78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-24

... container labels and carton labeling design, is the second in a series of three planned guidance documents...] Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To... entitled ``Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...

Guidance Program Assessment Procedures for Elementary and Secondary Schools. Georgia Comprehensive Guidance Series.

ERIC Educational Resources Information Center

Gunderson, Margaret S.; Moore, Earl J.

This manual provides a series of assessment instruments that guidance program planners may adopt or adapt to provide a basis for defining the guidance program, educating others about the program, or planning needed program changes. The assessment procedures are designed to gather information about students' needs and progress from the students,…

Software Safety Analysis of a Flight Guidance System

NASA Technical Reports Server (NTRS)

Butler, Ricky W. (Technical Monitor); Tribble, Alan C.; Miller, Steven P.; Lempia, David L.

2004-01-01

This document summarizes the safety analysis performed on a Flight Guidance System (FGS) requirements model. In particular, the safety properties desired of the FGS model are identified and the presence of the safety properties in the model is formally verified. Chapter 1 provides an introduction to the entire project, while Chapter 2 gives a brief overview of the problem domain, the nature of accidents, model based development, and the four-variable model. Chapter 3 outlines the approach. Chapter 4 presents the results of the traditional safety analysis techniques and illustrates how the hazardous conditions associated with the system trace into specific safety properties. Chapter 5 presents the results of the formal methods analysis technique model checking that was used to verify the presence of the safety properties in the requirements model. Finally, Chapter 6 summarizes the main conclusions of the study, first and foremost that model checking is a very effective verification technique to use on discrete models with reasonable state spaces. Additional supporting details are provided in the appendices.

International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice.

PubMed

2001-07-13

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.

Pollinator Risk Assessment Guidance

EPA Pesticide Factsheets

This Guidance is part of a long-term strategy to advance the science of assessing the risks posed by pesticides to honey bees, giving risk managers the means to further improve pollinator protection in our regulatory decisions.

LANL Safety Conscious Work Environment (SCWE) Self-Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hargis, Barbara C.

2014-01-29

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

INPRO Assessment of an INS in the Area of Safety of Fuel Cycle Installations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Raj, B.; Busurin, Y.; Depisch, F.

2006-07-01

INPRO has defined requirements organized in a hierarchy of Basic Principles, User Requirements and Criteria (consisting of an indicator and an acceptance limit) to be met by innovative nuclear reactor systems (INS) in six areas, namely: economics, safety, waste management, environment, proliferation resistance, and infrastructure. If an INS meets all requirements in all areas it represents a sustainable system for the supply of energy, capable of making a significant contribution to meeting the energy needs of the 21. century. Draft manuals have been developed, for each INPRO area, to provide guidance for performing an assessment of whether an INS meetsmore » the INPRO requirements in a given area. The manuals set out the information that needs to be assembled to perform an assessment and provide guidance on selecting the acceptance limits and, for a given INS, for determining the value of the indicators for comparison with the associated acceptance limits. Each manual also includes an example of a specific assessment to illustrate the guidance. This paper discusses the manual for performing an INPRO assessment in the area of safety of fuel cycle installations. The example, chosen solely for the purpose of illustrating the INPRO methodology, describes an assessment of an MOX fuel fabrication plant based on sol-gel technology and illustrates an assessment performed for an INS at an early stage of development. The safety issues and the assessment steps are presented in detail in the paper. (authors)« less

78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-08

...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Conference on Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER.

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

PubMed

Pöting, A; Schauzu, M

2010-06-01

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

76 FR 38597 - Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 383 and 390 [Docket No. FMCSA-2011-0146] Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators of Certain Farm Vehicles and Off-Road Agricultural Equipment AGENCY: Federal Motor...

76 FR 50433 - Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 383 and 390 [Docket No. FMCSA-2011-0146] Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators of Certain Farm Vehicles and Off-Road Agricultural Equipment AGENCY: Federal Motor...

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

PubMed

Serabian, M A; Pilaro, A M

1999-01-01

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

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

PubMed

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

2003-12-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0721] Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety Modernization Act... Administration (FDA) is announcing the availability of a guidance for industry entitled ``Implementation of the...

Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

EPA Science Inventory

The Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (also referred to as the Environmental Justice Technical Guidance or EJTG) is intended for use by Agency analysts, including risk assessors, economists, and other analytic staff that conduct analyse...

Regulatory guidance concerning the applicability of the Federal Motor Carrier Safety regulations to texting by commercial motor vehicle drivers

DOT National Transportation Integrated Search

2010-01-10

The FMCSA announces regulatory guidance concerning texting while driving a commercial motor vehicle (CMV). The guidance is applicable to all interstate drivers of CMVs subject to the Federal Motor Carrier Safety Regulations (FMCSRs).

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

NASA Technical Reports Server (NTRS)

Dennehy, Cornelius J.

2011-01-01

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

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

PubMed

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.

Key Performance Indicators for the Assessment of Pediatric Pharmacotherapeutic Guidance

PubMed Central

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

2008-01-01

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

Key performance indicators for the assessment of pediatric pharmacotherapeutic guidance.

PubMed

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

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

PubMed

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

2014-11-01

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

77 FR 7166 - Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-10

... clinical investigations in determining the amounts and types of safety data to collect in trials conducted... types of safety data that should be collected during late-stage premarket and postmarket clinical...] Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late Stage...

General RMP Guidance - Appendix D: OSHA Guidance on PSM

EPA Pesticide Factsheets

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

78 FR 45930 - Guidance for Industry: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-30

...] Guidance for Industry: Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

...] Draft Guidance for Industry on ``Target Animal Safety and Effectiveness Protocol Development and...) entitled ``Target Animal Safety and Effectiveness Protocol Development and Submission.'' The purpose of... Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce the time to...

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

PubMed

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

2015-01-01

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

Assessing Enterprise Capability: Guidance for Schools

ERIC Educational Resources Information Center

National Foundation for Educational Research, 2007

2007-01-01

This document offers guidance to schools on how assessment can support enterprise education. It presents the interim findings from research carried out by the National Foundation for Educational Research (NFER) for the Department for Education and Skills (DfES) in secondary schools in England. Enterprise capability is the key outcome of enterprise…

Guidance on Initial Site Assessment at Corrective Action Sites

EPA Pesticide Factsheets

Guidance to be used to conduct Corrective Action site assessment efforts. Informs Resource Conservation and Recovery Act (RCRA) permit writers and enforcement officials of procedures to be used in conducting RCRA Facility Assessments.

[Agricultural biotechnology safety assessment].

PubMed

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

2015-01-01

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

Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review.

PubMed

Sheehan, David V; Giddens, Jennifer M; Sheehan, Kathy Harnett

2014-09-01

Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification system should be robust enough to last over time and provide comparability between data collections. This article was designed to evaluate the extent to which the classification system contained in the United States Food and Drug Administration 2012 Draft Guidance for the prospective assessment and classification of suicidal ideation and behavior in clinical trials meets these criteria. A critical review is used to assess the extent to which the proposed categories contained in the Food and Drug Administration 2012 Draft Guidance are comprehensive, unambiguous, and robust. Assumptions that underlie the classification system are also explored. The Food and Drug Administration classification system contained in the 2012 Draft Guidance does not capture the full range of suicidal ideation and behavior (type II error). Definitions, moreover, are frequently ambiguous (susceptible to multiple interpretations), and the potential for misclassification (type I and type II errors) is compounded by frequent mismatches in category titles and definitions. These issues have the potential to compromise data comparability within clinical trial sites, across sites, and over time. These problems need to be remedied because of the potential for flawed data output and consequent threats to public health, to research on the safety of medications, and to the search for effective medication treatments for suicidality.

Assessment of Inaugural Two-Year NPM Guidance Process

EPA Pesticide Factsheets

Assessment intended to facilitate discussions among EPA Headquarters, Regional and state staff and management -- to identify opportunities to improve the two-year process for the FY 2018-2019 NPM Guidance development.

77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0339] Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

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

NASA Technical Reports Server (NTRS)

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.

76 FR 6087 - Draft Weapons Safety Assessment on the Use of Enhanced Weapons; Notice of Availability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

... holders, and other stakeholders on a draft guidance document entitled ``Weapons Safety Assessment'' (WSA... weapons under the NRC's proposed rule titled ``Enhanced Weapons, Firearms Background Checks, and Security.... You should not include any site-specific security information in your comments. Federal rulemaking Web...

Risk Assessment Guidance for Superfund (RAGS) Volume III: Part A

EPA Pesticide Factsheets

EPA's Risk Assessment Guidance for Superfund (RAGS) Volume 3A provides policies and guiding principles on the application of probabilistic risk assessment (PRA) methods to human health and ecological risk assessment in the EPA Superfund Program.

12 CFR Appendix C to Part 1720 - Policy Guidance; Safety and Soundness Standards for Information

Code of Federal Regulations, 2014 CFR

2014-01-01

... Standards for Information C Appendix C to Part 1720 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE..., App. C Appendix C to Part 1720—Policy Guidance; Safety and Soundness Standards for Information A... for Information 1. Information Security Program. 2. Objectives. C—Development and Implementation of...

12 CFR Appendix C to Part 1720 - Policy Guidance; Safety and Soundness Standards for Information

Code of Federal Regulations, 2012 CFR

2012-01-01

... for Information C Appendix C to Part 1720 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE..., App. C Appendix C to Part 1720—Policy Guidance; Safety and Soundness Standards for Information A... for Information 1. Information Security Program. 2. Objectives. C—Development and Implementation of...

12 CFR Appendix C to Part 1720 - Policy Guidance; Safety and Soundness Standards for Information

Code of Federal Regulations, 2010 CFR

2010-01-01

... for Information C Appendix C to Part 1720 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE..., App. C Appendix C to Part 1720—Policy Guidance; Safety and Soundness Standards for Information A... for Information 1. Information Security Program. 2. Objectives. C—Development and Implementation of...

New FDA draft guidance on immunogenicity.

PubMed

Parenky, Ashwin; Myler, Heather; Amaravadi, Lakshmi; Bechtold-Peters, Karoline; Rosenberg, Amy; Kirshner, Susan; Quarmby, Valerie

2014-05-01

A "Late Breaking" session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss the US Food and Drug Administration's (FDA) 2013 draft guidance on Immunogenicity Assessment for Therapeutic Protein Products. The session was initiated by a presentation from the FDA which highlighted several key aspects of the 2013 draft guidance pertaining to immunogenicity risk, the potential impact on patient safety and product efficacy, and risk mitigation. This was followed by an open discussion on the draft guidance which enabled delegates from biopharmaceutical companies to engage the FDA on topics that had emerged from their review of the draft guidance. The multidisciplinary audience fostered an environment that was conducive to scientific discussion on a broad range of topics such as clinical impact, immune mitigation strategies, immune prediction and the role of formulation, excipients, aggregates, and degradation products in immunogenicity. This meeting report highlights several key aspects of the 2013 draft guidance together with related dialog from the session.

HEALTH TECHNOLOGY ASSESSMENT OF PUBLIC HEALTH INTERVENTIONS: A SYNTHESIS OF METHODOLOGICAL GUIDANCE.

PubMed

Mathes, Tim; Antoine, Sunya-Lee; Prengel, Peggy; Bühn, Stefanie; Polus, Stephanie; Pieper, Dawid

2017-01-01

The evaluation of public health interventions poses some challenges. As a consequence, health technology assessment (HTA) methods for public health interventions (PHI) have to be adapted. This study aimed to summarize the available guidance on methods for HTA of PHI. We systematically searched for methodological guidance on HTA of PHIs. Our focus was on research synthesis methods to evaluate effectiveness. Relevant information was synthesized narratively in a standardized way. Only four guidance documents were identified specifically for HTAs of PHI. The approaches used for HTAs of PHIs are broader and more flexible than those for medical interventions. For this reason, there is a tendency to identify the intervention components and context factors that influence the effectiveness and transferability of an intervention rather than to assess its effectiveness in general. The details in the guidance vary without justification. Unjustified heterogeneity between the different guidance approaches is most pronounced for quality assessment, assessment of applicability, and methods to integrate qualitative and quantitative evidence. Descriptions for the assessment of integrity, heterogeneity, sustainability, context factors, and applicability are often vague. The heterogeneity in approaches indicates that there is currently no consensus on methods to deal with the challenges of the PHI evaluations. A possible explanation for this may be that the methods are not sufficiently developed, and advantages and disadvantages of a certain method in relation to the research question (e.g., broad/focused) have not yet been sufficiently evaluated.

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

NASA Astrophysics Data System (ADS)

Summerer, Leopold

2014-08-01

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

Patient safety and patient assessment in pre-hospital care: a study protocol.

PubMed

Hagiwara, Magnus Andersson; Nilsson, Lena; Strömsöe, Anneli; Axelsson, Christer; Kängström, Anna; Herlitz, Johan

2016-02-12

Patient safety issues in pre-hospital care are poorly investigated. The aim of the planned study is to survey patient safety problems in pre-hospital care in Sweden. The study is a retro-perspective structured medical record review based on the use of 11 screening criteria. Two instruments for structured medical record review are used: a trigger tool instrument designed for pre-hospital care and a newly development instrument designed to compare the pre-hospital assessment with the final hospital assessment. Three different ambulance organisations are participating in the study. Every month, one rater in each organisation randomly collects 30 medical records for review. With guidance from the review instrument, he/she independently reviews the record. Every month, the review team meet for a discussion of problematic reviews. The results will be analysed with descriptive statistics and logistic regression. The findings will make an important contribution to knowledge about patient safety issues in pre-hospital care.

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

PubMed

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

2004-07-01

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

Data Assessment and Reporting-Supplement to Section 106 Tribal Guidance

EPA Pesticide Factsheets

This document is intended to complement the Tribal 106 Guidance and provide additional detail to tribes concerning the reporting information requested by EPA. It addresses the water quality assessment component of a Tribal Assessment Report.

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

PubMed

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

2018-06-01

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

75 FR 54889 - Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

...] Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials...: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of...

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

EPA Pesticide Factsheets

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

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hughes, P. J.; Westwood, R.N; Mark, R. T.

2006-07-01

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

Can podcasts for assessment guidance and feedback promote self-efficacy among undergraduate nursing students? A qualitative study.

PubMed

McSwiggan, Linda C; Campbell, Maureen

2017-02-01

Improving assessment guidance and feedback for students has become an international priority within higher education. Podcasts have been proposed as a tool for enhancing teaching, learning and assessment. However, a stronger theory-based rationale for using podcasts, particularly as a means of facilitating assessment guidance and feedback, is required. To explore students' experiences of using podcasts for assessment guidance and feedback. To consider how these podcasts shaped beliefs about their ability to successfully engage with, and act on, assessment guidance and feedback Design Exploratory qualitative study. Setting Higher education institution in North-East Scotland. Participants Eighteen third year undergraduate nursing students who had utilised podcasts for assessment guidance and feedback within their current programme of study. Participants took part in one of four focus groups, conducted between July and September 2013. Purposive sampling was utilised to recruit participants of different ages, gender, levels of self-assessed information technology skills and levels of academic achievement. Data analysis was guided by the framework approach. Thematic analysis highlighted similarities and differences in terms of students' experiences of using podcasts for assessment guidance and feedback. Further analysis revealed that Self-Efficacy Theory provided deeper theoretical insights into how the content, structure and delivery of podcasts can be shaped to promote more successful engagement with assessment guidance and feedback from students. The structured, logical approach of assessment guidance podcasts appeared to strengthen self-efficacy by providing readily accessible support and by helping students convert intentions into action. Students with high self-efficacy in relation to tasks associated with assessment were more likely to engage with feedback, whereas those with low self-efficacy tended to overlook opportunities to access feedback due to feelings of

Safety analysis, risk assessment, and risk acceptance criteria

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jamali, K.; Stack, D.W.; Sullivan, L.H.

1997-08-01

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 andmore » 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.« less

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

NASA Technical Reports Server (NTRS)

Zelkin, Natalie; Henriksen, Stephen

2011-01-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

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

75 FR 70009 - Development of Health Risk Assessment Guidance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Development of Health Risk Assessment Guidance AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Request for Information. SUMMARY: The Centers for Disease...

9 CFR 392.9 - Availability of additional guidance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Availability of additional guidance. 392.9 Section 392.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS PETITIONS FOR RULEMAKING § 392.9 Availability of additional guidance....

9 CFR 392.9 - Availability of additional guidance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Availability of additional guidance. 392.9 Section 392.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS PETITIONS FOR RULEMAKING § 392.9 Availability of additional guidance....

9 CFR 392.9 - Availability of additional guidance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Availability of additional guidance. 392.9 Section 392.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS PETITIONS FOR RULEMAKING § 392.9 Availability of additional guidance....

9 CFR 392.9 - Availability of additional guidance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Availability of additional guidance. 392.9 Section 392.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS PETITIONS FOR RULEMAKING § 392.9 Availability of additional guidance....

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

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

Documentary analysis of risk-assessment and safety-planning policies and tools in a mental health context.

PubMed

Higgins, Agnes; Doyle, Louise; Morrissey, Jean; Downes, Carmel; Gill, Ailish; Bailey, Sive

2016-08-01

Despite the articulated need for policies and processes to guide risk assessment and safety planning, limited guidance exists on the processes or procedures to be used to develop such policies, and there is no body of research that examines the quality or content of the risk-management policies developed. The aim of the present study was to analyse the policies of risk and safety management used to guide mental health nursing practice in Ireland. A documentary analysis was performed on 123 documents received from 22 of the 23 directors of nursing contacted. Findings from the analysis revealed a wide variation in how risk, risk assessment, and risk management were defined. Emphasis within the risk documentation submitted was on risk related to self and others, with minimal attention paid to other types of risks. In addition, there was limited evidence of recovery-focused approaches to positive risk taking that involved service users and their families within the risk-related documentation. Many of the risk-assessment tools had not been validated, and lacked consistency or guidance in relation to how they were to be used or applied. The tick-box approach and absence of space for commentary within documentation have the potential to impact severely on the quality of information collected and documented, and subsequent clinical decision-making. Managers, and those tasked with ensuring safety and quality, need to ensure that policies and processes are, where possible, informed by best evidence and are in line with national mental health policy on recovery. © 2016 Australian College of Mental Health Nurses Inc.

Offshore safety case approach and formal safety assessment of ships.

PubMed

Wang, J

2002-01-01

Tragic marine and offshore accidents have caused serious consequences including loss of lives, loss of property, and damage of the environment. A proactive, risk-based "goal setting" regime is introduced to the marine and offshore industries to increase the level of safety. To maximize marine and offshore safety, risks need to be modeled and safety-based decisions need to be made in a logical and confident way. Risk modeling and decision-making tools need to be developed and applied in a practical environment. This paper describes both the offshore safety case approach and formal safety assessment of ships in detail with particular reference to the design aspects. The current practices and the latest development in safety assessment in both the marine and offshore industries are described. The relationship between the offshore safety case approach and formal ship safety assessment is described and discussed. Three examples are used to demonstrate both the offshore safety case approach and formal ship safety assessment. The study of risk criteria in marine and offshore safety assessment is carried out. The recommendations on further work required are given. This paper gives safety engineers in the marine and offshore industries an overview of the offshore safety case approach and formal ship safety assessment. The significance of moving toward a risk-based "goal setting" regime is given.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0470... Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability AGENCY: Food and... the availability of a guidance entitled ``M3(R2) Nonclinical Safety Studies for the Conduct of Human...

75 FR 82400 - Development of Health Risk Assessment Guidance; Public Forum

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

... Care Act (ACA) (Pub. L. 111-148) requires that a Health Risk Assessment be included in the annual... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Development of Health Risk Assessment Guidance; Public Forum AGENCY: Centers for Disease Control and Prevention (CDC...

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

NASA Technical Reports Server (NTRS)

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

2015-01-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-22

... considerations relevant to lead contamination of NLG traditional pottery, and labeling considerations for food... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0571] Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of...

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

PubMed

Reisenhofer, Sonia; Taft, Angela

2013-12-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

... Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals--Acoustic Threshold Levels for.... SUMMARY: The National Marine Fisheries Service (NMFS) on behalf of NMFS and the National Ocean Service... availability of draft guidance for assessing the effects of anthropogenic sound on marine mammal species under...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1038] Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products... regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create...

Safety assessment of a novel active ingredient, acetyl aspartic acid, according to the EU Cosmetics Regulation and the Scientific Committee on Consumer Safety guidelines.

PubMed

Daly, P; Moran, G

2015-10-01

Acetyl aspartic acid (A-A-A) was proposed as a new novel active ingredient for use in cosmetics. The safety of A-A-A was assessed by following an in-house-developed 'New Ingredient Testing Strategy', which was designed in accordance with the Scientific Committee on Consumer Safety (SCCS) notes of guidance and the requirements of Annex I of the EU Cosmetics Regulation. The aim of the project was to determine whether A-A-A was safe for use in cosmetics and to determine a maximum permitted safe level in the formulations. A literature review was conducted, consulting over 40 different information sources. This highlighted a number of gaps which required testing data. A-A-A was tested for phototoxicity according to OECD test guideline 432, skin irritation according to OECD test guideline 439 and eye irritation according to OECD test guideline 437. Dermal absorption of A-A-A was measured according to OECD test guideline 428 and was used to calculate the margin of safety (MoS). Finally, A-A-A was tested in a human repeat insult patch test (HRIPT) and a 14-day in-use tolerance study. A-A-A was non-phototoxic and was non-irritating to skin and eyes in in vitro testing. Dermal absorption was calculated to be 5%. The MoS for A-A-A was 351, at a level of 5%, for all cosmetic product types, indicating no systemic safety toxicity concern. A-A-A at 5% under occlusive patch on a panel of 50 adult volunteers induced no skin irritation or allergic reaction in the HRIPT study. Finally, repeated application of A-A-A to the periocular area, twice per day for 14 days, in 21 female volunteers, demonstrated that 1% A-A-A was well tolerated following dermatological and ophthalmological assessment in a cosmetic formulation. A-A-A was assessed as safe by the cosmetic safety assessor for use in cosmetics at a level of 5% in all cosmetic product types, in line with the requirements of the EU Cosmetics Regulation and in accordance with the SCCS notes of guidance. © 2015 Society of Cosmetic

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

PubMed

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.

Guidance on the prevention and mitigation of environmental, health and safety impacts of electromagnetic fields and radiation for electric transit systems

DOT National Transportation Integrated Search

2008-01-02

The Federal Transit Administration (FTA) Office of Planning and Environment (TPE) tasked the Volpe Center to develop guidance for transit planners, in order to address persisting public health and safety concerns with prolonged EMF environmental expo...

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

NASA Astrophysics Data System (ADS)

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

2015-04-01

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

Assessment of vocational guidance: the Berufsbilder test.

PubMed

Melo-Silva, Lucy Leal; Pasian, Sonia Regina; Assoni, Renata de Fátima; Bonfim, Talma Alzira

2008-05-01

The object of this study is to assess informative possibilities of some technical indicators of the Test of Photos of Professions (BBT--Berufsbilder test), a projective method to clarify professional inclination, proposed by Martin Achtnich. This psychological evaluation technique is composed of 96 photos of professionals, performing various types of activities. The test subject classifies the photos into three groups: positive (agreeable), negative (disagreeable) and indifferent (neutral). Among those chosen positively, five preferences are chosen and a story is developed that includes them, an activity that is requested two times during the Vocational Guidance process: in the beginning (or middle) and at the end of the intervention. In this study, 160 stories were created by 80 youths, between 15 and 20 years of age, in public and private schools in a mid-sized Brazilian city. The stories were compared in three analytical categories: protagonist, professional conflict and resolution. The results were submitted to Wilcoxon nonparametric statistical analysis (p < .05), significant and relevant indicators of resolution being found in the process of occupational choice. This technical resource was shown, from this empirical evidence, to be promising for use in evaluation of intervention processes of Vocational Guidance.

Predictors of health care provider anticipatory guidance provision for older drivers.

PubMed

Huseth-Zosel, Andrea L; Sanders, Gregory; O'Connor, Melissa

2016-11-16

The objective of this study was to determine the frequency of health care provider (HCP) driving safety/cessation-related anticipatory guidance provision and predictors of driving safety-related anticipatory guidance provision by HCPs. HCPs in several central/upper Midwest states were surveyed about frequency of anticipatory guidance provision (n = 265). More than half of HCPs stated that they frequently or always provide driving safety/cessation-related anticipatory guidance to patients aged 85 or older, 38.7% provided this guidance to patients aged 75 to 84, and 13.7% to patients aged 65 to 74. Predictors of driving safety/cessation-related anticipatory guidance provision differed by patient age. For patients aged 65-74, HCP personal experience with a motor vehicle crash (either the HCP themselves or a friend/family member) was significant in predicting anticipatory guidance provision. However, for patients aged 75 and older, significant predictors included HCP rural practice, HCP age, and percentage of HCP patients who were older adults. HCP counseling provision related to driving issues differs by patient age and several HCP characteristics, including HCP rurality, age, and personal experience with motor vehicle crashes. Because aging results in physical and mental changes that affect driving and can be identified by HCPs, HCPs are in a position to counsel patients on the potential impacts of aging on the act of driving. Future research should examine the reasons for the differences in anticipatory guidance provision found in this study.

Dose limits to the lens of the eye: International Basic Safety Standards and related guidance.

PubMed

Boal, T J; Pinak, M

2015-06-01

The International Atomic Energy Agency (IAEA) safety requirements: 'General Safety Requirements Part 3--Radiation protection and safety of radiation sources: International Basic Safety Standards' (BSS) was approved by the IAEA Board of Governors at its meeting in September 2011, and was issued as General Safety Requirements Part 3 in July 2014. The equivalent dose limit for the lens of the eye for occupational exposure in planned exposure situations was reduced from 150 mSv year(-1) to 20 mSv year(-1), averaged over defined periods of 5 years, with no annual dose in a single year exceeding 50 mSv. This reduction in the dose limit for the lens of the eye followed the recommendation of the International Commission on Radiological Protection in its statement on tissue reactions of 21 April 2011. IAEA has developed guidance on the implications of the new dose limit for the lens of the eye. This paper summarises the process that led to the inclusion of the new dose limit for the lens of the eye in the BSS, and the implications of the new dose limit. © The International Society for Prosthetics and Orthotics Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Correlation between safety climate and contractor safety assessment programs in construction

PubMed Central

Sparer, EH1; Murphy, LA; Taylor, KM; Dennerlein, Jt

2015-01-01

Background Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Methods 401 construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. Results There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers’ safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. Conclusions A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. PMID:24038403

76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-04

... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the... regulatory guidance concerning the use of electronic signatures and documents to comply with FMCSA...

EMP Attachment 3 DOE-SC PNNL Site Dose Assessment Guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

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 ofmore » 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.« less

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kot, C.

1999-05-10

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

Ecological Risk Assessment Guidance for Superfund: Process for Designing and Conducting Ecological Risk Assessments - Interim Final

EPA Pesticide Factsheets

This document provides guidance to site managers and Remedial Project Managers who are legally responsible for the management of a site on how to design and conduct technically defensible ecological risk assessments for the Superfund program.

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

PubMed

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

2013-12-01

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

78 FR 9054 - Issuance of Final Guidance Publication

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

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

75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-27

... comments on the draft guidance by March 29, 2010. ADDRESSES: Submit written requests for single copies of...] Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability AGENCY: Food and... psychoactive effects such as sedation, euphoria, or mood change. DATES: Although you can comment on any...

Technical Guidance for Assessing Environmental Justice in ...

EPA Pesticide Factsheets

The Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (also referred to as the Environmental Justice Technical Guidance or EJTG) is intended for use by Agency analysts, including risk assessors, economists, and other analytic staff that conduct analyses to evaluate EJ concerns in the context of regulatory actions. Senior EPA managers and decision makers also may find this document useful to understand analytic expectations and to ensure that EJ concerns are appropriately considered in the development of analyses to support regulatory actions under EPA’s action development process. Specifically, the document outlines approaches and methods to help Agency analysts evaluate EJ concerns. The document provides overarching direction to analysts by outlining a series of questions that will ensure the decision maker has appropriate information about baseline risks across population groups, and how those risks are distributed under the options being considered. In addition, the document provides a set of recommendations and requirements as well as best practices for use in analyzing and reporting results from consideration of EJ concerns. These principles will help ensure consistency, quality, and transparency across regulatory actions, while allowing for flexibility needed across different regulatory actions. The purpose of the EJTG is ensure consistency, quality, and transparency in considering environmental justice, while allowing f

16 CFR 1500.230 - Guidance for lead (Pb) in consumer products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Guidance for lead (Pb) in consumer products. 1500.230 Section 1500.230 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS... § 1500.230 Guidance for lead (Pb) in consumer products. (a) Summary. (1) The U.S. Consumer Product Safety...

76 FR 22106 - Issuance of Final Guidance Publication

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-20

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

Application of a screening method in assessing occupational safety and health of computer workstations.

PubMed

Niskanen, Toivo; Lehtelä, Jouni; Länsikallio, Riina

2014-01-01

Employers and workers need concrete guidance to plan and implement changes in the ergonomics of computer workstations. The Näppärä method is a screening tool for identifying problems requiring further assessment and corrective actions. The aim of this study was to assess the work of occupational safety and health (OSH) government inspectors who used Näppärä as part of their OSH enforcement inspections (430 assessments) related to computer work. The modifications in workstation ergonomics involved mainly adjustments to the screen, mouse, keyboard, forearm supports, and chair. One output of the assessment is an index indicating the percentage of compliance items. This method can be considered as exposure assessment and ergonomics intervention used as a benchmark for the level of ergonomics. Future research can examine whether the effectiveness of participatory ergonomics interventions should be investigated with Näppärä.

VLSI chips for vision-based vehicle guidance

NASA Astrophysics Data System (ADS)

Masaki, Ichiro

1994-02-01

Sensor-based vehicle guidance systems are gathering rapidly increasing interest because of their potential for increasing safety, convenience, environmental friendliness, and traffic efficiency. Examples of applications include intelligent cruise control, lane following, collision warning, and collision avoidance. This paper reviews the research trends in vision-based vehicle guidance with an emphasis on VLSI chip implementations of the vision systems. As an example of VLSI chips for vision-based vehicle guidance, a stereo vision system is described in detail.

Assessment and management of alcohol dependence and withdrawal in the acute hospital: concise guidance.

PubMed

Stewart, Stephen; Swain, Sharon

2012-06-01

Alcohol dependence is common among patients attending acute hospitals. It can be the major reason for attendance or a significant cofactor. Assessment of these patients in the acute setting can be challenging owing to the multidisciplinary approach required. Doctors in acute hospitals are often inexperienced in managing dependence, a mental health problem. They might focus on the physical harms or the withdrawal, a consequence of the dependence. For this reason, assessment of dependence and prevention and management of acute alcohol withdrawal are often suboptimal. There is little existing guidance on how to manage this patient population, especially in non-specialist settings. With recently published National Institute for Health and Clinical Excellence (NICE) guidance on the management of dependence and withdrawal, now is the perfect time to produce concise guidelines in the hope that a more succinct suite of guidance can reach a larger audience.

Federal Guidance for Radiation Protection

EPA Pesticide Factsheets

EPA produces federal guidance technical reports, which standardize dose and risk assessment and issues radiation protection guidance to federal agencies. This page provides links to federal guidance policy recommendations and technical reports.

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

PubMed

2010-01-21

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

Revisions to US EPA Superfund Risk and Dose Assessment Models and Guidance - 13403

DOE Office of Scientific and Technical Information (OSTI.GOV)

Walker, Stuart A.

2013-07-01

The U.S. Environmental Protection Agency (EPA) Superfund program's six Preliminary Remediation Goal (PRG) and Dose Compliance Concentration (DCC) internet based calculators for risk and dose assessment at Superfund sites are being revised to reflect better science, revisions to existing exposure scenarios and new scenarios, and changes to match up more closely with the EPA chemical regional screening level calculator. A revised version of the 1999 guidance document that provides an overview for the Superfund risk assessment process at radioactively contaminated sites, 'Radiation Risk Assessment At CERCLA Sites: Q and A', is being completed that will reflect Superfund recommended guidance andmore » other technical documents issued over the past 13 years. EPA is also issuing a series of fact sheets in the document 'Superfund Radiation Risk Assessment: A Community Tool-kit'. This presentation would go over those changes that are expected to be finished by this spring. (authors)« less

Advanced Guidance and Control Project for Reusable Launch Vehicles

NASA Technical Reports Server (NTRS)

Hanson, John M.

