private sector are becoming more and more familiar with the benefits associated with risk-based approaches to managing safety and consequently reducing crisis in maritime transportation.

Business risks, functions, methods of assessment and ways to reduce risk

Directory of Open Access Journals (Sweden)

A.V. Mihalchuk

2015-06-01

Full Text Available For successful existence in a market economy entrepreneur have to take bold actions, and this increases the risk. The article describes the concept of entrepreneurship and business risk, positive and negative aspects of functions of risk in business. Therefore, it is necessary to assess the risk properly and be able to manage it to achieve the most effective results in the market. In market conditions the problem of assessing and accounting market becomes independent theoretical and practical significance as an important component of the theory and practice of management. Risk - a key element of business activities. Development of risk situations can lead to both the occurrence of adverse effects (losses, lost profits, and positive results for a company in the form of increased profit. This article describes: the concept of entrepreneurship, risk and business risks, characteristic of positive and negative aspects of risk functions in business, methods of assessment and risk reduction, shows formulae and examples you can use to assess risk in an enterprise. Analyzing already established methods of risk assessment a number of rules were proposed in order to reduce business risk.

Risk Assessment

OpenAIRE

Hrdová, Edita

2012-01-01

This diploma thesis is focused on companies risk evaluation before endorsement of Loan deriving from business relationships. The aim of this thesis is not only to describe individual steps of risk assessment, but also perfom analysis of particular companies based on available data, i.e. Balance sheet, Profit and Loss statement and external rating and after that propose solution for each company. My analysis will be based on theoretical knowledge, further on experience related to my job role a...

HTGR accident and risk assessment

International Nuclear Information System (INIS)

Silady, F.A.; Everline, C.J.; Houghton, W.J.

1982-01-01

This paper is a synopsis of the high-temperature gas-cooled reactor probabilistic risk assessments (PRAs) performed by General Atomic Company. Principal topics presented include: HTGR safety assessments, peer interfaces, safety research, process gas explosions, quantitative safety goals, licensing applications of PRA, enhanced safety, investment risk assessments, and PRA design integration

Anthropic Risk Assessment on Biodiversity

Science.gov (United States)

Piragnolo, M.; Pirotti, F.; Vettore, A.; Salogni, G.

2013-01-01

This paper presents a methodology for risk assessment of anthropic activities on habitats and species. The method has been developed for Veneto Region, in order to simplify and improve the quality of EIA procedure (VINCA). Habitats and species, animals and plants, are protected by European Directive 92/43/EEC and 2009/147/EC but they are subject at hazard due to pollution produced by human activities. Biodiversity risks may conduct to deterioration and disturbance in ecological niches, with consequence of loss of biodiversity. Ecological risk assessment applied on Natura 2000 network, is needed to best practice of management and monitoring of environment and natural resources. Threats, pressure and activities, stress and indicators may be managed by geodatabase and analysed using GIS technology. The method used is the classic risk assessment in ecological context, and it defines the natural hazard as influence, element of risk as interference and vulnerability. Also it defines a new parameter called pressure. It uses risk matrix for the risk analysis on spatial and temporal scale. The methodology is qualitative and applies the precautionary principle in environmental assessment. The final product is a matrix which excludes the risk and could find application in the development of a territorial information system.

Risk assessment and the environment

International Nuclear Information System (INIS)

Fisk, D.J.

1992-01-01

This paper reviews the use of risk assessment techniques in the field of environment protection. I will argue that in some important instances the development of environment policy has been a source of fruitful development of a risk based methodologies. In other cases the importation of risk assessment techniques has proved much more problematic. As the scope of environmental regulation increases so does the possibility of inconsistent and arbitrary solutions to problems. The need for a more systematic approach to the development of environmental regulation has never been stronger, so it is important to understand the reasons for the mixed success of risk assessment. This applies equally to those nations with long traditions of the regulation of private sector industry and those just beginning on this course. The way ahead may be to extend our ideas of how to express risk and uncertainty. Some of the recent cause celebres of environment policy show this challenge very clearly. As an example, this paper will look at the problem of assessing the risk of man-made climate change

Risk assessment and the environment

Energy Technology Data Exchange (ETDEWEB)

Fisk, D J [Department of the Environment (United Kingdom)

1992-07-01

This paper reviews the use of risk assessment techniques in the field of environment protection. I will argue that in some important instances the development of environment policy has been a source of fruitful development of a risk based methodologies. In other cases the importation of risk assessment techniques has proved much more problematic. As the scope of environmental regulation increases so does the possibility of inconsistent and arbitrary solutions to problems. The need for a more systematic approach to the development of environmental regulation has never been stronger, so it is important to understand the reasons for the mixed success of risk assessment. This applies equally to those nations with long traditions of the regulation of private sector industry and those just beginning on this course. The way ahead may be to extend our ideas of how to express risk and uncertainty. Some of the recent cause celebres of environment policy show this challenge very clearly. As an example, this paper will look at the problem of assessing the risk of man-made climate change.