2000-01-01

The goals of this project are to significantly reduce the time and cost associated with guidance and control design for reusable launch vehicles, and to increase their safety and reliability. Success will lead to reduced cycle times during vehicle design and to reduced costs associated with flying to new orbits, with new payloads, and with modified vehicles. Success will also lead to more robustness to unforeseen circumstances in flight thereby enhancing safety and reducing risk. There are many guidance and control methods available that hold some promise for improvement in the desired areas. Investigators are developing a representative set of independent guidance and control methods for this project. These methods are being incorporated into a high-fidelity off is being conducted across a broad range of flight requirements. The guidance and control methods that perform the best will have demonstrated the desired qualities.

The revised HSE fatigue guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stacey, A.; Sharp, J.V.

1995-12-31

Fatigue cracking has been a principal cause of damage to North Sea structures and consequently considerable attention has been given to the development of guidance for the prediction of fatigue performance. The fatigue guidance of the Offshore Safety Division of the Health and Safety Executive (HSE) was recently revised and published, following a significant offshore industry review in the period 1987 to 1990, and is based on the results of a considerable amount of research and development work on the fatigue behavior of welded tubular and plated joints. As a result of this review, the revised fatigue guidance incorporates severalmore » new clauses and recommendations. The revised recommendations apply to joint classification, basic design S-N curves for welded joints and cast or forged steel components, the thickness effect, the effects of environment and the treatment of low and high stress ranges. Additionally, a new appendix on the derivation of stress concentration factors is included. The new clauses cover high strength steels, bolts and threaded connectors, moorings, repaired joints and the use of fracture mechanics analysis. This paper presents an overview of the revisions to the fatigue guidance, the associated background technical information and aspects of the fatigue behavior of offshore structures which are considered to require further investigation. 67 refs., 7 figs., 8 tabs.« less

Augmented reality guidance system for peripheral nerve blocks

NASA Astrophysics Data System (ADS)

Wedlake, Chris; Moore, John; Rachinsky, Maxim; Bainbridge, Daniel; Wiles, Andrew D.; Peters, Terry M.

2010-02-01

Peripheral nerve block treatments are ubiquitous in hospitals and pain clinics worldwide. State of the art techniques use ultrasound (US) guidance and/or electrical stimulation to verify needle tip location. However, problems such as needle-US beam alignment, poor echogenicity of block needles and US beam thickness can make it difficult for the anesthetist to know the exact needle tip location. Inaccurate therapy delivery raises obvious safety and efficacy issues. We have developed and evaluated a needle guidance system that makes use of a magnetic tracking system (MTS) to provide an augmented reality (AR) guidance platform to accurately localize the needle tip as well as its projected trajectory. Five anesthetists and five novices performed simulated nerve block deliveries in a polyvinyl alcohol phantom to compare needle guidance under US alone to US placed in our AR environment. Our phantom study demonstrated a decrease in targeting attempts, decrease in contacting of critical structures, and an increase in accuracy of 0.68 mm compared to 1.34mm RMS in US guidance alone. Currently, the MTS uses 18 and 21 gauge hypodermic needles with a 5 degree of freedom sensor located at the needle tip. These needles can only be sterilized using an ethylene oxide process. In the interest of providing clinicians with a simple and efficient guidance system, we also evaluated attaching the sensor at the needle hub as a simple clip-on device. To do this, we simultaneously performed a needle bending study to assess the reliability of a hub-based sensor.

Guidance for Data Useability in Risk Assessment (Part B-4), Final, May, 1992

EPA Pesticide Factsheets

This chapter provides guidance to the RPM and the risk assessor for designing an effective sampling plan and selecting suitable analytical methods to collect environmental data for use in baseline risk assessments.

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

PubMed

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

2017-11-01

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

Highway Safety Program Manual: Volume 14: Pedestrian Safety.

ERIC Educational Resources Information Center

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

Volume 14 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on pedestrian safety. The purpose and objectives of a pedestrian safety program are outlined. Federal authority in the area of pedestrian safety and policies regarding a safety program…

Pandemic influenza guidance for corporations.

PubMed

2011-06-01

The purpose of this guidance document is to assist members of the American College of Occupational and Environmental Medicine (ACOEM), and the organizations for which they work, in managing the impact of a pandemic of influenza or other contagious respiratory disease on patients, employees, and business. This guidance document outlines actions to take before and during an influenza pandemic on the basis of two main strategies: (1) reducing the spread of the virus within facilities; and (2) providing medical care and medical surveillance to client/patient populations. Facilities in which ACOEM members serve include government agencies and the military, universities, and corporations, which generally have multiple locations/sites and their own medical staff, with members responsible for medical care and disease control. This guidance is for organizations with outpatient occupational medicine services, to be used as appropriate. Medical centers should also use guidance that addresses additional employee and external patient care needs.1–3 The ACOEM fully supports implementation of occupational influenza programs that conform with guidance from the Centers for Disease Control and Prevention (CDC), with other guidance from the US Department of Health and Human Services (DHHS), and Occupational Safety and Health Administration (OSHA) regulations and guidance.

Safety Auditing and Assessments

NASA Technical Reports Server (NTRS)

Goodin, James Ronald (Ronnie)

2005-01-01

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

Safety Auditing and Assessments

NASA Astrophysics Data System (ADS)

Goodin, Ronnie

2005-12-01

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

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

PubMed

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.

An assessment by the Statin Muscle Safety Task Force: 2014 update.

PubMed

Rosenson, Robert S; Baker, Steven K; Jacobson, Terry A; Kopecky, Stephen L; Parker, Beth A; The National Lipid Association's Muscle Safety Expert Panel

2014-01-01

The National Lipid Association's Muscle Safety Expert Panel was charged with the duty of examining the definitions for statin-associated muscle adverse events, development of a clinical index to assess myalgia, and the use of diagnostic neuromuscular studies to investigate muscle adverse events. We provide guidance as to when a patient should be considered for referral to neuromuscular specialists and indications for the performance of a skeletal muscle biopsy. Based on this review of evidence, we developed an algorithm for the evaluation and treatment of patients who may be intolerant to statins as the result of adverse muscle events. The panel was composed of clinical cardiologists, clinical lipidologists, an exercise physiologist, and a neuromuscular specialist. Copyright © 2014 National Lipid Association. Published by Elsevier Inc. All rights reserved.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-01

... environmental justice assessments of its regulatory actions for years. This experience and body of work... set of questions to guide analysts in evaluating potential environmental justice concerns in EPA rules.... This guidance takes into account EPA's past experience in integrating EJ into the rulemaking process...

Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics - Current challenges and approaches.

PubMed

Broschard, Thomas H; Glowienke, Susanne; Bruen, Uma S; Nagao, Lee M; Teasdale, Andrew; Stults, Cheryl L M; Li, Kim L; Iciek, Laurie A; Erexson, Greg; Martin, Elizabeth A; Ball, Douglas J

2016-11-01

Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies may be performed as a risk mitigation activity to identify potential leachables for dosage forms with a high degree of concern associated with the route of administration. To address safety concerns, approaches to toxicological safety evaluation of extractables and leachables have been developed and applied by pharmaceutical and biologics manufacturers. Details of these approaches may differ depending on the nature of the final drug product. These may include application, the formulation, route of administration and length of use. Current regulatory guidelines and industry standards provide general guidance on compound specific safety assessments but do not provide a comprehensive approach to safety evaluations of leachables and/or extractables. This paper provides a perspective on approaches to safety evaluations by reviewing and applying general concepts and integrating key steps in the toxicological evaluation of individual extractables or leachables. These include application of structure activity relationship studies, development of permitted daily exposure (PDE) values, and use of safety threshold concepts. Case studies are provided. The concepts presented seek to encourage discussion in the scientific community, and are not intended to represent a final opinion or "guidelines." Copyright © 2016 Elsevier Inc. All rights reserved.

Highway Safety Program Manual: Volume 3: Motorcycle Safety.

ERIC Educational Resources Information Center

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

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

77 FR 74194 - Issuance of Final Guidance Publication

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-13

... NIOSH-238] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC... Respiratory Disease from Exposures Caused by Dampness in Office Buildings, Schools, and Other Nonindustrial...

A comprehensive conceptual framework for road safety strategies.

PubMed

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

2016-05-01

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

Assessment of Electrical Safety in Afghanistan

DTIC Science & Technology

2009-07-24

effectiveness of command efforts to ensure the electrical safety of Department of Defense occupied and constructed facilities in Afghanistan. We...March 31, 2009, we announced the Assessment of Electrical Safety in Afghanistan. The objective of this assessment was to review the effectiveness of...used contractors to review and identify electrical deficiencies to include life, health , and safety issues at FOBs. According to TF POWER

Systematic assessment of laser safety in otolaryngology

NASA Astrophysics Data System (ADS)

Oswal, V. H.

2001-01-01

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

Guidance on Data Quality Assessment for Life Cycle Inventory ...

EPA Pesticide Factsheets

Data quality within Life Cycle Assessment (LCA) is a significant issue for the future support and development of LCA as a decision support tool and its wider adoption within industry. In response to current data quality standards such as the ISO 14000 series, various entities within the LCA community have developed different methodologies to address and communicate the data quality of Life Cycle Inventory (LCI) data. Despite advances in this field, the LCA community is still plagued by the lack of reproducible data quality results and documentation. To address these issues, US EPA has created this guidance in order to further support reproducible life cycle inventory data quality results and to inform users of the proper application of the US EPA supported data quality system. The work for this report was begun in December 2014 and completed as of April 2016.The updated data quality system includes a novel approach to the pedigree matrix by addressing data quality at the flow and the process level. Flow level indicators address source reliability, temporal correlation, geographic correlation, technological correlation and data sampling methods. The process level indicators address the level of review the unit process has undergone and its completeness. This guidance is designed to be updatable as part of the LCA Research Center’s continuing commitment to data quality advancements. Life cycle assessment is increasingly being used as a tool to identify areas of

Ward round template: enhancing patient safety on ward rounds.

PubMed

Gilliland, Niall; Catherwood, Natalie; Chen, Shaouyn; Browne, Peter; Wilson, Jacob; Burden, Helena

2018-01-01

Concerns had been raised at clinical governance regarding the safety of our inpatient ward rounds with particular reference to: documentation of clinical observations and National Early Warning Score (NEWS), compliance with Trust guidance for venous thromboembolism (VTE) risk assessment, antibiotic stewardship, palliative care and treatment escalation plans (TEP). This quality improvement project was conceived to ensure these parameters were considered and documented during the ward round, thereby improving patient care and safety. These parameters were based on Trust patient safety guidance and CQUIN targets. The quality improvement technique of plan-do-study-act (PDSA) was used in this project. We retrospectively reviewed ward round entries to record baseline measurements, based on the above described parameters, prior to making any changes. Following this, the change applied was the introduction of a ward round template to include the highlighted important baseline parameters. Monthly PDSA cycles are performed, and baseline measurements are re-examined, then relevant changes were made to the ward round template. Documentation of baseline measurements was poor prior to introduction of the ward round template; this improved significantly following introduction of a standardised ward round template. Following three cycles, documentation of VTE risk assessments increased from 14% to 92%. Antibiotic stewardship documentation went from 0% to 100%. Use of the TEP form went from 29% to 78%. Following introduction of the ward round template, compliance improved significantly in all safety parameters. Important safety measures being discussed on ward rounds will lead to enhanced patient safety and will improve compliance to Trust guidance and comissioning for quality and innovation (CQUIN) targets. Ongoing change implementation will focus on improving compliance with usage of the template on all urology ward rounds.

Integrated deterministic and probabilistic safety analysis for safety assessment of nuclear power plants

DOE PAGES

Di Maio, Francesco; Zio, Enrico; Smith, Curtis; ...

2015-07-06

The present special issue contains an overview of the research in the field of Integrated Deterministic and Probabilistic Safety Assessment (IDPSA) of Nuclear Power Plants (NPPs). Traditionally, safety regulation for NPPs design and operation has been based on Deterministic Safety Assessment (DSA) methods to verify criteria that assure plant safety in a number of postulated Design Basis Accident (DBA) scenarios. Referring to such criteria, it is also possible to identify those plant Structures, Systems, and Components (SSCs) and activities that are most important for safety within those postulated scenarios. Then, the design, operation, and maintenance of these “safety-related” SSCs andmore » activities are controlled through regulatory requirements and supported by Probabilistic Safety Assessment (PSA).« less

Questions and Answers: EPA's Guidelines for Carcinogen Risk Assessment and Supplemental Guidance from Assessing Susceptibility from Early-Life Exposure to Carcinogens

EPA Science Inventory

Questions and Answers

The following questions ...

Constantly evolving safety assessment protocols for GM foods.

PubMed

Sesikeran, B; Vasanthi, Siruguri

2008-01-01

he introduction of GM foods has led to the evolution of a food safety assessment paradigm that establishes safety of the GM food relative to its conventional counterpart. The GM foods currently approved and marketed in several countries have undergone extensive safety testing under a structured safety assessment framework evolved by international organizations like FAO, WHO, Codex and OECD. The major elements of safety assessment include molecular characterization of inserted genes and stability of the trait, toxicity and allergenicity potential of the expressed substances, compositional analysis, potential for gene transfer to gut microflora and unintentional effects of the genetic modification. As more number and type of food crops are being brought under the genetic modification regime, the adequacy of existing safety assessment protocols for establishing safety of these foods has been questioned. Such crops comprise GM crops with higher agronomic vigour, nutritional or health benefit/ by modification of plant metabolic pathways and those expressing bioactive substances and pharmaceuticals. The safety assessment challenges of these foods are the potential of the methods to detect unintentional effects with higher sensitivity and rigor. Development of databases on food compositions, toxicants and allergens is currently seen as an important aid to development of safety protocols. With the changing global trends in genetic modification technology future challenge would be to develop GM crops with minimum amount of inserted foreign DNA so as to reduce the burden of complex safety assessments while ensuring safety and utility of the technology.

Smart Stylet: The development and use of a bedside external ventricular drain image-guidance system

PubMed Central

Patil, Vaibhav; Gupta, Rajiv; Estépar, Raúl San José; Lacson, Ronilda; Cheung, Arnold; Wong, Judith M.; Popp, A. John; Golby, Alexandra; Ogilvy, Christopher; Vosburgh, Kirby G.

2015-01-01

Background Placement accuracy of ventriculostomy catheters is reported in a wide and variable range. Development of an efficient image-guidance system may improve physician performance and patient safety. Objective We evaluate the prototype of Smart Stylet, a new electromagnetic image-guidance system for use during bedside ventriculostomy. Methods Accuracy of the Smart Stylet system was assessed. System operators were evaluated for their ability to successfully target the ipsilateral frontal horn in a phantom model. Results Target registration error across 15 intracranial targets ranged from 1.3 – 4.6 mm (mean 3.1 mm). Using Smart Stylet guidance, a test operator successfully passed a ventriculostomy catheter to a shifted ipsilateral frontal horn 20/20 (100%) times from the frontal approach in a skull phantom. Without Smart Stylet guidance, the operator was successful 4/10 (40 %) from the right frontal approach and 6/10 (60 %) from the left frontal approach. In a separate experiment, resident operators were successful 2/4 (50%) when targeting the shifted ipsilateral frontal horn with Smart Stylet guidance and 0/4 (0 %) without image-guidance using a skull phantom. Conclusions Smart Stylet may improve the ability to successfully target the ventricles during frontal ventriculostomy. PMID:25662506

HFE Process Guidance and Standards for potential application to updating NRC guidance

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jacques Hugo; J. J. Persensky

2012-07-01

The U.S. Nuclear Regulatory Commission (NRC) reviews and evaluates the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed tomore » the periodic update and improvement of these guidance documents to ensure that they remain state-of-the-art design evaluation tools. Thus, the NRC has initiated a project with BNL to update the NRC guidance to remain current with recent research on human performance, advances in HFE methods and tools, and new technology. INL supported Brookhaven National Lab (BNL) to update the detailed HFE review criteria contained in NUREG-0711 and NUREG-0700 based on (1) feedback obtained from end users, (2) the results of NRC research and development efforts supporting the NRC staff’s HFE safety reviews, and (3) other material the project staff identify as applicable to the update effort. INL submitted comments on development plans and sections of NUREGs 0800, 0711, and 0700. The contractor prepared the report attached here as the deliverable for this work.« less

Assessment of Adaptive Guidance for Responsive Launch Vehicles and Spacecraft

DTIC Science & Technology

2009-04-29

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

GUIDANCE ON SELECTING AGE GROUPS FOR MONITORING AND ASSESSING CHILDHOOD EXPOSURES TO ENVIRONMENTAL CONTAMINANTS

EPA Science Inventory

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 und...

Does haptic steering guidance instigate speeding? A driving simulator study into causes and remedies.

PubMed

Melman, T; de Winter, J C F; Abbink, D A

2017-01-01

An important issue in road traffic safety is that drivers show adverse behavioral adaptation (BA) to driver assistance systems. Haptic steering guidance is an upcoming assistance system which facilitates lane-keeping performance while keeping drivers in the loop, and which may be particularly prone to BA. Thus far, experiments on haptic steering guidance have measured driver performance while the vehicle speed was kept constant. The aim of the present driving simulator study was to examine whether haptic steering guidance causes BA in the form of speeding, and to evaluate two types of haptic steering guidance designed not to suffer from BA. Twenty-four participants drove a 1.8m wide car for 13.9km on a curved road, with cones demarcating a single 2.2m narrow lane. Participants completed four conditions in a counterbalanced design: no guidance (Manual), continuous haptic guidance (Cont), continuous guidance that linearly reduced feedback gains from full guidance at 125km/h towards manual control at 130km/h and above (ContRF), and haptic guidance provided only when the predicted lateral position was outside a lateral bandwidth (Band). Participants were familiarized with each condition prior to the experimental runs and were instructed to drive as they normally would while minimizing the number of cone hits. Compared to Manual, the Cont condition yielded a significantly higher driving speed (on average by 7km/h), whereas ContRF and Band did not. All three guidance conditions yielded better lane-keeping performance than Manual, whereas Cont and ContRF yielded lower self-reported workload than Manual. In conclusion, continuous steering guidance entices drivers to increase their speed, thereby diminishing its potential safety benefits. It is possible to prevent BA while retaining safety benefits by making a design adjustment either in lateral (Band) or in longitudinal (ContRF) direction. Copyright © 2016. Published by Elsevier Ltd.

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

PubMed

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

2017-11-01

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

Guidance on Cumulative Risk Assessment of Pesticide Chemicals that have a Common Mechanism of Toxicity

EPA Pesticide Factsheets

This document provides guidance to OPP scientists for evaluating and estimating the potential human risks associated with such multichemical and multipathway exposures to pesticides. This process is referred to as cumulative risk assessment.

Probability-based hazard avoidance guidance for planetary landing

NASA Astrophysics Data System (ADS)

Yuan, Xu; Yu, Zhengshi; Cui, Pingyuan; Xu, Rui; Zhu, Shengying; Cao, Menglong; Luan, Enjie

2018-03-01

Future landing and sample return missions on planets and small bodies will seek landing sites with high scientific value, which may be located in hazardous terrains. Autonomous landing in such hazardous terrains and highly uncertain planetary environments is particularly challenging. Onboard hazard avoidance ability is indispensable, and the algorithms must be robust to uncertainties. In this paper, a novel probability-based hazard avoidance guidance method is developed for landing in hazardous terrains on planets or small bodies. By regarding the lander state as probabilistic, the proposed guidance algorithm exploits information on the uncertainty of lander position and calculates the probability of collision with each hazard. The collision probability serves as an accurate safety index, which quantifies the impact of uncertainties on the lander safety. Based on the collision probability evaluation, the state uncertainty of the lander is explicitly taken into account in the derivation of the hazard avoidance guidance law, which contributes to enhancing the robustness to the uncertain dynamics of planetary landing. The proposed probability-based method derives fully analytic expressions and does not require off-line trajectory generation. Therefore, it is appropriate for real-time implementation. The performance of the probability-based guidance law is investigated via a set of simulations, and the effectiveness and robustness under uncertainties are demonstrated.

Final OSWER Vapor Intrusion Guidance

EPA Science Inventory

EPA is preparing to finalize its guidance on assessing and addressing vapor intrusion, which is defined as migration of volatile constituents from contaminated media in the subsurface (soil or groundwater) into the indoor environment. In November 2002, EPA issued draft guidance o...

New portable voice guidance device for the manual wheelchair transfer: a pilot study in patients with hemiplegia.

PubMed

Yoshida, Taiki; Otaka, Yohei; Osu, Rieko; Kita, Kahori; Sakata, Sachiko; Kondo, Kunitsugu

2017-05-01

Older and/or cognitively impaired patients require verbal guidance to prevent accidents during wheelchair operation, thus increasing the burden on caregivers. This study aimed to develop a new portable voice guidance device for manual wheelchairs and examine its clinical usefulness. We developed a portable voice guidance device to monitor the statuses of wheelchair brakes and footrests and automatically provide voice guidance for operation. The device comprises a microcomputer, four magnets and magnetic sensors, speaker and battery. Device operation was assessed during the transfer from a wheelchair to bed six times per day over three days for a total of 90 transfers in five stroke patients (mean age: 79.6 years) who required verbal guidance to direct wheelchair operation. Device usability was also assessed using a questionnaire. The device performed perfectly during all attempted transfers (100%). To ensure safety, the assessor needed to add verbal guidance during 33 of 90 attempted transfers (36.6%). Overall, the device usability was favourable. However, some assessors were unsatisfied with the volume of the device voice, guidance timing and burden reduction. Our device could facilitate wheelchair operation and might potentially be used to reduce fall risk in stroke patients and the burden on caregivers. Implications for Rehabilitation The acquisition of transfer independence is an important step in the rehabilitation of patients with mobility issues. Many patients require supervision and guidance regarding the operation of brakes and footrests on manual wheelchairs. This newly developed voice guidance device for manual wheelchair transfers worked well in patients with hemiplegia and might be helpful to reduce the fall risks and the burden of care.

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

PubMed

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

2016-01-01

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

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

PubMed

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

2017-08-01

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

Optimizing EEMCO guidance for the assessment of dry skin (xerosis) for pharmacies.

PubMed

Kang, B C; Kim, Y E; Kim, Y J; Chang, M J; Choi, H D; Li, K; Shin, W G

2014-02-01

People with dry skin (xerosis) are common in community pharmacies, but there is no consistent guidance for community pharmacists to evaluate and alleviate dry skin. Through evaluating any difference of the clinical scoring systems of EEMCO guidance between a dermatologist and pharmacists and the efficacy of moisturizers for the treatment of dry skin recommended by community pharmacists, we aim to validate a dry skin guidance through the help of community pharmacists. These results provide insight into how community pharmacists can help patients with dry skin. The clinical scoring systems of EEMCO guidance used in this study comprised analog scales, the overall dry skin score (ODS), and the specific symptom sum score (SRRC) system. All pictures of the dry skin scored by pharmacists were visually evaluated by a dermatologist. The efficacy of the moisturizers was determined by the difference of the scales on day 0 and on day 28. In this study, 387 patients with dry skin from 157 community pharmacies were evaluated by pharmacists. Visual scale with divisions, ODS and SRRC that were evaluated by pharmacists on day 0 and day 28 were moderately reliable by a dermatologist. All parameters of dry skin were significantly improved by the moisturizers which were recommended by community pharmacists on day 28. Visual scale, ODS and SRRC can be generally measured to evaluate dry skin in community pharmacies with moderate degree of reliability. This finding has possible applications for investigating the assessment of the community pharmacists on clinical scoring system of dry skin and moisturizers. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Guidance on the Technology Performance Level (TPL) Assessment Methodology

DOE Office of Scientific and Technical Information (OSTI.GOV)

Weber, Jochem; Roberts, Jesse D.; Babarit, Aurelien

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 themore » 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.« less

76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... process includes submitting a time and extent application (TEA) to determine whether a condition is..., submitting safety and effectiveness data. This guidance is designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the draft guidance for industry entitled ``Time...

Guidance for Considering and Using Open Literature Toxicity Studies to Support Human Health Risk Assessment

EPA Pesticide Factsheets

This guidance was developed to assist OPP scientists and is intended for use in OPP’s risk assessments. It is intended to ensure consistent consideration, use, and documentation of information in the open literature by OPP scientists and risk assessors.

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

PubMed

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

2009-07-01

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

Monitoring guidance for patients with hypophosphatasia treated with asfotase alfa.

PubMed

Kishnani, Priya S; Rush, Eric T; Arundel, Paul; Bishop, Nick; Dahir, Kathryn; Fraser, William; Harmatz, Paul; Linglart, Agnès; Munns, Craig F; Nunes, Mark E; Saal, Howard M; Seefried, Lothar; Ozono, Keiichi

2017-09-01

Hypophosphatasia (HPP) is a rare, inherited, systemic, metabolic disorder caused by autosomal recessive mutations or a single dominant-negative mutation in the gene encoding tissue-nonspecific alkaline phosphatase (TNSALP). The disease is associated with a broad range of signs, symptoms, and complications, including impaired skeletal mineralization, altered calcium and phosphate metabolism, recurrent fractures, pain, respiratory problems, impaired growth and mobility, premature tooth loss, developmental delay, and seizures. Asfotase alfa is a human, recombinant enzyme replacement therapy that is approved in many countries for the treatment of patients with HPP. To address the unmet need for guidance in the monitoring of patients receiving asfotase alfa, an international panel of physicians with experience in diagnosing and managing HPP convened in May 2016 to discuss treatment monitoring parameters. The panel discussions focused on recommendations for assessing and monitoring patients after the decision to treat with asfotase alfa had been made and did not include recommendations for whom to treat. Based on the consensus of panel members, this review provides guidance on the monitoring of patients with HPP during treatment with asfotase alfa, including recommendations for laboratory, efficacy, and safety assessments and the frequency with which these should be performed during the course of treatment. Recommended assessments are based on patient age and include regular monitoring of biochemistry, skeletal radiographs, respiratory function, growth, pain, mobility and motor function, and quality of life. Because of the systemic presentation of HPP, a coordinated, multidisciplinary, team-based, patient-focused approach is recommended in the management of patients receiving asfotase alfa. Monitoring of efficacy and safety outcomes must be tailored to the individual patient, depending on medical history, clinical manifestations, availability of resources in the clinical

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

PubMed

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

2018-02-26

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

78 FR 4150 - Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

...; NIOSH-134-B] Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance AGENCY: National... Nanotechnology Strategic Plan for Research and Guidance. SUMMARY: The National Institute for Occupational Safety... NIOSH FY2013-FY2016 nanotechnology strategic plan. This draft strategic plan (Protecting the...

Safety assessment of plant food supplements (PFS).

PubMed

van den Berg, Suzanne J P L; Serra-Majem, Lluis; Coppens, Patrick; Rietjens, Ivonne M C M

2011-12-01

Botanicals and botanical preparations, including plant food supplements (PFS), are widely used in Western diets. The growing use of PFS is accompanied by an increasing concern because the safety of these PFS is not generally assessed before they enter the market. Regulatory bodies have become more aware of this and are increasing their efforts to ensure the safety of PFS. The present review describes an overview of the general framework for the safety assessment of PFS, focusing on the different approaches currently in use to assess the safety of botanicals and/or botanical compounds, including their history of safe use, the tiered approach proposed by the European Food Safety Authority (EFSA), the Threshold of Toxicological Concern (TTC) and the Margin of Exposure (MOE) concept. Moreover, some examples of botanical compounds in PFS that may be of concern are discussed. Altogether, it is clear that "natural" does not equal "safe" and that PFS may contain compounds of concern at levels far above those found in the regular diet. In addition, the traditional use of a PFS compound as a herb or tea does not guarantee its safety when used as a supplement. This points at a need for stricter regulation and control of botanical containing products, especially given their expanding market volume.

Flight assessment of a data-link-based navigation-guidance concept

NASA Technical Reports Server (NTRS)

Abbott, T. S.

1983-01-01

With the proposed introduction of a data-link provision into the Air-Traffic-control (ATC) system, the capability will exist to supplement the ground-air, voice (radio) link with digital, data-link information. Additionally, ATC computers could provide, via the data link guidance and navigation information to the pilot which could then be presented in much the same manner as conventional navigation information. The primary objective of this study was to assess the feasibility and acceptability of using 4-sec and 12-sec information updating to drive conventional cockpit-navigation-instrument formats for path-tracking guidance. A flight test, consisting of 19 tracking tasks, was conducted and, through the use of pilot questionnaires and performance data, the following results were obtained. From a performance standpoint, the 4-sec and 12-sec updating led to a slight degradation in path-tracking performance, relative to continuous updating. From the pilot's viewpoint, the 12-sec data interval was suitable for long path segments (greater than 2 min of flight time), but it was difficult to use on shorter segments because of higher work load and insufficient stabilization time. Overall, it was determined that the utilization of noncontinuous data for navigation was both feasible and acceptable for the prescribed task.

Flight Guidance System Requirements Specification

NASA Technical Reports Server (NTRS)

Miller, Steven P.; Tribble, Alan C.; Carlson, Timothy M.; Danielson, Eric J.

2003-01-01

This report describes a requirements specification written in the RSML-e language for the mode logic of a Flight Guidance System of a typical regional jet aircraft. This model was created as one of the first steps in a five-year project sponsored by the NASA Langley Research Center, Rockwell Collins Inc., and the Critical Systems Research Group of the University of Minnesota to develop new methods and tools to improve the safety of avionics designs. This model will be used to demonstrate the application of a variety of methods and techniques, including safety analysis of system and subsystem requirements, verification of key properties using theorem provers and model checkers, identification of potential sources mode confusion in system designs, partitioning of applications based on the criticality of system hazards, and autogeneration of avionics quality code. While this model is representative of the mode logic of a typical regional jet aircraft, it does not describe an actual or planned product. Several aspects of a full Flight Guidance System, such as recovery from failed sensors, have been omitted, and no claims are made regarding the accuracy or completeness of this specification.

Safety Assessment of Polyether Lanolins as Used in Cosmetics.

PubMed

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

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

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

PubMed

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

2016-03-01

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.

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

PubMed Central

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

A New Technique for Femoral Venous Access in Infants Using Arterial Injection Venous Return Guidance

PubMed Central

Ebishima, Hironori; Kitano, Masataka; Kurosaki, Kenichi; Shiraishi, Isao

2017-01-01

Objectives: Although venography guidance is helpful for central venous catheter placement, it is sometimes difficult to place a peripheral intravenous cannula for enhancement. We designed a new technique for establishing femoral venous access using venography guidance in the return phase of peripheral arteriography. This new technique was named arterial injection venous return guidance. Here we assessed the efficacy and safety of arterial injection venous return guidance. Methods: We reviewed data of 29 infants less than 6 months old undergoing catheter intervention at our institute in 2014. Of the 29 patients, femoral venous cannulation was performed using arterial injection venous return guidance in 5 patients, venography in 20 patients, and the landmark method in 4 patients. The technical success rates and incidence of complications were compared. Results: The overall success rates were 100% in the arterial injection venous return-guided and venography-guided groups. The mean procedure duration and mean contrast material injection time were similar between the groups. The contrast effect on the femoral vein in the arterial injection venous return-guided group was lower than that in the venography-guided group, but adequate for surgery. The overall complication rate was 17%, and obstruction of previously placed intravenous catheters was the most common complication. Conclusions: Therefore, the arterial injection venous return guidance technique was as safe and efficient as venography for establishing venous access. PMID:29034015

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

PubMed

Haslberger, Alexander G

2006-05-03

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

76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-05

...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related... ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement...

Safety assessment and detection methods of genetically modified organisms.

PubMed

Xu, Rong; Zheng, Zhe; Jiao, Guanglian

2014-01-01

Genetically modified organisms (GMOs), are gaining importance in agriculture as well as the production of food and feed. Along with the development of GMOs, health and food safety concerns have been raised. These concerns for these new GMOs make it necessary to set up strict system on food safety assessment of GMOs. The food safety assessment of GMOs, current development status of safety and precise transgenic technologies and GMOs detection have been discussed in this review. The recent patents about GMOs and their detection methods are also reviewed. This review can provide elementary introduction on how to assess and detect GMOs.

Co-operation of employers in the area of personal monitoring: a commentary on BIR guidance on the UK regulatory situation.

PubMed

Rogers, Andy

2017-11-01

The requirement for organizations to co-operate regarding doses to staff who work across organizational boundaries is well established. However, in the field of personal dosimetry there is little guidance as to how to actually achieve legal compliance. Following improvement action in the UK by the regulator, The Health & Safety Executive, a guidance document was developed by the leading professional bodies in this area. This guidance was also commented on by the Health & Safety Executive Specialist Inspectorate (Radiation) enabling the published guidance to represent a compliant standard. This commentary describes the guidance and discusses the issues involved with developing systems for compliance in this area.

Analysis of safety impacts of access management alternatives using the surrogate safety assessment model : final report.

DOT National Transportation Integrated Search

2017-06-01

The purpose of this study was to evaluate if the Surrogate Safety Assessment Model (SSAM) could be used to assess the safety of a highway segment or an intersection in terms of the number and type of conflicts and to compare the safety effects of mul...

76 FR 70768 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-15

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0254] Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft Report for Comment; Correction AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for comment; correction. SUMMARY: This document corrects a notice appearing...

Comparative safety assessment of plant-derived foods.

PubMed

Kok, E J; Keijer, J; Kleter, G A; Kuiper, H A

2008-02-01

The second generation of genetically modified (GM) plants that are moving towards the market are characterized by modifications that may be more complex and traits that more often are to the benefit of the consumer. These developments will have implications for the safety assessment of the resulting plant products. In part of the cases the same crop plant can, however, also be obtained by 'conventional' breeding strategies. The breeder will decide on a case-by-case basis what will be the best strategy to reach the set target and whether genetic modification will form part of this strategy. This article discusses important aspects of the safety assessment of complex products derived from newly bred plant varieties obtained by different breeding strategies. On the basis of this overview, we conclude that the current process of the safety evaluation of GM versus conventionally bred plants is not well balanced. GM varieties are elaborately assessed, yet at the same time other crop plants resulting from conventional breeding strategies may warrant further food safety assessment for the benefit of the consumer. We propose to develop a general screening frame for all newly developed plant varieties to select varieties that cannot, on the basis of scientific criteria, be considered as safe as plant varieties that are already on the market.

Initial development of a practical safety audit tool to assess fleet safety management practices.

PubMed

Mitchell, Rebecca; Friswell, Rena; Mooren, Lori

2012-07-01

Work-related vehicle crashes are a common cause of occupational injury. Yet, there are few studies that investigate management practices used for light vehicle fleets (i.e. vehicles less than 4.5 tonnes). One of the impediments to obtaining and sharing information on effective fleet safety management is the lack of an evidence-based, standardised measurement tool. This article describes the initial development of an audit tool to assess fleet safety management practices in light vehicle fleets. The audit tool was developed by triangulating information from a review of the literature on fleet safety management practices and from semi-structured interviews with 15 fleet managers and 21 fleet drivers. A preliminary useability assessment was conducted with 5 organisations. The audit tool assesses the management of fleet safety against five core categories: (1) management, systems and processes; (2) monitoring and assessment; (3) employee recruitment, training and education; (4) vehicle technology, selection and maintenance; and (5) vehicle journeys. Each of these core categories has between 1 and 3 sub-categories. Organisations are rated at one of 4 levels on each sub-category. The fleet safety management audit tool is designed to identify the extent to which fleet safety is managed in an organisation against best practice. It is intended that the audit tool be used to conduct audits within an organisation to provide an indicator of progress in managing fleet safety and to consistently benchmark performance against other organisations. Application of the tool by fleet safety researchers is now needed to inform its further development and refinement and to permit psychometric evaluation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Animal-Free Chemical Safety Assessment

PubMed Central

Loizou, George D.

2016-01-01

The exponential growth of the Internet of Things and the global popularity and remarkable decline in cost of the mobile phone is driving the digital transformation of medical practice. The rapidly maturing digital, non-medical world of mobile (wireless) devices, cloud computing and social networking is coalescing with the emerging digital medical world of omics data, biosensors and advanced imaging which offers the increasingly realistic prospect of personalized medicine. Described as a potential “seismic” shift from the current “healthcare” model to a “wellness” paradigm that is predictive, preventative, personalized and participatory, this change is based on the development of increasingly sophisticated biosensors which can track and measure key biochemical variables in people. Additional key drivers in this shift are metabolomic and proteomic signatures, which are increasingly being reported as pre-symptomatic, diagnostic and prognostic of toxicity and disease. These advancements also have profound implications for toxicological evaluation and safety assessment of pharmaceuticals and environmental chemicals. An approach based primarily on human in vivo and high-throughput in vitro human cell-line data is a distinct possibility. This would transform current chemical safety assessment practice which operates in a human “data poor” to a human “data rich” environment. This could also lead to a seismic shift from the current animal-based to an animal-free chemical safety assessment paradigm. PMID:27493630

77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-18

... the availability of a draft guidance for industry entitled ``Certification Process for Designated Medical Gases.'' This draft guidance describes the new certification process created by the Food and Drug Administration Safety and Innovation Act (FDASIA) for certain medical gases and explains how FDA plans to...

16 CFR 1500.231 - Guidance for hazardous liquid chemicals in children's products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... children's products. 1500.231 Section 1500.231 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION.... The U.S. Consumer Product Safety Commission issues this guidance to manufacturers, importers... subsequent hand-to-mouth or hand-to-eye activity. The specific type and frequency of behavior that a child...

Safety assessment for hair-spray resins: risk assessment based on rodent inhalation studies.

PubMed

Carthew, Philip; Griffiths, Heather; Keech, Stephen; Hartop, Peter

2002-04-01

The methods involved in the safety assessment of resins used in hair-spray products have received little peer review, or debate in the published literature, despite their widespread use, in both hairdressing salons and the home. The safety assessment for these resins currently involves determining the type of lung pathology that can be caused in animal inhalation exposure studies, and establishing the no-observable-effect level (NOEL) for these pathologies. The likely human consumer exposure is determined by techniques that model the simulated exposure under "in use" conditions. From these values it is then possible to derive the likely safety factors for human exposure. An important part of this process would be to recognize the intrinsic differences between rodents and humans in terms of the respiratory doses that each species experiences during inhalation exposures, for the purpose of the safety assessment. Interspecies scaling factors become necessary when comparing the exposure doses experienced by rats, compared to humans, because of basic differences between species in lung clearance rates and the alveolar area in the lungs. The rodent inhalation data and modeled human exposure to Resin 6965, a resin polymer that is based on vinyl acetate, has been used to calculate the safety factor for human consumer exposure to this resin, under a range of "in use" exposure conditions. The use of this safety assessment process clearly demonstrates that Resin 6965 is acceptable for human consumer exposure under the conditions considered in this risk assessment.

Regulatory Forum Opinion Piece: Review of FDA Draft Guidance Testicular Toxicity-Evaluation during Drug Development Guidance for Industry.

PubMed

Hukkanen, Renee R; Halpern, Wendy G; Vidal, Justin D

2016-10-01

In July 2015, the U.S. Food and Drug Administration (FDA) posted a new draft guidance entitled "Testicular Toxicity: Evaluation during Drug Development Guidance for Industry," with a 90-day public comment period. As the nonclinical assessment of testicular toxicity often relies on the expert interpretation of pathology affecting the male reproductive tract, this draft guidance is considered directly relevant to the toxicologic pathology community. Therefore, a working group was formed through the Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathologists (STPs) to provide a detailed review of the draft guidance. Specific comments on the guidance were submitted to the FDA by the STP. The draft guidance and all comments received are currently under review with the FDA. This commentary provides a summary of the components of the draft guidance and the comments submitted by the STP with acknowledgment of different perspectives reflected in comments from other respondents. © The Author(s) 2016.

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

Trends in HFE Methods and Tools and Their Applicability to Safety Reviews

DOE Office of Scientific and Technical Information (OSTI.GOV)

O'Hara, J.M.; Plott, C.; Milanski, J.

2009-09-30

The U.S. Nuclear Regulatory Commission's (NRC) conducts human factors engineering (HFE) safety reviews of applicant submittals for new plants and for changes to existing plants. The reviews include the evaluation of the methods and tools (M&T) used by applicants as part of their HFE program. The technology used to perform HFE activities has been rapidly evolving, resulting in a whole new generation of HFE M&Ts. The objectives of this research were to identify the current trends in HFE methods and tools, determine their applicability to NRC safety reviews, and identify topics for which the NRC may need additional guidance tomore » support the NRC's safety reviews. We conducted a survey that identified over 100 new HFE M&Ts. The M&Ts were assessed to identify general trends. Seven trends were identified: Computer Applications for Performing Traditional Analyses, Computer-Aided Design, Integration of HFE Methods and Tools, Rapid Development Engineering, Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. We assessed each trend to determine its applicability to the NRC's review by considering (1) whether the nuclear industry is making use of M&Ts for each trend, and (2) whether M&Ts reflecting the trend can be reviewed using the current design review guidance. We concluded that M&T trends that are applicable to the commercial nuclear industry and are expected to impact safety reviews may be considered for review guidance development. Three trends fell into this category: Analysis of Cognitive Tasks, Use of Virtual Environments and Visualizations, and Application of Human Performance Models. The other trends do not need to be addressed at this time.« less

Pharmacological mechanism-based drug safety assessment and prediction.

PubMed

Abernethy, D R; Woodcock, J; Lesko, L J

2011-06-01

Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.

2010 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2010-01-01

this report provides a NASA Range Safety overview for current and potential range users. This report contains articles which cover a variety of subject areas, summaries of various NASA Range Safety Program activities conducted during the past year, links to past reports, and information on several projects that may have a profound impact on the way business will be done in the future. Specific topics discussed in the 2010 NASA Range Safety Annual Report include a program overview and 2010 highlights; Range Safety Training; Range Safety Policy revision; Independent Assessments; Support to Program Operations at all ranges conducting NASA launch/flight operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. Once again, the web-based format was used to present the annual report.

Essentials for starting a pediatric clinical study (4): Clinical pediatric safety planning based on preclinical toxicity studies and pediatric pharmacovigilance guidance.

PubMed

Sheth, Neha

2009-01-01

Juvenile toxicology studies in animals provide useful information to guide monitoring of potential adverse effects in children especially on growth and development. In order to continue to gain knowledge and build upon these preclinical studies, recent experience has suggested that additional approaches for monitoring of safety concerns in the pediatric population may be required. Recently, pediatric guidance has become available from the health authorities which provide pharmacovigilance concepts as they specifically relate to drugs being developed for pediatric indications. Clinical trials are typically not robust enough to detect rare or delayed safety effects as the pediatric trials are relatively short-term. Furthermore, such long term or rare effects may not be detected via standard voluntary postmarketing surveillance. Safety monitoring of children with Juvenile Inflammatory Arthritis (JIA) taking nonsteroid anti-inflammatory drug (NSAID)s will be used as an example to describe a post-marketing risk management and pharmacovigilance program that serves to better evaluate safety data from various sources. The intent of this program is to identify adverse events (AE), including events with longer latency, which may be associated with NSAID use in a pediatric population. In this presentation, the 4 major components of the program are to be addressed. Such a program may serve as a model to proactively generate and monitor safety data in order to identify AEs that may be associated with new therapeutics for a pediatric population.

Stall Recovery Guidance Algorithms Based on Constrained Control Approaches

NASA Technical Reports Server (NTRS)

Stepanyan, Vahram; Krishnakumar, Kalmanje; Kaneshige, John; Acosta, Diana

2016-01-01

Aircraft loss-of-control, in particular approach to stall or fully developed stall, is a major factor contributing to aircraft safety risks, which emphasizes the need to develop algorithms that are capable of assisting the pilots to identify the problem and providing guidance to recover the aircraft. In this paper we present several stall recovery guidance algorithms, which are implemented in the background without interfering with flight control system and altering the pilot's actions. They are using input and state constrained control methods to generate guidance signals, which are provided to the pilot in the form of visual cues. It is the pilot's decision to follow these signals. The algorithms are validated in the pilot-in-the loop medium fidelity simulation experiment.

DOE standard 3009 - a reasoned, practical approach to integrating criticality safety into SARs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vessard, S.G.

1995-12-31

In the past there have been efforts by the U.S. Department of Energy (DOE) to provide guidance on those elements that should be included in a facility`s safety analysis report (SAR). In particular, there are two DOE Orders (5480.23, {open_quotes}Nuclear Safety Analysis Reports,{close_quotes} and 5480.24, {open_quotes}Nuclear Criticality Safety{close_quotes}), an interpretive guidance document (NE-70, Interpretive Guidance for DOE Order 5480.24, {open_quotes}Nuclear Criticality Safety{close_quotes}), and DOE Standard DOE-STD-3009-94 {open_quotes}Preparation Guide for U.S. Department of Energy Nonreactor Nuclear Facility Safety Analysis Reports.{close_quotes} Of these, the most practical and useful (pertaining to the application of criticality safety) is DOE-STD-3009-94. This paper is a reviewmore » of Chapters 3, 4, and 6 of this standard and how they provide very clear, helpful, and reasoned criticality safety guidance.« less

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

ERIC Educational Resources Information Center

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…

Measurement tools and process indicators of patient safety culture in primary care. A mixed methods study by the LINNEAUS collaboration on patient safety in primary care.

PubMed

Parker, Dianne; Wensing, Michel; Esmail, Aneez; Valderas, Jose M

2015-09-01

There is little guidance available to healthcare practitioners about what tools they might use to assess the patient safety culture. To identify useful tools for assessing patient safety culture in primary care organizations in Europe; to identify those aspects of performance that should be assessed when investigating the relationship between safety culture and performance in primary care. Two consensus-based studies were carried out, in which subject matter experts and primary healthcare professionals from several EU states rated (a) the applicability to their healthcare system of several existing safety culture assessment tools and (b) the appropriateness and usefulness of a range of potential indicators of a positive patient safety culture to primary care settings. The safety culture tools were field-tested in four countries to ascertain any challenges and issues arising when used in primary care. The two existing tools that received the most favourable ratings were the Manchester patient safety framework (MaPsAF primary care version) and the Agency for healthcare research and quality survey (medical office version). Several potential safety culture process indicators were identified. The one that emerged as offering the best combination of appropriateness and usefulness related to the collection of data on adverse patient events. Two tools, one quantitative and one qualitative, were identified as applicable and useful in assessing patient safety culture in primary care settings in Europe. Safety culture indicators in primary care should focus on the processes rather than the outcomes of care.

Guidance for Evaluating the Safety of Experimental Releases of Mosquitoes, Emphasizing Mark-Release-Recapture Techniques

PubMed Central

Charlwood, J. Derek; Harrington, Laura C.; Lounibos, L. Philip; Reisen, William K.; Tabachnick, Walter J.

2018-01-01

Abstract Experimental releases of mosquitoes are performed to understand characteristics of populations related to the biology, ability to transmit pathogens, and ultimately their control. In this article, we discuss considerations related to the safety of experimental releases of living mosquitoes, applying principles of good practice in vector biology that protect human health and comfort. We describe specific factors of experimental releases of mosquitoes that we believe are critical to inform institutional biosafety committees and similar review boards to which proposals to conduct mosquito release experiments have been submitted. In this study, “experimental releases” means those that do not significantly increase vector capacity or nuisance biting relative to the unperturbed natural baseline. This document specifically does not address releases of mosquitoes for ongoing control programs or trials of new control methods for which broader assessments of risk are required. It also does not address releases of transgenic or exotic (non-native) mosquito species, both of which require particular regulatory approval. Experimental releases may include females and males and evaluation must consider their effects based on the number released, their genotype and phenotype, the environment into which they are released, and postrelease collection activities. We consider whether increases of disease transmission and nuisance biting might result from proposed experimental releases against the backdrop of natural population size variation. We recommend that experimental releases be conducted in a manner that can be reasonably argued to have insignificant negative effects. Reviewers of proposals for experimental releases should expect applicants to provide such an argument based on evidence from similar studies and their planned activities. This document provides guidance for creating and evaluating such proposals. PMID:29337660

Guidance for Evaluating the Safety of Experimental Releases of Mosquitoes, Emphasizing Mark-Release-Recapture Techniques.

PubMed

Benedict, Mark Q; Charlwood, J Derek; Harrington, Laura C; Lounibos, L Philip; Reisen, William K; Tabachnick, Walter J

2018-01-01

Experimental releases of mosquitoes are performed to understand characteristics of populations related to the biology, ability to transmit pathogens, and ultimately their control. In this article, we discuss considerations related to the safety of experimental releases of living mosquitoes, applying principles of good practice in vector biology that protect human health and comfort. We describe specific factors of experimental releases of mosquitoes that we believe are critical to inform institutional biosafety committees and similar review boards to which proposals to conduct mosquito release experiments have been submitted. In this study, "experimental releases" means those that do not significantly increase vector capacity or nuisance biting relative to the unperturbed natural baseline. This document specifically does not address releases of mosquitoes for ongoing control programs or trials of new control methods for which broader assessments of risk are required. It also does not address releases of transgenic or exotic (non-native) mosquito species, both of which require particular regulatory approval. Experimental releases may include females and males and evaluation must consider their effects based on the number released, their genotype and phenotype, the environment into which they are released, and postrelease collection activities. We consider whether increases of disease transmission and nuisance biting might result from proposed experimental releases against the backdrop of natural population size variation. We recommend that experimental releases be conducted in a manner that can be reasonably argued to have insignificant negative effects. Reviewers of proposals for experimental releases should expect applicants to provide such an argument based on evidence from similar studies and their planned activities. This document provides guidance for creating and evaluating such proposals.

NCRP Program Area Committee 2: Operational Radiation Safety

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pryor, Kathryn H.; Goldin, Eric M.

2016-02-29

Program Area Committee 2 of the National Council on Radiation Protection and Measurements provides guidance for radiation safety in occupational settings in a variety of industries and activities. The committee completed three reports in recent years covering recommendations for the development and administration of radiation safety programs for smaller educational institutions, requirements for self-assessment programs that improve radiation safety and identify and correct deficiencies, and a comprehensive process for effective investigation of radiological incidents. Ongoing work includes a report on sealed radioactive source controls and oversight of a report on radioactive nanomaterials focusing on gaps within current radiation safety programs.more » Future efforts may deal with operational radiation safety programs in fields such as the safe use of handheld and portable X-Ray fluorescence analyzers, occupational airborne radioactive contamination, unsealed radioactive sources, or industrial accelerators.« less

Environmental assessment overview

NASA Technical Reports Server (NTRS)

Valentino, A. R.

1980-01-01

The assessment program has as its objectives: to identify the environmental issues associated with the SPS Reference System; to prepare a preliminary assessment based on existing data; to suggest mitigating strategies and provide environmental data and guidance to other components of the program as required; and to plan long-range research to reduce the uncertainty in the preliminary assessment. The key environmental issues associated with the satellite power system are discussed and include human health and safety, ecosystems, climate, and interaction with electromagnetic systems.

GPs' compliance with health and safety legislation and their occupational health needs in one London health authority.

PubMed Central

Kennedy, Ioanna; Williams, Siân; Reynolds, Anne; Cockcroft, Anne; Solomon, Jack; Farrow, Stephen

2002-01-01

This survey assessed general practitioners' (GPs') knowledge of and compliance with, health and safety legislation and occupational health guidance in one London health authority. The response rate was 85%. Although the majority of practices were aware of the most important piece of legislation--The Management of Health and Safety at Work Regulations, 1992--less than one in ten practices had carried out the required systematic risk assessments. Compliance with other health and safety legislation and related employment issues was also poor. The health of GPs and their staff may be at risk and these general practices may be vulnerable to prosecution by the Health and Safety Executive. PMID:12236278

Safety management system needs assessment.

DOT National Transportation Integrated Search

2016-04-01

The safety of the traveling public is critical as each year there are approximately 200 highway fatalities in Nebraska and numerous crash injuries. The objective of this research was to conduct a needs assessment to identify the requirements of a sta...

Test Results for Entry Guidance Methods for Space Vehicles

NASA Technical Reports Server (NTRS)

Hanson, John M.; Jones, Robert E.

2004-01-01

There are a number of approaches to advanced guidance and control that have the potential for achieving the goals of significantly increasing reusable launch vehicle (or any space vehicle that enters an atmosphere) safety and reliability, and reducing the cost. This paper examines some approaches to entry guidance. An effort called Integration and Testing of Advanced Guidance and Control Technologies has recently completed a rigorous testing phase where these algorithms faced high-fidelity vehicle models and were required to perform a variety of representative tests. The algorithm developers spent substantial effort improving the algorithm performance in the testing. This paper lists the test cases used to demonstrate that the desired results are achieved, shows an automated test scoring method that greatly reduces the evaluation effort required, and displays results of the tests. Results show a significant improvement over previous guidance approaches. The two best-scoring algorithm approaches show roughly equivalent results and are ready to be applied to future vehicle concepts.

Background report guidance for roadway safety data to support the highway safety improvement program.

DOT National Transportation Integrated Search

2011-06-01

"Quality data are the foundation for making important decisions regarding the design, operation, and safety of : roadways. The Highway Safety Improvement Program (HSIP) provides information on how safety data should be : used. However, there are no d...

BENCHMARK DOSE TECHNICAL GUIDANCE DOCUMENT ...

EPA Pesticide Factsheets

The U.S. EPA conducts risk assessments for an array of health effects that may result from exposure to environmental agents, and that require an analysis of the relationship between exposure and health-related outcomes. The dose-response assessment is essentially a two-step process, the first being the definition of a point of departure (POD), and the second extrapolation from the POD to low environmentally-relevant exposure levels. The benchmark dose (BMD) approach provides a more quantitative alternative to the first step in the dose-response assessment than the current NOAEL/LOAEL process for noncancer health effects, and is similar to that for determining the POD proposed for cancer endpoints. As the Agency moves toward harmonization of approaches for human health risk assessment, the dichotomy between cancer and noncancer health effects is being replaced by consideration of mode of action and whether the effects of concern are likely to be linear or nonlinear at low doses. Thus, the purpose of this project is to provide guidance for the Agency and the outside community on the application of the BMD approach in determining the POD for all types of health effects data, whether a linear or nonlinear low dose extrapolation is used. A guidance document is being developed under the auspices of EPA's Risk Assessment Forum. The purpose of this project is to provide guidance for the Agency and the outside community on the application of the benchmark dose (BMD) appr

78 FR 42387 - Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

... Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug... Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled... Administration Safety and Innovation Act (FDASIA) added a new provision to the Food, Drug, and Cosmetic Act (FD&C...

Methodology to assess clinical liver safety data.

PubMed

Merz, Michael; Lee, Kwan R; Kullak-Ublick, Gerd A; Brueckner, Andreas; Watkins, Paul B

2014-11-01

Analysis of liver safety data has to be multivariate by nature and needs to take into account time dependency of observations. Current standard tools for liver safety assessment such as summary tables, individual data listings, and narratives address these requirements to a limited extent only. Using graphics in the context of a systematic workflow including predefined graph templates is a valuable addition to standard instruments, helping to ensure completeness of evaluation, and supporting both hypothesis generation and testing. Employing graphical workflows interactively allows analysis in a team-based setting and facilitates identification of the most suitable graphics for publishing and regulatory reporting. Another important tool is statistical outlier detection, accounting for the fact that for assessment of Drug-Induced Liver Injury, identification and thorough evaluation of extreme values has much more relevance than measures of central tendency in the data. Taken together, systematical graphical data exploration and statistical outlier detection may have the potential to significantly improve assessment and interpretation of clinical liver safety data. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability. Notice.

PubMed

2016-07-19

The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.

76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.

Human-system Interfaces to Automatic Systems: Review Guidance and Technical Basis

DOE Office of Scientific and Technical Information (OSTI.GOV)

OHara, J.M.; Higgins, J.C.

Automation has become ubiquitous in modern complex systems and commercial nuclear power plants are no exception. Beyond the control of plant functions and systems, automation is applied to a wide range of additional functions including monitoring and detection, situation assessment, response planning, response implementation, and interface management. Automation has become a 'team player' supporting plant personnel in nearly all aspects of plant operation. In light of the increasing use and importance of automation in new and future plants, guidance is needed to enable the NRC staff to conduct safety reviews of the human factors engineering (HFE) aspects of modern automation.more » The objective of the research described in this report was to develop guidance for reviewing the operator's interface with automation. We first developed a characterization of the important HFE aspects of automation based on how it is implemented in current systems. The characterization included five dimensions: Level of automation, function of automation, modes of automation, flexibility of allocation, and reliability of automation. Next, we reviewed literature pertaining to the effects of these aspects of automation on human performance and the design of human-system interfaces (HSIs) for automation. Then, we used the technical basis established by the literature to develop design review guidance. The guidance is divided into the following seven topics: Automation displays, interaction and control, automation modes, automation levels, adaptive automation, error tolerance and failure management, and HSI integration. In addition, we identified insights into the automaton design process, operator training, and operations.« less

Application of image guidance in pituitary surgery

PubMed Central

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

Design Guidance for New Windows | Efficient Windows Collaborative

Science.gov Websites

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 Websites

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

UV DISINFECTION GUIDANCE MANUAL FOR THE ...

EPA Pesticide Factsheets

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.

Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics.

PubMed

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

2015-01-01

The Cosmetic Ingredient Review Expert Panel (the Panel) reviewed the safety of synthetic fluorphlogopite as used in cosmetics. Synthetic fluorphlogopite functions as a bulking agent and a viscosity-increasing agent. The Panel reviewed available animal and human data related to this ingredient along with a previous safety assessment of other magnesium silicates. The Panel concluded that synthetic fluorphlogopite was safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

A novel safety assessment strategy applied to non-selective extracts.

PubMed

Koster, Sander; Leeman, Winfried; Verheij, Elwin; Dutman, Ellen; van Stee, Leo; Nielsen, Lene Munch; Ronsmans, Stefan; Noteborn, Hub; Krul, Lisette

2015-06-01

A main challenge in food safety research is to demonstrate that processing of foodstuffs does not lead to the formation of substances for which the safety upon consumption might be questioned. This is especially so since food is a complex matrix in which the analytical detection of substances, and consequent risk assessment thereof, is difficult to determine. Here, a pragmatic novel safety assessment strategy is applied to the production of non-selective extracts (NSEs), used for different purposes in food such as for colouring purposes, which are complex food mixtures prepared from reference juices. The Complex Mixture Safety Assessment Strategy (CoMSAS) is an exposure driven approach enabling to efficiently assess the safety of the NSE by focussing on newly formed substances or substances that may increase in exposure during the processing of the NSE. CoMSAS enables to distinguish toxicologically relevant from toxicologically less relevant substances, when related to their respective levels of exposure. This will reduce the amount of work needed for identification, characterisation and safety assessment of unknown substances detected at low concentration, without the need for toxicity testing using animal studies. In this paper, the CoMSAS approach has been applied for elderberry and pumpkin NSEs used for food colouring purposes. Copyright © 2015 Elsevier Ltd. All rights reserved.

Mine safety assessment using gray relational analysis and bow tie model

PubMed Central

2018-01-01

Mine safety assessment is a precondition for ensuring orderly and safety in production. The main purpose of this study was to prevent mine accidents more effectively by proposing a composite risk analysis model. First, the weights of the assessment indicators were determined by the revised integrated weight method, in which the objective weights were determined by a variation coefficient method and the subjective weights determined by the Delphi method. A new formula was then adopted to calculate the integrated weights based on the subjective and objective weights. Second, after the assessment indicator weights were determined, gray relational analysis was used to evaluate the safety of mine enterprises. Mine enterprise safety was ranked according to the gray relational degree, and weak links of mine safety practices identified based on gray relational analysis. Third, to validate the revised integrated weight method adopted in the process of gray relational analysis, the fuzzy evaluation method was used to the safety assessment of mine enterprises. Fourth, for first time, bow tie model was adopted to identify the causes and consequences of weak links and allow corresponding safety measures to be taken to guarantee the mine’s safe production. A case study of mine safety assessment was presented to demonstrate the effectiveness and rationality of the proposed composite risk analysis model, which can be applied to other related industries for safety evaluation. PMID:29561875

Internet safety education for youth: stakeholder perspectives.

PubMed

Moreno, Megan A; Egan, Katie G; Bare, Kaitlyn; Young, Henry N; Cox, Elizabeth D

2013-06-05

Internet use is nearly ubiquitous among US youth; risks to internet use include cyberbullying, privacy violations and unwanted solicitation. Internet safety education may prevent these negative consequences; however, it is unclear at what age this education should begin and what group is responsible for teaching this topic. Surveys were distributed to key stakeholders in youth safety education including public school teachers, clinicians, parents and adolescents. Surveys assessed age at which internet safety education should begin, as well as experiences teaching and learning internet safety. Surveys of adults assessed willingness to teach internet safety. Finally, participants were asked to identify a group whose primary responsibility it should be to teach internet safety. A total of 356 participants completed the survey (93.4% response rate), including 77 teachers, 111 clinicians, 72 parents and 96 adolescents. Stakeholders felt the optimal mean age to begin teaching internet safety was 7.2 years (SD = 2.5), range 2-15. Internet safety was regularly taught by some teachers (20.8%), few clinicians (2.6%) and many parents (40.3%). The majority of teachers, clinicians and parents were willing to teach internet safety, but all groups surveyed identified parents as having primary responsibility for teaching this topic. Findings suggest agreement among key stakeholders for teaching internet safety at a young age, and for identifying parents as primary teachers of this topic. Clinicians have a unique opportunity to support parents by providing resources, guidance and support.

Measurement tools and process indicators of patient safety culture in primary care. A mixed methods study by the LINNEAUS collaboration on patient safety in primary care

PubMed Central

Parker, Dianne; Wensing, Michel; Esmail, Aneez; Valderas, Jose M

2015-01-01

ABSTRACT Background: There is little guidance available to healthcare practitioners about what tools they might use to assess the patient safety culture. Objective: To identify useful tools for assessing patient safety culture in primary care organizations in Europe; to identify those aspects of performance that should be assessed when investigating the relationship between safety culture and performance in primary care. Methods: Two consensus-based studies were carried out, in which subject matter experts and primary healthcare professionals from several EU states rated (a) the applicability to their healthcare system of several existing safety culture assessment tools and (b) the appropriateness and usefulness of a range of potential indicators of a positive patient safety culture to primary care settings. The safety culture tools were field-tested in four countries to ascertain any challenges and issues arising when used in primary care. Results: The two existing tools that received the most favourable ratings were the Manchester patient safety framework (MaPsAF primary care version) and the Agency for healthcare research and quality survey (medical office version). Several potential safety culture process indicators were identified. The one that emerged as offering the best combination of appropriateness and usefulness related to the collection of data on adverse patient events. Conclusion: Two tools, one quantitative and one qualitative, were identified as applicable and useful in assessing patient safety culture in primary care settings in Europe. Safety culture indicators in primary care should focus on the processes rather than the outcomes of care. PMID:26339832

Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers

PubMed Central

Calvert, Melanie; Kyte, Derek; Duffy, Helen; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; Ives, Jonathan; Draper, Heather; Brundage, Michael; Blazeby, Jane; King, Madeleine

2014-01-01

Background 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. Methods and Findings 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. Conclusions 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

The practice of pre-marketing safety assessment in drug development.

PubMed

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

Risk assessment guidance for Superfund: Volume 1 -- Human health evaluation manual. Supplement to Part A: Community involvement in Superfund risk assessments

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1999-03-01

The purpose of the guidance document is to provide the site team--risk assessor, remedial project manager (RPM), and community involvement coordinator--with information to improve community involvement in the Superfund risk assessment process. Specifically, the document: provides suggestions for how Superfund staff and community members can work together during the early stages of Superfund cleanup; identifies where, within the framework of the human health risk assessment methodology, community input can augment and improve EPA`s estimates of exposure and risk; recommends questions the site team should ask the community; and illustrates why community involvement is valuable during the human health assessment atmore » Superfund sites.« less

Bioactive nutrients - Time for tolerable upper intake levels to address safety.