Nuclear insurance risk assessment using risk-based methodology

International Nuclear Information System (INIS)

Wendland, W.G.

1992-01-01

This paper presents American Nuclear Insurers' (ANI's) and Mutual Atomic Energy Liability Underwriters' (MAELU's) process and experience for conducting nuclear insurance risk assessments using a risk-based methodology. The process is primarily qualitative and uses traditional insurance risk assessment methods and an approach developed under the auspices of the American Society of Mechanical Engineers (ASME) in which ANI/MAELU is an active sponsor. This process assists ANI's technical resources in identifying where to look for insurance risk in an industry in which insurance exposure tends to be dynamic and nonactuarial. The process is an evolving one that also seeks to minimize the impact on insureds while maintaining a mutually agreeable risk tolerance

Risk assessment for halogenated solvents

International Nuclear Information System (INIS)

Travis, C.C.

1988-01-01

A recent development in the cancer risk area is the advent of biologically based pharmacokinetic and pharmacodynamic models. These models allow for the incorporation of biological and mechanistic data into the risk assessment process. These advances will not only improve the risk assessment process for halogenated solvents but will stimulate and guide basic research in the biological area

RESIDUAL RISK ASSESSMENT: ETHYLENE OXIDE ...

Science.gov (United States)

This document describes the residual risk assessment for the Ethylene Oxide Commercial Sterilization source category. For stationary sources, section 112 (f) of the Clean Air Act requires EPA to assess risks to human health and the environment following implementation of technology-based control standards. If these technology-based control standards do not provide an ample margin of safety, then EPA is required to promulgate addtional standards. This document describes the methodology and results of the residual risk assessment performed for the Ethylene Oxide Commercial Sterilization source category. The results of this analyiss will assist EPA in determining whether a residual risk rule for this source category is appropriate.

Application of image guidance in pituitary surgery

Science.gov (United States)

de Lara, Danielle; Filho, Leo F. S. Ditzel; Prevedello, Daniel M.; Otto, Bradley A.; Carrau, Ricardo L.

2012-01-01

Background: Surgical treatment of pituitary pathologies has evolved along the years, adding safety and decreasing morbidity related to the procedure. Advances in the field of radiology, coupled with stereotactic technology and computer modeling, have culminated in the contemporary and widespread use of image guidance systems, as we know them today. Image guidance navigation has become a frequently used technology that provides continuous three-dimensional information for the accurate performance of neurosurgical procedures. We present a discussion about the application of image guidance in pituitary surgeries. Methods: Major indications for image guidance neuronavigation application in pituitary surgery are presented and demonstrated with illustrative cases. Limitations of this technology are also presented. Results: Patients presenting a history of previous transsphenoidal surgeries, anatomical variances of the sphenoid sinus, tumors with a close relation to the internal carotid arteries, and extrasellar tumors are the most important indications for image guidance in pituitary surgeries. The high cost of the equipment, increased time of surgery due to setup time, and registration and the need of specific training for the operating room personnel could be pointed as limitations of this technology. Conclusion: Intraoperative image guidance systems provide real-time images, increasing surgical accuracy and enabling safe, minimally invasive interventions. However, the use of intraoperative navigation is not a replacement for surgical experience and a systematic knowledge of regional anatomy. It must be recognized as a tool by which the neurosurgeon can reduce the risk associated with surgical approach and treatment of pituitary pathologies. PMID:22826819

Risk assessment: An employer's perspective

International Nuclear Information System (INIS)

Williams, K.C.