PubMed

Yates, Allison A; Erdman, John W; Shao, Andrew; Dolan, Laurie C; Griffiths, James C

2017-03-01

There is increasing interest by consumers, researchers, and regulators into the roles that certain bioactive compounds, derived from plants and other natural sources, can play in health maintenance and promotion, and even prolonging a productive quality of life. Research has rapidly emerged suggesting that a wide range of compounds and mixtures in and from plants (such as fruits and vegetables, tea and cocoa) and animals (such as fish and probiotics) may exert substantial health benefits. There is interest in exploring the possibility of establishing recommended intakes or dietary guidance for certain bioactive substances to help educate consumers. A key aspect of establishing dietary guidance is the assessment of safety/toxicity of these substances. Toxicologists need to be involved in both the development of the safety framework and in the evaluation of the science to establish maximum intake/upper limits. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Bayesian-network-based safety risk assessment for steel construction projects.

PubMed

Leu, Sou-Sen; Chang, Ching-Miao

2013-05-01

There are four primary accident types at steel building construction (SC) projects: falls (tumbles), object falls, object collapse, and electrocution. Several systematic safety risk assessment approaches, such as fault tree analysis (FTA) and failure mode and effect criticality analysis (FMECA), have been used to evaluate safety risks at SC projects. However, these traditional methods ineffectively address dependencies among safety factors at various levels that fail to provide early warnings to prevent occupational accidents. To overcome the limitations of traditional approaches, this study addresses the development of a safety risk-assessment model for SC projects by establishing the Bayesian networks (BN) based on fault tree (FT) transformation. The BN-based safety risk-assessment model was validated against the safety inspection records of six SC building projects and nine projects in which site accidents occurred. The ranks of posterior probabilities from the BN model were highly consistent with the accidents that occurred at each project site. The model accurately provides site safety-management abilities by calculating the probabilities of safety risks and further analyzing the causes of accidents based on their relationships in BNs. In practice, based on the analysis of accident risks and significant safety factors, proper preventive safety management strategies can be established to reduce the occurrence of accidents on SC sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

NOAA Safety and Environmental Compliance Office (NESSO)

Science.gov Websites

Intranet NOAA Environmental, Safety, and Sustainability Office NOAA's Environmental, Safety, and Atmospheric Administration's (NOAA) policy and provides guidance, and oversight in the areas of Safety and with regulatory, internal, and other requirements and to drive toward continuous improvement in Safety

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

Federal Register 2010, 2011, 2012, 2013, 2014

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...

Extended time-to-collision measures for road traffic safety assessment.

PubMed

Minderhoud, M M; Bovy, P H

2001-01-01

This article describes two new safety indicators based on the time-to-collision notion suitable for comparative road traffic safety analyses. Such safety indicators can be applied in the comparison of a do-nothing case with an adapted situation, e.g. the introduction of intelligent driver support systems. In contrast to the classical time-to-collision value, measured at a cross section, the improved safety indicators use vehicle trajectories collected over a specific time horizon for a certain roadway segment to calculate the overall safety indicator value. Vehicle-specific indicator values as well as safety-critical probabilities can easily be determined from the developed safety measures. Application of the derived safety indicators is demonstrated for the assessment of the potential safety impacts of driver support systems from which it appears that some Autonomous Intelligent Cruise Control (AICC) designs are more safety-critical than the reference case without these systems. It is suggested that the indicator threshold value to be applied in the safety assessment has to be adapted when advanced AICC-systems with safe characteristics are introduced.

77 FR 33331 - Regulatory Guidance on the Applicability of Property-Carrier Hours-of-Service Rules to the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-06

... Regulatory Guidance on the Applicability of Property-Carrier Hours-of-Service Rules to the Driveaway Operation of Vehicles Designed to Transport Passengers AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: The property-carrier hours-of-service (HOS...

Safety analysis and review system (SARS) assessment report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Browne, E.T.

1981-03-01

Under DOE Order 5481.1, Safety Analysis and Review System for DOE Operations, safety analyses are required for DOE projects in order to ensure that: (1) potential hazards are systematically identified; (2) potential impacts are analyzed; (3) reasonable measures have been taken to eliminate, control, or mitigate the hazards; and (4) there is documented management authorization of the DOE operation based on an objective assessment of the adequacy of the safety analysis. This report is intended to provide the DOE Office of Plans and Technology Assessment (OPTA) with an independent evaluation of the adequacy of the ongoing safety analysis effort. Asmore » part of this effort, a number of site visits and interviews were conducted, and FE SARS documents were reviewed. The latter included SARS Implementation Plans for a number of FE field offices, as well as safety analysis reports completed for certain FE operations. This report summarizes SARS related efforts at the DOE field offices visited and evaluates the extent to which they fulfill the requirements of DOE 5481.1.« less

Test Results for Entry Guidance Methods for Reusable Launch Vehicles

NASA Technical Reports Server (NTRS)

Hanson, John M.; Jones, Robert E.

2003-01-01

There are a number of approaches to advanced guidance and control (AG&C) that have the potential for achieving the goals of significantly increasing reusable launch vehicle (RLV) safety and reliability, and reducing the cost. This paper examines some approaches to entry guidance. An effort called Integration and Testing of Advanced Guidance and Control Technologies (ITAGCT) has recently completed a rigorous testing phase where these algorithms faced high-fidelity vehicle models and were required to perform a variety of representative tests. The algorithm developers spent substantial effort improving the algorithm performance in the testing. This paper lists the test cases used to demonstrate that the desired results are achieved, shows an automated test scoring method that greatly reduces the evaluation effort required, and displays results of the tests. Results show a significant improvement over previous guidance approaches. The two best-scoring algorithm approaches show roughly equivalent results and are ready to be applied to future reusable vehicle concepts.

Use of the Home Safety Self-Assessment Tool (HSSAT) within Community Health Education to Improve Home Safety.

PubMed

Horowitz, Beverly P; Almonte, Tiffany; Vasil, Andrea

2016-10-01

This exploratory research examined the benefits of a health education program utilizing the Home Safety Self-Assessment Tool (HSSAT) to increase perceived knowledge of home safety, recognition of unsafe activities, ability to safely perform activities, and develop home safety plans of 47 older adults. Focus groups in two senior centers explored social workers' perspectives on use of the HSSAT in community practice. Results for the health education program found significant differences between reported knowledge of home safety (p = .02), ability to recognize unsafe activities (p = .01), safely perform activities (p = .04), and develop a safety plan (p = .002). Social workers identified home safety as a major concern and the HSSAT a promising assessment tool. Research has implications for reducing environmental fall risks.

Implementing AORN recommended practices for medication safety.

PubMed

Hicks, Rodney W; Wanzer, Linda J; Denholm, Bonnie

2012-12-01

Medication errors in the perioperative setting can result in patient morbidity and mortality. The AORN "Recommended practices for medication safety" provide guidance to perioperative nurses in developing, implementing, and evaluating safe medication use practices. These practices include recognizing risk points in the medication use process, collaborating with pharmacy staff members, conducting preoperative assessments and postoperative evaluations (eg, medication reconciliation), and handling hazardous medications and pharmaceutical waste. Strategies for successful implementation of the recommended practices include promoting a basic understanding of the nurse's role in the medication use process and developing a medication management plan as well as policies and procedures that support medication safety and activities to measure compliance with safe practices. Published by Elsevier Inc.

Comprehensive safety management and assessment at rugby football competitions.

PubMed

Tajima, T; Chosa, E; Kawahara, K; Nakamura, Y; Yoshikawa, D; Yamaguchi, N; Kashiwagi, T

2014-11-01

The present study aims to improve medical systems by designing objective safety assessment criteria for rugby competitions. We evaluated 195 competitions between 2002 and 2011 using an original safety scale comprising the following sections: 1) competence of staff such as referees, medical attendants and match day doctor; 2) environment such as weather, wet bulb globe temperature and field conditions; and 3) emergency medical care systems at the competitions. Each section was subdivided into groups A, B and C according to good, normal or fair degrees of safety determined by combinations of the results.Overall safety was assessed as A, B and C for 110, 78 and 7 competitions, respectively. The assessments of individual major factors were mostly favorable for staff, but the environment and medical care systems were assessed as C in 25 and 70, respectively, of the 195 competitions. Medical management involves not having a match day doctor, but also comprehensive management including preventive factors and responses from the staff, environment and medical-care systems. 6 cases of severe injuries and accidents occurred between 2002 and 2011, which were observed in Grade A competition. These cases revealed better prognosis without obvious impairment, thus confirming the value of the present assessment scale. © Georg Thieme Verlag KG Stuttgart · New York.

Safety Assessment of Alkyl Esters as Used in Cosmetics.

PubMed

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

2015-09-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 237 alkyl esters for use in cosmetics. The alkyl esters included in this assessment have a variety of reported functions in cosmetics, with skin-conditioning agent being the most common function. The Panel reviewed available animal and clinical data in making its determination of safety on these ingredients, and where there were data gaps, similarity in structure, properties, functions, and uses of these ingredients allowed for extrapolation of the available toxicological data to assess the safety of the entire group. The Panel concluded that these ingredients are safe in cosmetic formulations in the present practices of use and concentration when formulated to be nonirritating. © The Author(s) 2015.

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

PubMed

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

2008-12-15

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

Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics.

PubMed

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

2015-09-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 16 pentaerythrityl tetraester compounds as used in cosmetics. These ingredients mostly function as hair-conditioning agents, skin-conditioning agents-miscellaneous and binders, skin-conditioning agents-occlusive, viscosity-increasing agents-nonaqueous, and skin-conditioning agents-emollient. The Panel reviewed the available animal and human data related to these ingredients and previous safety assessments of the fatty acid moieties. The Panel concluded that pentaerythrityl tetraisostearate and the other pentaerythrityl tetraester compounds were safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

Cost-effective safety treatments for low-volume roads.

DOT National Transportation Integrated Search

2012-08-01

The majority of roadside safety guidance pertains to high-volume roads. Very little guidance exists to assist engineers in : treating common obstacles found alongside low-volume roads. In general, it is assumed that low traffic volumes can effectivel...

75 FR 45678 - Notice of Availability of Interim Staff Guidance Document for Fuel Cycle Facilities

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

... Document for Fuel Cycle Facilities AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability..., Division of Fuel Cycle Safety and Safeguards, Office of Nuclear Material Safety and Safeguards, U.S... Commission (NRC) prepares and issues Interim Staff Guidance (ISG) documents for fuel cycle facilities. These...

A guidance and control assessment of three vertical landing options for RLV

NASA Technical Reports Server (NTRS)

Gallaher, M.; Coughlin, D.; Krupp, D

1995-01-01

The National Aeronautics and Space Administration is considering a vertical lander as a candidate concept for a single-stage-to-orbit reusable launch vehicle (RLV). Three strategies for guiding and controlling the inversion of a reentering RLV from a nose-first attitude to a vertical landing attitude are suggested. Each option is simulated from a common reentry state to touchdown, using a common guidance algorithm and different controllers. Results demonstrate the characteristics that typify and distinguish each concept and help to identify peculiar problems, level of guidance and control sophistication required, feasibility concerns, and areas in which stringent subsystem requirements will be imposed by guidance and control.

Processes of technology assessment: The National Transportation Safety Board

NASA Technical Reports Server (NTRS)

Weiss, E.

1972-01-01

The functions and operations of the Safety Board as related to technology assessment are described, and a brief history of the Safety Board is given. Recommendations made for safety in all areas of transportation and the actions taken are listed. Although accident investigation is an important aspect of NTSB's activity, it is felt that the greatest contribution is in pressing for development of better accident prevention programs. Efforts of the Safety Board in changing transportation technology to improve safety and prevent accidents are illustrated.

Comparison of AIHA ISO 9001-based occupational health and safety management system guidance document with a manufacturer's occupational health and safety assessment instrument.

PubMed

Dyjack, D T; Levine, S P; Holtshouser, J L; Schork, M A

1998-06-01

Numerous manufacturing and service organizations have integrated or are considering integration of their respective occupational health and safety management and audit systems into the International Organization for Standardization-based (ISO) audit-driven Quality Management Systems (ISO 9000) or Environmental Management Systems (ISO 14000) models. Companies considering one of these options will likely need to identify and evaluate several key factors before embarking on such efforts. The purpose of this article is to identify and address the key factors through a case study approach. Qualitative and quantitative comparisons of the key features of the American Industrial Hygiene Association ISO-9001 harmonized Occupational Health and Safety Management System with The Goodyear Tire & Rubber Co. management and audit system were conducted. The comparisons showed that the two management systems and their respective audit protocols, although structured differently, were not substantially statistically dissimilar in content. The authors recommend that future studies continue to evaluate the advantages and disadvantages of various audit protocols. Ideally, these studies would identify those audit outcome measures that can be reliably correlated with health and safety performance.

New developments at the Flood Forecasting Centre: operational flood risk assessment and guidance

NASA Astrophysics Data System (ADS)

Pilling, Charlie

2017-04-01

The Flood Forecasting Centre (FFC) is a partnership between the UK Met Office, the Environment Agency and Natural Resources Wales. The FFC was established in 2009 to provide an overview of flood risk across England and Wales and to provide flood guidance services primarily for the emergency response community. The FFC provides forecasts for all natural sources of flooding, these being fluvial, surface water, coastal and groundwater. This involves an assessment of possible hydrometeorological events and their impacts over the next five days. During times of heightened flood risk, the close communication between the FFC, the Environment Agency and Natural Resources Wales allows mobilization and deployment of staff and flood defences. Following a number of severe flood events during winters 2013-14 and 2015-16, coupled with a drive from the changing landscape in national incident response, there is a desire to identify flood events at even longer lead time. This earlier assessment and mobilization is becoming increasingly important and high profile within Government. For example, following the exceptional flooding across the north of England in December 2015 the Environment Agency have invested in 40 km of temporary barriers that will be moved around the country to help mitigate against the impacts of large flood events. Efficient and effective use of these barriers depends on identifying the broad regions at risk well in advance of the flood, as well as scaling the magnitude and duration of large events. Partly in response to this, the FFC now produce a flood risk assessment for a month ahead. In addition, since January 2017, the 'new generation' daily flood guidance statement includes an assessment of flood risk for the 6 to 10 day period. Examples of both these new products will be introduced, as will some of the new developments in science and technical capability that underpin these assessments. Examples include improvements to fluvial forecasting from 'fluvial

Safety Assessment of Talc as Used in Cosmetics.

PubMed

Fiume, Monice M; Boyer, Ivan; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of talc for use in cosmetics. The safety of talc has been the subject of much debate through the years, partly because the relationship between talc and asbestos is commonly misunderstood. Industry specifications state that cosmetic-grade talc must contain no detectable fibrous, asbestos minerals. Therefore, the large amount of available animal and clinical data the Panel relied on in assessing the safety of talc only included those studies on talc that did not contain asbestos. The Panel concluded that talc is safe for use in cosmetics in the present practices of use and concentration (some cosmetic products are entirely composed of talc). Talc should not be applied to the skin when the epidermal barrier is missing or significantly disrupted. © The Author(s) 2015.

Safety assessment methodology in management of spent sealed sources.

PubMed

Mahmoud, Narmine Salah

2005-02-14

Environmental hazards can be caused from radioactive waste after their disposal. It was therefore important that safety assessment methodologies be developed and established to study and estimate the possible hazards, and institute certain safety methodologies that lead and prevent the evolution of these hazards. Spent sealed sources are specific type of radioactive waste. According to IAEA definition, spent sealed sources are unused sources because of activity decay, damage, misuse, loss, or theft. Accidental exposure of humans from spent sealed sources can occur at the moment they become spent and before their disposal. Because of that reason, safety assessment methodologies were tailored to suit the management of spent sealed sources. To provide understanding and confidence of this study, validation analysis was undertaken by considering the scenario of an accident that occurred in Egypt, June 2000 (the Meet-Halfa accident from an iridium-192 source). The text of this work includes consideration related to the safety assessment approaches of spent sealed sources which constitutes assessment context, processes leading an active source to be spent, accident scenarios, mathematical models for dose calculations, and radiological consequences and regulatory criteria. The text also includes a validation study, which was carried out by evaluating a theoretical scenario compared to the real scenario of Meet-Halfa accident depending on the clinical assessment of affected individuals.

System-wide safety treatments and design guidance for j-turns : final report.

DOT National Transportation Integrated Search

2016-06-01

In an effort Toward Zero Deaths (TZD) the Missouri Department of Transportation (MoDOT) initiated this research : project to develop guidance on treatments that can reduce crashes and fatalities. The project first synthesized the : literature and sta...

76 FR 74723 - New Car Assessment Program (NCAP); Safety Labeling

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 575 [Docket No. NHTSA 2010-0025] RIN 2127-AK51 New Car Assessment Program (NCAP); Safety Labeling AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION...

High-Throughput Toxicity Testing: New Strategies for Assessing Chemical Safety

EPA Science Inventory

In recent years, the food industry has made progress in improving safety testing methods focused on microbial contaminants in order to promote food safety. However, food industry toxicologists must also assess the safety of food-relevant chemicals including pesticides, direct add...

Assessment of Safety Standards for Automotive Electronic Control Systems

DOT National Transportation Integrated Search

2016-06-01

This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

Guidance for medical screening of commercial aerospace passengers : final report.

DOT National Transportation Integrated Search

2006-01-01

This document provides general guidance for operators of manned commercial aerospace flights (suborbital and orbital) in the medical assessment of prospective passengers. : This guidance is designed to identify those individuals who have medical cond...

Why the Eurocontrol Safety Regulation Commission Policy on Safety Nets and Risk Assessment is Wrong

NASA Astrophysics Data System (ADS)

Brooker, Peter

2004-05-01

Current Eurocontrol Safety Regulation Commission (SRC) policy says that the Air Traffic Management (ATM) system (including safety minima) must be demonstrated through risk assessments to meet the Target Level of Safety (TLS) without needing to take safety nets (such as Short Term Conflict Alert) into account. This policy is wrong. The policy is invalid because it does not build rationally and consistently from ATM's firm foundations of TLS and hazard analysis. The policy is bad because it would tend to retard safety improvements. Safety net policy must rest on a clear and rational treatment of integrated ATM system safety defences. A new safety net policy, appropriate to safe ATM system improvements, is needed, which recognizes that safety nets are an integrated part of ATM system defences. The effects of safety nets in reducing deaths from mid-air collisions should be fully included in hazard analysis and safety audits in the context of the TLS for total system design.

Ultrasound-Guided Regional Anesthesia and Patient Safety: Update of an Evidence-Based Analysis.

PubMed

Neal, Joseph M

2016-01-01

In 2010, the American Society of Regional Anesthesia and Pain Medicine's evidence-based medicine assessment of ultrasound (US)-guided regional anesthesia (UGRA) analyzed the effect of this nerve localization technology on patient safety. That analysis focused on 4 important regional anesthesia complications: peripheral nerve injury, local anesthetic systemic toxicity (LAST), hemidiaphragmatic paresis (HDP), and pneumothorax. In the intervening 5 years, further research has allowed us to refine our original conclusions. This update reviews previous findings and critically evaluates new literature published since late 2009 that compares the patient safety attributes of UGRA with those of traditional nerve localization methods. As with the previous version of this exercise, analysis focused on randomized controlled trials that compared UGRA with an alternative neural localization method and case series of more than 500 patients. The Jadad score was used to grade individual study quality, and conclusions were graded as to strength of evidence. Of those randomized controlled trials identified by our search techniques, 28 compared the incidence of postoperative nerve symptoms, 27 assessed LAST parameters, 7 studied HDP, and 9 reported the incidence of pneumothorax. The current analysis strengthens our original conclusions that US guidance has no significant effect on the incidence of postoperative neurologic symptoms and that UGRA reduces the incidence and intensity of HDP but does so in an unpredictable manner. Conversely, emerging evidence supports the effectiveness of US guidance for reducing LAST across its clinical presentation continuum. The predicted frequency of pneumothorax has grown smaller in tandem with increased experience with US-guided supraclavicular block. This evidence-based review summarizes both the power and the limitations of UGRA as a tool for improving patient safety. Since the original 2010 publication of this analysis, evidence has continued to

75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-12

...] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters... a draft guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' Dear Health Care Provider (DHCP) Letters are correspondence...

Risk assessment of nanomaterials in cosmetics: a European union perspective.

PubMed

Henkler, Frank; Tralau, Tewes; Tentschert, Jutta; Kneuer, Carsten; Haase, Andrea; Platzek, Thomas; Luch, Andreas; Götz, Mario E

2012-11-01

In Europe, the data requirements for the hazard and exposure characterisation of chemicals are defined according to the REACH regulation and its guidance on information requirements and chemical safety assessment (Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and its guidance documents; available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF ; and at: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm ). This is the basis for any related risk assessment. The standard reference for the testing of cosmetic ingredients is the SCCP's 'Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation' (The SCCP's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (2006); available at: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf ), which refers to the OECD guidelines for the testing of chemicals (The OECD Guidelines for the Testing of Chemicals as a collection of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to assess the safety of chemical products; available at: http://www.oecd.org/topic/0,2686,en_2649_34377_1_1_1_1_37407,00.html ). According to the cosmetics directive [76/768/EEC], compounds that are classified as mutagenic, carcinogenic or toxic to reproduction are banned for the use in cosmetic products. Since December 2010, the respective labelling is based on the rules of regulation (EC) No. 1272/2008 (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, Official Journal L 353, 31

Safety Panel Resources

NASA Technical Reports Server (NTRS)

Stewart, Christine E.

2008-01-01

The goal of this paper is to explore what resources are potentially available to safety panels and to provide some guidance on how to utilize those resources. While the examples used in this paper will concentrate on the Flight Equipment and Reliability Review Panel (FESRRP) and Extravehicular Activity (EVA) hardware that have come through that panel, as well as resources at Johnson Space Center, the paper will address how this applies to safety panels in general, and where possible cite examples for other safety panels.

Independent Orbiter Assessment (IOA): Analysis of the guidance, navigation, and control subsystem

NASA Technical Reports Server (NTRS)

Trahan, W. H.; Odonnell, R. A.; Pietz, K. C.; Hiott, J. M.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) is presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results corresponding to the Orbiter Guidance, Navigation, and Control (GNC) Subsystem hardware are documented. The function of the GNC hardware is to respond to guidance, navigation, and control software commands to effect vehicle control and to provide sensor and controller data to GNC software. Some of the GNC hardware for which failure modes analysis was performed includes: hand controllers; Rudder Pedal Transducer Assembly (RPTA); Speed Brake Thrust Controller (SBTC); Inertial Measurement Unit (IMU); Star Tracker (ST); Crew Optical Alignment Site (COAS); Air Data Transducer Assembly (ADTA); Rate Gyro Assemblies; Accelerometer Assembly (AA); Aerosurface Servo Amplifier (ASA); and Ascent Thrust Vector Control (ATVC). The IOA analysis process utilized available GNC hardware drawings, workbooks, specifications, schematics, and systems briefs for defining hardware assemblies, components, and circuits. Each hardware item was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

Safety Sufficiency for NextGen: Assessment of Selected Existing Safety Methods, Tools, Processes, and Regulations

NASA Technical Reports Server (NTRS)

Xu, Xidong; Ulrey, Mike L.; Brown, John A.; Mast, James; Lapis, Mary B.

2013-01-01

NextGen is a complex socio-technical system and, in many ways, it is expected to be more complex than the current system. It is vital to assess the safety impact of the NextGen elements (technologies, systems, and procedures) in a rigorous and systematic way and to ensure that they do not compromise safety. In this study, the NextGen elements in the form of Operational Improvements (OIs), Enablers, Research Activities, Development Activities, and Policy Issues were identified. The overall hazard situation in NextGen was outlined; a high-level hazard analysis was conducted with respect to multiple elements in a representative NextGen OI known as OI-0349 (Automation Support for Separation Management); and the hazards resulting from the highly dynamic complexity involved in an OI-0349 scenario were illustrated. A selected but representative set of the existing safety methods, tools, processes, and regulations was then reviewed and analyzed regarding whether they are sufficient to assess safety in the elements of that OI and ensure that safety will not be compromised and whether they might incur intolerably high costs.

Assessment of Service Delivery in Guidance and Counselling Units in Selected Secondary Schools in Eldoret Municipality, Kenya

ERIC Educational Resources Information Center

Owino, Elizabeth Akinyi

2015-01-01

This paper assesses the type of services delivered by the existing Guidance and Counselling units in secondary schools in Kenya based on a survey conducted in Eldoret Municipality in Uasin Gishu County, Kenya. The study adopted an ex-post facto research design the target population being all secondary schools in the Municipality where a sample was…

Measuring Best Practices for Workplace Safety, Health, and Well-Being: The Workplace Integrated Safety and Health Assessment.

PubMed

Sorensen, Glorian; Sparer, Emily; Williams, Jessica A R; Gundersen, Daniel; Boden, Leslie I; Dennerlein, Jack T; Hashimoto, Dean; Katz, Jeffrey N; McLellan, Deborah L; Okechukwu, Cassandra A; Pronk, Nicolaas P; Revette, Anna; Wagner, Gregory R

2018-05-01

To present a measure of effective workplace organizational policies, programs, and practices that focuses on working conditions and organizational facilitators of worker safety, health and well-being: the workplace integrated safety and health (WISH) assessment. Development of this assessment used an iterative process involving a modified Delphi method, extensive literature reviews, and systematic cognitive testing. The assessment measures six core constructs identified as central to best practices for protecting and promoting worker safety, health and well-being: leadership commitment; participation; policies, programs, and practices that foster supportive working conditions; comprehensive and collaborative strategies; adherence to federal and state regulations and ethical norms; and data-driven change. The WISH Assessment holds promise as a tool that may inform organizational priority setting and guide research around causal pathways influencing implementation and outcomes related to these approaches.

NSRD-10: Leak Path Factor Guidance Using MELCOR

DOE Office of Scientific and Technical Information (OSTI.GOV)

Louie, David; Humphries, Larry L.

Estimates of the source term from a U.S. Department of Energy (DOE) nuclear facility requires that the analysts know how to apply the simulation tools used, such as the MELCOR code, particularly for a complicated facility that may include an air ventilation system and other active systems that can influence the environmental pathway of the materials released. DOE has designated MELCOR 1.8.5, an unsupported version, as a DOE ToolBox code in its Central Registry, which includes a leak-path-factor guidance report written in 2004 that did not include experimental validation data. To continue to use this MELCOR version requires additional verificationmore » and validations, which may not be feasible from a project cost standpoint. Instead, the recent MELCOR should be used. Without any developer support and lack of experimental data validation, it is difficult to convince regulators that the calculated source term from the DOE facility is accurate and defensible. This research replaces the obsolete version in the 2004 DOE leak path factor guidance report by using MELCOR 2.1 (the latest version of MELCOR with continuing modeling development and user support) and by including applicable experimental data from the reactor safety arena and from applicable experimental data used in the DOE-HDBK-3010. This research provides best practice values used in MELCOR 2.1 specifically for the leak path determination. With these enhancements, the revised leak-path-guidance report should provide confidence to the DOE safety analyst who would be using MELCOR as a source-term determination tool for mitigated accident evaluations.« less

NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

NASA Technical Reports Server (NTRS)

Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

2003-01-01

The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

What guidance is available for researchers conducting overviews of reviews of healthcare interventions? A scoping review and qualitative metasummary.

PubMed

Pollock, Michelle; Fernandes, Ricardo M; Becker, Lorne A; Featherstone, Robin; Hartling, Lisa

2016-11-14

Overviews of reviews (overviews) compile data from multiple systematic reviews to provide a single synthesis of relevant evidence for decision-making. Despite their increasing popularity, there is limited methodological guidance available for researchers wishing to conduct overviews. The objective of this scoping review is to identify and collate all published and unpublished documents containing guidance for conducting overviews examining the efficacy, effectiveness, and/or safety of healthcare interventions. Our aims were to provide a map of existing guidance documents; identify similarities, differences, and gaps in the guidance contained within these documents; and identify common challenges involved in conducting overviews. We conducted an iterative and extensive search to ensure breadth and comprehensiveness of coverage. The search involved reference tracking, database and web searches (MEDLINE, EMBASE, DARE, Scopus, Cochrane Methods Studies Database, Google Scholar), handsearching of websites and conference proceedings, and contacting overview producers. Relevant guidance statements and challenges encountered were extracted, edited, grouped, abstracted, and presented using a qualitative metasummary approach. We identified 52 guidance documents produced by 19 research groups. Relatively consistent guidance was available for the first stages of the overview process (deciding when and why to conduct an overview, specifying the scope, and searching for and including systematic reviews). In contrast, there was limited or conflicting guidance for the latter stages of the overview process (quality assessment of systematic reviews and their primary studies, collecting and analyzing data, and assessing quality of evidence), and many of the challenges identified were also related to these stages. An additional, overarching challenge identified was that overviews are limited by the methods, reporting, and coverage of their included systematic reviews. This compilation

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

EPA Pesticide Factsheets

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.

A quantitative risk-assessment system (QR-AS) evaluating operation safety of Organic Rankine Cycle using flammable mixture working fluid.

PubMed

Tian, Hua; Wang, Xueying; Shu, Gequn; Wu, Mingqiang; Yan, Nanhua; Ma, Xiaonan

2017-09-15

Mixture of hydrocarbon and carbon dioxide shows excellent cycle performance in Organic Rankine Cycle (ORC) used for engine waste heat recovery, but the unavoidable leakage in practical application is a threat for safety due to its flammability. In this work, a quantitative risk assessment system (QR-AS) is established aiming at providing a general method of risk assessment for flammable working fluid leakage. The QR-AS covers three main aspects: analysis of concentration distribution based on CFD simulations, explosive risk assessment based on the TNT equivalent method and risk mitigation based on evaluation results. A typical case of propane/carbon dioxide mixture leaking from ORC is investigated to illustrate the application of QR-AS. According to the assessment results, proper ventilation speed, safe mixture ratio and location of gas-detecting devices have been proposed to guarantee the security in case of leakage. The results revealed that this presented QR-AS was reliable for the practical application and the evaluation results could provide valuable guidance for the design of mitigation measures to improve the safe performance of ORC system. Copyright © 2017 Elsevier B.V. All rights reserved.

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

NASA Technical Reports Server (NTRS)

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.

The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development.

PubMed

Dobo, Krista L; Greene, Nigel; Cyr, Michelle O; Caron, Stéphane; Ku, Warren W

2006-04-01

Starting materials and intermediates used to synthesize pharmaceuticals are reactive in nature and may be present as impurities in the active pharmaceutical ingredient (API) used for preclinical safety studies and clinical trials. Furthermore, starting materials and intermediates may be known or suspected mutagens and/or carcinogens. Therefore, during drug development due diligence need be applied from two perspectives (1) to understand potential mutagenic and carcinogenic risks associated with compounds used for synthesis and (2) to understand the capability of synthetic processes to control genotoxic impurities in the API. Recently, a task force comprised of experts from pharmaceutical industry proposed guidance, with recommendations for classification, testing, qualification and assessing risk of genotoxic impurities. In our experience the proposed structure-based classification, has differentiated 75% of starting materials and intermediates as mutagenic and non-mutagenic with high concordance (92%) when compared with Ames results. Structure-based assessment has been used to identify genotoxic hazards, and prompted evaluation of fate of genotoxic impurities in API. These two assessments (safety and chemistry) culminate in identification of genotoxic impurities known or suspected to exceed acceptable levels in API, thereby triggering actions needed to assure appropriate control and measurement methods are in place. Hypothetical case studies are presented demonstrating this multi-disciplinary approach.

Patient safety competencies in undergraduate nursing students: a rapid evidence assessment.

PubMed

Bianchi, Monica; Bressan, Valentina; Cadorin, Lucia; Pagnucci, Nicola; Tolotti, Angela; Valcarenghi, Dario; Watson, Roger; Bagnasco, Annamaria; Sasso, Loredana

2016-12-01

To identify patient safety competencies, and determine the clinical learning environments that facilitate the development of patient safety competencies in nursing students. Patient safety in nursing education is of key importance for health professional environments, settings and care systems. To be effective, safe nursing practice requires a good integration between increasing knowledge and the different clinical practice settings. Nurse educators have the responsibility to develop effective learning processes and ensure patient safety. Rapid Evidence Assessment. MEDLINE, CINAHL, SCOPUS and ERIC were searched, yielding 500 citations published between 1 January 2004-30 September 2014. Following the Rapid Evidence Assessment process, 17 studies were included in this review. Hawker's (2002) quality assessment tool was used to assess the quality of the selected studies. Undergraduate nursing students need to develop competencies to ensure patient safety. The quality of the pedagogical atmosphere in the clinical setting has an important impact on the students' overall level of competence. Active student engagement in clinical processes stimulates their critical reasoning, improves interpersonal communication and facilitates adequate supervision and feedback. Few studies describe the nursing students' patient safety competencies and exactly what they need to learn. In addition, studies describe only briefly which clinical learning environments facilitate the development of patient safety competencies in nursing students. Further research is needed to identify additional pedagogical strategies and the specific characteristics of the clinical learning environments that encourage the development of nursing students' patient safety competencies. © 2016 John Wiley & Sons Ltd.

An Augmentation of G-Guidance Algorithms

NASA Technical Reports Server (NTRS)

Carson, John M. III; Acikmese, Behcet

2011-01-01

The original G-Guidance algorithm provided an autonomous guidance and control policy for small-body proximity operations that took into account uncertainty and dynamics disturbances. However, there was a lack of robustness in regards to object proximity while in autonomous mode. The modified GGuidance algorithm was augmented with a second operational mode that allows switching into a safety hover mode. This will cause a spacecraft to hover in place until a mission-planning algorithm can compute a safe new trajectory. No state or control constraints are violated. When a new, feasible state trajectory is calculated, the spacecraft will return to standard mode and maneuver toward the target. The main goal of this augmentation is to protect the spacecraft in the event that a landing surface or obstacle is closer or further than anticipated. The algorithm can be used for the mitigation of any unexpected trajectory or state changes that occur during standard mode operations

Edible safety requirements and assessment standards for agricultural genetically modified organisms.

PubMed

Deng, Pingjian; Zhou, Xiangyang; Zhou, Peng; Du, Zhong; Hou, Hongli; Yang, Dongyan; Tan, Jianjun; Wu, Xiaojin; Zhang, Jinzhou; Yang, Yongcun; Liu, Jin; Liu, Guihua; Li, Yonghong; Liu, Jianjun; Yu, Lei; Fang, Shisong; Yang, Xiaoke

2008-05-01

This paper describes the background, principles, concepts and methods of framing the technical regulation for edible safety requirement and assessment of agricultural genetically modified organisms (agri-GMOs) for Shenzhen Special Economic Zone in the People's Republic of China. It provides a set of systematic criteria for edible safety requirements and the assessment process for agri-GMOs. First, focusing on the degree of risk and impact of different agri-GMOs, we developed hazard grades for toxicity, allergenicity, anti-nutrition effects, and unintended effects and standards for the impact type of genetic manipulation. Second, for assessing edible safety, we developed indexes and standards for different hazard grades of recipient organisms, for the influence of types of genetic manipulation and hazard grades of agri-GMOs. To evaluate the applicability of these criteria and their congruency with other safety assessment systems for GMOs applied by related organizations all over the world, we selected some agri-GMOs (soybean, maize, potato, capsicum and yeast) as cases to put through our new assessment system, and compared our results with the previous assessments. It turned out that the result of each of the cases was congruent with the original assessment.

There is more to risk and safety planning than dramatic risks: Mental health nurses' risk assessment and safety-management practice.

PubMed

Higgins, Agnes; Doyle, Louise; Downes, Carmel; Morrissey, Jean; Costello, Paul; Brennan, Michael; Nash, Michael

2016-04-01

Risk assessment and safety planning are considered a cornerstone of mental health practice, yet limited research exists into how mental health nurses conceptualize 'risk' and how they engage with risk assessment and safety planning. The aim of the present study was to explore mental health nurses' practices and confidence in risk assessment and safety planning. A self-completed survey was administered to 381 mental health nurses in Ireland. The findings indicate that nurses focus on risk to self and risk to others, with the risk of suicide, self-harm, substance abuse, and violence being most frequently assessed. Risk from others and 'iatrogenic' risk were less frequently considered. Overall, there was limited evidence of recovery-oriented practice in relation to risk. The results demonstrate a lack of meaningful engagement with respect to collaborative safety planning, the identification and inclusion of protective factors, and the inclusion of positive risk-taking opportunities. In addition, respondents report a lack of confidence working with positive risk taking and involving family/carers in the risk-assessment and safety-planning process. Gaps in knowledge about risk-assessment and safety-planning practice, which could be addressed through education, are identified, as are the implications of the findings for practice and research. © 2015 Australian College of Mental Health Nurses Inc.

Toward a "Common Definition of English Learner": Guidance for States and State Assessment Consortia in Defining and Addressing Policy and Technical Issues and Options

ERIC Educational Resources Information Center

Linquanti, Robert; Cook, H. Gary

2013-01-01

States participating in the four federally-funded assessment consortia are required to establish a "common definition of English Learner." This includes the two Race to the Top academic assessment consortia and the two Enhanced Assessment Grant English language proficiency (ELP) assessment consortia. This paper provides guidance that…

Safety assessment of Vitis vinifera (grape)-derived ingredients as used in cosmetics.

PubMed

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

2014-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments. © The Author(s) 2014.

Respiratory Protection Toolkit: Providing Guidance Without Changing Requirements-Can We Make an Impact?

PubMed

Bien, Elizabeth Ann; Gillespie, Gordon Lee; Betcher, Cynthia Ann; Thrasher, Terri L; Mingerink, Donna R

2016-12-01

International travel and infectious respiratory illnesses worldwide place health care workers (HCWs) at increasing risk of respiratory exposures. To ensure the highest quality safety initiatives, one health care system used a quality improvement model of Plan-Do-Study-Act and guidance from Occupational Safety and Health Administration's (OSHA) May 2015 Hospital Respiratory Protection Program (RPP) Toolkit to assess a current program. The toolkit aided in identification of opportunities for improvement within their well-designed RPP. One opportunity was requiring respirator use during aerosol-generating procedures for specific infectious illnesses. Observation data demonstrated opportunities to mitigate controllable risks including strap placement, user seal check, and reuse of disposable N95 filtering facepiece respirators. Subsequent interdisciplinary collaboration resulted in other ideas to decrease risks and increase protection from potentially infectious respiratory illnesses. The toolkit's comprehensive document to evaluate the program showed that while the OSHA standards have not changed, the addition of the toolkit can better protect HCWs. © 2016 The Author(s).

Space shuttle guidance, navigation, and control design equations. Volume 3: Guidance

NASA Technical Reports Server (NTRS)

1973-01-01

Space shuttle guidance, navigation, and control design equations are presented. The space-shuttle mission includes three relatively distinct guidance phases which are discussed; atmospheric boost, which is characterized by an adaptive guidance law; extra-atmospheric activities; and re-entry activities, where aerodynamic surfaces are the principal effectors. Guidance tasks include pre-maneuver targeting and powered flight guidance, where powered flight is defined to include the application of aerodynamic forces as well as thruster forces. A flow chart which follows guidance activities throughout the mission from the pre-launch phase through touchdown is presented. The main guidance programs and subroutines used in each phase of a typical rendezvous mission are listed. Detailed software requirements are also presented.

Quantitative safety assessment of air traffic control systems through system control capacity

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the

Guide for Maintaining Pedestrian Facilities for Enhanced Safety.

DOT National Transportation Integrated Search

2013-10-01

A Guide for Maintaining Pedestrian Facilities for Enhanced Safety provides guidance for maintaining pedestrian facilities with the primary goal of increasing safety and mobility. The Guide addresses the needs for pedestrian facility maintenance; comm...

Software Safety Progress in NASA

NASA Technical Reports Server (NTRS)

Radley, Charles F.

1995-01-01

NASA has developed guidelines for development and analysis of safety-critical software. These guidelines have been documented in a Guidebook for Safety Critical Software Development and Analysis. The guidelines represent a practical 'how to' approach, to assist software developers and safety analysts in cost effective methods for software safety. They provide guidance in the implementation of the recent NASA Software Safety Standard NSS-1740.13 which was released as 'Interim' version in June 1994, scheduled for formal adoption late 1995. This paper is a survey of the methods in general use, resulting in the NASA guidelines for safety critical software development and analysis.

Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.

PubMed

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

2016-11-01

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment. © The Author(s) 2016.

Highway Safety Program Manual: Volume 13: Traffic Engineering Services.

ERIC Educational Resources Information Center

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

Volume 13 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) focuses on traffic engineering services. The introduction outlines the purposes and objectives of Highway Safety Program Standard 13 and the Highway Safety Program Manual. Program development and…

Health and Safety Checklist for Early Care and Education Programs to Assess Key National Health and Safety Standards.

PubMed

Alkon, Abbey; Rose, Roberta; Wolff, Mimi; Kotch, Jonathan B; Aronson, Susan S

2016-01-01

The project aims were to (1) develop an observational Health and Safety Checklist to assess health and safety practices and conditions in early care and education (ECE) programs using Stepping Stones To Caring For Our Children, 3rd Edition national standards, (2) pilot test the Checklist, completed by nurse child care health consultants, to assess feasibility, ease of completion, objectivity, validity, and reliability, and (3) revise the Checklist based on the qualitative and quantitative results of the pilot study. The observable national health and safety standards were identified and then rated by health, safety, and child care experts using a Delphi technique to validate the standards as essential to prevent harm and promote health. Then, child care health consultants recruited ECE centers and pilot tested the 124-item Checklist. The pilot study was conducted in Arizona, California and North Carolina. The psychometric properties of the Checklist were assessed. The 37 participating ECE centers had 2627 children from ethnically-diverse backgrounds and primarily low-income families. The child care health consultants found the Checklist easy to complete, objective, and useful for planning health and safety interventions. The Checklist had content and face validity, inter-rater reliability, internal consistency, and concurrent validity. Based on the child care health consultant feedback and psychometric properties of the Checklist, the Checklist was revised and re-written at an 8th grade literacy level. The Health and Safety Checklist provides a standardized instrument of observable, selected national standards to assess the quality of health and safety in ECE centers.

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

PubMed

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

2018-06-01

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.

Initial Experimental Airworthiness Certification Guidance for UAS. UAS Experimental Certification Process and Guidance

NASA Technical Reports Server (NTRS)

2005-01-01

This paper addresses the regulatory processes and requirements already in place by which an applicant might obtain experimental airworthiness certification for a civil Unmanned Aircraft System (UAS). It is more extensive and subsequent to an earlier, similar deliverable, PD007, which was an interim study of the same topic. Since few regulatory airworthiness and operating standards exist for UAS like those for traditional manned aircraft and since most UAS have historically been developed and operated under military auspices, civil use of UAS in the NAS is a new and unfamiliar challenge requiring specific and unique considerations. Experimental certification is the most basic level of FAA approval toward routine UAS operation in the NAS. The paper reviews and explains existing FAA requirements for an applicant seeking experimental airworthiness approval and details the process for submission of necessary information. It summarizes the limited purposes for which experimental aircraft may be used and addresses pertinent aspects of UAS design, construction and operation in the NAS in harmony with traditional manned aircraft. Policy IPT position is that UAS, while different from manned aircraft, can use the same initial processes to gain civil operating experience under the experimental approval. Particular note is taken of those UAS-unique characteristics which require extra attention to assure equivalent safety of operation, such as the UAS control station and sense-and-avoid. The paper also provides "best practices" guidance for UAS manufacturers and FAA personnel in two appendices. The material in Appendix A is intended to provide guidance on assuring UAS safety to FAA, and provides FAA personnel with a suggested list of items to review, with a focus on UAS unique factors, prior to issuance of an experimental airworthiness certificate. Appendix B provides an outline for a program letter which a manufacturer could use in preparing the application for an UAS

Ultrasound-guided lumbar puncture in pediatric patients: technical success and safety.

PubMed

Pierce, David B; Shivaram, Giri; Koo, Kevin S H; Shaw, Dennis W W; Meyer, Kirby F; Monroe, Eric J

2018-06-01

Disadvantages of fluoroscopically guided lumbar puncture include delivery of ionizing radiation and limited resolution of incompletely ossified posterior elements. Ultrasound (US) allows visualization of critical soft tissues and the cerebrospinal fluid (CSF) space without ionizing radiation. To determine the technical success and safety of US-guided lumbar puncture in pediatric patients. A retrospective review identified all patients referred to interventional radiology for lumbar puncture between June 2010 and June 2017. Patients who underwent lumbar puncture with fluoroscopic guidance alone were excluded. For the remaining procedures, technical success and procedural complications were assessed. Two hundred and one image-guided lumbar punctures in 161 patients were included. Eighty patients (43%) had previously failed landmark-based attempts. One hundred ninety-six (97.5%) patients underwent lumbar puncture. Five procedures (2.5%) were not attempted after US assessment, either due to a paucity of CSF or unsafe window for needle placement. Technical success was achieved in 187 (95.4%) of lumbar punctures attempted with US guidance. One hundred seventy-seven (90.3%) were technically successful with US alone (age range: 2 days-15 years, weight range: 1.9-53.1 kg) and an additional 10 (5.1%) were successful with US-guided thecal access and subsequent fluoroscopic confirmation. Three (1.5%) cases were unsuccessful with US guidance but were subsequently successful with fluoroscopic guidance. Of the 80 previously failed landmark-based lumbar punctures, 77 (96.3%) were successful with US guidance alone. There were no reported complications. US guidance is safe and effective for lumbar punctures and has specific advantages over fluoroscopy in pediatric patients.

IPM in Schools - Model Pesticide Safety and IPM Guidance Policy for School Districts

EPA Pesticide Factsheets

This model guidance for implementation of integrated pest management in schools can be used by administrators, educators, parents and others to help inform the development, adoption and improvement of policies for school districts.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1038.... DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that... guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The...

Environment, Safety, and Health Self-Assessment Report, Fiscal Year 2008

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chernowski, John

2009-02-27

Lawrence Berkeley National Laboratory's Environment, Safety, and Health (ES&H) Self-Assessment Program ensures that Integrated Safety Management (ISM) is implemented institutionally and by all divisions. The Self-Assessment Program, managed by the Office of Contract Assurance (OCA), provides for an internal evaluation of all ES&H programs and systems at LBNL. The functions of the program are to ensure that work is conducted safely, and with minimal negative impact to workers, the public, and the environment. The Self-Assessment Program is also the mechanism used to institute continuous improvements to the Laboratory's ES&H programs. The program is described in LBNL/PUB 5344, Environment, Safety, andmore » Health Self-Assessment Program and is composed of four distinct assessments: the Division Self-Assessment, the Management of Environment, Safety, and Health (MESH) review, ES&H Technical Assurance, and the Appendix B Self-Assessment. The Division Self-Assessment uses the five core functions and seven guiding principles of ISM as the basis of evaluation. Metrics are created to measure performance in fulfilling ISM core functions and guiding principles, as well as promoting compliance with applicable regulations. The five core functions of ISM are as follows: (1) Define the Scope of Work; (2) Identify and Analyze Hazards; (3) Control the Hazards; (4) Perform the Work; and (5) Feedback and Improvement. The seven guiding principles of ISM are as follows: (1) Line Management Responsibility for ES&H; (2) Clear Roles and Responsibilities; (3) Competence Commensurate with Responsibilities; (4) Balanced Priorities; (5) Identification of ES&H Standards and Requirements; (6) Hazard Controls Tailored to the Work Performed; and (7) Operations Authorization. Performance indicators are developed by consensus with OCA, representatives from each division, and Environment, Health, and Safety (EH&S) Division program managers. Line management of each division performs the Division

76 FR 5494 - Pipeline Safety: Mechanical Fitting Failure Reporting Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-01

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Safety: Mechanical Fitting Failure Reporting Requirements AGENCY: Pipeline and Hazardous Materials Safety... tightening. A widely accepted industry guidance document, Gas Pipeline Technical Committee (GPTC) Guide, does...

Safety assessment of modified terephthalate polymers as used in cosmetics.

PubMed

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

2014-01-01

The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents-nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration's determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment. © The Author(s) 2014.

Navigational Guidance and Ablation Planning Tools for Interventional Radiology.

PubMed

Sánchez, Yadiel; Anvari, Arash; Samir, Anthony E; Arellano, Ronald S; Prabhakar, Anand M; Uppot, Raul N

Image-guided biopsy and ablation relies on successful identification and targeting of lesions. Currently, image-guided procedures are routinely performed under ultrasound, fluoroscopy, magnetic resonance imaging, or computed tomography (CT) guidance. However, these modalities have their limitations including inadequate visibility of the lesion, lesion or organ or patient motion, compatibility of instruments in an magnetic resonance imaging field, and, for CT and fluoroscopy cases, radiation exposure. Recent advances in technology have resulted in the development of a new generation of navigational guidance tools that can aid in targeting lesions for biopsy or ablations. These navigational guidance tools have evolved from simple hand-held trajectory guidance tools, to electronic needle visualization, to image fusion, to the development of a body global positioning system, to growth in cone-beam CT, and to ablation volume planning. These navigational systems are promising technologies that not only have the potential to improve lesion targeting (thereby increasing diagnostic yield of a biopsy or increasing success of tumor ablation) but also have the potential to decrease radiation exposure to the patient and staff, decrease procedure time, decrease the sedation requirements, and improve patient safety. The purpose of this article is to describe the challenges in current standard image-guided techniques, provide a definition and overview for these next-generation navigational devices, and describe the current limitations of these, still evolving, next-generation navigational guidance tools. Copyright © 2017 Elsevier Inc. All rights reserved.

Simulating geriatric home safety assessments in a three-dimensional virtual world.

PubMed

Andrade, Allen D; Cifuentes, Pedro; Mintzer, Michael J; Roos, Bernard A; Anam, Ramanakumar; Ruiz, Jorge G

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with spatial ability, self-efficacy, cognitive load, and presence. In this study, 30 medical trainees found the home safety simulation easy to use, and their self-efficacy was improved. Men performed better than women in hazard identification. Presence and spatial ability were correlated significantly with performance. Educators should consider spatial ability and gender differences when implementing virtual world training for geriatric home safety assessments.

Safety Arguments for Next Generation, Location Aware Computing

NASA Technical Reports Server (NTRS)

Johnson, C. W.; Holloway, C. M.

2010-01-01

Concerns over accuracy, availability, integrity, and continuity have limited the integration of Global Positioning System (GPS) and Global Navigation Satellite System (GLONASS) for safety-critical applications. More recent augmentation systems, such as the European Geostationary Navigation Overlay Service (EGNOS) and the North American Wide Area Augmentation System (WAAS) have begun to address these concerns. Augmentation architectures build on the existing GPS/GLONASS infrastructures to support location based services in Safety of Life (SoL) applications. Much of the technical development has been directed by air traffic management requirements, in anticipation of the more extensive support to be offered by GPS III and Galileo. WAAS has already been approved to provide vertical guidance for aviation applications. During the next twelve months, the full certification of EGNOS for SoL applications is expected. This paper discusses similarities and differences between the safety assessment techniques used in Europe and North America.

Safety assessment of genetically modified plants with deliberately altered composition

PubMed Central

Halford, Nigel G; Hudson, Elizabeth; Gimson, Amy; Weightman, Richard; Shewry, Peter R; Tompkins, Steven

2014-01-01

The development and marketing of ‘novel’ genetically modified (GM) crops in which composition has been deliberately altered poses a challenge to the European Union (EU)'s risk assessment processes, which are based on the concept of substantial equivalence with a non-GM comparator. This article gives some examples of these novel GM crops and summarizes the conclusions of a report that was commissioned by the European Food Safety Authority on how the EU's risk assessment processes could be adapted to enable their safety to be assessed. PMID:24735114

National Partnership for Maternal Safety: Consensus Bundle on Venous Thromboembolism.

PubMed

D'Alton, Mary E; Friedman, Alexander M; Smiley, Richard M; Montgomery, Douglas M; Paidas, Michael J; D'Oria, Robyn; Frost, Jennifer L; Hameed, Afshan B; Karsnitz, Deborah; Levy, Barbara S; Clark, Steven L

2016-10-01

Obstetric venous thromboembolism is a leading cause of severe maternal morbidity and mortality. Maternal death from thromboembolism is amenable to prevention, and thromboprophylaxis is the most readily implementable means of systematically reducing the maternal death rate. Observational data support the benefit of risk-factor-based prophylaxis in reducing obstetric thromboembolism. This bundle, developed by a multidisciplinary working group and published by the National Partnership for Maternal Safety under the guidance of the Council on Patient Safety in Women's Health Care, supports routine thromboembolism risk assessment for obstetric patients, with appropriate use of pharmacologic and mechanical thromboprophylaxis. Safety bundles outline critical clinical practices that should be implemented in every maternity unit. The safety bundle is organized into four domains: Readiness, Recognition, Response, and Reporting and Systems Learning. Although the bundle components may be adapted to meet the resources available in individual facilities, standardization within an institution is strongly encouraged.

Listen to the public and fulfil their information interests - translating vaccine communication research findings into guidance for regulators.

PubMed

Bahri, Priya; Castillon Melero, Mireia

2018-03-24

Regulatory authorities have a crucial role in communicating about the vaccines they license. In terms of content and timing, their communication to the public is usually driven by data on quality, safety and efficacy. However, concerns over safety and vaccine hesitancy have emerged in some communities in various countries, and this demands a new approach to communication, starting with listening to the public debate. Reviewing communication research findings, coming in particular from the cognitive, decision-making and media sciences, constitutes one mechanism of listening and has led the European Union (EU) regulatory network to developing guidance about which common concerns and information needs of the public to address through proactive and prepared communication. The guidance has been welcomed by EU and international fora. The current article summarizes the recommendations and shares the underlying research findings, as well as a proof of concept that communication research can be valuable for regulators. It is critical that regulators integrate the communication process with product risk assessment in the framework of pharmacovigilance, to ensure that public concerns are addressed in the assessments and that information about evidence and uncertainty relating to safety is provided to the public and vaccination policy makers in a specific, clear and accurate manner. Additionally, information from regulatory authorities should support healthcare professionals in their communication with patients. Meeting the information interests of the public is the principal prerequisite for informed decisions as well as safe and effective use of vaccines and medicines overall. This is also fundamental for trust in the authorities' commitment to patient and population health. © 2018 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Data collection and analysis for local roadway safety assessment.

DOT National Transportation Integrated Search

2014-11-01

The project Data Analysis for Local Roadway : Assessment conducted systematic road-safety : assessment and identified major risks that can be el : iminated or reduced by pr : actical road-improvement : measures. Specifically, the primary task o...

Ex-ante assessment of the safety effects of intelligent transport systems.

PubMed

Kulmala, Risto

2010-07-01

There is a need to develop a comprehensive framework for the safety assessment of Intelligent Transport Systems (ITS). This framework should: (1) cover all three dimensions of road safety-exposure, crash risk and consequence, (2) cover, in addition to the engineering effect, also the effects due to behavioural adaptation and (3) be compatible with the other aspects of state of the art road safety theories. A framework based on nine ITS safety mechanisms is proposed and discussed with regard to the requirements set to the framework. In order to illustrate the application of the framework in practice, the paper presents a method based on the framework and the results from applying that method for twelve intelligent vehicle systems in Europe. The framework is also compared to two recent frameworks applied in the safety assessment of intelligent vehicle safety systems. Copyright 2010 Elsevier Ltd. All rights reserved.

49 CFR 190.11 - Availability of informal guidance and interpretive assistance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... guidance and interpretive assistance. (a) Availability of telephonic and Internet assistance. (1) PHMSA has established a website on the Internet and a telephone line at the Office of Pipeline Safety headquarters where... accessed via the Internet at http://ops.dot.gov. (2) PHMSA's Office of the Chief Counsel (OCC) is available...

Assessment of elementary school safety restraint programs.

DOT National Transportation Integrated Search

1985-06-01

The purpose of this research was to identify elementary school (K-6) safety belt : education programs in use in the United States, to review their development, and : to make administrative and impact assessments of their use in selected States. : Six...

Ultraviolet safety assessments of insect light traps.

PubMed

Sliney, David H; Gilbert, David W; Lyon, Terry

2016-01-01

Near-ultraviolet (UV-A: 315-400 nm), "black-light," electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV "Black-light" ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products.

Safety Assessment of Acyl Glucuronides-A Simplified Paradigm.

PubMed

Smith, Dennis A; Hammond, Timothy; Baillie, Thomas A

2018-06-01

While simple O - (ether-linked) and N -glucuronide drug conjugates generally are unreactive and considered benign from a safety perspective, the acyl glucuronides that derive from metabolism of carboxylic acid-containing xenobiotics can exhibit a degree of chemical reactivity that is dependent upon their molecular structure. As a result, concerns have arisen over the safety of acyl glucuronides as a class, several members of which have been implicated in the toxicity of their respective parent drugs. However, direct evidence in support of these claims remains sparse, and due to frequently encountered species differences in the systemic exposure to acyl glucuronides (both of the parent drug and oxidized derivatives thereof), coupled with their instability in aqueous media and potential to undergo chemical rearrangement (acyl migration), qualification of these conjugates by traditional safety assessment methods can be very challenging. In this Commentary, we discuss alternative (non-acyl glucuronide) mechanisms by which carboxylic acids may cause serious adverse reactions, and propose a novel, practical approach to compare systemic exposure to acyl glucuronide metabolites in humans to that in animal species used in preclinical safety assessment based on relative estimates of the total body burden of these circulating conjugates. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

Child passenger safety.

PubMed

Durbin, Dennis R

2011-04-01

Despite significant reductions in the number of children killed in motor vehicle crashes over the past decade, crashes continue to be the leading cause of death for children 4 years and older. Therefore, the American Academy of Pediatrics continues to recommend inclusion of child passenger safety anticipatory guidance at every health-supervision visit. This technical report provides a summary of the evidence in support of 5 recommendations for best practices to optimize safety in passenger vehicles for children from birth through adolescence that all pediatricians should know and promote in their routine practice. These recommendations are presented in the revised policy statement on child passenger safety in the form of an algorithm that is intended to facilitate their implementation by pediatricians with their patients and families. The algorithm is designed to cover the majority of situations that pediatricians will encounter in practice. In addition, a summary of evidence on a number of additional issues that affect the safety of children in motor vehicles, including the proper use and installation of child restraints, exposure to air bags, travel in pickup trucks, children left in or around vehicles, and the importance of restraint laws, is provided. Finally, this technical report provides pediatricians with a number of resources for additional information to use when providing anticipatory guidance to families.

77 FR 17491 - National Offshore Safety Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

... from the Mobile Offshore Drilling Unit Guidance Policy, Notice of Availability, request for comments... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2012-0091] National Offshore Safety... Management; Notice of Federal Advisory Committee Meetings. SUMMARY: The National Offshore Safety Advisory...

Human factors engineering in oil and gas--a review of industry guidance.

PubMed

Robb, Martin; Miller, Gerald

2012-01-01

Oil and gas exploration and production activities are carried out in hazardous environments in many parts of the world. Recent events in the Gulf of Mexico highlight those risks and underline the importance of considering human factors during facility design. Ergonomic factors such as machinery design, facility and accommodation layout and the organization of work activities have been systematically considered over the past twenty years on a limited number of offshore facility design projects to a) minimize the occupational risks to personnel, b) support operations and maintenance tasks and c) improve personnel wellbeing. During this period, several regulators and industry bodies such as the American Bureau of Shipping (ABS), the American Society of Testing and Materials (ASTM), the UK's Health and Safety Executive (HSE), Oil and Gas Producers (OGP), and Norway's Petroleum Safety Authority (PSA) have developed specific HFE design standards and guidance documents for the application of Human Factors Engineering (HFE) to the design and operation of Oil and Gas projects. However, despite the existence of these guidance and recommended design practise documents, and documented proof of their value in enhancing crew safety and efficiency, HFE is still not well understood across the industry and application across projects is inconsistent. This paper summarizes the key Oil and Gas industry bodies' HFE guidance documents, identifies recurring themes and current trends in the use of these standards, provides examples of where and how these HFE standards have been used on past major offshore facility design projects, and suggests criteria for selecting the appropriate HFE strategy and tasks for future major oil and gas projects. It also provides a short history of the application of HFE to the offshore industry, beginning with the use of ASTM F 1166 to a major operator's Deepwater Gulf of Mexico facility in 1990 and the application of HFE to diverse world regions. This

Development of guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act---a Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway Safety Plan (SHSP) and incorporate data-driven approaches to prioritize and evaluate program outcomes: Failure to do so resulted in funding sanctioning. In conjunction with the legislation, research efforts have also been progressing toward the development of new safety analysis tools such as IHSDM (Interactive Highway Safety Design Model), SafetyAnalyst, and HSM (Highway Safety Manual). These software and analysis tools are comparatively more advanced in statistical theory and level of accuracy, and have a tendency to be more data intensive. A review of the 2009 five-percent reports and excerpts from the nationwide survey revealed astonishing facts about the continuing use of traditional methods including crash frequencies and rates for site selection and prioritization. The intense data requirements and statistical complexity of advanced safety tools are considered as a hindrance to their adoption. In this context, this research aims at identifying the data requirements and data availability for SafetyAnalyst and HSM by working with both the tools. This research sets the stage for working with the Empirical Bayes approach by highlighting some of the biases and issues associated with the traditional methods of selecting projects such as greater emphasis on traffic volume and regression-to-mean phenomena. Further, the not-so-obvious issue with shorter segment lengths, which effect the results independent of the methods used, is also discussed. The more reliable and statistically acceptable Empirical Bayes methodology requires safety performance functions (SPFs), regression equations predicting the relation between crashes

VTOL shipboard letdown guidance system analysis

NASA Technical Reports Server (NTRS)

Phatak, A. V.; Karmali, M. S.

1983-01-01

Alternative letdown guidance strategies are examined for landing of a VTOL aircraft onboard a small aviation ship under adverse environmental conditions. Off line computer simulation of shipboard landing task is utilized for assessing the relative merits of the proposed guidance schemes. The touchdown performance of a nominal constant rate of descent (CROD) letdown strategy serves as a benchmark for ranking the performance of the alternative letdown schemes. Analysis of ship motion time histories indicates the existence of an alternating sequence of quiescent and rough motions called lulls and swells. A real time algorithms lull/swell classification based upon ship motion pattern features is developed. The classification algorithm is used to command a go/no go signal to indicate the initiation and termination of an acceptable landing window. Simulation results show that such a go/no go pattern based letdown guidance strategy improves touchdown performance.

A TIERED APPROACH TO LIFE STAGES TESTING FOR AGRICULTURAL CHEMICAL SAFETY ASSESSMENT

EPA Science Inventory

A proposal has been developed by the Agricultural Chemical Safety Assessment (ACSA) Technical Committee of the ILSI Health and Environmental Sciences Institute (HESI) for an improved approach to assessing the safety of crop protection chemicals. The goal is to ensure that studie...

What is safety?: Miracles, benefit-risk assessments, and the "right to try".