1992-01-01

There is no question that a careful assessment of risk is essential for safe industrial operations. For that reason, a thoughtful analysis of the effectiveness of available risk assessment technologies is prerequisite for responsible corporate decision making. An 'employer's' perspective on risk assessment cannot be constrained by any artificial restrictions which that term may imply. In reality, all those who are involved in the execution of an industrial enterprise: managers, regulators, the affected public, and especially those employees exposed to hazards, are necessarily partners in assessment of risk. The perspective of this paper is that of the oil and gas industry, in which the author's organization, Exxon Company, International, participates. The paper addresses what Exxon requires to assess and manage risk in its worldwide operations. The author is aware, however, through contacts with industry colleagues, that some of Exxon's initiatives are representative of similar actions being taken by others. 1992 is the European Year of Safety, Health and Hygiene, coinciding with the United Kingdom's Presidency of the European Council. It is also the year in which new 'goal-setting' regulations covering safety in the U.K. offshore oil industry were put forward by the Health and Safety Commission. These regulations, based largely on Lord Cullen's recommendations following the Piper Alpha tragedy, set the pace for safety in the British North Sea and will significantly impact the safety of offshore oil installations worldwide. The requirement for risk assessment, using a systematic process of analysing and evaluating risk, is a key component of this safety regime

Risk assessment: An employer's perspective

Energy Technology Data Exchange (ETDEWEB)

Williams, K C [Exxon International (United States)

1992-07-01

There is no question that a careful assessment of risk is essential for safe industrial operations. For that reason, a thoughtful analysis of the effectiveness of available risk assessment technologies is prerequisite for responsible corporate decision making. An 'employer's' perspective on risk assessment cannot be constrained by any artificial restrictions which that term may imply. In reality, all those who are involved in the execution of an industrial enterprise: managers, regulators, the affected public, and especially those employees exposed to hazards, are necessarily partners in assessment of risk. The perspective of this paper is that of the oil and gas industry, in which the author's organization, Exxon Company, International, participates. The paper addresses what Exxon requires to assess and manage risk in its worldwide operations. The author is aware, however, through contacts with industry colleagues, that some of Exxon's initiatives are representative of similar actions being taken by others. 1992 is the European Year of Safety, Health and Hygiene, coinciding with the United Kingdom's Presidency of the European Council. It is also the year in which new 'goal-setting' regulations covering safety in the U.K. offshore oil industry were put forward by the Health and Safety Commission. These regulations, based largely on Lord Cullen's recommendations following the Piper Alpha tragedy, set the pace for safety in the British North Sea and will significantly impact the safety of offshore oil installations worldwide. The requirement for risk assessment, using a systematic process of analysing and evaluating risk, is a key component of this safety regime.

RELEVANCE OF PROCESS RISK ASSESSMENT IN AIRLINES

OpenAIRE

Oksana G. Feoktistova; Igor K. Turkin; Sergey V. Barinov

2017-01-01

The notion of “the concept on assumed risk” that took over from the outdated concept of absolute security is analyzed, the increasing significance of operating risk assessment at the present stage is noted. Some basic risk assessment techniques are considered. Matrix technique of risk assessment is considered more thoroughly, and it may be used in risk assessment of airlines in the context of labour protection management system.The ability to correctly assess risks and develop appropriate pre...

An abuse of risk assessment: how regulatory agencies improperly adopted LNT for cancer risk assessment.

Science.gov (United States)

Calabrese, Edward J

2015-04-01

The Genetics Panel of the National Academy of Sciences' Committee on Biological Effects of Atomic Radiation (BEAR) recommended the adoption of the linear dose-response model in 1956, abandoning the threshold dose-response for genetic risk assessments. This recommendation was quickly generalized to include somatic cells for cancer risk assessment and later was instrumental in the adoption of linearity for carcinogen risk assessment by the Environmental Protection Agency. The Genetics Panel failed to provide any scientific assessment to support this recommendation and refused to do so when later challenged by other leading scientists. Thus, the linearity model used in cancer risk assessment was based on ideology rather than science and originated with the recommendation of the NAS BEAR Committee Genetics Panel. Historical documentation in support of these conclusions is provided in the transcripts of the Panel meetings and in previously unexamined correspondence among Panel members.

A framework for combining social impact assessment and risk assessment

NARCIS (Netherlands)

Mahmoudi, Hossein; Renn, Ortwin; Vanclay, Frank; Hoffmann, Volker; Karami, Ezatollah

An increasing focus on integrative approaches is one of the current trends in impact assessment. There is potential to combine impact assessment with various other forms of assessment, such as risk assessment, to make impact assessment and the management of social risks more effective. We identify

A framework for combining social impact assessment and risk assessment

NARCIS (Netherlands)

Mahmoudi, Hossein; Renn, Ortwin; Vanclay, Frank; Hoffmann, Volker; Karami, Ezatollah

2013-01-01

An increasing focus on integrative approaches is one of the current trends in impact assessment. There is potential to combine impact assessment with various other forms of assessment, such as risk assessment, to make impact assessment and the management of social risks more effective. We identify

Risk indices in comparative risk assessment studies

International Nuclear Information System (INIS)

Hubert, P.