PubMed

DeTora, Lisa M

2017-07-01

Public discourse is full of quick solutions to health care problems like cancer and rare diseases. Among these is Right to Try legislation for experimental therapies. Right to Try legislation is based on the premise that all experimental agents in clinical trials are safe and guaranteed to produce miracles. Unfortunately, this notion is at odds with expert understanding, which indicates that the benefits and risks of drug products can only be understood together and evaluated incrementally and over time. The current manuscript examines why benefit to risk considerations, a lynchpin of the ethical conduct of clinical research since the Nuremberg Code, might be easily elided from public discourse. This paper considers guidelines for regulatory writing, which routinely separate discussions of effectiveness and safety, as a possible source for some confusion. The internationally-accepted ICH M4E (Common Technical Document) guideline published in 2016 now provides additional guidance for composing Benefits and Risks Conclusions, which weigh and consider effectiveness and safety together. Yet fundamental differences in understanding the "safety" of medicinal products continue to exist between experts in biomedicine, politicians, and healthcare activists. Examining differences in the understanding of "safety" between experts and non-experts also may help explain the source for flawed logic about the safety of investigational products in Right To Try narratives. No drug product is 100% safe. Continuing to weigh benefits and risks together is an important intellectual practice necessary to safeguard human health worldwide, and testing clinical safety is the only way to provide meaningful protections to patients. Science, not miracles, can ensure the protection of patients in clinical research as well as clinical practice. Weighing benefits and risks is an essential intellectual act that informs public health. Science, not miracles, can guide this work. © 2017 John Wiley

Safety Assessment of Dialkyl Sulfosuccinate Salts as Used in Cosmetics.

PubMed

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

2016-11-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 8 dialkyl sulfosuccinate salts for use in cosmetics, finding that these ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be nonirritating. The dialkyl sulfosuccinate salts primarily function as surfactants in cosmetics. The Panel reviewed the new and existing available animal and clinical data in making its determination of safety. The Panel found it appropriate to extrapolate the data on diethylhexyl sodium sulfosuccinate to assess the safety of the entire group because all of the diesters are of a similar alkyl chain length, all are symmetrically substituted, and all have similar functions in cosmetic formulations. © The Author(s) 2016.

Assessment of patient safety culture in private and public hospitals in Peru.

PubMed

Arrieta, Alejandro; Suárez, Gabriela; Hakim, Galed

2018-04-01

To assess the patient safety culture in Peruvian hospitals from the perspective of healthcare professionals, and to test for differences between the private and public healthcare sectors. Patient safety is defined as the avoidance and prevention of patient injuries or adverse events resulting from the processes of healthcare delivery. A non-random cross-sectional study conducted online. An online survey was administered from July to August 2016, in Peru. This study reports results from Lima and Callao, which are the capital and the port region of Peru. A total of 1679 healthcare professionals completed the survey. Participants were physicians, medical residents and nurses working in healthcare facilities from the private sector and public sector. Assessment of the degree of patient safety and 12 dimensions of patient safety culture in hospital units as perceived by healthcare professionals. Only 18% of healthcare professionals assess the degree of patient safety in their unit of work as excellent or very good. Significant differences are observed between the patient safety grades in the private sector (37%) compared to the public sub-sectors (13-15%). Moreover, in all patient safety culture dimensions, healthcare professionals from the private sector give more favorable responses for patient safety, than those from the public sub-systems. The most significant difference in support comes from patient safety administrators through communication and information about errors. Overall, the degree of patient safety in Peru is low, with significant gaps that exist between the private and the public sectors.

Post-earthquake building safety assessments for the Canterbury Earthquakes

USGS Publications Warehouse

Marshall, J.; Barnes, J.; Gould, N.; Jaiswal, K.; Lizundia, B.; Swanson, David A.; Turner, F.

2012-01-01

This paper explores the post-earthquake building assessment program that was utilized in Christchurch, New Zealand following the Canterbury Sequence of earthquakes beginning with the Magnitude (Mw.) 7.1 Darfield event in September 2010. The aftershocks or triggered events, two of which exceeded Mw 6.0, continued with events in February and June 2011 causing the greatest amount of damage. More than 70,000 building safety assessments were completed following the February event. The timeline and assessment procedures will be discussed including the use of rapid response teams, selection of indicator buildings to monitor damage following aftershocks, risk assessments for demolition of red-tagged buildings, the use of task forces to address management of the heavily damaged downtown area and the process of demolition. Through the post-event safety assessment program that occurred throughout the Canterbury Sequence of earthquakes, many important lessons can be learned that will benefit future response to natural hazards that have potential to damage structures.

Method of operator safety assessment for underground mobile mining equipment

NASA Astrophysics Data System (ADS)

Działak, Paulina; Karliński, Jacek; Rusiński, Eugeniusz

2018-01-01

The paper presents a method of assessing the safety of operators of mobile mining equipment (MME), which is adapted to current and future geological and mining conditions. The authors focused on underground mines, with special consideration of copper mines (KGHM). As extraction reaches into deeper layers of the deposit it can activate natural hazards, which, thus far, have been considered unusual and whose range and intensity are different depending on the field of operation. One of the main hazards that affect work safety and can become the main barrier in the exploitation of deposits at greater depths is climate threat. The authors have analysed the phenomena which may impact the safety of MME operators, with consideration of accidents that have not yet been studied and are not covered by the current safety standards for this group of miners. An attempt was made to develop a method for assessing the safety of MME operators, which takes into account the mentioned natural hazards and which is adapted to current and future environmental conditions in underground mines.

Safety assessment of discharge chute isolation barrier preparation and installation. Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meichle, R.H.

1994-10-10

This revision responds to RL comments and increases the discussion of the ``effective hazard categorization`` and the readiness review basis. The safety assessment is made for the activities for the preparation and installation of the discharge chute isolation barriers. The safety assessment includes a hazard assessment and comparison of potential accidents/events to those addressed by the current safety basis documentation. No significant hazards were identified. An evaluation against the USQ evaluation questions were made and the determination made that the activities do not represent a USQ. Hazard categorization techniques were used to provide a basis for readiness review classification.

Ultraviolet safety assessments of insect light traps

PubMed Central

Sliney, David H.; Gilbert, David W.; Lyon, Terry

2016-01-01

ABSTRACT Near-ultraviolet (UV-A: 315–400 nm), “black-light,” electric lamps were invented in 1935 and ultraviolet insect light traps (ILTs) were introduced for use in agriculture around that time. Today ILTs are used indoors in several industries and in food-service as well as in outdoor settings. With recent interest in photobiological lamp safety, safety standards are being developed to test for potentially hazardous ultraviolet emissions. A variety of UV “Black-light” ILTs were measured at a range of distances to assess potential exposures. Realistic time-weighted human exposures are shown to be well below current guidelines for human exposure to ultraviolet radiation. These UV-A exposures would be far less than the typical UV-A exposure in the outdoor environment. Proposals are made for realistic ultraviolet safety standards for ILT products. PMID:27043058

Guidance on spatial wildland fire analysis: models, tools, and techniques

Treesearch

Richard D. Stratton

2006-01-01

There is an increasing need for spatial wildland fire analysis in support of incident management, fuel treatment planning, wildland-urban assessment, and land management plan development. However, little guidance has been provided to the field in the form of training, support, or research examples. This paper provides guidance to fire managers, planners, specialists,...

Validity of instruments to assess students' travel and pedestrian safety.

PubMed

Mendoza, Jason A; Watson, Kathy; Baranowski, Tom; Nicklas, Theresa A; Uscanga, Doris K; Hanfling, Marcus J

2010-05-18

Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI) and intraclass correlations (ICC) across research assistant ratings. The SRTS travel survey had high test-retest reliability (kappa = 0.97, n = 96, p < 0.001) and convergent validity (kappa = 0.87, n = 81, p < 0.001). The pedestrian safety behavior checklist had moderate reliability across research assistants' ratings (ICC = 0.48) and moderate correlation with the PI (r = 0.55, p = < 0.01). When two raters simultaneously used the instrument, the ICC increased to 0.65. Overall percent agreement (91%), sensitivity (85%) and specificity (83%) were acceptable. These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work.

Validity of instruments to assess students' travel and pedestrian safety

PubMed Central

2010-01-01

Background Safe Routes to School (SRTS) programs are designed to make walking and bicycling to school safe and accessible for children. Despite their growing popularity, few validated measures exist for assessing important outcomes such as type of student transport or pedestrian safety behaviors. This research validated the SRTS school travel survey and a pedestrian safety behavior checklist. Methods Fourth grade students completed a brief written survey on how they got to school that day with set responses. Test-retest reliability was obtained 3-4 hours apart. Convergent validity of the SRTS travel survey was assessed by comparison to parents' report. For the measure of pedestrian safety behavior, 10 research assistants observed 29 students at a school intersection for completion of 8 selected pedestrian safety behaviors. Reliability was determined in two ways: correlations between the research assistants' ratings to that of the Principal Investigator (PI) and intraclass correlations (ICC) across research assistant ratings. Results The SRTS travel survey had high test-retest reliability (κ = 0.97, n = 96, p < 0.001) and convergent validity (κ = 0.87, n = 81, p < 0.001). The pedestrian safety behavior checklist had moderate reliability across research assistants' ratings (ICC = 0.48) and moderate correlation with the PI (r = 0.55, p =< 0.01). When two raters simultaneously used the instrument, the ICC increased to 0.65. Overall percent agreement (91%), sensitivity (85%) and specificity (83%) were acceptable. Conclusions These validated instruments can be used to assess SRTS programs. The pedestrian safety behavior checklist may benefit from further formative work. PMID:20482778

Adverse Outcome Pathways can drive non-animal approaches for safety assessment

PubMed Central

Burden, Natalie; Sewell, Fiona; Andersen, Melvin E; Boobis, Alan; Chipman, J Kevin; Cronin, Mark T D; Hutchinson, Thomas H; Kimber, Ian; Whelan, Maurice

2015-01-01

Adverse Outcome Pathways (AOPs) provide an opportunity to develop new and more accurate safety assessment processes for drugs and other chemicals, and may ultimately play an important role in regulatory decision making. Not only can the development and application of AOPs pave the way for the development of improved evidence-based approaches for hazard and risk assessment, there is also the promise of a significant impact on animal welfare, with a reduced reliance on animal-based methods. The establishment of a useable and coherent knowledge framework under which AOPs will be developed and applied has been a first critical step towards realizing this opportunity. This article explores how the development of AOPs under this framework, and their application in practice, could benefit the science and practice of safety assessment, while in parallel stimulating a move away from traditional methods towards an increased acceptance of non-animal approaches. We discuss here the key areas where current, and future initiatives should be focused to enable the translation of AOPs into routine chemical safety assessment, and lasting 3Rs benefits. © 2015 The Authors. Journal of Applied Toxicology published by John Wiley & Sons Ltd. This article explores how the development and application of Adverse Outcome Pathways (AOPs) could benefit the science and practice of chemical safety assessment, with a particular focus on how their use in practice could reduce reliance on traditional animal toxicity tests. This includes discussion of the key areas where current and future initiatives should be focused to enable the translation of AOPs into routine chemical safety assessment, and lasting 3Rs benefits. PMID:25943792

Revealing and Resolving Patient Safety Defects: The Impact of Leadership WalkRounds on Frontline Caregiver Assessments of Patient Safety

PubMed Central

Frankel, Allan; Grillo, Sarah Pratt; Pittman, Mary; Thomas, Eric J; Horowitz, Lisa; Page, Martha; Sexton, Bryan

2008-01-01

Objective To evaluate the impact of rigorous WalkRounds on frontline caregiver assessments of safety climate, and to clarify the steps and implementation of rigorous WalkRounds. Data Sources/Study Setting Primary outcome variables were baseline and post WalkRounds safety climate scores from the Safety Attitudes Questionnaire (SAQ). Secondary outcomes were safety issues elicited through WalkRounds. Study period was August 2002 to April 2005; seven hospitals in Massachusetts agreed to participate; and the project was implemented in all patient care areas. Study Design Prospective study of the impact of rigorously applied WalkRounds on frontline caregivers assessments of safety climate in their patient care area. WalkRounds were conducted weekly and according to the seven-step WalkRounds Guide. The SAQ was administered at baseline and approximately 18 months post-WalkRounds implementation to all caregivers in patient care areas. Results Two of seven hospitals complied with the rigorous WalkRounds approach; hospital A was an academic teaching center and hospital B a community teaching hospital. Of 21 patient care areas, SAQ surveys were received from 62 percent of respondents at baseline and 60 percent post WalkRounds. At baseline, 10 of 21 care areas (48 percent) had safety climate scores below 60 percent, whereas post-WalkRounds three care areas (14 percent) had safety climate scores below 60 percent without improving by 10 points or more. Safety climate scale scores in hospital A were 62 percent at baseline and 77 percent post-WalkRounds (t=2.67, p=.03), and in hospital B were 46 percent at baseline and 56 percent post WalkRounds (t=2.06, p=.06). Main safety issues by category were equipment/facility (A [26 percent] and B [33 percent]) and communication (A [24 percent] and B [18 percent]). Conclusions WalkRounds implementation requires significant organizational will; sustainability requires outstanding project management and leadership engagement. In the patient

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

2012-01-01

Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

A 2-year study of patient safety competency assessment in 29 clinical laboratories.

PubMed

Reed, Robyn C; Kim, Sara; Farquharson, Kara; Astion, Michael L

2008-06-01

Competency assessment is critical for laboratory operations and is mandated by the Clinical Laboratory Improvement Amendments of 1988. However, no previous reports describe methods for assessing competency in patient safety. We developed and implemented a Web-based tool to assess performance of 875 laboratory staff from 29 laboratories in patient safety. Question categories included workplace culture, categorizing error, prioritization of patient safety interventions, strength of specific interventions, and general patient safety concepts. The mean score was 85.0%, with individual scores ranging from 56% to 100% and scores by category from 81.3% to 88.6%. Of the most difficult questions (<72% correct), 6 were about intervention strength, 3 about categorizing error, 1 about workplace culture, and 1 about prioritization of interventions. Of the 13 questions about intervention strength, 6 (46%) were in the lowest quartile, suggesting that this may be a difficult topic for laboratory technologists. Computer-based competency assessments help laboratories identify topics for continuing education in patient safety.

Safety assessment for In-service Pressure Bending Pipe Containing Incomplete Penetration Defects

NASA Astrophysics Data System (ADS)

Wang, M.; Tang, P.; Xia, J. F.; Ling, Z. W.; Cai, G. Y.

2017-12-01

Incomplete penetration defect is a common defect in the welded joint of pressure pipes. While the safety classification of pressure pipe containing incomplete penetration defects, according to periodical inspection regulations in present, is more conservative. For reducing the repair of incomplete penetration defect, a scientific and applicable safety assessment method for pressure pipe is needed. In this paper, the stress analysis model of the pipe system was established for the in-service pressure bending pipe containing incomplete penetration defects. The local finite element model was set up to analyze the stress distribution of defect location and the stress linearization. And then, the applicability of two assessment methods, simplified assessment and U factor assessment method, to the assessment of incomplete penetration defects located at pressure bending pipe were analyzed. The results can provide some technical supports for the safety assessment of complex pipelines in the future.

Highway Safety Program Manual: Volume 15: Police Traffic Services.

ERIC Educational Resources Information Center

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

Volume 15 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) focuses on police traffic services. The purpose and objectives of a police services program are described. Federal authority in the areas of highway safety and policies regarding a police traffic…

Current issues and perspectives in food safety and risk assessment.

PubMed

Eisenbrand, G

2015-12-01

In this review, current issues and opportunities in food safety assessment are discussed. Food safety is considered an essential element inherent in global food security. Hazard characterization is pivotal within the continuum of risk assessment, but it may be conceived only within a very limited frame as a true alternative to risk assessment. Elucidation of the mode of action underlying a given hazard is vital to create a plausible basis for human toxicology evaluation. Risk assessment, to convey meaningful risk communication, must be based on appropriate and reliable consideration of both exposure and mode of action. New perspectives, provided by monitoring human exogenous and endogenous exposure biomarkers, are considered of great promise to support classical risk extrapolation from animal toxicology. © The Author(s) 2015.

The Morality and Economics of Safety in Defence Procurement

NASA Astrophysics Data System (ADS)

Clement, Tim

Ministry of Defence policy is to conform as closely as possible to UK health and safety legislation in all its operations. We consider the implications of the law and the guidance provided by the Health and Safety Executive for the arguments we need to make for the safety of defence procurements, and extract four general principles to help in answering the questions that arise when considering the safety of systems with complex behaviour. One of these principles is analysed further to identify how case law and the guidance interpret the requirement for risks to be reduced so far as is reasonably practicable. We then apply the principles to answer some questions that have arisen in our work as Independent Safety Auditors, including the limits to the tolerability of risk to armed forces personnel and civilians in wartime, and the acceptability of the transfer of risk from one group to another when controls on risk are introduced.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-07

... Health's (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final... products, FDA headquarters and field personnel, and the public of CDRH's proposed approach on the safety of... limits. While this rulemaking process is ongoing, CDRH encourages manufacturers to keep children's toy...

Joint Ordnance Test Procedure (JOTP)-001 Allied Ammunition Safety and Suitability for Service Assessment Testing Publication - Guidance

DTIC Science & Technology

2013-01-08

hazard due to enemy attack or accident (e.g. Insensitive Munitions (IM) and Electromagnetic Environmental Effects (E3)) and the explosive materials...of mitigating potential explosive remnants of war hazards , particularly from unexploded ordnance , should be conducted. 6.5 Munition Software System...TYPE Final 3. DATES COVERED (From - To) 4. TITLE AND SUBTITLE Joint Ordnance Test Procedure (JOTP)-001 Allied Ammunition Safety and

Guidance for updating clinical practice guidelines: a systematic review of methodological handbooks.

PubMed

Vernooij, Robin W M; Sanabria, Andrea Juliana; Solà, Ivan; Alonso-Coello, Pablo; Martínez García, Laura

2014-01-02

Updating clinical practice guidelines (CPGs) is a crucial process for maintaining the validity of recommendations. Methodological handbooks should provide guidance on both developing and updating CPGs. However, little is known about the updating guidance provided by these handbooks. We conducted a systematic review to identify and describe the updating guidance provided by CPG methodological handbooks and included handbooks that provide updating guidance for CPGs. We searched in the Guidelines International Network library, US National Guidelines Clearinghouse and MEDLINE (PubMed) from 1966 to September 2013. Two authors independently selected the handbooks and extracted the data. We used descriptive statistics to analyze the extracted data and conducted a narrative synthesis. We included 35 handbooks. Most handbooks (97.1%) focus mainly on developing CPGs, including variable degrees of information about updating. Guidance on identifying new evidence and the methodology of assessing the need for an update is described in 11 (31.4%) and eight handbooks (22.8%), respectively. The period of time between two updates is described in 25 handbooks (71.4%), two to three years being the most frequent (40.0%). The majority of handbooks do not provide guidance for the literature search, evidence selection, assessment, synthesis, and external review of the updating process. Guidance for updating CPGs is poorly described in methodological handbooks. This guidance should be more rigorous and explicit. This could lead to a more optimal updating process, and, ultimately to valid trustworthy guidelines.

Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chopra, Omesh K.; Diercks, Dwight R.; Ma, David Chia-Chiun

At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC’s assessment processes. In themore » U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned

Using driving simulators to assess driving safety.

PubMed

Boyle, Linda Ng; Lee, John D

2010-05-01

Changes in drivers, vehicles, and roadways pose substantial challenges to the transportation safety community. Crash records and naturalistic driving data are useful for examining the influence of past or existing technology on drivers, and the associations between risk factors and crashes. However, they are limited because causation cannot be established and technology not yet installed in production vehicles cannot be assessed. Driving simulators have become an increasingly widespread tool to understand evolving and novel technologies. The ability to manipulate independent variables in a randomized, controlled setting also provides the added benefit of identifying causal links. This paper introduces a special issue on simulator-based safety studies. The special issue comprises 25 papers that demonstrate the use of driving simulators to address pressing transportation safety problems and includes topics as diverse as neurological dysfunction, work zone design, and driver distraction. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

Derivation of a chemical-specific adjustment factor (CSAF) for use in the assessment of risk from chronic exposure to ethylene glycol: Application of international programme for chemical safety guidelines

DOE Office of Scientific and Technical Information (OSTI.GOV)

Palmer, Robert B.; Brent, Jeffrey

2005-09-01

The International Programme for Chemical Safety (IPCS) has developed a set of guidelines ('the Guidance') for the establishment of Chemical-Specific Adjustment Factors (CSAFs) for in the assessment of toxicity risk to the human population as a result of chemical exposure. The development of case studies is encouraged in the Guidance document and comments on them have been encouraged by the IPCS. One provision in the Guidance is for the determination of CSAFs based on human data. We present a case study of the use of the Guidance for the determination of the CSAF for ethylene glycol (EG) primarily utilizing clinicallymore » obtained data. The most relevant endpoint for this analysis was deemed to be acute renal injury. These data were applied based on an assessment of the known pharmaco/toxico-kinetic properties of EG. Because of the lack of both bioaccumulation of EG and reports of chronic or progressive renal injury from EG, it was concluded that the most appropriate model of chronic exposure is one of repeated acute episodes. The most relevant exposure metric was determined to be plasma glycolate concentration. Based on a prospective human study of EG-poisoned patients, the NOAEL for glycolate was found to be 10.1 mM. This value is similar to that obtained from animal data. The application of the Guidelines to this data resulted in a CSAF of 10.24, corresponding to a daily EG dose of 43.7 mg/kg/day. In 2000, Health Canada (HC) produced an animal data-based analysis of the maximum tolerated dose of EG. The results of our analysis are compared with those of HC, and the strengths and weaknesses of these two data types related to EG are discussed.« less

A quantitative risk assessment for the safety of carcase storage systems for scrapie infected farms.

PubMed

Adkin, A; Jones, D L; Eckford, R L; Edwards-Jones, G; Williams, A P

2014-10-01

To determine the risk associated with the use of carcase storage vessels on a scrapie infected farm. A stochastic quantitative risk assessment was developed to determine the rate of accumulation and fate of scrapie in a novel low-input storage system. For an example farm infected with classical scrapie, a mean of 10(3·6) Ovine Oral ID50 s was estimated to accumulate annually. Research indicates that the degradation of any prions present may range from insignificant to a magnitude of one or two logs over several months of storage. For infected farms, the likely partitioning of remaining prion into the sludge phase would necessitate the safe operation and removal of resulting materials from these systems. If complete mixing could be assumed, on average, the concentrations of infectivity are estimated to be slightly lower than that measured in placenta from infected sheep at lambing. This is the first quantitative assessment of the scrapie risk associated with fallen stock on farm and provides guidance to policy makers on the safety of one type of storage system and the relative risk when compared to other materials present on an infected farm. © 2014 Crown Copyright. Journal of Applied Microbiology © 2014 Society for Applied Microbiology This article is published with the permission of the Controller of HMSO and the Queen's Printer for Scotland.

Unified State Plan for Guidance, Counseling and Placement in Colorado. Grades 7-12.

ERIC Educational Resources Information Center

Terrill, Jerry; And Others

This guide, one of three units in the Colorado state plan for guidance program development, is written for educators as both a guideline and a needs assessment instrument to assist in the identification of deficit areas in school guidance programs. In a beginning section, this unit for grades 7-12 provides a brief philosophy of guidance and…

Highway Safety Program Manual: Volume 6: Codes and Laws.

ERIC Educational Resources Information Center

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

Volume 6 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred safety practices) concentrates on codes and laws. The purpose and specific objectives of the Codes and Laws Program, Federal authority in the area of highway safety, and policies regarding traffic regulation are described.…

INTERPRETING SPONTANEOUS RENAL LESIONS IN SAFETY AND RISK ASSESSMENT

EPA Science Inventory

Interpreting Spontaneous Renal Lesions in Safety and Risk Assessment
Douglas C. Wolf, D.V.M., Ph.D.

Introduction

Risk assessment is a process whereby the potential adverse health effects from exposure to a xenobiotic are predicted after evaluation of the availab...

Surrogate Safety Assessment Model (SSAM)--software user manual

DOT National Transportation Integrated Search

2008-05-01

This document presents guidelines for the installation and use of the Surrogate Safety Assessment Model (SSAM) software. For more information regarding the SSAM application, including discussion of theoretical background and the results of a series o...

Food safety management and risk assessment in the fresh produce supply chain

NASA Astrophysics Data System (ADS)

Jacxsens, L.; Uyttendaele, M.; Luning, P.; Allende, A.

2017-04-01

This paper is the output of several years of scientific research coordinated by Laboratory of Food Preservation and Food Microbiology at UGent, within the EU FP7 Research project Veg-i-trade (www.vegitrade.org), in collaboration with among other partners, Wageningen University and Cebas-CSIC. Fresh produce and derived products are globally traded and subjected to an inherent sensitive towards enteric pathogens as Salmonella and pathogenic E. coli due to their cultivation practices. As fruits and vegetables are increasingly being consumed raw, a potential health risk towards consumers is present. In the Veg-i-Trade project the extend of presence of pathogens in leafy greens and strawberry fruit and their cultivation environment (as water, soil, manured soil, etc.) was analysed. Insight in the food safety management system enlighted the need for further fostering and guidance towards farmers in good practices in order to reduce the potential pressure of the presence of the pathogens both in EU and non EU countries. Exposure assessment calculations demonstrated the usefulness of mathematic modelling to gain more insight in fragmented microbiological analysis and information of cultivation practices, as such the impact of contamination of irrigation water and the impact of a flooding event. Veg-i-Trade was a challenging project both in scientific and management perspective as 23 partners collaborated.

A Framework for Assessment of Aviation Safety Technology Portfolios

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.

2014-01-01

The programs within NASA's Aeronautics Research Mission Directorate (ARMD) conduct research and development to improve the national air transportation system so that Americans can travel as safely as possible. NASA aviation safety systems analysis personnel support various levels of ARMD management in their fulfillment of system analysis and technology prioritization as defined in the agency's program and project requirements. This paper provides a framework for the assessment of aviation safety research and technology portfolios that includes metrics such as projected impact on current and future safety, technical development risk and implementation risk. The paper also contains methods for presenting portfolio analysis and aviation safety Bayesian Belief Network (BBN) output results to management using bubble charts and quantitative decision analysis techniques.

AGRICULTURAL CHEMICAL SAFETY ASSESSMENT: A MULTISECTOR APPROACH TO THE MODERNIZATION OF HUMAN SAFETY REQUIREMENTS.

EPA Science Inventory

Better understanding of toxicological mechanisms, enhanced testing capabilities, and demands for more sophisticated data for safety and health risk assessment have generated international interest in improving the current testing paradigm for agricultural chemicals. To address th...

Quality assurance and quality control in mammography: a review of available guidance worldwide.

PubMed

Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos

2013-10-01

Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.

A hybrid approach to near-optimal launch vehicle guidance

NASA Technical Reports Server (NTRS)

Leung, Martin S. K.; Calise, Anthony J.

1992-01-01

This paper evaluates a proposed hybrid analytical/numerical approach to launch-vehicle guidance for ascent to orbit injection. The feedback-guidance approach is based on a piecewise nearly analytic zero-order solution evaluated using a collocation method. The zero-order solution is then improved through a regular perturbation analysis, wherein the neglected dynamics are corrected in the first-order term. For real-time implementation, the guidance approach requires solving a set of small dimension nonlinear algebraic equations and performing quadrature. Assessment of performance and reliability are carried out through closed-loop simulation for a vertically launched 2-stage heavy-lift capacity vehicle to a low earth orbit. The solutions are compared with optimal solutions generated from a multiple shooting code. In the example the guidance approach delivers over 99.9 percent of optimal performance and terminal constraint accuracy.

Guidance from an NIH Workshop on Designing, Implementing, and Reporting Clinical Studies of Soy Interventions1–4

PubMed Central

Klein, Marguerite A.; Nahin, Richard L.; Messina, Mark J.; Rader, Jeanne I.; Thompson, Lilian U.; Badger, Thomas M.; Dwyer, Johanna T.; Kim, Young S.; Pontzer, Carol H.; Starke-Reed, Pamela E.; Weaver, Connie M.

2010-01-01

The NIH sponsored a scientific workshop, “Soy Protein/Isoflavone Research: Challenges in Designing and Evaluating Intervention Studies,” July 28–29, 2009. The workshop goal was to provide guidance for the next generation of soy protein/isoflavone human research. Session topics included population exposure to soy; the variability of the human response to soy; product composition; methods, tools, and resources available to estimate exposure and protocol adherence; and analytical methods to assess soy in foods and supplements and analytes in biologic fluids and other tissues. The intent of the workshop was to address the quality of soy studies, not the efficacy or safety of soy. Prior NIH workshops and an evidence-based review questioned the quality of data from human soy studies. If clinical studies are pursued, investigators need to ensure that the experimental designs are optimal and the studies properly executed. The workshop participants identified methodological issues that may confound study results and interpretation. Scientifically sound and useful options for dealing with these issues were discussed. The resulting guidance is presented in this document with a brief rationale. The guidance is specific to soy clinical research and does not address nonsoy-related factors that should also be considered in designing and reporting clinical studies. This guidance may be used by investigators, journal editors, study sponsors, and protocol reviewers for a variety of purposes, including designing and implementing trials, reporting results, and interpreting published epidemiological and clinical studies. PMID:20392880

Safety Assessment of Alkyl Ethylhexanoates as Used in Cosmetics.

PubMed

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

2015-01-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 16 alkyl ethylhexanoates for use in cosmetics, concluding that these ingredients are safe in cosmetic formulations in the present practices of use and concentrations when formulated to be nonirritating. The alkyl ethylhexanoates primarily function as skin-conditioning agents in cosmetics. The highest concentration of use reported for any of the alkyl ethylhexanoates is 77.3% cetyl ethylhexanoate in rinse-off formulations used near the eye, and the highest leave-on use reported is 52% cetyl ethylhexanoate in lipstick formulations. The Panel reviewed available animal and clinical data related to these ingredients, and the similarities in structure, properties, functions, and uses of ingredients from previous CIR assessments on constituent alcohols that allowed for extrapolation of the available toxicological data to assess the safety of the entire group. © The Author(s) 2015.

Biosafety Risk Assessment Methodology

DOE Office of Scientific and Technical Information (OSTI.GOV)

Caskey, Susan Adele; Gaudioso, Jennifer M.; Salerno, Reynolds Mathewson

2010-10-01

Laboratories that work with biological agents need to manage their safety risks to persons working the laboratories and the human and animal community in the surrounding areas. Biosafety guidance defines a wide variety of biosafety risk mitigation measures, which include measures which fall under the following categories: engineering controls, procedural and administrative controls, and the use of personal protective equipment; the determination of which mitigation measures should be used to address the specific laboratory risks are dependent upon a risk assessment. Ideally, a risk assessment should be conducted in a manner which is standardized and systematic which allows it tomore » be repeatable and comparable. A risk assessment should clearly define the risk being assessed and avoid over complication.« less

Evaluating Alerting and Guidance Performance of a UAS Detect-And-Avoid System

NASA Technical Reports Server (NTRS)

Lee, Seung Man; Park, Chunki; Thipphavong, David P.; Isaacson, Douglas R.; Santiago, Confesor

2016-01-01

A key challenge to the routine, safe operation of unmanned aircraft systems (UAS) is the development of detect-and-avoid (DAA) systems to aid the UAS pilot in remaining "well clear" of nearby aircraft. The goal of this study is to investigate the effect of alerting criteria and pilot response delay on the safety and performance of UAS DAA systems in the context of routine civil UAS operations in the National Airspace System (NAS). A NAS-wide fast-time simulation study was conducted to assess UAS DAA system performance with a large number of encounters and a broad set of DAA alerting and guidance system parameters. Three attributes of the DAA system were controlled as independent variables in the study to conduct trade-off analyses: UAS trajectory prediction method (dead-reckoning vs. intent-based), alerting time threshold (related to predicted time to LoWC), and alerting distance threshold (related to predicted Horizontal Miss Distance, or HMD). A set of metrics, such as the percentage of true positive, false positive, and missed alerts, based on signal detection theory and analysis methods utilizing the Receiver Operating Characteristic (ROC) curves were proposed to evaluate the safety and performance of DAA alerting and guidance systems and aid development of DAA system performance standards. The effect of pilot response delay on the performance of DAA systems was evaluated using a DAA alerting and guidance model and a pilot model developed to support this study. A total of 18 fast-time simulations were conducted with nine different DAA alerting threshold settings and two different trajectory prediction methods, using recorded radar traffic from current Visual Flight Rules (VFR) operations, and supplemented with DAA-equipped UAS traffic based on mission profiles modeling future UAS operations. Results indicate DAA alerting distance threshold has a greater effect on DAA system performance than DAA alerting time threshold or ownship trajectory prediction method

Impact of NICE guidance on rates of haemorrhage after tonsillectomy: an evaluation of guidance issued during an ongoing national tonsillectomy audit.