1984-01-01

More than a decade ago the development of comparative risk assessment studies aroused overwhelming interest. There was no doubt that data on the health and safety aspects of energy systems would greatly benefit, or even end, the debate on nuclear energy. Although such attempts are still strongly supported, the rose-coloured expectations of the early days have faded. The high uncertainties, and the contradictory aspect, of the first results might explain this evolution. The loose connection between the range of computed risk indices and the questions on which the debate was focused is another reason for this decline in interest. Important research work is being carried out aiming at reducing the different kinds of uncertainties. Rather than the uncertainties, the paper considers the meaning of available risk indices and proposes more significant indices with respect to the goals of risk assessment. First, the indices which are of frequent use in comparative studies are listed. The stress is put on a French comparative study from which most examples are drawn. Secondly, the increase in magnitude of the indices and the decrease in the attributability of the risk to a given system is shown to be a consequence of the trend towards more comprehensive analyses. Thirdly, the ambiguity of such indices as the collective occupational risk is underlined, and a possible solution is suggested. Whenever risk assessments are related to pragmatic decision making problems it is possible to find satisfactory risk indices. The development of cost-effectiveness analyses and the proposals for quantitative safety goals clearly demonstrate this point. In the field of comparison of social impacts some proposals are made, but there remain some gaps still to be filled. (author)

Aspects regarding explosion risk assessment

Directory of Open Access Journals (Sweden)

Părăian Mihaela

2017-01-01

Full Text Available Explosive risk occurs in all activities involving flammable substances in the form of gases, vapors, mists or dusts which, in mixture with air, can generate an explosive atmosphere. As explosions can cause human losses and huge material damage, the assessment of the explosion risk and the establishment of appropriate measures to reduce it to acceptable levels according to the standards and standards in force is of particular importance for the safety and health of people and goods.There is no yet a recognized method of assessing the explosion risk, but regardless of the applied method, the likelihood of an explosive atmosphere occurrence has to be determined, together with the occurrence of an efficient ignition source and the magnitude of foreseeable consequences. In assessment processes, consequences analysis has a secondary importance since it’s likely that explosions would always involve considerable damage, starting from important material damages and up to human damages that could lead to death.The purpose of the work is to highlight the important principles and elements to be taken into account for a specific risk assessment. An essential element in assessing the risk of explosion in workplaces where explosive atmospheres may occur is technical installations and personal protective equipment (PPE that must be designed, manufactured, installed and maintained so that they cannot generate a source of ignition. Explosion prevention and protection requirements are governed by specific norms and standards, and a main part of the explosion risk assessment is related to the assessment of the compliance of the equipment / installation with these requirements.

A quantitative assessment of risks of heavy metal residues in laundered shop towels and their use by workers.

Science.gov (United States)

Connor, Kevin; Magee, Brian

2014-10-01

This paper presents a risk assessment of exposure to metal residues in laundered shop towels by workers. The concentrations of 27 metals measured in a synthetic sweat leachate were used to estimate the releasable quantity of metals which could be transferred to workers' skin. Worker exposure was evaluated quantitatively with an exposure model that focused on towel-to-hand transfer and subsequent hand-to-food or -mouth transfers. The exposure model was based on conservative, but reasonable assumptions regarding towel use and default exposure factor values from the published literature or regulatory guidance. Transfer coefficients were derived from studies representative of the exposures to towel users. Contact frequencies were based on assumed high-end use of shop towels, but constrained by a theoretical maximum dermal loading. The risk estimates for workers developed for all metals were below applicable regulatory risk benchmarks. The risk assessment for lead utilized the Adult Lead Model and concluded that predicted lead intakes do not constitute a significant health hazard based on potential worker exposures. Uncertainties are discussed in relation to the overall confidence in the exposure estimates developed for each exposure pathway and the likelihood that the exposure model is under- or overestimating worker exposures and risk. Copyright © 2014 Elsevier Inc. All rights reserved.

International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.

Science.gov (United States)

2009-04-08

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." 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 describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."