PubMed

Audit, National Prospective Tonsillectomy

2008-08-01

The National Institute for Health and Clinical Excellence (NICE) issued guidance on surgical techniques for tonsillectomy during a national audit of surgical practice and postoperative complications. To assess the impact of the guidance on tonsillectomy practice and outcomes. An interrupted time-series analysis of routinely collected Hospital Episodes Statistics data, and an analysis of longitudinal trends in surgical technique using data from the National Prospective Tonsillectomy Audit. Patients undergoing tonsillectomy in English NHS hospitals between January 2002 and December 2004. Postoperative haemorrhage within 28 days. The rate of haemorrhage increased by 0.5% per year from 2002, reaching 6.4% when the guidance was published. After publication, the rate of haemorrhage fell immediately to 5.7% (difference 0.7%: 95% CI -1.3% to 0.0%) and the rate of increase appeared to have stopped. Data from the National Prospective Tonsillectomy Audit showed that the fall coincided with a shift in surgical techniques, which was consistent with the guidance. NICE guidance influenced surgical tonsillectomy technique and in turn produced an immediate fall in postoperative haemorrhage. The ongoing national audit and strong support from the surgical specialist association may have aided its implementation.

Regulatory guidance on soil cover systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kane, J.D.

1991-12-31

The US Nuclear Regulatory Commission (NRC) in September 1991, completed revisions to 14 sections of the Standard Review Plan (SRP) for the Review of a License Application for a Low-Level Radioactive Waste Disposal Facility. The major purposes of the SRP are to ensure the quality and uniformity of the NRC staff`s safety reviews, and to present a well-defined base from which to evaluate the acceptability of information and data provided in the Safety Analysis Report (SAR) portion of the license application. SRP 3.2, entitled, Design Considerations for Normal and Abnormal/Accident Conditions, was one of the sections that was revised bymore » the NRC staff. This revision was completed to provide additional regulatory guidance on the important considerations that need to be addressed for the proper design and construction of soil cover systems that are to be placed over the LLW. The cover system over the waste is acknowledged to be one of the most important engineered barriers for the long-term stable performance of the disposal facility. The guidance in revised SRP 3.2 summarizes the previous efforts and recommendations of the US Army Corps of Engineers (COE), and a peer review panel on the placement of soil cover systems. NRC published these efforts in NUREG/CR-5432. The discussions in this paper highlight selected recommendations on soil cover issues that the NRC staff considers important for ensuring the safe, long-term performance of the soil cover systems. The development phases to be discussed include: (1) cover design; (2) cover material selection; (3) laboratory and field testing; (4) field placement control and acceptance; and (5) penetrations through the constructed covers.« less

Assessment of insurance incentives for safety belt usage

DOT National Transportation Integrated Search

1983-05-12

This study assesses the feasibility of insurance companies to offer incentives, in the form of premium reductions or additional benefits, which would be effective in increasing safety belt usage. The insurance types considered in this report are auto...

Safety: the heart of the matter.

PubMed

Hayat, Sajad A; Senior, Roxy

2005-08-01

An integral part of evaluation of cardiac disease in modern day medicine is echocardiography. It has made great strides since the initial collaboration of Dr. Helmut Hertz and Dr. Inge Edler. In its modern day form, echocardiography maintains a legacy of a bedside utility while adopting many of the technologic advances ushered in by the digital era. As a result, it boasts a broad and growing spectrum of application including routine use in primary cardiac diagnosis and screening, therapeutic assessment, and guidance of interventional and surgical procedures. With the advent of ultrasound contrast agents it is now arguably the most complete 'one-stop' investigational tool to assess cardiac structure, function and perfusion. However, has it maintained its safety profile? The familiar and oft quoted dictum in medicine of "first do no harm" is of great importance for any diagnostic tool and patient safety should remain a primary consideration for any new investigational technique. In this issue Cosyns' et al. have examined whether some of the theoretical and in vitro experimental concerns surrounding myocardial injury during and following contrast echocardiography result in any detectable change in cardiac function.

In situ medical simulation investigation of emergency department procedural sedation with randomized trial of experimental bedside clinical process guidance intervention.

PubMed

Siegel, Nathan A; Kobayashi, Leo; Dunbar-Viveiros, Jennifer A; Devine, Jeffrey; Al-Rasheed, Rakan S; Gardiner, Fenwick G; Olsson, Krister; Lai, Stella; Jones, Mark S; Dannecker, Max; Overly, Frank L; Gosbee, John W; Portelli, David C; Jay, Gregory D

2015-06-01

Patient safety during emergency department procedural sedation (EDPS) can be difficult to study. Investigators sought to delineate and experimentally assess EDPS performance and safety practices of senior-level emergency medicine residents through in situ simulation. Study sessions used 2 pilot-tested EDPS scenarios with critical action checklists, institutional forms, embedded probes, and situational awareness questionnaires. An experimental informatics system was separately developed for bedside EDPS process guidance. Postgraduate year 3 and 4 subjects completed both scenarios in randomized order; only experimental subjects were provided with the experimental system during second scenarios. Twenty-four residents were recruited into a control group (n = 12; 6.2 ± 7.4 live EDPS experience) and experimental group (n = 12; 11.3 ± 8.2 live EDPS experience [P = 0.10]). Critical actions for EDPS medication selection, induction, and adverse event recognition with resuscitation were correctly performed by most subjects. Presedation evaluations, sedation rescue preparation, equipment checks, time-outs, and documentation were frequently missed. Time-outs and postsedation assessments increased during second scenarios in the experimental group. Emergency department procedural sedation safety probe detection did not change across scenarios in either group. Situational awareness scores were 51% ± 7% for control group and 58% ± 12% for experimental group. Subjects using the experimental system completed more time-outs and scored higher Simulation EDPS Safety Composite Scores, although without comprehensive improvements in EDPS practice or safety. Study simulations delineated EDPS and assessed safety behaviors in senior emergency medicine residents, who exhibited the requisite medical knowledge base and procedural skill set but lacked some nontechnical skills that pertain to emergency department microsystem functions and patient safety. The experimental system exhibited

A Conceptual Model for Promoting Study Skills and Test-Taking Techniques among Secondary School Students: Curricular, Instructional/Guidance, and Assessment Perspectives.

ERIC Educational Resources Information Center

Guedry-Hymel, Linda; Hymel, Glenn M.

This paper develops a conceptual model involving curricular, instructional/guidance, and assessment perspectives on the promotion of study skills and test-taking techniques among secondary school students. From the curricular standpoint, consideration is given to a recommended range of topical coverage and a diversified array of printed/mediated…

Querying Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

2014-01-01

Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

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

PubMed

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

Human Guidance Behavior Decomposition and Modeling

NASA Astrophysics Data System (ADS)

Feit, Andrew James

Trained humans are capable of high performance, adaptable, and robust first-person dynamic motion guidance behavior. This behavior is exhibited in a wide variety of activities such as driving, piloting aircraft, skiing, biking, and many others. Human performance in such activities far exceeds the current capability of autonomous systems in terms of adaptability to new tasks, real-time motion planning, robustness, and trading safety for performance. The present work investigates the structure of human dynamic motion guidance that enables these performance qualities. This work uses a first-person experimental framework that presents a driving task to the subject, measuring control inputs, vehicle motion, and operator visual gaze movement. The resulting data is decomposed into subspace segment clusters that form primitive elements of action-perception interactive behavior. Subspace clusters are defined by both agent-environment system dynamic constraints and operator control strategies. A key contribution of this work is to define transitions between subspace cluster segments, or subgoals, as points where the set of active constraints, either system or operator defined, changes. This definition provides necessary conditions to determine transition points for a given task-environment scenario that allow a solution trajectory to be planned from known behavior elements. In addition, human gaze behavior during this task contains predictive behavior elements, indicating that the identified control modes are internally modeled. Based on these ideas, a generative, autonomous guidance framework is introduced that efficiently generates optimal dynamic motion behavior in new tasks. The new subgoal planning algorithm is shown to generate solutions to certain tasks more quickly than existing approaches currently used in robotics.

Hazard Identification and Risk Assessment of Health and Safety Approach JSA (Job Safety Analysis) in Plantation Company

NASA Astrophysics Data System (ADS)

Sugarindra, Muchamad; Ragil Suryoputro, Muhammad; Tiya Novitasari, Adi

2017-06-01

Plantation company needed to identify hazard and perform risk assessment as an Identification of Hazard and Risk Assessment Crime and Safety which was approached by using JSA (Job Safety Analysis). The identification was aimed to identify the potential hazards that might be the risk of workplace accidents so that preventive action could be taken to minimize the accidents. The data was collected by direct observation to the workers concerned and the results were recorded on a Job Safety Analysis form. The data were as forklift operator, macerator worker, worker’s creeper, shredder worker, workers’ workshop, mechanical line worker, trolley cleaning workers and workers’ crepe decline. The result showed that shredder worker value was 30 and had the working level with extreme risk with the risk value range was above 20. So to minimize the accidents could provide Personal Protective Equipment (PPE) which were appropriate, information about health and safety, the company should have watched the activities of workers, and rewards for the workers who obey the rules that applied in the plantation.

Apollo lunar descent guidance

NASA Technical Reports Server (NTRS)

Klumpp, A. R.

1974-01-01

Apollo lunar-descent guidance transfers the Lunar Module from a near-circular orbit to touchdown, traversing a 17 deg central angle and a 15 km altitude in 11 min. A group of interactive programs in an onboard computer guide the descent, controlling altitude and the descent propulsion system throttle. A ground-based program pre-computes guidance targets. The concepts involved in this guidance are described. Explicit and implicit guidance are discussed, guidance equations are derived, and the earlier Apollo explicit equation is shown to be an inferior special case of the later implicit equation. Interactive guidance, by which the two-man crew selects a landing site in favorable terrain and directs the trajectory there, is discussed. Interactive terminal-descent guidance enables the crew to control the essentially vertical descent rate in order to land in minimum time with safe contact speed. The altitude maneuver routine uses concepts that make gimbal lock inherently impossible.

Promoting driving safety for teens and adults.

PubMed

Wilson, D; Molloy-Martinez, T

1989-10-01

Traffic accidents are a major cause of death and disability, accounting for significant numbers of brain injuries. The purpose of this article is to discuss those conditions that can affect driver safety. The role of the nurse practitioner in primary prevention involves assessing the health status of drivers, including risk-taking behavior, age-related factors, use of alcohol and medications, and chronic illnesses and physical conditions that can result in driver impairment. Interventions can include patient education, anticipatory guidance, role-playing, referral for skill-building or driver evaluation, and reporting potentially unsafe drivers in keeping with state guidelines. Practitioner involvement in grass-roots community groups is encouraged.

Payload Safety: Risk and Characteristic-Based Control of Engineered Nanomaterials

NASA Astrophysics Data System (ADS)

Abou, Seraphin Chally; Saad, Maarouf

2013-09-01

In the last decade progress has been made to assist organizations that are developing payloads intended for flight on the International Space Station (ISS) and/or Space Shuttle. Collaboration programs for comprehensive risk assessment have been initiated between the U.S. and the European Union to generate requirements and data needed to comply with payloads safety and to perform risk assessment and controls guidance. Yet, substantial research gaps remain, as do challenges in the translation of these research findings to control for exposure to nanoscale material payloads, and the health effects. Since nanomaterial structures are different from traditional molecules, some standard material properties can change at size of 50nm or less. Changes in material properties at this scale challenge our understanding of hazards posed by nanomaterial payloads in the ISS realistic exposure conditions, and our ability to anticipate, evaluate, and control potential health issues, and safety. The research question addressed in this framework is: what kind of descriptors can be developed for nanomaterial payloads risks assessment? Methods proposed incorporate elements of characteristic- based risk an alysis: (1) to enable characterization of anthropogenic nanomaterials which can result in incidental from natural nanoparticles; and (2) to better understand safety attributes in terms of human health impacts from exposure to varying types of engineered nanomaterials.

Management of radioactive material safety programs at medical facilities. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Camper, L.W.; Schlueter, J.; Woods, S.

A Task Force, comprising eight US Nuclear Regulatory Commission and two Agreement State program staff members, developed the guidance contained in this report. This report describes a systematic approach for effectively managing radiation safety programs at medical facilities. This is accomplished by defining and emphasizing the roles of an institution`s executive management, radiation safety committee, and radiation safety officer. Various aspects of program management are discussed and guidance is offered on selecting the radiation safety officer, determining adequate resources for the program, using such contractual services as consultants and service companies, conducting audits, and establishing the roles of authorized usersmore » and supervised individuals; NRC`s reporting and notification requirements are discussed, and a general description is given of how NRC`s licensing, inspection and enforcement programs work.« less

A Microbial Assessment Scheme to measure microbial performance of Food Safety Management Systems.

PubMed

Jacxsens, L; Kussaga, J; Luning, P A; Van der Spiegel, M; Devlieghere, F; Uyttendaele, M

2009-08-31

A Food Safety Management System (FSMS) implemented in a food processing industry is based on Good Hygienic Practices (GHP), Hazard Analysis Critical Control Point (HACCP) principles and should address both food safety control and assurance activities in order to guarantee food safety. One of the most emerging challenges is to assess the performance of a present FSMS. The objective of this work is to explain the development of a Microbial Assessment Scheme (MAS) as a tool for a systematic analysis of microbial counts in order to assess the current microbial performance of an implemented FSMS. It is assumed that low numbers of microorganisms and small variations in microbial counts indicate an effective FSMS. The MAS is a procedure that defines the identification of critical sampling locations, the selection of microbiological parameters, the assessment of sampling frequency, the selection of sampling method and method of analysis, and finally data processing and interpretation. Based on the MAS assessment, microbial safety level profiles can be derived, indicating which microorganisms and to what extent they contribute to food safety for a specific food processing company. The MAS concept is illustrated with a case study in the pork processing industry, where ready-to-eat meat products are produced (cured, cooked ham and cured, dried bacon).

Aligning the 3Rs with new paradigms in the safety assessment of chemicals.

PubMed

Burden, Natalie; Mahony, Catherine; Müller, Boris P; Terry, Claire; Westmoreland, Carl; Kimber, Ian

2015-04-01

There are currently several factors driving a move away from the reliance on in vivo toxicity testing for the purposes of chemical safety assessment. Progress has started to be made in the development and validation of non-animal methods. However, recent advances in the biosciences provide exciting opportunities to accelerate this process and to ensure that the alternative paradigms for hazard identification and risk assessment deliver lasting 3Rs benefits, whilst improving the quality and relevance of safety assessment. The NC3Rs, a UK-based scientific organisation which supports the development and application of novel 3Rs techniques and approaches, held a workshop recently which brought together over 20 international experts in the field of chemical safety assessment. The aim of this workshop was to review the current scientific, technical and regulatory landscapes, and to identify key opportunities towards reaching these goals. Here, we consider areas where further strategic investment will need to be focused if significant impact on 3Rs is to be matched with improved safety science, and why the timing is right for the field to work together towards an environment where we no longer rely on whole animal data for the accurate safety assessment of chemicals.

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

PubMed

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

Terrain Safety Assessment in Support of the Mars Science Laboratory Mission

NASA Technical Reports Server (NTRS)

Kipp, Devin

2012-01-01

In August 2012, the Mars Science Laboratory (MSL) mission will pioneer the next generation of robotic Entry, Descent, and Landing (EDL) systems by delivering the largest and most capable rover to date to the surface of Mars. The process to select the MSL landing site took over five years and began with over 50 initial candidate sites from which four finalist sites were chosen. The four finalist sites were examined in detail to assess overall science merit, EDL safety, and rover traversability on the surface. Ultimately, the engineering assessments demonstrated a high level of safety and robustness at all four finalist sites and differences in the assessment across those sites were small enough that neither EDL safety nor rover traversability considerations could significantly discriminate among the final four sites. Thus the MSL landing site at Gale Crater was selected from among the four finalists primarily on the basis of science considerations.

Assessing Explosives Safety Risks, Deviations, And Consequences

DTIC Science & Technology

2009-07-31

Technical Paper 23 31 July 2009 DDESB Assessing Explosives Safety Risks, Deviations, And Consequences ...Deviations, And Consequences 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER...and approaches to assist warfighters in executing their mission, conserving resources, and maximizing operational effectiveness . When mission risk

Guidance on How to Move from Current Practice to Recommended Practice in Life Cycle Impact Assessment (UNEP/SETAC Life Cycle Initiative Publication)

EPA Science Inventory

The report provides guidance on how to move from current practice to recommended practice in Life Cycle Impact Assessment. It is composed of three complementary parts elaborated in the first task force (TFI) of the LCIA programme, with contribution of the other three task forces:

Image Guidance Technologies for Interventional Pain Procedures: Ultrasound, Fluoroscopy, and CT.

PubMed

Wang, Dajie

2018-01-26

Chronic pain is a common medical condition. Patients who suffer uncontrolled chronic pain may require interventions including spinal injections and various nerve blocks. Interventional procedures have evolved and improved over time since epidural injection was first introduced for low back pain and sciatica in 1901. One of the major contributors in the improvement of these interventions is the advancement of imaging guidance technologies. The utilization of image guidance has dramatically improved the accuracy and safety of these interventions. The first image guidance technology adopted by pain specialists was fluoroscopy. This was followed by CT and ultrasound. Fluoroscopy can be used to visualize bony structures of the spine. It is still the most commonly used guidance technology in spinal injections. In the recent years, ultrasound guidance has been increasingly adopted by interventionists to perform various injections. Because its ability to visualize soft tissue, vessels, and nerves, this guidance technology appears to be a better option than fluoroscopy for interventions including SGB and celiac plexus blocks, when visualization of the vessels may prevent intravascular injection. The current evidence indicates the efficacies of these interventions are similar between ultrasound guidance and fluoroscopy guidance for SGB and celiac plexus blocks. For facet injections and interlaminar epidural steroid injections, it is important to visualize bony structures in order to perform these procedures accurately and safely. It is worth noting that facet joint injections can be done under ultrasound guidance with equivalent efficacy to fluoroscopic guidance. However, obese patients may present challenge for ultrasound guidance due to its poor visualization of deep anatomical structures. Regarding transforaminal epidural steroid injections, there are limited evidence to support that ultrasound guidance technology has equivalent efficacy and less complications comparing

Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens

EPA Pesticide Factsheets

This Supplemental Guidance does not establish any substantive “rules” under the Administrative Procedure Act or any other law and has no binding effect on EPA or any regulated entity, but instead represents a non-binding statement of policy.

Preliminary Marine Safety Risk Assessment, Brandon Road Lock and Dam Invasive Species Control Measures

DTIC Science & Technology

2016-12-01

i Classification | CG-926 RDC | author | audience | month year Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam...No. 4. Title and Subtitle Preliminary Marine Safety Risk Assessment, Brandon Road Lock & Dam Invasive Species Control Measures 5. Report Date...safety due to proposed invasive species control measures located in the vicinity of the Brandon Road Lock and Dam (BRLD) Navigation Project on the

Safety Assessment of Multi Purpose Small Payload Rack(MSPR)

NASA Astrophysics Data System (ADS)

Mizutani, Yoshinobu; Takada, Satomi; Murata, Kosei; Ozawa, Daisaku; Kobayashi, Ryoji; Nakamura, Yasuhiro

2010-09-01

We are reporting summary of preliminary safety assessment for Multi Purpose Small Payload Rack(MSPR), which is one of the micro gravity experiment facilities that are being developed for the 2nd phase JEM utilization(JEM: Japanese Experiment Module) that will be launched on H-II Transfer Vehicle(HTV) 2nd flight in 2011. MSPR is used for multi-purpose micro-g experiment providing experimental spaces and work stations. MSPR has three experimental spaces; first, there is a space called Work Volume(WV) with capacity volume of approximately 350 litters, in which multiple resources including electricity, communication, and moving image functions can be used. Within this space, installation of devices can be done by simple, prompt attachment by Velcro and pins with high degree of flexibility. Second, there is Small Experiment Area(SEA), with capacity volume of approximately 70 litters, in which electricity, communication, and moving image functions can also be used in the same way as WV. These spaces protect experiment devices and specimens from contingent loads by the crewmembers. Third, there is Work Bench with area of 0.5 square meters, on which can be used for maintenance, inspection and data operations of installed devices, etc. This bench can be stored in the rack during contingency. Chamber for Combustion Experiment(CCE) that is planned to be installed in WV is a pressure-resistant experimental container that can be used to seal hazardous materials from combustion experiments. This CCE has double sealing design in chamber itself, which resist gas leakage under normal the temperature and pressure. Electricity, communication, moving image function can be used in the same way as WV. JAXA Phase 2 Safety Review Panel(SRP) has been held in April, 2010. For safety analysis of MSPR, hazards were identified based on Fault Tree Analysis methodology and then these hazards were classified into either eight ISS standard-type hazards or eight unique-type hazards that requires

Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

PubMed

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

2008-12-15

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

International Harmonization of Food Safety Assessment of Pesticide Residues.

PubMed

Ambrus, Árpád

2016-01-13

This paper summarizes the development of principles and methods applied within the program of the FAO/WHO Codex Alimentarius during the past 50 years for the safety assessment of pesticide residues in food and feed and establishing maximum residue limits (MRLs) to promote free international trade and assure the safety of consumers. The role of major international organizations in this process, the FAO capacity building activities, and some problematic areas that require special attention are briefly described.

Use of botanicals in food supplements. Regulatory scope, scientific risk assessment and claim substantiation. 2005.

PubMed

Coppens, P; Delmulle, L; Gulati, O; Richardson, D; Ruthsatz, M; Sievers, H; Sidani, S

2006-01-01

In the European Union, an elaborate legal framework regulates botanical products both under food and medicinal law. The decision as to which legal framework applies to an individual product may differ between the Member States. In the case of botanical food supplements, all food law provisions apply to their manufacturing, composition and marketing, including the new claims legislation. Elements from EU and national law, scientific and other publications are brought together to investigate how to clarify the differentiation between the use of botanicals for medicinal and health-promoting purposes on a scientific basis. Guidance on the safety assessment and quality evaluation of botanicals is proposed in light of the different approaches described in the scientific literature with particular attention to the concept of long-term use as an integral part of safety evaluation. Guidance on claims substantiation is also included, taking into consideration the proposed legislation, the concept of long-term experience and grading of evidence. A model for safety and efficacy assessment of botanical food supplements in the EU is proposed, and should be taken into consideration in the development of legislation and scientific research on botanicals. Copyright 2006 S. Karger AG, Basel.

Food Safety Practices Assessment Tool: An Innovative Way to Test Food Safety Skills among Individuals with Special Needs

ERIC Educational Resources Information Center

Carbone, Elena T.; Scarpati, Stanley E.; Pivarnik, Lori F.

2013-01-01

This article describes an innovative assessment tool designed to evaluate the effectiveness of a food safety skills curriculum for learners receiving special education services. As schools respond to the increased demand for training students with special needs about food safety, the need for effective curricula and tools is also increasing. A…

Unified powered flight guidance

NASA Technical Reports Server (NTRS)

Brand, T. J.; Brown, D. W.; Higgins, J. P.

1973-01-01

A complete revision of the orbiter powered flight guidance scheme is presented. A unified approach to powered flight guidance was taken to accommodate all phases of exo-atmospheric orbiter powered flight, from ascent through deorbit. The guidance scheme was changed from the previous modified version of the Lambert Aim Point Maneuver Mode used in Apollo to one that employs linear tangent guidance concepts. This document replaces the previous ascent phase equation document.

NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines Consortium

PubMed Central

Waugh, Norman; Sharma, Pawana; Sculpher, Mark; Walker, Andrew

2012-01-01

Objectives To compare the timelines and recommendations of the Scottish Medicines Consortium (SMC) and National Institute of Health and Clinical Excellence (NICE), in particular since the single technology assessment (STA) process was introduced in 2005. Design Comparative study of drug appraisals published by NICE and SMC. Setting NICE and SMC. Participants All drugs appraised by SMC and NICE, from establishment of each organisation until August 2010, were included. Data were gathered from published reports on the NICE website, SMC annual reports and European Medicines Agency website. Primary and secondary outcome measures Primary outcome was time from marketing authorisation until publication of first guidance. The final outcome for each drug was documented. Drug appraisals by NICE (before and after the introduction of the STA process) and SMC were compared. Results NICE and SMC appraised 140 drugs, 415 were appraised by SMC alone and 102 by NICE alone. NICE recommended, with or without restriction, 90% of drugs and SMC 80%. SMC published guidance more quickly than NICE (median 7.4 compared with 21.4 months). Overall, the STA process reduced the average time to publication compared with multiple technology assessments (median 16.1 compared with 22.8 months). However, for cancer medications, the STA process took longer than multiple technology assessment (25.2 compared with 20.0 months). Conclusions Proportions of drugs recommended for NHS use by SMC and NICE are similar. SMC publishes guidance more quickly than NICE. The STA process has improved the time to publication but not for cancer drugs. The lengthier time for NICE guidance is partly due to measures to provide transparency and the widespread consultation during the NICE process. PMID:22290398

Highway Safety Program Manual: Volume 2: Motor Vehicle Registration.

ERIC Educational Resources Information Center

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

Volume 2 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) describes the purposes and specific objectives of motor vehicle registration. Federal authority for vehicle registration and general policies regarding vehicle registration systems are outlined.…

Marine safety manual, volume 4 : technical

DOT National Transportation Integrated Search

2005-01-01

A comprehensive manual which provides guidance on the application of Coast Guard regulations and explains the rationale behind their development is vital to the successful execution of the marine safety program. This volume is intended to serve that ...

[Post-marketing drug safety-risk management plan(RMP)].

PubMed

Ezaki, Asami; Hori, Akiko

2013-03-01

The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

NASA Technical Reports Server (NTRS)

Ancel, Ersin; Shih, Ann T.

2014-01-01

NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

Opportunities to Apply the 3Rs in Safety Assessment Programs

PubMed Central

Sewell, Fiona; Edwards, Joanna; Prior, Helen; Robinson, Sally

2016-01-01

Abstract Before a potential new medicine can be administered to humans it is essential that its safety is adequately assessed. Safety assessment in animals forms an integral part of this process, from early drug discovery and initial candidate selection to the program of recommended regulatory tests in animals. The 3Rs (replacement, reduction, and refinement of animals in research) are integrated in the current regulatory requirements and expectations and, in the EU, provide a legal and ethical framework for in vivo research to ensure the scientific objectives are met whilst minimizing animal use and maintaining high animal welfare standards. Though the regulations are designed to uncover potential risks, they are intended to be flexible, so that the most appropriate approach can be taken for an individual product. This article outlines current and future opportunities to apply the 3Rs in safety assessment programs for pharmaceuticals, and the potential (scientific, financial, and ethical) benefits to the industry, across the drug discovery and development process. For example, improvements to, or the development of, novel, early screens (e.g., in vitro, in silico, or nonmammalian screens) designed to identify compounds with undesirable characteristics earlier in development have the potential to reduce late-stage attrition by improving the selection of compounds that require regulatory testing in animals. Opportunities also exist within the current regulatory framework to simultaneously reduce and/or refine animal use and improve scientific outcomes through improvements to technical procedures and/or adjustments to study designs. It is important that approaches to safety assessment are continuously reviewed and challenged to ensure they are science-driven and predictive of relevant effects in humans. PMID:28053076

Assessment of patient safety culture in Palestinian public hospitals.

PubMed

Hamdan, Motasem; Saleem, Abed Alra'oof

2013-04-01

To assess the prevalent patient safety culture in Palestinian public hospitals. A cross-sectional design, Arabic translated version of the Hospital Survey on Patient Safety Culture was used. All the 11 general public hospitals in the West Bank. A total of 1460 clinical and non-clinical hospital staff. No. Twelve patient safety culture composites and 2 outcome variables (patient safety grade and events reported in the past year) were measured. Most of the participants were nurses and physicians (69.2%) with direct contact with patients (92%), mainly employed in medical/surgical units (55.1%). The patient safety composites with the highest positive scores were teamwork within units (71%), organizational learning and continuous improvement (62%) and supervisor/manager expectations and actions promoting patient safety (56%). The composites with the lowest scores were non-punitive response to error (17%), frequency of events reported (35%), communication openness (36%), hospital management support for patient safety (37%) and staffing (38%). Although 53.2% of the respondents did not report any event in the past year, 63.5% rated patient safety level as 'excellent/very good'. Significant differences in patient safety scores and outcome variables were found between hospitals of different size and in relation to staff positions and work hours. This study highlights the existence of a punitive and blame culture, under-reporting of events, lack of communication openness and inadequate management support that are key challenges for patient safe hospital care. The baseline survey results are valuable for designing and implementing the patient safety program and for measuring future progress.

International Conference on Harmonisation; Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers; availability. Notice.

PubMed

2012-02-21

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E7 Studies in Support of Special Populations: Geriatrics; Questions and Answers.'' 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 questions and answers (Q&A) guidance addresses special considerations for the design and conduct of clinical trials of drugs likely to have significant use in the elderly. The Q&As are intended to provide guidance on the use of geriatric data to adequately characterize and represent the safety and efficacy of a drug for a marketing application, including data collected postmarketing.

Highway Safety Program Manual: Volume 12: Highway Design, Construction and Maintenance.

ERIC Educational Resources Information Center

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

Volume 12 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) focuses on highway design, construction and maintenance. The purpose and specific objectives of such a program are described. Federal authority in the area of highway safety and policies regarding…

Simulating Geriatric Home Safety Assessments in a Three-Dimensional Virtual World

ERIC Educational Resources Information Center

Andrade, Allen D.; Cifuentes, Pedro; Mintzer, Michael J.; Roos, Bernard A.; Anam, Ramanakumar; Ruiz, Jorge G.

2012-01-01

Virtual worlds could offer inexpensive and safe three-dimensional environments in which medical trainees can learn to identify home safety hazards. Our aim was to evaluate the feasibility, usability, and acceptability of virtual worlds for geriatric home safety assessments and to correlate performance efficiency in hazard identification with…

The in-depth safety assessment (ISA) pilot projects in Ukraine.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kot, C. A.

1998-02-10

Ukraine operates pressurized water reactors of the Soviet-designed type, VVER. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs). After approval of the SARS by the Ukrainian Nuclear Regulatory Authority, the plants will be granted longer-term operating licenses. In September 1995, the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine issued a new contents requirement for the safety analysis reports of VVERs in Ukraine. It contains requirements in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. Themore » DBA requirements are an expanded version of the older SAR requirements. The last two requirements, on PRA and BDBA, are new. The US Department of Energy (USDOE), through the International Nuclear Safety Program (INSP), has initiated an assistance and technology transfer program to Ukraine to assist their nuclear power stations in developing a Western-type technical basis for the new SARS. USDOE sponsored In-Depth Safety Assessments (ISAs) have been initiated at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1. USDOE/INSP have structured the ISA program in such a way as to provide maximum assistance and technology transfer to Ukraine while encouraging and supporting the Ukrainian plants to take the responsibility and initiative and to perform the required assessments.« less

Portable Nanoparticle-Based Sensors for Food Safety Assessment

PubMed Central

Bülbül, Gonca; Hayat, Akhtar; Andreescu, Silvana

2015-01-01

The use of nanotechnology-derived products in the development of sensors and analytical measurement methodologies has increased significantly over the past decade. Nano-based sensing approaches include the use of nanoparticles (NPs) and nanostructures to enhance sensitivity and selectivity, design new detection schemes, improve sample preparation and increase portability. This review summarizes recent advancements in the design and development of NP-based sensors for assessing food safety. The most common types of NPs used to fabricate sensors for detection of food contaminants are discussed. Selected examples of NP-based detection schemes with colorimetric and electrochemical detection are provided with focus on sensors for the detection of chemical and biological contaminants including pesticides, heavy metals, bacterial pathogens and natural toxins. Current trends in the development of low-cost portable NP-based technology for rapid assessment of food safety as well as challenges for practical implementation and future research directions are discussed. PMID:26690169

Planning the Unplanned Experiment: Assessing the Efficacy of Standards for Safety Critical Software

NASA Technical Reports Server (NTRS)

Graydon, Patrick J.; Holloway, C. Michael

2015-01-01

We need well-founded means of determining whether software is t for use in safety-critical applications. While software in industries such as aviation has an excellent safety record, the fact that software aws have contributed to deaths illustrates the need for justi ably high con dence in software. It is often argued that software is t for safety-critical use because it conforms to a standard for software in safety-critical systems. But little is known about whether such standards `work.' Reliance upon a standard without knowing whether it works is an experiment; without collecting data to assess the standard, this experiment is unplanned. This paper reports on a workshop intended to explore how standards could practicably be assessed. Planning the Unplanned Experiment: Assessing the Ecacy of Standards for Safety Critical Software (AESSCS) was held on 13 May 2014 in conjunction with the European Dependable Computing Conference (EDCC). We summarize and elaborate on the workshop's discussion of the topic, including both the presented positions and the dialogue that ensued.

Making the message meaningful: a qualitative assessment of media promoting all-terrain vehicle safety.

PubMed

Brann, Maria; Mullins, Samantha Hope; Miller, Beverly K; Eoff, Shane; Graham, James; Aitken, Mary E

2012-08-01

Millions of all-terrain vehicles (ATV) are used around the world for recreation by both adults and youth. This increase in use has led to a substantial increase in the number of injuries and fatalities each year. Effective strategies for reducing this incidence are clearly needed; however, minimal research exists regarding effective educational interventions. This study was designed to assess rural ATV riders' preferences for and assessment of safety messages. 13 focus group discussions with youth and adult ATV riders were conducted. 88 formative research participants provided feedback on existing ATV safety materials, which was used to develop more useful ATV safety messages. 60 evaluative focus group participants critiqued the materials developed for this project. Existing ATV safety materials have limited effectiveness, in part because they may not address the content or design needs of the target population. ATV riders want educational and action-oriented safety messages that inform youth and adult riders about their responsibilities to learn, educate and implement safety behaviours (eg, appropriate-sized ATV, safety gear, solo riding, speed limits, riding locations). In addition, messages should be clear, realistic, visually appealing and easily accessible. Newly designed ATV safety materials using the acronym TRIPSS (training, ride off-road, impairment, plan ahead, safety gear, single rider) meet ATV riders' safety messaging needs. To reach a target population, it is crucial to include them in the development and assessment of safety messages. Germane to this particular study, ATV riders provided essential information for creating useful ATV safety materials.

Safety and feasibility of breast lesion localization using magnetic seeds (Magseed): a multi-centre, open-label cohort study.

PubMed

Harvey, James R; Lim, Yit; Murphy, John; Howe, Miles; Morris, Julie; Goyal, Amit; Maxwell, Anthony J

2018-06-01

Wire localization has several disadvantages, notably wire migration and difficulty scheduling the procedure close to surgery. Radioactive seed localization overcomes these disadvantages, but implementation is limited due to radiation safety requirements. Magnetic seeds potentially offer the logistical benefits and transcutaneous detection equivalence of a radioactive seed, with easier implementation. This study was designed to evaluate the feasibility and safety of using magnetic seeds for breast lesion localization. A two-centre open-label cohort study to assess the feasibility and safety of magnetic seed (Magseed) localization of breast lesions. Magseeds were placed under radiological guidance into women having total mastectomy surgery. The primary outcome measure was seed migration distance. Secondary outcome measures included accuracy of placement, ease of transcutaneous detection, seed integrity and safety. Twenty-nine Magseeds were placed into the breasts of 28 patients under ultrasound guidance. There was no migration of the seeds between placement and surgery. Twenty-seven seeds were placed directly in the target lesion with the other seeds being 2 and 3 mm away. All seeds were detectable transcutaneously in all breast sizes and at all depths. There were no complications or safety issues. Magnetic seeds are a feasible and safe method of breast lesion localization. They can be accurately placed, demonstrate no migration in this feasibility study and are detectable in all sizes and depths of breast tissue. Now that safety and feasibility have been demonstrated, further clinical studies are required to evaluate the seed's effectiveness in wide local excision surgery.

Guidance and Control Software Project Data - Volume 1: Planning Documents

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J. (Editor)

2008-01-01

The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the planning documents from the GCS project. Volume 1 contains five appendices: A. Plan for Software Aspects of Certification for the Guidance and Control Software Project; B. Software Development Standards for the Guidance and Control Software Project; C. Software Verification Plan for the Guidance and Control Software Project; D. Software Configuration Management Plan for the Guidance and Control Software Project; and E. Software Quality Assurance Activities.

Guidance and Control Software Project Data - Volume 3: Verification Documents

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J. (Editor)

2008-01-01

The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the verification documents from the GCS project. Volume 3 contains four appendices: A. Software Verification Cases and Procedures for the Guidance and Control Software Project; B. Software Verification Results for the Pluto Implementation of the Guidance and Control Software; C. Review Records for the Pluto Implementation of the Guidance and Control Software; and D. Test Results Logs for the Pluto Implementation of the Guidance and Control Software.

78 FR 69433 - Executive Order 13650 Improving Chemical Facility Safety and Security Listening Sessions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

... Chemical Facility Safety and Security Listening Sessions AGENCY: National Protection and Programs... from stakeholders on issues pertaining to Improving Chemical Facility Safety and Security (Executive... regulations, guidance, and policies; and identifying best practices in chemical facility safety and security...

LNG safety assessment evaluation methods : task 3 letter report.

DOT National Transportation Integrated Search

2016-07-01

Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods ...

Interpretation of aged sorption studies for pesticides and their use in European Union regulatory leaching assessments.

PubMed

Beulke, Sabine; van Beinum, Wendy; Suddaby, Laura

2015-04-01

First-tier regulatory exposure assessments for pesticides assume that pesticide sorption is instantaneous and fully reversible. In European Union (EU) regulatory guidance, an increase in sorption over time ("aged sorption") can be considered at the higher tier to refine predicted environmental concentrations in groundwater. Research commissioned by the UK Chemicals Regulation Directorate (CRD), funded by the Department for Environment Food & Rural Affairs (Defra), formed the basis of a draft regulatory guidance document proposing 1) a protocol on how to measure aged sorption of parent compounds in laboratory studies, 2) procedures to fit kinetic models to the experimental data, 3) criteria to test the reliability of the parameters, and 4) procedures for use of the parameters in the groundwater exposure assessment. The draft guidance was revised after feedback from stakeholders and testing of the guidance was performed against real data sets by an independent consultancy. The Chemicals Regulation Directorate submitted the revised document to the European Food Safety Authority (EFSA) for scrutiny. This article gives an overview of the draft guidance and explains the reasoning behind the recommendations made. 2015 Crown Copyright; Published 2015 SETAC.

Academic poster design at a national conference: a need for standardised guidance?

PubMed

Gopal, Alan; Redman, Melody; Cox, David; Foreman, David; Elsey, Elizabeth; Fleming, Simon

2017-10-01

Academic posters are a common means of disseminating information at conferences. Presentation at conferences is frequently given weight in postgraduate training programme recruitment. Some conferences provide guidance for visual presentation of posters. For the Association of the Study of Medical Education (ASME) Annual Scientific Meeting (ASM) 2015, poster abstract guidance was provided; however, the guidance on poster design was limited to size and orientation. The aim of this study was to investigate academic poster quality at a national medical education conference to identify where standards could be promoted and improved. Presentation at conferences is frequently given weight in postgraduate training programme recruitment METHODS: Six auditors assessed all posters displayed at the ASME ASM (15-17 July 2015) using guidelines based upon a modified checklist for academic posters. Ten criteria were agreed as assessment standards for poster design quality. One-hundred-and-eighty posters were assessed: 29 per cent had appropriate copyright for the materials displayed (n = 52); 41 per cent included suitable contact details (n = 73); 48 per cent (n = 87) had a text to graphic ratio of 50 : 50; 72 per cent (n = 130) met ASME guidance for layout and orientation; 76 per cent (n = 137) had appropriate referencing; 78 per cent showed evidence of proofreading for grammar and spelling (n = 140); 79 per cent (n = 142) were readable at a distance of 2 metres; and 87 per cent used appropriate academic logos (n = 156). There was variability in design quality as assessed by these criteria. We recommend that detailed guidance should be produced and disseminated by the organising conference. This may improve poster quality and aid in the communication of presented material. We aim to re-audit following the production and dissemination of poster presentation guidance. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical

Shuttle entry guidance revisited

NASA Technical Reports Server (NTRS)

Mease, Kenneth D.; Kremer, Jean-Paul

1992-01-01

The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

Highway Safety Program Manual: Volume 16: Debris Hazard Control and Cleanup.

ERIC Educational Resources Information Center

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

Volume 16 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on debris hazard control and cleanup. The purpose and objectives of such a program are outlined. Federal authority in the area of highway safety and policies regarding a debris control…

Transsphenoidal pituitary resection with intraoperative MR guidance: preliminary results

NASA Astrophysics Data System (ADS)

Pergolizzi, Richard S., Jr.; Schwartz, Richard B.; Hsu, Liangge; Wong, Terence Z.; Black, Peter M.; Martin, Claudia; Jolesz, Ferenc A.

1999-05-01

The use of intraoperative MR image guidance has the potential to improve the precision, extent and safety of transsphenoidal pituitary resections. At Brigham and Women's Hospital, an open-bore configuration 0.5T MR system (SIGNA SP, GE Medical Systems, Milwaukee, WI) has been used to provide image guidance for nine transsphenoidal pituitary adenoma resections. The intraoperative MR system allowed the radiologist to direct the surgeon toward the sella turcica successfully while avoiding the cavernous sinus, optic chiasm and other sensitive structures. Imaging performed during the surgery monitored the extent of resection and allowed for removal of tumor beyond the surgeon's view in five cases. Dynamic MR imaging was used to distinguish residual tumor from normal gland and postoperative changes permitting more precise tumor localization. A heme-sensitive long TE gradient echo sequence was used to evaluate for the presence of hemorrhagic debris. All patients tolerated the procedure well without significant complications.

Aiding Vertical Guidance Understanding

NASA Technical Reports Server (NTRS)

Feary, Michael; McCrobie, Daniel; Alkin, Martin; Sherry, Lance; Polson, Peter; Palmer, Everett; McQuinn, Noreen

1998-01-01

A two-part study was conducted to evaluate modern flight deck automation and interfaces. In the first part, a survey was performed to validate the existence of automation surprises with current pilots. Results indicated that pilots were often surprised by the behavior of the automation. There were several surprises that were reported more frequently than others. An experimental study was then performed to evaluate (1) the reduction of automation surprises through training specifically for the vertical guidance logic, and (2) a new display that describes the flight guidance in terms of aircraft behaviors instead of control modes. The study was performed in a simulator that was used to run a complete flight with actual airline pilots. Three groups were used to evaluate the guidance display and training. In the training, condition, participants went through a training program for vertical guidance before flying the simulation. In the display condition, participants ran through the same training program and then flew the experimental scenario with the new Guidance-Flight Mode Annunciator (G-FMA). Results showed improved pilot performance when given training specifically for the vertical guidance logic and greater improvements when given the training and the new G-FMA. Using actual behavior of the avionics to design pilot training and FMA is feasible, and when the automated vertical guidance mode of the Flight Management System is engaged, the display of the guidance mode and targets yields improved pilot performance.

The UK's Draft Guidance for Health in SEA in light of HIA community priorities and the UNECE SEA Protocol

DOE Office of Scientific and Technical Information (OSTI.GOV)

Posas, Paula J., E-mail: pjposas@gmail.co

2011-04-15

The Protocol on Strategic Environmental Assessment (SEA) to the United Nations Economic Commission for Europe (UNECE) Espoo Convention came into force on 11 July 2010. This Protocol, to which the European Union is party, gives a legal basis for enhanced attention to human health in the SEA process. In this context, the United Kingdom's (UK's) 2007 Draft Guidance on Health in Strategic Environmental Assessment represents an important early government-led effort to bring health issues and public health considerations more significantly into the SEA process. Since the UK is a worldwide leader in environmental and various other types of impact assessment,more » and since other countries may eventually consider its example in efforts to meet UNECE SEA Protocol requirements, scrutiny of its outputs is warranted. This paper thus examines the UK's Draft Guidance from both HIA academic and practitioner perspectives. First it assesses the extent to which the Draft Guidance reflects recent issues and lessons learned in the academic literature. In order to make the assessment, a meta-analysis of 70 HIA-related peer-reviewed articles was undertaken to extract authors' priority recommendations. These recommendations were subsequently compared with the contents of the Draft Guidance. Secondly, the Draft Guidance was assessed for its accordance with recommendations of the UNECE SEA Protocol background paper written by two HIA practitioners. Overall, the Draft Guidance's accordance with both sets of recommendations was found to be high, with only a few easily-remedied gaps. This evaluation suggests that the UK's Draft Guidance can be a useful starting point in the creation of future guidance on health in SEA in both the UK and other countries.« less

Assessing medical students' perceptions of patient safety: the medical student safety attitudes and professionalism survey.

PubMed

Liao, Joshua M; Etchegaray, Jason M; Williams, S Tyler; Berger, David H; Bell, Sigall K; Thomas, Eric J

2014-02-01

To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations. In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations (r = 0.37-0.69, P < .05) and at least one safety behavioral intent item. This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.

Guidance and Control Software Project Data - Volume 2: Development Documents

NASA Technical Reports Server (NTRS)

Hayhurst, Kelly J. (Editor)

2008-01-01

The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the development documents from the GCS project. Volume 2 contains three appendices: A. Guidance and Control Software Development Specification; B. Design Description for the Pluto Implementation of the Guidance and Control Software; and C. Source Code for the Pluto Implementation of the Guidance and Control Software

Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: an empirical assessment.

PubMed

Hammad, Tarek A; Neyarapally, George A; Pinheiro, Simone P; Iyasu, Solomon; Rochester, George; Dal Pan, Gerald

2013-01-01

Due to the sparse nature of serious drug-related adverse events (AEs), meta-analyses combining data from several randomized controlled trials (RCTs) to evaluate drug safety issues are increasingly being conducted and published, influencing clinical and regulatory decision making. Evaluation of meta-analyses involves the assessment of both the individual constituent trials and the approaches used to combine them. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting framework is designed to enhance the reporting of systematic reviews and meta-analyses. However, PRISMA may not cover all critical elements useful in the evaluation of meta-analyses with a focus on drug safety particularly in the regulatory-public health setting. This work was conducted to (1) evaluate the adherence of a sample of published drug safety-focused meta-analyses to the PRISMA reporting framework, (2) identify gaps in this framework based on key aspects pertinent to drug safety, and (3) stimulate the development and validation of a more comprehensive reporting tool that incorporates elements unique to drug safety evaluation. We selected a sample of meta-analyses of RCTs based on review of abstracts from high-impact journals as well as top medical specialty journals between 2009 and 2011. We developed a preliminary reporting framework based on PRISMA with specific additional reporting elements critical for the evaluation of drug safety meta-analyses of RCTs. The reporting of pertinent elements in each meta-analysis was reviewed independently by two authors; discrepancies in the independent evaluations were resolved through discussions between the two authors. A total of 27 meta-analyses, 12 from highest impact journals, 13 from specialty medical journals, and 2 from Cochrane reviews, were identified and evaluated. The great majority (>85%) of PRISMA elements were addressed in more than half of the meta-analyses reviewed. However, the majority of meta

Highway Safety Program Manual: Volume 11: Emergency Medical Services.

ERIC Educational Resources Information Center

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

Volume 11 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on emergency medical services. The purpose of the program, Federal authority in the area of medical services, and policies related to an emergency medical services (EMS) program are…

Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

PubMed

Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

2013-09-01

The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

A Practical Risk Assessment Methodology for Safety-Critical Train Control Systems

DOT National Transportation Integrated Search

2009-07-01

This project proposes a Practical Risk Assessment Methodology (PRAM) for analyzing railroad accident data and assessing the risk and benefit of safety-critical train control systems. This report documents in simple steps the algorithms and data input...

Safety assessment of foods from genetically modified crops in countries with developing economies.

PubMed

Delaney, Bryan

2015-12-01

Population growth particularly in countries with developing economies will result in a need to increase food production by 70% by the year 2050. Biotechnology has been utilized to produce genetically modified (GM) crops for insect and weed control with benefits including increased crop yield and will also be used in emerging countries. A multicomponent safety assessment paradigm has been applied to individual GM crops to determine whether they as safe as foods from non-GM crops. This paper reviews methods to assess the safety of foods from GM crops for safe consumption from the first generation of GM crops. The methods can readily be applied to new products developed within country and this paper will emphasize the concept of data portability; that safety data produced in one geographic location is suitable for safety assessment regardless of where it is utilized. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Use of evidential reasoning and AHP to assess regional industrial safety.

PubMed

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Yang, Zaili; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China's fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others.

Survey of EPA and Other Federal Agency Scientific Data Management Policies and Guidance, 2009

EPA Science Inventory

The purpose of this study is to compile and assess internal Environmental Protection Agency (EPA) scientific data management (SDM) policies and guidance. Additionally, this study examines SDM policies and guidance from other Federal Agencies engaged in science and technology, an...

Safety assessment in the urban park environment in Alborz Province, Iran.

PubMed

Oostakhan, Morteza; Babaei, Aliakbar

2013-01-01

Urban parks, as one of the recreational and sports sectors, could cause serious injuries among different ages if the safety issues in their design are not considered. These injuries can result from the equipment in the park, including play and sports equipment, or even from environmental factors, too. Lack of safety benchmark in parks will impact on the development of future proposals. In this article, attempts are made to survey the important safety factors in the urban parks including playgrounds, fitness equipment, pedestrian surface and environmental factors into a risk assessment. Hence, a checklist of safety factors was used. A Yes or No descriptor was allocated to any factor for determining safety level. The study also suggests recommendations for future planning concerning existing failures for designers. It was found that the safety level of the regional and local parks differ from each other.

Food and Feed Safety Assessment: The Importance of Proper Sampling.

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-03-24

The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial role of sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as test materials for hazard identification, toxicological and nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compounds of concern for humans and animals. The importance of representative sampling is emphasized through examples of risk analyses in different areas of foods/feed production. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved in the field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS must be integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decision making process.

Food and feed safety assessment: the importance of proper sampling.

PubMed

Kuiper, Harry A; Paoletti, Claudia

2015-01-01

The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial role of sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as test materials for hazard identification, toxicological and nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compounds of concern for humans and animals. The importance of representative sampling is emphasized through examples of risk analyses in different areas of foods/feed production. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved in the field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS must be integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decision making process.

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

PubMed Central

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

Vocational Guidance Books' Assessment of the Social Responsibility of the Press.

ERIC Educational Resources Information Center

Steiner, Linda

As literature designed specifically to help young adults make appropriate career decisions, vocational guidance books explain what background, experiences, and personal traits are necessary to succeed in various careers. They are of interest to researchers because of the attitudes they reveal about journalism as a field. A review of 30 journalism…

Development and application of a safety assessment methodology for waste disposals

DOE Office of Scientific and Technical Information (OSTI.GOV)

Little, R.H.; Torres, C.; Schaller, K.H.

1996-12-31

As part of a European Commission funded research programme, QuantiSci (formerly the Environmental Division of Intera Information Technologies) and Instituto de Medio Ambiente of the Centro de Investigaciones Energeticas Medioambientales y Tecnologicas (IMA/CIEMAT) have developed and applied a comprehensive, yet practicable, assessment methodology for post-disposal safety assessment of land-based disposal facilities. This Safety Assessment Comparison (SACO) Methodology employs a systematic approach to the collection, evaluation and use of waste and disposal system data. It can be used to assess engineered barrier performance, the attenuating properties of host geological formations, and the long term impacts of a facility on the environmentmore » and human health, as well as allowing the comparison of different disposal options for radioactive, mixed and non-radioactive wastes. This paper describes the development of the methodology and illustrates its use.« less

2011 NASA Range Safety Annual Report

NASA Technical Reports Server (NTRS)

Dumont, Alan G.

2012-01-01

Welcome to the 2011 edition of the NASA Range Safety Annual Report. Funded by NASA Headquarters, this report provides a NASA Range Safety overview for current and potential range users. As is typical with odd year editions, this is an abbreviated Range Safety Annual Report providing updates and links to full articles from the previous year's report. It also provides more complete articles covering new subject areas, summaries of various NASA Range Safety Program activities conducted during the past year, and information on several projects that may have a profound impact on the way business will be done in the future. Specific topics discussed and updated in the 2011 NASA Range Safety Annual Report include a program overview and 2011 highlights; Range Safety Training; Range Safety Policy revision; Independent Assessments; Support to Program Operations at all ranges conducting NASA launch/flight operations; a continuing overview of emerging range safety-related technologies; and status reports from all of the NASA Centers that have Range Safety responsibilities. Every effort has been made to include the most current information available. We recommend this report be used only for guidance and that the validity and accuracy of all articles be verified for updates. Once again the web-based format was used to present the annual report. We continually receive positive feedback on the web-based edition and hope you enjoy this year's product as well. As is the case each year, contributors to this report are too numerous to mention, but we thank individuals from the NASA Centers, the Department of Defense, and civilian organizations for their contributions. In conclusion, it has been a busy and productive year. I'd like to extend a personal Thank You to everyone who contributed to make this year a successful one, and I look forward to working with all of you in the upcoming year.

[Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

PubMed

Niimi, Shingo

2015-01-01

Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

78 FR 19495 - Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

...-based assessment approaches and quality by design principles. These efforts will also be considered part... processes being referenced. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g... on the final version of the guidance and on any other part of the SUPAC guidance series, submit...

Augmented reality-based electrode guidance system for reliable electroencephalography.

PubMed

Song, Chanho; Jeon, Sangseo; Lee, Seongpung; Ha, Ho-Gun; Kim, Jonghyun; Hong, Jaesung

2018-05-24

In longitudinal electroencephalography (EEG) studies, repeatable electrode positioning is essential for reliable EEG assessment. Conventional methods use anatomical landmarks as fiducial locations for the electrode placement. Since the landmarks are manually identified, the EEG assessment is inevitably unreliable because of individual variations among the subjects and the examiners. To overcome this unreliability, an augmented reality (AR) visualization-based electrode guidance system was proposed. The proposed electrode guidance system is based on AR visualization to replace the manual electrode positioning. After scanning and registration of the facial surface of a subject by an RGB-D camera, the AR of the initial electrode positions as reference positions is overlapped with the current electrode positions in real time. Thus, it can guide the position of the subsequently placed electrodes with high repeatability. The experimental results with the phantom show that the repeatability of the electrode positioning was improved compared to that of the conventional 10-20 positioning system. The proposed AR guidance system improves the electrode positioning performance with a cost-effective system, which uses only RGB-D camera. This system can be used as an alternative to the international 10-20 system.

The visibility of QSEN competencies in clinical assessment tools in Swedish nurse education.

PubMed

Nygårdh, Annette; Sherwood, Gwen; Sandberg, Therese; Rehn, Jeanette; Knutsson, Susanne

2017-12-01

Prospective nurses need specific and sufficient knowledge to be able to provide quality care. The Swedish Society of Nursing has emphasized the importance of the six quality and safety competencies (QSEN), originated in the US, in Swedish nursing education. To investigate the visibility of the QSEN competencies in the assessment tools used in clinical practice METHOD: A quantitative descriptive method was used to analyze assessment tools from 23 universities. Teamwork and collaboration was the most visible competency. Patient-centered care was visible to a large degree but was not referred to by name. Informatics was the least visible, a notable concern since all nurses should be competent in informatics to provide quality and safety in care. These results provide guidance as academic and clinical programs around the world implement assessment of how well nurses have developed these essential quality and safety competencies. Copyright © 2017 Elsevier Ltd. All rights reserved.

Biomarkers: Dynamic "Tools" for Health and Safety Risk Assessment

EPA Science Inventory

Today informational flow from biomarkers contributes importantly to various types of health effects research, risk assessment and risk management decisions that impact, or have the potential to impact, public health and safety. Therefore, dependent upon the nature of the health r...

t4 report*: Toward Good Read-Across Practice (GRAP) Guidance

PubMed Central

Ball, Nicholas; Cronin, Mark T. D.; Shen, Jie; Blackburn, Karen; Booth, Ewan D.; Bouhifd, Mounir; Donley, Elizabeth; Egnash, Laura; Hastings, Charles; Juberg, Daland R.; Kleensang, Andre; Kleinstreuer, Nicole; Kroese, E. Dinant; Lee, Adam C.; Luechtefeld, Thomas; Maertens, Alexandra; Marty, Sue; Naciff, Jorge M.; Palmer, Jessica; Pamies, David; Penman, Mike; Richarz, Andrea-Nicole; Russo, Daniel P.; Stuard, Sharon B.; Patlewicz, Grace; van Ravenzwaay, Bennard; Wu, Shengde; Zhu, Hao; Hartung, Thomas

2017-01-01

Summary Grouping of substances and utilizing read-across of data within those groups represents an important data gap filling technique for chemical safety assessments. Categories/analogue groups are typically developed based on structural similarity and, increasingly often, also on mechanistic (biological) similarity. While read-across can play a key role in complying with legislation such as the European REACH regulation, the lack of consensus regarding the extent and type of evidence necessary to support it often hampers its successful application and acceptance by regulatory authorities. Despite a potentially broad user community, expertise is still concentrated across a handful of organizations and individuals. In order to facilitate the effective use of read-across, this document presents the state of the art, summarizes insights learned from reviewing ECHA published decisions regarding the relative successes/pitfalls surrounding read-across under REACH, and compiles the relevant activities and guidance documents. Special emphasis is given to the available existing tools and approaches, an analysis of ECHA's published final decisions associated with all levels of compliance checks and testing proposals, the consideration and expression of uncertainty, the use of biological support data, and the impact of the ECHA Read-Across Assessment Framework (RAAF) published in 2015. PMID:26863606

77 FR 45297 - Children's Toys and Child Care Articles Containing Phthalates; Proposed Guidance on Inaccessible...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1199 [Docket No. CPSC-2012-0040] Children's Toys... containing phthalates does not apply to any component part of children's toys or child care articles that is... guidance on inaccessible component parts in children's toys or child care articles subject to section 108...

Assessment of a personalized and distributed patient guidance system.

PubMed

Peleg, Mor; Shahar, Yuval; Quaglini, Silvana; Broens, Tom; Budasu, Roxana; Fung, Nick; Fux, Adi; García-Sáez, Gema; Goldstein, Ayelet; González-Ferrer, Arturo; Hermens, Hermie; Hernando, M Elena; Jones, Val; Klebanov, Guy; Klimov, Denis; Knoppel, Daniel; Larburu, Nekane; Marcos, Carlos; Martínez-Sarriegui, Iñaki; Napolitano, Carlo; Pallàs, Àngels; Palomares, Angel; Parimbelli, Enea; Pons, Belén; Rigla, Mercedes; Sacchi, Lucia; Shalom, Erez; Soffer, Pnina; van Schooten, Boris

2017-05-01

' compliance to CIG recommendations and their satisfaction and quality of life. Our evaluation has demonstrated the system's capability for supporting distributed decision-making and its use by patients and clinicians. The results show that compliance of GDM patients to the most important monitoring targets - blood glucose levels (performance of four measurements a day: 0.87±0.11; measurement according to the recommended frequency of every day or twice a week: 0.99±0.03), ketonuria (0.98±0.03), and blood pressure (0.82±0.24) - was high in most GDM patients, while compliance of AF patients to the most important targets was quite high, considering the required ECG measurements (0.65±0.28) and blood-pressure measurements (0.75±1.33). This outcome was viewed by the clinicians as a major potential benefit of the system, and the patients have demonstrated that they are capable of self-monitoring - something that they had not experienced before. In addition, the system caused the clinicians managing the AF patients to change their diagnosis and subsequent treatment for two of the ten AF patients, and caused the clinicians managing the GDM patients to start insulin therapy earlier in two of the 19 patients, based on system's recommendations. Based on the end-of-study questionnaires, the sense of safety that the system has provided to the patients was its greatest asset. Analysis of the patients' quality of life (QoL) questionnaires for the AF patients was inconclusive, because while most patients reported an improvement in their quality of life in the EuroQoL questionnaire, most AF patients reported a deterioration in the AFEQT questionnaire. Feasibility and some of the potential benefits of an evidence-based distributed patient-guidance system were demonstrated in both clinical domains. The potential application of MobiGuide to other medical domains is supported by its standards-based patient health record with multiple electronic medical record linking capabilities, generic

Analysis of Regulatory Guidance for Health Monitoring

NASA Technical Reports Server (NTRS)

Munns, Thomas E.; Beard, Richard E.; Culp, Aubrey M.; Murphy, Dennis A.; Kent, Renee M.; Cooper, Eric G. (Technical Monitor)

2000-01-01

The purpose of this study was to assess the connection between current FAA regulations and the incorporation of Health Management (HM) systems into commercial aircraft. To address the overall objectives ARINC: (1) investigated FAA regulatory guidance, (2) investigated airline maintenance practices, (3) systematically identified regulations and practices that would be affected or could act as barriers to the introduction of HM technology, and (4) assessed regulatory and operational tradeoffs that should be considered for implementation. The assessment procedure was validated on a postulated structural HM capability for the B757 horizontal stabilizer.

Safety Assessment for a Surface Repository in the Chernobyl Exclusion Zone - Methodology for Assessing Disposal under Intervention Conditions - 13476

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haverkamp, B.; Krone, J.; Shybetskyi, I.

The Radioactive Waste Disposal Facility (RWDF) Buryakovka was constructed in 1986 as part of the intervention measures after the accident at Chernobyl NPP (ChNPP). Today, RWDF Buryakovka is still being operated but its maximum capacity is nearly reached. Plans for enlargement of the facility exist since more than 10 years but have not been implemented yet. In the framework of an European Commission Project DBE Technology GmbH prepared a safety analysis report of the facility in its current state (SAR) and a preliminary safety analysis report (PSAR) based on the planned enlargement. Due to its history RWDF Buryakovka does notmore » fully comply with today's best international practices and the latest Ukrainian regulations in this area. The most critical aspects are its inventory of long-lived radionuclides, and the non-existent multi-barrier waste confinement system. A significant part of the project was dedicated, therefore, to the development of a methodology for the safety assessment taking into consideration the facility's special situation and to reach an agreement with all stakeholders involved in the later review and approval procedure of the safety analysis reports. Main aspect of the agreed methodology was to analyze the safety, not strictly based on regulatory requirements but on the assessment of the actual situation of the facility including its location within the Exclusion Zone. For both safety analysis reports, SAR and PSAR, the assessment of the long-term safety led to results that were either within regulatory limits or within the limits allowing for a specific situational evaluation by the regulator. (authors)« less

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

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 (Interimmore » 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.« less

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2011 CFR

2011-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2013 CFR

2013-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2010 CFR

2010-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2012 CFR

2012-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

23 CFR 971.212 - Federal lands safety management system (SMS).

Code of Federal Regulations, 2014 CFR

2014-04-01

.... (b) The SMS may be based on the guidance in “Safety Management Systems: Good Practices for Development and Implementation.”3 3 “Safety Management Systems: Good Practices for Development and... various levels of complexity depending on the nature of the facility and/or network involved. (e) The SMS...

Urban transport safety assessment in akure based on corresponding performance indicators

NASA Astrophysics Data System (ADS)

Oye, Adedamola; Aderinlewo, Olufikayo; Croope, Silvana

2013-03-01

The level of safety of the transportation system in Akure, Nigeria was assessed by identifying the associated road safety problems and developing the corresponding safety performance indicators. These indicators were analysed with respect to accidents that occurred within the city from the year 2005 to 2009 based on the corresponding attributable risk measures. The results of the analysis showed the state of existing safety programs in Akure town. Six safety performance indicators were identified namely alcohol and drug use, excessive speeds, protection system (use of seat belts and helmets), use of day time running lights, state of vehicles (passive safety) and road condition. These indicators were used to determine the percentage of injury accidents as follows: 83.33% and 86.36% for years 2005 and 2006 respectively, 81.46% for year 2007 while years 2008 and 2009 had 82.86% and 78.12% injury accidents respectively.

Image guidance improves localization of sonographically occult colorectal liver metastases